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Maropitant
Maropitant
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Maropitant
Clinical data
Pronunciation/məˈrɒpɪtænt/ mə-ROP-i-tant
Trade namesCerenia, others
Other names(2S,3S)-2-Benzhydryl-N-(5-tert-butyl-2-methoxybenzyl) quinuclidin-3-amine, maropitant citrate (USAN US)
AHFS/Drugs.comInternational Drug Names
License data
Routes of
administration
Oral, subcutaneous, Intravenous transdermal
Drug classAntiemetic
ATCvet code
Legal status
Legal status
Pharmacokinetic data
BioavailabilityOral: 20–30% dogs, 50% cats
SQ: 90% (both)
Protein binding99.5%
MetabolismLiver (CYP3A12 and CYP2D15)
MetabolitesCJ-18,518
Elimination half-life6–8 hours (SQ)
Duration of action24 hours (SQ)
Identifiers
  • (2S,3S)-N-(5-tert-Butyl-2-methoxybenzyl)-2-(diphenylmethyl)-1-azabicyclo[2.2.2]octan-3-amine
CAS Number
PubChem CID
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC32H40N2O
Molar mass468.685 g·mol−1
3D model (JSmol)
  • O=C(O)C(O)(CC(=O)O)CC(=O)O.O.O(c1ccc(cc1CN[C@@H]2[C@@H](N3CCC2CC3)C(c4ccccc4)c5ccccc5)C(C)(C)C)C
  • InChI=1S/C32H40N2O.C6H8O7.H2O/c1-32(2,3)27-15-16-28(35-4)26(21-27)22-33-30-25-17-19-34(20-18-25)31(30)29(23-11-7-5-8-12-23)24-13-9-6-10-14-24;7-3(8)1-6(13,5(11)12)2-4(9)10;/h5-16,21,25,29-31,33H,17-20,22H2,1-4H3;13H,1-2H2,(H,7,8)(H,9,10)(H,11,12);1H2/t30-,31-;;/m0../s1 checkY
  • Key:PGVSXRHFXJOMGW-YBZGWEFGSA-N checkY
  (verify)

Maropitant (INN;[3] brand name: Cerenia, used as maropitant citrate (USAN), is a neurokinin-1 (NK1) receptor antagonist developed by Zoetis specifically for the treatment of motion sickness and vomiting in dogs. It was approved by the FDA in 2007, for use in dogs[4][5] and in 2012, for cats.[6]

Maropitant mildly reduces intra-procedural inhaled anesthesia dose requirements but does not confer analgesia itself.[7][8]

Veterinary uses

[edit]

Injectable maropitant is used in dogs to treat and prevent acute vomiting; tablets are used for preventing vomiting from a variety of causes, though it requires a higher dose to prevent vomiting from motion sickness. The injectable version is also licensed for preventing and treating acute vomiting in cats.[9][5][10][11]

Maropitant is effective in treating vomiting from a variety of causes, including gastroenteritis, chemotherapy, and kidney failure;[12][13] when given beforehand, it can prevent vomiting caused by using an opioid as a premedication.[10][14] Some have claimed that maropitant is better at treating vomiting than nausea, pointing to cats with chronic kidney disease who, when receiving maropitant, had a reduction in vomiting but no corresponding increase in appetite.[6]

Maropitant has been used in acute cases of rapid or labored breathing to prevent vomiting that could lead to aspiration pneumonia.[15] It has been given in combination with a benzodiazepine to cats prior to stressful events (such as a veterinary visit) to possibly relieve hypersensitivity.[16]

When compared to other antiemetics, maropitant has similar or greater effectiveness to chlorpromazine and metoclopramide for centrally mediated vomiting induced by apomorphine or xylazine.[11] It works better than chlorpromazine and metoclopramide for vomiting peripherally induced induced with syrup of ipecac.[17] Unlike dimenhydrinate and acepromazine, which are used for motion sickness, maropitant does not cause sedation.[18]

