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Abrocitinib
Abrocitinib
Abrocitinib
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Abrocitinib
Clinical data
Trade namesCibinqo
Other namesPF-04965842
AHFS/Drugs.comMonograph
MedlinePlusa622008
License data
Pregnancy
category
Routes of
administration		By mouth
Drug classJanus kinase inhibitor
ATC code
Legal status
Legal status
Pharmacokinetic data
Elimination half-life2.8–5.2 h
Excretion1.0–4.4% unchanged in urine
Identifiers
  • N-{cis-3-[(7H-pyrrolo[2,3-d]pyrimidin-4-yl)(methyl)amino]cyclobutyl}propanesulfonamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
ECHA InfoCard100.251.498 Edit this at Wikidata
Chemical and physical data
FormulaC14H21N5O2S
Molar mass323.42 g·mol−1
3D model (JSmol)
  • CCCS(=O)(=O)NC1CC(N(C)c2ncnc3[nH]ccc23)C1
  • InChI=1S/C14H21N5O2S/c1-3-6-22(20,21)18-10-7-11(8-10)19(2)14-12-4-5-15-13(12)16-9-17-14/h4-5,9-11,18H,3,6-8H2,1-2H3,(H,15,16,17)/t10-,11+
  • Key:IUEWXNHSKRWHDY-PHIMTYICSA-N

Abrocitinib, sold under the brand name Cibinqo, is a medication used for the treatment of atopic dermatitis (eczema).[7][8] It is a Janus kinase inhibitor and it was developed by Pfizer.[7][8] It is taken by mouth.[7]

The most common side effects include nausea (feeling sick), headache, acne, herpes simplex (viral infection of the mouth or the genitals), increased levels of creatine phosphokinase in the blood (an enzyme released into the blood when muscle is damaged), vomiting, dizziness and pain in the upper belly.[8]

Abrocitinib was approved for medical use in the European Union in December 2021,[8] and in the United States in January 2022.[9][10]

Medical uses

[edit]

In the EU, abrocitinib is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.[8]

In the US, abrocitinib is indicated for the treatment of people twelve years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.[7]

Efficacy of abrocitinib in treating atopic dermatitis

[edit]

According to the latest meta-analysis in 2023, abrocitinib is both efficient and safe in treating moderate-to-severe AD in adolescents and adults. It also relieves itching rapidly and alleviates symptoms of AD. Abrocitinib gives significantly better results than the placebo at both 100 mg and 200 mg.[11] The severity of AD is quantified through Eczema Area and Severity Index (EASI), which is based on the severity of lesion clinical signs. Abrocitinib was more effective than placebo in terms of EASI-reduction, but it also decreased other symptoms.[11] The improvement of depression and anxiety was better in the experimental group than that in the control group.[12] In another meta-analysis including 2256 patients from three different studies have shown that abrocitinib improved the EASI scores in comparison with dupilumab, even in the second week of treatment. A faster onset of Investigator's Global Assessment (IGA) response at the second week was also achieved by administering abrocitinib and early relief of itching occurred at 2 weeks.[11] In other studies, abrocitinib (200 mg dose) achieved rapid relief from itching after four days of treatment compared with dupilumab and placebo in AD patients.[13]

Side effects

[edit]

The most common adverse effects in studies were upper respiratory tract infection, headache, nausea, and diarrhea.[14]

The most common side effects in clinical trials were nasopharyngitis, nausea, headaches, herpes simplex (including oral herpes, ophthalmic herpes, herpes dermatitis and genital herpes), and increase in blood creatine phosphokinase.[10] Abrocitinib can cause serious infections, malignancy, major cardiac events, thrombosis and other laboratory abnormalities including thrombocytopenia, lymphopenia, and lipid elevations.[10] However, according to clinical data, Abrocitinib is well tolerated. The total adverse reactions were not statistically different between the placebo and the dose of 100 mg of abrocitinib. However, it was slightly higher for the dose of 200 mg of abrocitinib.[12] Symptoms such as acne, headache, and nausea, appeared in the first two weeks of starting abrocitinib, and it was not necessary to interrupt the treatment.[15] In general, the AE frequency of abrocitinib was the same or a little bit higher than in case of placebo or dupilumab.[11][12]

Pharmacology

[edit]

Mechanism of action

[edit]

It is a selective inhibitor of the enzyme janus kinase 1 (JAK1).[14] It inhibits JAK1 by 28 fold of selectivity over JAK2 and more than 340 fold of selectivity over JAK3. Two mechanisms are involved in atopic dermatitis, one involves epidermal barrier disruptions, and the other one is cutaneous inflammation due to the immune system over response. Acute inflammation in AD typically involves IL-13, IL-4, and IL-33.[16] Consequently, inhibiting JAK1 results in suppressing the signaling cytokines IL-4, IL-3, and IL-31. Many other cytokines are involved in AD and mediated by JAK1 such as type II cytokine receptors for IL-22, IL-19, IL-10, IL-20 and glycoprotein 130 (gp130) including IL-6 and IL-12 which are also associated with JAK2 and TYK2; IFN-α and INF-β signal.[16][17]

Pharmacokinetics

[edit]

Abrocitinib is quickly absorbed from the gut and generally reaches highest blood plasma concentrations within one hour. Only 1.0 to 4.4% of the dose are found unmetabolized in the urine.[18] The half-life of abrocitinib is 5 hours and the absorption is not affected by food. A higher dose (400–800 mg) would delay the absorption to 1.5–4 hours. A steady plasma concentration of abrocitinib can be obtained within 48 hours of treatments.[16][17] The dose is one daily, and abrocitinib is metabolized mainly by cytochrome P450 (CYP450) in liver such as CYP2C9, CYP2C19, CYP3A4 and CYP2B6. The major metabolites of abrocitinib are pyrrolidinone pyrimidine (inactive), 2-hydroxypropyl (active), and 3-hydroxypropyl (active).[16][17] Dose reduction to half is advisable when abrocitinib is taken with strong inhibitors of CYP2C19. According to phase 1 clinical trials on abrocitinib oral dose of 200 mg, hepatic functions were not altered. However, it is advisable to reduce the dose by half in case of reduced renal function. In serious hepatic impairment and final stages of renal disease, Abrocitinib is contraindicated.[16] Some changes may occur during the abrocitinib treatment such as the reduction in platelet counts after 4 weeks of starting Abrocitinib. However, they will return to normal at the end of the treatment. An increase in LDL, HDL, and total cholesterol levels was also recorded after 4 weeks of Abrocitinib treatment. The increased levels depend on the abrocitinib dose (15% increase in LDL with 200 mg dose versus 10% increase with 100 mg).[16][17]