Maropitant has been used as an adjunct treatment in severe bronchitis due to its weak anti-inflammatory effects.[15] It alleviates visceral pain and has been found to reduce the amount of general anesthesia (both sevoflurane and isoflurane) needed in some operations.[12][19]

Some believe that maropitant can be used in rabbits and guinea pigs to relieve pain caused by ileus (impaired bowel movements), though it lacks antiemetic effects in rabbits, who cannot vomit.[20]

Maropitant is given orally, subcutaneously, and intravenously.[5]

Contraindications

[edit]

Maropitant is only indicated for dogs at least 16 weeks old, as some very young puppies suffered bone marrow hypoplasia (incomplete development ).[5] It should also be used with caution in animals with suspected GI obstruction or toxin ingestion, as it can mask symptoms, thereby delaying the diagnosis.[13][18]

It is not recommended to give maropitant for more than five consecutive days, as it tends to accumulate in the body due to one of the liver enzymes responsible for its metabolism, CYP2D15, becoming saturated. However, there have been studies where beagles who were given maropitant for two weeks in a row showed no signs of toxicity.[18]

Because maropitant is metabolized by the liver, caution should be taken when giving it to dogs with liver dysfunction.[5][12] Caution should also be taken when giving it with other drugs that are also highly protein-bound, such as NSAIDs, anticonvulsants, and some behavior-modifying drugs;[5] such drugs compete with maropitant for binding to plasma proteins, increasing the concentration of unbound maropitant in the blood.[21] Maropitant should also not be used with calcium channel antagonists (used to treat high blood pressure) or in animals with heart disease, as it has a slight affinity for calcium and potassium channels.[22]

Side effects

[edit]

Maropitant is safer than other antiemetics used in veterinary medicine, in part because of its high specificity for its target and thus not binding to other receptors in the central nervous system.[6] Side effects in dogs and cats include hypersalivation, diarrhea, loss of appetite, and vomiting.[12][16] Eight percent of dogs taking maropitant at doses meant to prevent motion sickness vomited right after, likely due to the local effects maropitant had on the gastrointestinal tract. Small amounts of food beforehand can prevent such post-administration vomiting.[11]

One of the most common side effects of subcutaneous administration is moderate to severe pain at the injection site.[10] Although the manufacturer recommends keeping maropitant at room temperature, many people have noted that keeping it in the fridge reduces the sting upon injection. Only unbound maropitant causes pain – it is normally formulated with beta-cyclodextrin to increase solubility; at cooler temperatures, more of the maropitant remains bound to the cyclodextrin, leaving less maropitant unbound.[14][20]

While there is no pain related to the intravenous administration of maropitant, pushing a dose in too quickly can temporarily reduce blood pressure.[10][18]

Fewer than 1 in 10,000 dogs and cats experience anaphylactic reactions.[22]

Overdose

[edit]

Signs of maropitant overdose include lethargy, irregular or labored breathing, lack of muscle coordination, and tremors. Overdose of the oral formulation can cause salivation and nasal discharge, while overdose of intravenous maropitant can sometimes lead to reddish urine.[12] The LD50 is high, being over 2,000 mg/kg for oral maropitant in rats.[23]

Green package and dark brown vial
Packaging of injectable maropitant (Cerenia), as sold by Zoetis

Pharmacology

[edit]

Mechanism of action

[edit]

Vomiting is caused when impulses from the chemoreceptor trigger zone (CRTZ) in the brain are sent to the vomiting center in the medulla. Motion sickness specifically occurs when signals to the CRTZ originate from the inner ear: motion is sensed by the fluid of the semicircular canals, which causes overstimulation. The signal travels to the brain's vestibular nuclei, then to the CRTZ, and finally to the vomiting center.[24]