History

[edit]
  • April 2016: initiation of Phase 2b trial
  • December 2017: initiation of JADE Mono-1 Phase 3 trial[19]
  • May 2018: Results of Phase 2b trial posted
  • October 2019: Results of Phase 3 trial presented[20]
  • June 2020: Results of second Phase 3 trial published[21]

The US Food and Drug Administration (FDA) approved abrocitinib based on evidence from three controlled clinical trials enrolling a total of 1615 participants supporting efficacy and safety.[10] Two of the trials enrolled participants twelve years of age and older with moderate-to-severe atopic dermatitis and one trial enrolled adults with moderate-to-severe atopic dermatitis.[10] The trials were conducted at multiple sites in 18 countries (i.e., United States, Canada, Australia, Mexico, Chile, Great Britain, Poland, Germany, Bulgaria, Hungary, Czech Republic, Latvia, Slovakia, Spain, Italy, Japan, Korea, Taiwan).[10] In addition, safety analyses were performed on the combined results of these 3 controlled clinical trials and one additional controlled study in a total of 1,540 participants.[10]

All three trials evaluated two doses of abrocitinib: 100 mg and 200 mg. The monotherapy trials were identically designed, 16-week, randomized, multicenter, double-blind, placebo-controlled, parallel group, phase 3 trials.[10] Trial-AD-3 with concomitant background therapy was a 24-week, multicenter, randomized, double-blind, active-comparator (dupilumab) and placebo-controlled, phase 3 trial.[10] In this trial, at Week 16, subjects previously receiving placebo were re-randomized to receive abrocitinib 100 mg or 200 mg, subjects previously receiving abrocitinib continued on their respective dose and subjects previously receiving dupilumab continued to take placebo.[10]

Society and culture

[edit]
[edit]

In October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Cibinqo, intended for the treatment of atopic dermatitis.[22] The applicant for this medicinal product is Pfizer Europe MA EEIG.[22] In December 2021, the European Commission approved abrocitinib for the treatment of atopic dermatitis.[8][23][24]

In January 2022, the US Food and Drug Administration (FDA) approved abrocitinib for adults with moderate-to-severe atopic dermatitis.[25]

Other therapeutic effects of abrocitinib

[edit]

In pediatric peanut allergy

[edit]

Abrocitinib has the ability to decrease T-cell activation and the allergen-specific basophil in the case of peanut allergy. Subsequently, the in vitro allergic responses of peanut allergy are reduced. Abrocitinib may play the role of an immune modulator in oral immunotherapy of peanut or may be administered alone as monotherapy in cases of allergy to certain food.[26]

Therapy of oral lichen planus

[edit]

Oral lichen planus (OLP) is a chronic inflammatory T- cellular disorder that strikes the oral mucosa. In a clinical report in 2022,[27] a fast resolving of OLP was achieved in a patient treated with Abrocitinib. A dose of 200 mg of Abrocitinib was administered daily as monotherapy for twelve weeks. A constant improvement of lesions, a depletion of Wickham striae, and a disappearance of erosions were observed at weeks four and eight of treatment. At week twelve, there was a total recovery of the right buccal mucosa. No adverse events have occurred during the treatment and Abrocitinib was well tolerated by the patient.[27]

Improving the lesions of extensive necrobiosis lipoidica

[edit]

Necrobiosis lipoidica (NL) is chronic granulomatous disease of the skin. It involves shiny patches or plaques with a sclerotic center and inflammatory edge. It may appear on different parts of the body and specially, the front part of the legs. The atrophic scars remain after healing which can be inconvenient for patients. Nevertheless, new lesions may occur.[28] Systemic therapy with abrocitinib was administered at 200 mg/day for 12 weeks and then reduced to 100 mg. A slight stomach ache accompanies the 200 mg dose and no adverse events occurred with the 100 mg dose. An improvement with the old lesions was obvious and no new lesions were observed. The inflammatory edges decreased and the lesions disappeared. Thus, abrocitinib is linked to improving the life quality of the patient.[28]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia

Abrocitinib

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from Grokipedia
Abrocitinib, sold under the brand name CIBINQO, is a selective Janus kinase 1 (JAK1) inhibitor approved for the treatment of refractory, moderate-to-severe in adults and pediatric patients aged 12 years and older whose condition is not adequately controlled with other systemic drug therapies or for whom such therapies are inadvisable. Developed by , it is administered orally as a once-daily tablet in strengths of 50 mg, 100 mg, or 200 mg, with the recommended starting dose being 100 mg, which may be increased to 200 mg after 12 weeks if an adequate response is not achieved. The U.S. (FDA) granted initial approval on January 14, 2022, based on clinical trials demonstrating its efficacy in reducing skin inflammation and itch in patients unresponsive to topical treatments or other systemic options. Abrocitinib functions by reversibly inhibiting JAK1, a key in the Janus kinase-signal transducer and activator of transcription (JAK-STAT) signaling pathway, which is involved in inflammatory responses triggered by cytokines implicated in . This selectivity—approximately 28-fold over JAK2, more than 340-fold over JAK3, and 43-fold over TYK2—allows it to target inflammatory signaling with reduced impact on other JAK family members, potentially minimizing certain side effects associated with broader JAK inhibition. Chemically, abrocitinib is described as N-((1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl)propane-1-sulfonamide, with a molecular formula of C14H21N5O2S and a molecular weight of 323.42 g/mol; it appears as a white to pale yellow powder with low (0.04 mg/mL at 25°C). Use of abrocitinib carries significant safety considerations, including an increased risk of serious infections (such as , herpes zoster, and opportunistic infections), malignancies, (MACE), and , leading to a from the FDA. Use of abrocitinib is not recommended in patients with active serious infections or severe hepatic impairment, or in combination with other potent immunosuppressants such as , cyclosporine, or , and requires screening for and prior to initiation. Dosage adjustments are recommended for patients with moderate renal impairment, severe hepatic impairment (not recommended), or those who are poor metabolizers of the enzyme. Clinical studies supporting approval, including phase 3 trials JADE MONO-I, JADE MONO-II, and JADE COMPARE, showed significant improvements in measures like the Eczema Area and Severity Index (EASI) score and Investigator's Global Assessment (IGA) compared to placebo or .

Medical uses

Indications

Abrocitinib, marketed under the brand name Cibinqo, is indicated for the treatment of refractory moderate-to-severe in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. This approval applies to patients with eczema that has not been sufficiently managed by topical treatments or for whom such therapies are not suitable. In the , abrocitinib is authorized for moderate-to-severe in adults and adolescents 12 years and older who are candidates for . The U.S. Food and Drug Administration expanded the indication to include pediatric patients aged 12 to 17 years in February 2023, based on evidence from clinical trials demonstrating efficacy and safety profiles consistent with those observed in adults. The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for the extension to adolescents 12 years and older in February 2024, with European Commission approval in March 2024. As of 2025, real-world studies have confirmed favorable efficacy and safety in adolescents with moderate-to-severe atopic dermatitis, supporting its expanded use in this population.

Dosing and administration

Abrocitinib is administered orally as a tablet once daily, with or without food, and the tablet must be swallowed whole without crushing, splitting, or chewing. The recommended starting dose for adults and pediatric patients 12 years of age and older who weigh at least 25 kg is 100 mg once daily, with the option to increase to 200 mg once daily after 12 weeks if an adequate response is not achieved; the 100 mg dose is preferred to minimize the risk of adverse events. If no response is observed after 12 weeks at 200 mg, treatment should be discontinued. Dose adjustments are required for moderate renal impairment (eGFR 30-59 mL/min), starting at 50 mg once daily and potentially increasing to 100 mg, while the drug is not recommended for severe renal impairment or end-stage renal disease. Similarly, for patients who are CYP2C19 poor metabolizers, the starting dose is 50 mg once daily, with possible escalation to 100 mg. For adolescents (12 to 17 years), dosing in the aligns with adult recommendations without weight-based distinctions. In the , weight-based dosing is recommended: patients weighing 25 to less than 59 kg should start at 100 mg and escalate to 200 mg only if needed, while those weighing 59 kg or more may initiate at either 100 mg or 200 mg based on clinical judgment. Dose interruption is advised for active serious infections, severe ( less than 500 cells/mm³), or confirmed deep vein thrombosis, , or arterial thrombosis, with resumption at the same or reduced dose once resolved. Prior to initiating abrocitinib, patients should receive age-appropriate vaccinations, including non-live , at least 2 weeks before starting treatment to reduce risks. Monitoring includes a (CBC) at baseline, 4 to 8 weeks after initiation, and 4 to 8 weeks after any dose increase, with ongoing periodic assessments; lipid levels should be evaluated 4 to 8 weeks after starting and periodically thereafter. Liver enzyme tests are recommended at baseline and as clinically indicated. Real-world data from 2025 highlight the use of age-influenced dosing strategies, where patients aged 12 to 17 years were more frequently started on 100 mg compared to 200 mg in adults aged 18 to 64 years, demonstrating favorable tolerability and supporting flexible adjustments in moderate-to-severe management.

Efficacy in atopic dermatitis

Abrocitinib, a selective Janus kinase 1 (JAK1) inhibitor, has demonstrated efficacy in reducing associated with through targeted inhibition of signaling pathways. In the pivotal phase 3 JADE MONO-1 and JADE MONO-2 trials, monotherapy with abrocitinib led to significant improvements in skin clearance among adults and adolescents with moderate-to-severe . At week 12, the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear) with a ≥2-point improvement from baseline was 44% for the 200 mg dose in JADE MONO-1 (versus 8% with ) and 38% in JADE MONO-2 (versus 9% with ). Similarly, ≥75% improvement in Eczema Area and Severity Index (EASI-75) was achieved by 63% of patients on 200 mg in JADE MONO-1 (versus 12% ) and 61% in JADE MONO-2 (versus 10% ), with responses observed as early as week 2 and sustained through week 12. These trials established dose-dependent , with the 200 mg dose showing superior outcomes compared to 100 mg across both co-primary endpoints. Long-term efficacy data from the JADE EXTEND open-label extension study, presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, indicate sustained benefits over up to 4.5 years of treatment in patients rolling over from prior abrocitinib trials. Maintenance of skin clearance was evident, with approximately 50-60% of patients achieving IGA 0/1 at extended time points, alongside continued reductions in disease severity. Improvements in pruritus, measured by the Peak Pruritus Numerical Rating Scale (NRS), were also sustained, with mean reductions of 4-5 points from baseline maintained in long-term responders. Comparative efficacy was evaluated in the phase 3 JADE COMPARE trial, where abrocitinib (100 mg or 200 mg) plus background topical was superior to and showed non-inferiority to in reducing lesion area and severity at week 16. EASI-75 response rates were 71% for 200 mg abrocitinib, 60% for 100 mg, 66% for , and 31% for , with similar patterns for IGA 0/1 (48%, 35%, 39%, and 13%, respectively). Abrocitinib also improved patient-reported outcomes, including sleep quality and , comparable to . Real-world evidence from the 2025 European Academy of Dermatology and Venereology (EADV) Congress highlighted rapid pruritus relief with abrocitinib, with ≥4-point improvement in Peak Pruritus NRS observed within 2-4 weeks in adolescents and adults. High treatment persistence rates exceeding 80% at 12 months were reported in adolescent cohorts, supporting its effectiveness in routine clinical practice.