Maropitant has a similar structure to substance P, the key neurotransmitter in causing vomiting, which allows it to act as an antagonist and bind to the substance P receptor neurokinin 1 (NK1).[5][25] It is highly selective for NK1 over NK2 and NK3.[10][20] Maropitant binds to the neurokinin receptors in the vagus nerves leaving the GI tract, as well as to receptors in the CRTZ and the vomiting center.[17][24] By virtue of working at the last step in triggering vomiting, it can prevent a broader range of stimuli than most antiemetics can.[25] It is effective against emetogens that act at the central nervous system (such as apomorphine in dogs and xylazine in cats), those that act in the periphery (e.g. syrup of ipecac),[14][18] and those that act in both (e.g. cisplatin).[11]

4 boxes
Packaging of oral maropitant

Pharmacokinetics

[edit]

Maropitant's bioavailability is unaffected by the presence of food.[12] Bioavailability is 91% at the standard subcutaneous dose but 24% at the standard oral dose; the standard oral dose is higher to partially compensate for incomplete bioavailability.[5][18] It binds to plasma proteins at a rate of 99.5%; it has a low volume of distribution (9 L/kg) and is thus not extensively absorbed.[5][10] Subcutaneously administered maropitant had peak plasma concentration around half an hour after administration; the mean half-life is 6–8 hours, and a single dose lasts 24 hours in dogs.[10] Orally administered maropitant reached its peak plasma concentration within two hours.[12]

Maropitant undergoes 1st-pass metabolism by liver enzymes, mainly CYP2D15 (which has high affinity for maropitant and clears over 90% of it) but also by the lower-affinity CYP3A12.[11][12] Repeat dosing of maropitant eventually saturates CYP2D15, causing the drug to accumulate due to reduced clearance.[5] Thus, it is recommended to not use maropitant for more than five days straight, and to have a two-day rest period to allow maropitant to clear the body to prevent accumulation.[18][26] Maropitant has over 21 metabolites, though its major one (produced by hydroxylation) is CJ-18,518.[12]

Maropitant clearance is slower in cats.[18]

Society and culture

[edit]
[edit]

In February 2025, the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the veterinary medicinal product Elmaro for cats and dogs.[27] The applicant for this veterinary medicinal product is Elanco GmbH.[27] Elmaro is a generic of Cerenia, which has been authorized in the EU since June 2006.[27]

In April 2025, the CVMP adopted a positive opinion, recommending the granting of a marketing authorization for the veterinary medicinal product Emevet, chewable tablet, intended for dogs.[28] The applicant for this veterinary medicinal product is CP-Pharma Handelsgesellschaft mbH.[28]

References

[edit]
[edit]
Revisions and contributorsEdit on WikipediaRead on Wikipedia
from Grokipedia
Maropitant citrate is a selective neurokinin-1 (NK1) used primarily as an in to prevent and treat in dogs and cats. Developed by (formerly Animal Health), it is marketed under the brand name Cerenia and was first approved by the U.S. (FDA) on January 29, 2007, for use in dogs via subcutaneous injection and oral tablets. By blocking the binding of , an endogenous involved in the emetic reflex, maropitant inhibits signals in the that trigger , providing effective control without significant sedation. In dogs, maropitant is indicated for the prevention and treatment of acute , including that associated with or other emetogenic stimuli, at doses of 2 mg/kg orally or 1 mg/kg subcutaneously, as well as for when administered orally at 8 mg/kg. For cats, an FDA supplemental approval on May 31, 2012, extended its use to the treatment of via subcutaneous injection at 1 mg/kg, offering a targeted option for feline patients where may be challenging. Available in tablet form (16 mg, 24 mg, 60 mg, and 160 mg strengths) and as a 10 mg/mL injectable solution, the drug is generally well-tolerated, though caution is advised in animals with hepatic impairment or gastrointestinal obstruction due to potential prolonged effects. Beyond its primary role, maropitant has shown adjunctive benefits in managing pruritus in cats with allergic and mild effects in dogs by modulating pathways involving NK1 receptors, though these uses are off-label and supported by clinical studies rather than formal FDA indications. As the first FDA-approved veterinary NK1 antagonist, maropitant represents a significant advancement in supportive care for gastrointestinal disorders in companion animals, with generics approved starting in 2023 to improve accessibility.