Contraindications and precautions

Contraindications

Abrocitinib, marketed as Cibinqo, has specific absolute contraindications that prohibit its use to prevent serious harm due to its immunosuppressive effects and pharmacokinetic profile. These restrictions are outlined in regulatory prescribing information and vary slightly by region, with the providing a broader list compared to the U.S. Food and Drug Administration (FDA). Hypersensitivity to abrocitinib or any of its excipients represents a key , as prior allergic reactions could lead to severe or other responses upon re-exposure. This is universally recognized across regulatory bodies to ensure . Active serious systemic infections, such as , active or C, or untreated , are strictly prohibited due to the heightened risk of exacerbating these conditions, potentially leading to disseminated disease or fatal outcomes. Regulatory guidance emphasizes screening and treatment resolution prior to initiation. Severe hepatic impairment, classified as Child-Pugh C , abrocitinib use because systemic exposure to the drug increases substantially (up to fourfold), elevating toxicity risks without established safety data. Dose adjustments are not recommended in this population, rendering therapy inappropriate. In the U.S., an additional applies to concurrent use with antiplatelet therapies (other than low-dose aspirin ≤81 mg daily) during the first three months of treatment, owing to increased bleeding risk from potential . Live vaccines should be avoided during abrocitinib treatment and for at least four weeks prior to initiation or after discontinuation, as the drug's immunomodulatory action may diminish or provoke uncontrolled ; guidelines for inhibitors support this temporal restriction.

Special populations

Abrocitinib is approved for use in pediatric patients aged 12 years and older with refractory, moderate-to-severe . Studies in adolescents have demonstrated and profiles similar to those observed in adults, with significant improvements in disease severity scores such as EASI and IGA by week 12, and low rates of adverse events including mild s or gastrointestinal issues. Close monitoring for signs of is recommended due to the immunosuppressive effects of inhibitors, and growth parameters should be assessed periodically in this population to detect any potential impacts. In elderly patients over 65 years of age, no dosage adjustment is required for abrocitinib, but caution is advised due to an increased risk of and other age-related adverse events such as or laboratory abnormalities. The risk of thromboembolic events may be mitigated by initiating therapy at the lower dose of 100 mg daily. Abrocitinib has not been assigned a traditional , and there are limited human data available as of 2025 regarding its use during . In the , use during is contraindicated; in the , have indicated potential risks of developmental at exposures approximately five times the maximum recommended human dose, suggesting embryofetal harm, and abrocitinib should be avoided during , with effective contraception recommended for women of reproductive potential during treatment and for at least one week after the last dose. In the , breastfeeding is also contraindicated; in the , there are no data on the presence of abrocitinib in human milk, but due to potential risks of serious adverse effects in adults such as infections, , and , breastfeeding is not recommended during treatment and for at least one week after discontinuation. No dosage adjustment is necessary for patients with mild (eGFR 60-89 mL/min) or moderate (Child-Pugh A or B) hepatic impairment, or for mild renal impairment (eGFR 60-89 mL/min). In moderate renal impairment (eGFR 30-59 mL/min), therapy should be initiated at 50 mg once daily, with potential increase to 100 mg if inadequate response after 12 weeks. Abrocitinib is not recommended in severe hepatic impairment (Child-Pugh C) or severe renal impairment (eGFR <30 mL/min), including end-stage renal disease. Lipid parameters should be monitored in all patients approximately 4-12 weeks after initiation of abrocitinib and managed with lipid-lowering therapy if elevations occur. Real-world data from 2025 confirm the tolerability of age-based dosing in adolescents, with 100 mg daily showing favorable efficacy and a low incidence of mild adverse events in a cohort of patients aged 12-17 years, supporting its use with standard monitoring protocols.

Adverse effects

Common side effects

The most common side effects of abrocitinib, reported in placebo-controlled clinical trials involving patients with moderate-to-severe atopic dermatitis, are generally mild and include nasopharyngitis, headache, nausea, and acne. Nasopharyngitis occurred in 8.6% to 12.3% of patients receiving abrocitinib 100 mg or 200 mg daily, compared to 7.9% with placebo. Headache was observed in 5.9% to 7.8% of abrocitinib-treated patients versus 3.5% on placebo. Nausea affected 6.1% to 14.6% of those on abrocitinib, compared to 2.0% with placebo, and was typically mild and transient. Acne developed in 1.6% to 4.7% of patients on the drug, with no cases reported in the placebo group. Gastrointestinal effects beyond nausea are less frequent, with diarrhea reported in approximately 1.6% to 2.7% of abrocitinib recipients versus 2.9% on placebo. Dermatologic issues such as folliculitis occurred in 1.0% to 1.7% of treated patients, compared to 2.0% with placebo. Initial worsening of eczema was noted in 4.1% to 7.4% of abrocitinib patients, lower than the 10.8% seen with placebo. Laboratory abnormalities commonly include dose-related elevations in creatine kinase and lipids. Elevated creatine kinase levels occurred at rates of 6.9 to 12.3 per 100 patient-years in patients on abrocitinib, compared to 7.5 per 100 patient-years on placebo. Increases in total cholesterol (>=20% from baseline) affected 18.2% to 27.5% of treated patients, while (>=20% from baseline) elevations occurred in 15.8% to 23.4%. Mild , defined as decreases, was reported in 1.3% to 2.1% of abrocitinib users. In long-term extension studies with over 4 years of exposure, the overall safety profile remains manageable, with discontinuation rates due to adverse events below 5% in most patient groups. Regular monitoring of laboratory parameters is recommended to detect these effects early.