Uses

In Dogs

Maropitant is indicated in dogs for the prevention and treatment of acute associated with various etiologies, including , chemotherapy-induced emesis, and parvoviral , as well as for the prevention of due to . As a neurokinin-1 (NK1) , it targets the central emetic pathway to control these symptoms. For the prevention and treatment of acute , the recommended dose is 1 mg/kg administered subcutaneously or intravenously once daily for up to 5 consecutive days, with the injection typically given approximately 1 hour prior to an anticipated emetic challenge or as needed for ongoing episodes. at 2 mg/kg once daily is also effective for acute , in dogs 2 months and older, until clinical resolution. Maropitant is available in injectable solution (10 mg/mL) for subcutaneous or intravenous use and in oral tablets of varying strengths (16 mg, 24 mg, 60 mg, 160 mg) to accommodate different body weights. Clinical field studies supporting the 2007 FDA approval demonstrated maropitant's superiority over in controlling emesis, with injectable administration achieving over 90% reduction in episodes in cases of cisplatin-induced (94.9% of treated dogs had no emetic events compared to 4.9% in ) and a 57% overall reduction in general acute cases (21.4% incidence in treated vs. 50% in ). For motion sickness prevention, oral dosing at 8 mg/kg administered 1-2 hours prior to travel, with dogs fasted for 3 hours beforehand, reduced incidence by approximately 86% in controlled trials (e.g., 6.6% vs. 55% ). In addition to primary indications, maropitant serves as an adjunct for preventing opioid-induced during , with studies showing significant reduction in emesis when administered 15-30 minutes prior to opioids like or (e.g., 0% incidence vs. 100% in controls). It also aids in reducing post-operative and in canine patients undergoing . Generic versions of maropitant citrate oral tablets were approved by the FDA in 2023 for use in dogs.

In Cats

Maropitant is indicated for the treatment of vomiting in cats, particularly for preventing and managing acute episodes associated with various underlying conditions such as chronic kidney disease (CKD), chemotherapy-induced nausea, and hairball-related emesis. It also serves as an adjunct therapy for visceral pain relief in conditions like pancreatitis, where its antiemetic properties help alleviate associated discomfort by blocking neurokinin-1 (NK1) receptor signaling that contributes to both emesis and pain perception. The recommended dosing regimen for cats is 1 mg/kg administered subcutaneously (SC) or intravenously (IV) once daily for up to 5 consecutive days, with IV injections given slowly over 1-2 minutes to minimize discomfort. Unlike in dogs, no oral tablet is approved for cats, making administration exclusively injectable due to species-specific pharmacokinetic considerations and requirements. The U.S. (FDA) approved the injectable solution for feline use in 2012 under NADA #141-263, supported by clinical studies demonstrating rapid within approximately 1 hour and a 24-hour duration of effect. To reduce injection-site pain, the refrigerated product is preferred, and cats should be at least 4 months old for safe use. Off-label applications in cats include its use as an in upper respiratory infections, where intranasal administration has shown promise in reducing associated , and in critical care settings to manage persistent . Emerging evidence also supports its role in mitigating stress-related , particularly in hospitalized or anxious felines, by targeting central emetic pathways exacerbated by environmental stressors. Post-2012 clinical studies have established maropitant's , with field trials reporting emesis control in approximately 98% of treated cats compared to 82% in groups over 24 hours across various etiologies. In cats with renal disease, including CKD, randomized controlled trials demonstrated significant reductions in frequency (P < 0.01), aiding nutritional management without notable accumulation at standard doses. These findings highlight its value in feline patients where oral options are unavailable, distinguishing its application from broader canine protocols that emphasize motion sickness prevention.

Safety Profile

Contraindications

Maropitant is not recommended in dogs younger than 16 weeks of age or weighing less than 2.2 kg for the higher dose (8 mg/kg) used in motion sickness prevention, as safety and efficacy have not been established in these populations. In cats, maropitant is not recommended for kittens younger than 16 weeks of age, as safety and efficacy have not been established. Additionally, maropitant should not be used in animals with known hypersensitivity to maropitant, as rare anaphylactic reactions have been reported. Use with caution in cases of known or suspected gastrointestinal obstruction or toxin ingestion in both dogs and cats, as safety has not been evaluated and it may mask clinical signs, delaying diagnosis or appropriate intervention. Use with caution in animals with hepatic dysfunction (mild to severe), given maropitant's metabolism primarily via the liver (CYP3A and CYP2D15 in dogs, CYP1A in cats); accumulation may occur. Dehydrated patients require careful monitoring, as dehydration may exacerbate risks associated with hepatic processing or underlying conditions. Furthermore, caution is recommended in animals with compromised blood-brain barrier integrity, such as those with central nervous system disorders, due to potential enhanced central effects. Maropitant may cause slight prolongation of the QT interval at therapeutic doses, as observed in a 2025 study in healthy dogs (as of June 2025). Regarding drug interactions, maropitant should not be administered concurrently with calcium channel blockers, as it exhibits affinity for calcium channels and may prolong the QT interval, increasing arrhythmia risk. Potential interactions exist with other highly protein-bound drugs, such as phenobarbital, where displacement could enhance effects of either agent; close monitoring is advised. Similarly, combined use with central nervous system depressants may potentiate sedation or lethargy, necessitating dose adjustments. Treatment with maropitant is not recommended beyond 5 consecutive days in dogs or cats, as prolonged use may lead to hepatic accumulation given its elimination pathway. In pregnant or lactating animals, data are limited, with safety not fully established in dogs or cats; use only if the potential benefits outweigh the risks. Rodent studies have shown no teratogenic effects, supporting cautious application in veterinary practice.

Side Effects

In dogs, the most frequently reported side effects of maropitant at therapeutic doses for prevention of acute vomiting (2 mg/kg orally or subcutaneously) include diarrhea (3.9%), anorexia (1.5%), and lethargy (up to 2.6%), based on U.S. field studies involving over 200 dogs. For motion sickness prevention at higher doses (8 mg/kg orally), hypersalivation occurs in approximately 12.5% of dogs, with paradoxical vomiting in 5.3% and muscle tremors in 1%, as observed in U.S. clinical trials. European field studies report slightly higher rates of vomiting (9%) and drowsiness/lethargy (8%) at these doses. Transient pain or soreness at the subcutaneous injection site is also noted in about 4% of cases. Post-approval surveillance in dogs has identified rare adverse events, including anaphylaxis (frequency <1 in 10,000 doses), ataxia, convulsions, and elevated liver enzymes, though exact incidences are not reliably estimable due to voluntary reporting. These effects are often linked to individual hypersensitivity rather than dose-related toxicity at standard levels. In cats, maropitant is administered subcutaneously at 1 mg/kg, and the most common side effect is pain or vocalization upon injection, with moderate reactions in 22.6% and significant reactions in 11.3% of cats in field studies (totaling about 34%). Other effects at therapeutic doses include lethargy/depression (1.5%), anorexia (0.8%), hypersalivation (0.8%), and fever (1.5%), with dehydration reported in 2.3%. Paradoxical vomiting occurs infrequently (<5%), primarily in post-approval data. Rare side effects in cats from post-marketing surveillance encompass ataxia, muscle tremors, panting, recumbency, and dyspnea, with anaphylaxis and elevated liver enzymes also documented at low rates (<1%). Hypersalivation in both species may relate briefly to the drug's NK1 receptor antagonism in central emetic pathways, but it typically resolves without intervention. Most side effects in dogs and cats are mild and self-limiting, resolving within 24 hours post-administration; monitoring during this period is recommended, particularly for injection-site reactions or signs of hypersensitivity. In FDA approval trials, rebound emesis was noted in about 8% of dogs, underscoring the need to address underlying causes of vomiting alongside treatment.