Serious adverse effects

Abrocitinib carries a for serious s, increased mortality, malignancies, (MACE), and , based on data from patients treated with () inhibitors, including higher rates compared to blockers. Patients should be evaluated for prior to initiation, and treatment discontinued if a serious develops. Serious infections, including bacterial, fungal, viral, and opportunistic types leading to hospitalization or , occur at rates of 1.3 to 3.9 per 100 patient-years across doses in placebo-controlled trials, with zoster reported in 1.9 to 5.1 per 100 patient-years, higher at the 200 mg dose. In long-term data from over 5,200 patient-years of exposure, serious infection incidence remains consistent at 2.2 to 2.7 per 100 patient-years, with zoster at 2.1 to 4.7 per 100 patient-years, elevated in patients aged 65 years or older, those on 200 mg, and Asian residents. Malignancies, including and nonmelanoma (NMSC), show an incidence of 0.3 to 0.5 per 100 patient-years in clinical trials, with long-term rates of 0.1 to 0.3 per 100 patient-years excluding NMSC, and up to 0.9 per 100 patient-years for NMSC in current or former smokers. Risks are higher in smokers and those with prior history. Thrombosis events, such as deep vein thrombosis and , occur at 0.1 to 0.4 per 100 patient-years, more frequently at the 200 mg dose, with venous at 0.1 to 0.2 per 100 patient-years in extended exposure. Incidence of MACE, including cardiovascular death, , and , is low at 0.1 to 0.3 per 100 patient-years but elevated in patients with cardiovascular risk factors and those aged 65 years or older. Hematologic effects include rare thrombocytopenia (less than 1% incidence, or 0.9 per 100 patient-years at 200 mg) and lymphopenia (1.2 per 100 patient-years at 200 mg), with discontinuation recommended if absolute lymphocyte count falls below 500/mm³ or platelets below 50,000/mm³. These events are more common in older patients. Long-term safety data through 2025, encompassing up to four years of exposure in over 3,800 patients, confirm a manageable profile for these serious effects, with no new signals but heightened risks in smokers, those with cardiovascular risk factors, and patients aged 65 years or older, emphasizing dose adjustment in vulnerable groups.

Drug interactions

Interactions with other medications

Abrocitinib is primarily metabolized by enzymes, including (approximately 53%), (30%), and to a lesser extent (11%), making it susceptible to interactions with inhibitors and inducers of these pathways. Strong inhibitors, such as or , significantly increase abrocitinib exposure; for instance, coadministration with results in approximately 4.8-fold higher systemic exposure compared to abrocitinib alone, potentially elevating the risk of adverse reactions. In such cases, the dose of abrocitinib should be reduced to 50 mg once daily, with potential increase to 100 mg after 12 weeks if inadequate response occurs. Moderate to strong inhibitors of both and , like , should be avoided due to substantial increases in exposure of abrocitinib and its active metabolites. Strong inducers of or , such as rifampin, decrease abrocitinib exposure and may reduce its efficacy; coadministration with rifampin lowers abrocitinib's maximum concentration by about 79% and area under the curve by a similar magnitude. Concomitant use of such inducers is not recommended. Strong inhibitors like can also increase abrocitinib levels by inhibiting its , though the effect is less pronounced than with primary CYP pathways; monitoring or dose adjustment may be warranted. Abrocitinib is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic disease-modifying antirheumatic drugs (such as ), or potent including , due to additive immunosuppression that heightens risk; close monitoring for infections is advised if unavoidable. As a (P-gp) inhibitor, abrocitinib can increase exposure to P-gp substrates like , necessitating dosage monitoring or to prevent . Concomitant use with antiplatelet agents, except low-dose aspirin (≤81 mg daily) during the first 3 months of treatment, is contraindicated owing to abrocitinib-induced and heightened risk. For anticoagulants like , the risk of may increase due to , requiring enhanced monitoring of parameters and clinical signs of hemorrhage. Caution is also advised with , as abrocitinib may elevate their plasma levels (e.g., ) via P-gp inhibition, potentially necessitating lipid monitoring or statin dose adjustments, particularly given abrocitinib's association with . As of 2025, no major new drug interactions have been identified in post-marketing surveillance or recent studies, though ongoing vigilance for combinations affecting CYP or P-gp pathways remains essential.

Interactions with or lifestyle factors

Abrocitinib can be administered with or without , as co-administration with a high-fat meal results in no clinically relevant changes to its absorption, with only modest increases in exposure metrics (AUC by approximately 26% and Cmax by 29%) and a slight delay in time to maximum concentration. This dosing flexibility allows patients to take the medication at approximately the same time each day regardless of meals, potentially aiding adherence. Current or past long-time is associated with an elevated risk of (MACE) and venous in patients treated with abrocitinib, a , due to the additive prothrombotic effects of use on vascular health. Patients should be advised to cease to mitigate these risks, particularly if they have additional cardiovascular risk factors. Live attenuated vaccines should be avoided immediately prior to initiation of abrocitinib, during treatment, and shortly after discontinuation to prevent potential disseminated infections from vaccine-derived pathogens in immunocompromised patients. Prior to starting therapy, patients are recommended to complete or update vaccinations with non-live according to current guidelines to ensure adequate protection against preventable diseases. No direct pharmacokinetic or pharmacodynamic interactions between abrocitinib and alcohol have been identified, but given the potential for abrocitinib to cause elevations in liver enzymes, patients consuming alcohol should undergo regular monitoring of hepatic function to detect any additive hepatotoxic effects early. Patients on abrocitinib should limit sun exposure and use broad-spectrum with protective clothing, as the drug increases the risk of non-melanoma skin cancers, and radiation may exacerbate , a common treatment-emergent occurring in up to 5% of users. For prevention, especially in physically active individuals, 2025 guidelines emphasize vigilant practices, such as frequent handwashing and avoiding close contact during outbreaks, alongside prompt reporting of symptoms due to abrocitinib's immunosuppressive effects that heighten susceptibility to opportunistic pathogens.

Pharmacology

Mechanism of action

Abrocitinib is a selective Janus kinase 1 (JAK1) inhibitor that reversibly binds to the (ATP) binding site on the JAK1 enzyme, thereby preventing its activation and subsequent of signal transducer and activator of transcription (STAT) proteins in the . This inhibition disrupts the downstream signaling of multiple cytokines involved in inflammatory processes, particularly those relevant to immune-mediated diseases like . Abrocitinib demonstrates high selectivity for JAK1, with approximately 28-fold selectivity over JAK2, greater than 340-fold over JAK3, and 43-fold over tyrosine kinase 2 (TYK2) in cell-free enzymatic assays. This JAK1-specific profile is designed to target inflammatory pathways while minimizing off-target effects associated with broader JAK inhibition, such as those mediated by JAK2, which plays a key role in hematopoiesis and can lead to dose-limiting hematologic toxicities like or in pan-JAK inhibitors. By blocking JAK1, abrocitinib reduces signaling from pro-inflammatory cytokines, including interleukin-4 (IL-4), IL-13, and IL-31, which are central to type 2 (Th2) helper T-cell driven characteristic of . These cytokines promote immune cell recruitment, skin barrier dysfunction, and itch sensation, and their inhibition leads to decreased production of inflammatory mediators like (TSLP) and C-C motif chemokine ligand 17 (). At the cellular level, abrocitinib decreases allergen-specific basophil activation and suppresses effector T-cell responses in allergic conditions, thereby attenuating IgE-mediated hypersensitivity and Th2-skewed immune reactions without broadly impairing regulatory T-cell function.

Pharmacodynamics

Abrocitinib exerts its pharmacodynamic effects primarily through selective inhibition of JAK1, leading to downstream suppression of inflammatory signaling in immune cells. At the recommended doses of 100 mg and 200 mg once daily, it demonstrates dose-dependent inhibition of JAK1 activity, with greater suppression at the higher dose correlating to enhanced biomarker reductions. Steady-state pharmacodynamic effects, including maximal pathway inhibition, are achieved by day 7 of continuous dosing. The drug induces dose-dependent reductions in key pro-inflammatory cytokines, including IL-6 and IFN-γ, alongside Th2 markers such as IL-31 and thymus and activation-regulated chemokine (TARC). These changes contribute to decreased IgE production and reduced activity, reflecting broader attenuation of in . Serum levels of high-sensitivity (hsCRP), another marker, also decline in a dose-related manner, with effects reversible upon discontinuation within 4 weeks. Abrocitinib further modulates immune function by suppressing allergen-specific responses, including basophil activation and effector T-cell proliferation in response to allergens like peanut. In terms of lipid metabolism, it is associated with dose-dependent elevations in both high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, maintaining a stable LDL/HDL ratio over treatment.

Pharmacokinetics

Abrocitinib is rapidly absorbed following , with over 91% extent of oral absorption and an absolute of approximately 60%. Peak plasma concentrations are achieved within 1 hour (Tmax ~1 hour), and the are linear and dose-proportional across the therapeutic dose range of 100 to 200 mg once daily. Steady-state plasma concentrations are reached within 48 hours of once-daily dosing. The volume of distribution of abrocitinib is approximately 100 L following intravenous administration. It is moderately bound to plasma proteins, primarily , with approximately 64% binding for the parent drug, 37% for metabolite M1, and 29% for metabolite M2. Abrocitinib and its metabolites distribute into , consistent with its in dermatological conditions. Abrocitinib undergoes extensive hepatic metabolism primarily via enzymes, with contributing approximately 53%, 30%, 11%, and 6% to its clearance. The major circulating metabolites are monohydroxylated forms M1, M2, and M4, with M1 and M2 exhibiting JAK1 inhibitory activity comparable to or less than the parent compound; M4 is inactive. No unchanged accumulation occurs, and there are no other active metabolites of . Elimination of abrocitinib occurs mainly through , with an elimination of 3 to 5 hours. Less than 1% of the dose is excreted unchanged in the , while approximately 85% of the administered dose is recovered in as metabolites (primarily M1, , and M4 via the OAT3 transporter) and about 10% in . Total clearance is primarily metabolic, with no significant biliary of the parent drug. In special populations, abrocitinib pharmacokinetics show no clinically meaningful differences based on age, including in adolescents aged 12 years and older, where exposure is similar to that in adults. In patients with renal impairment, exposure to abrocitinib and active metabolites increases; moderate impairment (eGFR 30-59 mL/min/1.73 m²) results in approximately 1.8-fold higher AUC, while severe impairment (eGFR 15-29 mL/min/1.73 m²) leads to about 2.3-fold increase. Use is not recommended in end-stage renal disease (eGFR <15 mL/min/1.73 m²). Hepatic impairment also elevates exposure: moderate (Child-Pugh B) increases AUC by 1.7-fold, and severe (Child-Pugh C) by 3.6-fold; use is contraindicated in severe hepatic impairment. Poor metabolizers of CYP2C19 exhibit approximately 2.7-fold higher exposure compared to normal metabolizers. Dosage adjustments are required for moderate renal or hepatic impairment and CYP2C19 poor metabolizers.

Chemistry

Chemical structure and properties

Abrocitinib has the IUPAC name N-{cis-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]cyclobutyl}propane-1-sulfonamide and the molecular formula C14H21N5O2S, with a molecular weight of 323.42 g/mol. The chemical structure consists of a 7H-pyrrolo[2,3-d]pyrimidine core linked via a methylamino group to a cyclobutyl ring in cis configuration, with the cyclobutyl further substituted by a propane-1-sulfonamide at the 3-position. The cis-cyclobutyl linker and sulfonamide moiety enable preferential binding to the ATP site of JAK1 over other isoforms, as determined by X-ray crystallography of the inhibitor bound to JAK1 and JAK2. Abrocitinib is a white to pale yellow solid powder. It shows low aqueous solubility of 0.04 mg/mL at 25°C and pH-dependent behavior, but good solubility in DMSO (>10 mg/mL) and moderate solubility in . The compound has a logP value of 1.7, reflecting moderate suitable for oral absorption. Abrocitinib has a pKa of 5.3 and a of approximately 189°C. Abrocitinib demonstrates at under dry conditions, with no significant degradation observed over extended storage periods in sealed containers. This stability supports its as an oral tablet, while the low water contributes to its pharmacokinetic profile by influencing dissolution and .