Overdose

Maropitant exhibits low acute toxicity in veterinary species, with an oral LD50 exceeding 2,000 mg/kg in rats, though specific LD50 values for dogs and cats have not been established. In dogs, the drug is well-tolerated at up to three times the recommended oral dose of 2 mg/kg or 8 mg/kg (depending on indication) and for three times the maximum treatment duration, while in cats, safety has been demonstrated at up to five times the recommended subcutaneous or intravenous dose of 1 mg/kg. At 3-5 times therapeutic doses, common symptoms in dogs include ataxia, muscle tremors, lethargy, hypersalivation, vomiting, diarrhea, and decreased appetite; severe overdoses exceeding 20 mg/kg may lead to cardiovascular effects such as bradycardia, ECG abnormalities (e.g., prolonged P-R interval), electrolyte imbalances, and rarely seizures. Similar amplified gastrointestinal and neurological signs, including weakness, excessive drooling, and soft stools, occur in cats at supratherapeutic doses, though data are more limited. There is no specific antidote for maropitant overdose, and treatment focuses on supportive care, including intravenous fluid administration to maintain hydration and electrolyte balance, and monitoring vital signs for at least 72 hours given the drug's plasma half-life of approximately 4-9 hours in dogs and 13-17 hours in cats. For oral overdoses detected within 2 hours, gastric lavage may be considered under veterinary supervision, while anti-convulsants such as diazepam can be used if seizures occur. Veterinary toxicology centers report full recovery in most cases with prompt intervention, even at doses up to 10 times therapeutic levels. Prevention of overdose relies on accurate weight-based dosing, as maropitant tablets are not precisely divisible, and owners should consult veterinarians for any administration errors.

Pharmacology

Mechanism of Action

Maropitant acts as a selective antagonist at neurokinin-1 (NK1) receptors, competitively inhibiting the binding of , a key involved in emetic signaling, in both the central and peripheral nervous systems. By blocking this interaction, maropitant prevents the activation of NK1 receptors that mediate the transmission of emetic signals. This selective antagonism is particularly effective against , the primary endogenous ligand for NK1 receptors, with maropitant demonstrating high affinity for these sites in canine and feline species. At the physiological level, maropitant inhibits the emetic reflex by targeting NK1 receptors in the brainstem's vomiting center and the (CTZ), regions critical for coordinating the vomiting response. It readily crosses the blood-brain barrier, enabling central effects that disrupt neural pathways triggered by both central and peripheral emetogens. Maropitant exhibits high specificity for NK1 receptors, showing minimal activity at NK2 and NK3 receptors, which reduces off-target effects on other tachykinin-mediated pathways. Beyond its role, maropitant has been investigated for potential central effects through NK1 receptor blockade in the , which may help alleviate by interrupting substance P-mediated nociceptive signaling. binding studies confirm maropitant's potent and selective antagonism at NK1 receptors, while models, such as those using to induce emesis in dogs, demonstrate its ability to prevent vomiting by effectively blocking central emetic pathways.

Pharmacokinetics

Maropitant exhibits route-dependent absorption in both dogs and cats, with providing near-complete compared to oral dosing. In dogs, subcutaneous is approximately 91% at 1 mg/kg, while oral ranges from 24% to 37% at 2 mg/kg, primarily limited by extensive first-pass hepatic metabolism. Peak plasma concentrations occur rapidly, typically within 1 hour for intravenous or subcutaneous routes and 2 hours for oral administration in dogs. In cats, oral is higher at around 50%, with subcutaneous also near 90%, and peak levels achieved in 2 to 3 hours after oral dosing. The drug is highly lipophilic, facilitating broad tissue distribution, with a volume of distribution of approximately 4.4 to 7.0 L/kg in dogs and 2.3 L/kg in cats. Maropitant readily penetrates the , supporting its central blockade of neurokinin-1 receptors. Protein binding is extensive at over 99% in both species. Metabolism occurs primarily in the liver via enzymes, producing inactive metabolites with no active forms identified. In dogs, key isoforms include CYP2D15 and CYP3A12, while in cats, CYP1A and CYP3A-related enzymes predominate. Elimination is biphasic, with the terminal averaging 6 to 8 hours in dogs (7.75 hours after subcutaneous dosing) and longer at 13 to 17 hours in cats across routes. Following metabolism, the major metabolite is recovered in (10.4%) and (9.3%), with less than 1% of unchanged drug appearing in or , indicating minimal direct renal or fecal elimination of the parent compound. Species differences include higher oral and prolonged in cats compared to dogs, along with potential accumulation (index of 1.3) after repeated oral dosing beyond 5 days in some feline studies. These profiles are derived from pivotal pharmacokinetic studies conducted between 2007 and 2008, with confirmatory analyses in recent veterinary research up to 2024.