Synthesis and formulation

Abrocitinib is synthesized through a multi-step process starting from 4-chloro-7H-pyrrolo[2,3-d], involving with (1s,3s)-3-aminocyclobutan-1-ol to attach the cyclobutyl moiety, conversion of the hydroxyl group to a , displacement with to form the N-methylamino linkage, and final sulfonylation with propane-1-sulfonyl to introduce the propane-1-sulfonamide group. This route ensures stereoselective construction of the cis-(1s,3s)-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclobutyl group as a , with overall control of impurities and yield optimization suitable for commercial scale. The (API) is produced as the Form 1 polymorph of the cis isomer with relative configuration (1s,3s), featuring two stereocenters, confirmed stable under manufacturing conditions. The commercial manufacturing process for abrocitinib API consists of a five-step synthesis with three covalent bond-forming steps, conducted under (GMP) at facilities such as Ireland Pharmaceuticals in , . Starting materials are redefined for efficiency, and the process includes purification to meet impurity specifications per ICH Q3A guidelines. No significant changes to the core synthesis route have been reported as of 2025, though production capacity has been scaled to support expanded indications, including ongoing evaluations for younger pediatric populations. Abrocitinib is formulated as immediate-release, film-coated tablets available in 50 mg, 100 mg, and 200 mg strengths, designed for once-daily . The tablet core comprises the blended with excipients including (as diluent), anhydrous dibasic (filler), sodium starch glycolate (disintegrant), and (lubricant), enabling direct compression via Pfizer's continuous manufacturing platform. The film coating consists of , , lactose monohydrate, , , and red (for the 100 mg and 200 mg tablets), providing protection and color differentiation while maintaining across strengths—confirmed by studies showing two 100 mg tablets equivalent to one 200 mg tablet under conditions. All excipients comply with Ph. Eur. standards, with no novel components; the formulation is free of requirements and supports absorption independent of food. Stability studies under ICH conditions demonstrate robust performance, with the API stable for 24 months at temperatures not exceeding 30°C and insensitive to light. The finished tablets exhibit a of 30 months for 100 mg and 200 mg strengths and 24 months for 50 mg when packaged in PVDC blisters or HDPE bottles, stored below 30°C in their original containers. Minor cosmetic changes, such as coating cracks at elevated , do not impact potency or , ensuring consistent through 2025 production batches.

History

Development and clinical trials

Abrocitinib (PF-04965842), developed by Pfizer, represents the first selective Janus kinase 1 (JAK1) inhibitor designed primarily for treating moderate-to-severe atopic dermatitis (AD). Preclinical studies in the early 2010s focused on its potential to target JAK1-mediated inflammatory signaling pathways implicated in AD pathogenesis. Early clinical evaluation began with a phase 1, first-in-human study initiated in May 2013, which assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers. This trial, completed by late 2013, demonstrated favorable PK/PD profiles and supported advancement to patient studies. Subsequent phase 1 trials, including evaluations in hepatic impairment and drug interactions, further confirmed its safety profile through 2017. Phase 2 development occurred from 2016 to 2018, with a key randomized, double-blind, placebo-controlled trial (NCT02780167) enrolling adults with moderate-to-severe starting in April 2016 and completing primary endpoints in April 2017. This study evaluated doses of 10–200 mg once daily over 12 weeks, showing dose-dependent improvements in clearance and reduction alongside a manageable safety profile, including mild adverse events and transient platelet reductions. Additional phase 2 investigations in 2017–2018 refined dosing and confirmed PK/PD consistency in patients. The phase 3 JADE program, comprising multiple pivotal trials, was initiated in December 2017 to assess efficacy and safety in adolescents and adults. Key monotherapy studies (JADE MONO-1 and JADE MONO-2) enrolled patients from October 2018 to mid-2019, demonstrating superior skin and symptom improvements with 100 mg and 200 mg doses compared to at week 12. (JADE COMPARE) and long-term extension (JADE EXTEND, NCT03422822, initiated 2018) followed, with top-line results reported in 2019–2020 confirming sustained benefits and safety. A pediatric-focused extension within JADE EXTEND began incorporating data analysis in 2022 for adolescents aged 12–17. Key regulatory milestones included submission of the (NDA) to the FDA in October 2020, granting . The FDA approved abrocitinib for adults with moderate-to-severe AD in January 2022, based on the JADE program data from over 1,600 patients. The (EMA) accepted the Marketing Authorisation Application in October 2020 and granted approval in December 2021 for adults and adolescents aged 12 and older. As of 2025, ongoing long-term extension trials, including JADE EXTEND, continue to evaluate safety and durability of response, with interim analyses through 2024 confirming a consistent profile of infections, headaches, and acne as common adverse events, without new safety signals in up to four years of exposure.

Regulatory approvals

Abrocitinib, marketed as Cibinqo, received initial approval from the U.S. Food and Drug Administration (FDA) on January 14, 2022, for the treatment of adults with refractory, moderate-to-severe atopic dermatitis. In February 2023, the FDA expanded the approval to include adolescents aged 12 to less than 18 years with the same indication, based on supportive data from clinical studies demonstrating efficacy and safety in this population. The prescribing information includes a boxed warning, updated in 2023, highlighting increased risks of serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis associated with Janus kinase inhibitors like abrocitinib. The (EMA) granted marketing authorization for abrocitinib on December 9, 2021, for the treatment of moderate-to-severe in adults and adolescents aged 12 years and older who are candidates for . This approval encompassed both 100 mg and 200 mg doses, with the indication covering patients whose condition is not adequately controlled with topical therapies or for whom topical treatments are inappropriate. In 2025, the EMA extended the approval to include children and adolescents aged 2 years and older, reflecting ongoing pediatric development under the agreed paediatric investigation plan. Abrocitinib was approved in by the (PMDA) in September 2021 for moderate-to-severe in adults and adolescents aged 12 years and older. In , authorized the drug on June 29, 2022, for moderate-to-severe in patients aged 12 years and older. As of November 2025, no withdrawals of approval have occurred in these jurisdictions. Post-marketing commitments for abrocitinib include monitoring through to assess long-term , particularly regarding infections, malignancies, and cardiovascular events, as outlined by regulatory authorities. The FDA requires ongoing studies to evaluate these risks in broader populations, while the EMA's mandates periodic updates and additional data collection on lipid effects and opportunistic infections. No specific Risk Evaluation and Mitigation Strategy (REMS) program is required for abrocitinib .

Society and culture

Brand names and availability

Abrocitinib is marketed under the brand name Cibinqo by in the United States, the , and . In Indonesia, it is available under the brand name Freorla. As of November 2025, no generic versions of abrocitinib are available worldwide, owing to patent exclusivity that extends until at least 2034. The medication is widely available in major markets such as the , EU, and , where it is supplied as film-coated oral tablets in strengths of 50 mg, 100 mg, and 200 mg. Access remains limited in low-income countries, primarily due to high costs and regulatory barriers in those regions. In the United States, the approximate monthly for a standard 100 mg dose is $5,000, though patient assistance programs offered by can help reduce out-of-pocket expenses for eligible individuals. Abrocitinib is classified as a prescription-only in the United States, approved by the (FDA) for the treatment of refractory, moderate-to-severe in adults and pediatric patients aged 12 years and older. It is not a under the (DEA) scheduling system, reflecting its low potential for abuse due to the absence of psychoactive effects or dependency risks associated with its mechanism as a (JAK) inhibitor. While it carries a for serious risks such as infections, malignancies, and cardiovascular events—common to JAK inhibitors—it does not require a specific Risk Evaluation and Mitigation Strategy (REMS) program beyond standard prescribing guidelines. In the , abrocitinib holds centralized marketing authorization from the (EMA), making it available as a prescription across all member states for the treatment of moderate-to-severe in adults and adolescents aged 12 years and older. As of 2025, its legal status remains unchanged, with expanded pediatric access to patients 12 years and older approved without introducing new regulatory restrictions or scheduling classifications. Internationally, abrocitinib is not included on the World Health Organization's Model List of Essential Medicines, as it is not designated for broad essential use in resource-limited settings. However, it is recommended in various international and national guidelines for managing moderate-to-severe in eligible patients.

Investigational uses in allergies

Abrocitinib is under investigation for its role in managing allergic conditions beyond approved indications, particularly through its selective inhibition of JAK1, which disrupts signaling of type 2 cytokines like IL-4 and IL-13 central to allergic . In pediatric peanut allergy, a 2023 ex vivo study using blood and peripheral blood mononuclear cells from affected children showed that abrocitinib dose-dependently reduced peanut-specific activation (measured by expression) and effector + T-cell responses (via upregulation), while preserving regulatory T-cell activation ( expression) and suppressing pro-allergic cytokines such as IL-5, IL-13, and IL-9. These findings indicate potential for abrocitinib as an adjunct to oral or as monotherapy to mitigate reactions. A phase 1/2 pilot (NCT05069831), which was completed, evaluated abrocitinib's monotherapy efficacy and safety in adults with IgE-mediated allergies, focusing on changes in skin prick tests and activation. As of November 2025, no results have been posted, with data anticipated in a forthcoming manuscript. Studies have also observed decreased allergen-specific responses with abrocitinib in other allergy contexts, such as reduced IgE and production in preclinical models. A 2024 review of JAK inhibitors in allergies highlighted JAK1 modulation's promise for desensitization, supported by preclinical and early-phase clinical data showing suppression of and T-cell activation, though no regulatory approvals exist for these applications.

Off-label applications in dermatology

Abrocitinib, a selective Janus kinase 1 (JAK1) inhibitor approved for moderate-to-severe , has been investigated off-label for several immune-mediated due to its and immunomodulatory effects. Emerging case reports and small series suggest potential efficacy in disorders involving pruritus, , and autoimmune mechanisms, though these applications remain investigational and lack large-scale randomized trials. In , abrocitinib has shown promise in repigmentation, with 12 reported cases demonstrating favorable clinical responses, including partial or complete repigmentation in affected areas after 3-6 months of treatment at 100-200 mg daily. Similarly, for , a condition characterized by intensely pruritic nodules often refractory to conventional therapies, abrocitinib led to significant pruritus reduction and lesion clearance in 12 cases, particularly in patients who failed , with improvements noted within 4 weeks. , including chronic and hyperkeratotic variants, benefited from abrocitinib in 12 documented instances, resulting in decreased , scaling, and fissuring, alongside reduced requirements. Lichen sclerosus, a chronic inflammatory disorder affecting genital and extragenital skin, responded positively in 10 cases, with abrocitinib alleviating symptoms such as itching and sclerosis, and promoting resolution in some patients after 8-12 weeks of therapy. , an autoimmune hair loss condition, saw regrowth in 5 pediatric and adult cases, including severe chronic forms, with abrocitinib at 100 mg daily yielding significant coverage improvements over 3-6 months. Other off-label dermatological applications include chronic pruritus of unknown origin (10 cases with pruritus relief), (5 cases showing scaling and erythema reduction), and erythematotelangiectatic or steroid-induced (4 cases each, mostly favorable except one suboptimal response). Case reports also highlight utility in rarer conditions: resolved nearly completely in a 16-year-old after 4 weeks of 100 mg daily combined with cyclosporine; livedoid vasculopathy achieved remission in a 31-year-old after 6 weeks of monotherapy; and cleared lesions in a 17-year-old within 6 weeks alongside . Additional reports note benefits in Netherton syndrome, oral , granulomatous , Hailey-Hailey disease, necrobiosis lipoidica, and , with consistent symptom improvement but limited long-term data. Across 103 reviewed patients from these off-label uses, outcomes were satisfactory in 102 cases, with common doses of 100-200 mg daily and monitoring for adverse events like infections or laboratory abnormalities, underscoring the need for cautious application in non-approved indications.

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