Development and Regulation

History and Approvals

Maropitant, a selective neurokinin-1 (NK1) receptor antagonist, was developed by Animal Health (now ) in the early 2000s as part of research into agents for veterinary use, specifically targeting emesis in companion animals. The compound emerged from efforts to address unmet needs in preventing and treating , with initial focus on dogs experiencing and acute emetic episodes. Development involved extensive preclinical and clinical testing, culminating in pivotal and field studies conducted between 2003 and 2004 that demonstrated its efficacy against induced emesis (e.g., from and ) and naturally occurring from various etiologies, including chemotherapy-induced cases. Pre-approval efforts included multicenter field trials that confirmed maropitant's ability to significantly reduce frequency—such as limiting emetic events to 21.4% in treated dogs versus 50% in controls—while establishing safety for at 1 mg/kg once daily for up to five days. These studies, sponsored by , supported the compound's advancement toward regulatory review, with an emphasis on its broad-spectrum potential beyond alone. By the late 2000s, maropitant's development was firmly established as veterinary-specific. Key regulatory milestones began with (EMA) authorization on September 29, 2006, for use in dogs via oral and injectable formulations to prevent associated with emetogenic stimuli. The U.S. (FDA) followed with approval on January 29, 2007, under NADA 141-263, for both injectable solution and tablets in dogs aged 16 weeks and older, marking the first broad for canine acute and prevention. A supplemental FDA approval on January 11, 2008, extended injectable use to cats aged 16 weeks and older for treating , broadening its application in feline . advancements have since included label expansions, such as intravenous administration approval on January 14, 2016, while ongoing research explores enhanced delivery options like alternative preservatives to improve local tolerance in subcutaneous injections. Maropitant, marketed under the brand name Cerenia by , is classified as a veterinary prescription-only (Rx) medication in the United States, , , and most other countries where it is approved, requiring administration by or under the order of a licensed due to the need for professional oversight in dosing and monitoring. It is not subject to controlled substance scheduling under international or national drug regulations. The original patents for maropitant's expired prior to 2023, paving the way for generic approvals, while certain formulation patents extended into the mid-2020s but did not prevent market entry of equivalents following regulatory demonstrations of . In the United States, the FDA approved the first generic maropitant citrate tablets on March 31, 2023, for the prevention of acute vomiting and in dogs. In the , the Committee for Veterinary Medicinal Products (CVMP) of the (EMA) issued a positive opinion in February 2025 for Elmaro, a generic injectable solution of maropitant citrate monohydrate for subcutaneous or intravenous use in cats and dogs, with full marketing authorization granted on March 28, 2025, under Article 18 of Regulation (EU) 2019/6 as a generic of the reference product Cerenia. Similarly, in April 2025, the EMA authorized Emevet as a generic chewable tablet formulation for dogs, confirming its equivalence to the originator through studies. Maropitant is approved for veterinary use in over 50 countries worldwide, including major markets in , , , and , though availability remains limited in some developing regions due to high costs and import restrictions. The original Cerenia product typically costs between $5 and $10 per tablet dose (depending on strength and pack size), with no over-the-counter availability permitted. Generic versions, such as those approved in 2023 in the and 2025 in the , are anticipated to reduce prices by 25-50% through competitive market dynamics, enhancing access while maintaining to the reference product as verified in regulatory reviews.

References

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