Community hub
Recent from talks
Contribute something
Nothing was collected or created yet.
Imlunestrant
View on Wikipedia
 | |
| Clinical data | |
|---|---|
| Trade names | Inluriyo |
| Other names | LY3484356, LY-3484356 |
| AHFS/Drugs.com | Inluriyo |
| License data |
|
| Routes of administration | By mouth |
| Drug class | Estrogen receptor antagonist |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| |
| CAS Number |
|
| PubChem CID | |
| DrugBank | |
| ChemSpider | |
| UNII |
|
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C29H24F4N2O3 |
| Molar mass | 524.516 g·mol−1 |
| 3D model (JSmol) | |
| |
| |
Imlunestrant, sold under the brand name Inluriyo, is an anti-cancer medication used for the treatment of breast cancer.[1] It is an estrogen receptor antagonist.[1] It is used as the salt, imlunestrant tosylate.[2] It is taken by mouth.[1] It was developed by Eli Lilly and Company.[2]
The most common adverse events and laboratory abnormalities include decreased hemoglobin, musculoskeletal pain, decreased calcium, decreased neutrophils, increased AST, fatigue, diarrhea, increased ALT, increased triglycerides, nausea, decreased platelets, constipation, increased cholesterol, and abdominal pain.[2]
Imlunestrant was approved for medical use in the United States in September 2025.[2]
Medical uses
[edit]Imlunestrant is indicated for the treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.[1][2]
History
[edit]Efficacy was evaluated in EMBER-3 (NCT04975308), a randomized, open-label, active-controlled, multi-center trial that enrolled 874 participants with ER-positive, HER2-negative locally advanced or metastatic breast cancer previously treated with an aromatase inhibitor either alone or in combination with a CDK4/6 inhibitor.[2] Participants were excluded if they were eligible to receive a PARP inhibitor.[2]
Participants were randomized 1:1:1 to imlunestrant, an investigator's choice of endocrine therapy (fulvestrant or exemestane), or an additional investigational combination regimen.[2] Randomization was stratified by previous treatment with a CDK4/6 inhibitor, presence of visceral metastasis, and geographic region.[2] ESR1 mutational status was determined by blood circulating tumor deoxyribonucleic acid (ctDNA) analysis using the Guardant360 CDx assay and was limited to specific ESR1 mutations in the ligand-binding domain.[2]
The US Food and Drug Administration granted the application of imlunestrant fast track designation.[2]
Society and culture
[edit]Legal status
[edit]Imlunestrant was approved for medical use in the United States in September 2025.[2][3]
Names
[edit]Imlunestrant is the international nonproprietary name.[4]
Imlunestrant is sold under the brand name Inluriyo.[1]
References
[edit]- ^ a b c d e f https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218881s000lbl.pdf
- ^ a b c d e f g h i j k l "FDA approves imlunestrant for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer". U.S. Food and Drug Administration (FDA). 25 September 2025. Retrieved 27 September 2025.
This article incorporates text from this source, which is in the public domain.
- ^ "U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer" (Press release). Eli Lilly. 25 September 2025. Retrieved 27 September 2025 – via PR Newswire.
- ^ World Health Organization (2022). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 88". WHO Drug Information. 36 (3). hdl:10665/363551.
Further reading
[edit]- Jhaveri, Komal L.; Jeselsohn, Rinath; Lim, Elgene; Hamilton, Erika P.; Yonemori, Kan; Beck, J. Thaddeus; et al. (June 2022). "A phase 1a/b trial of imlunestrant (LY3484356), an oral selective estrogen receptor degrader (SERD) in ER-positive (ER+) advanced breast cancer (aBC) and endometrial endometrioid cancer (EEC): Monotherapy results from EMBER". Journal of Clinical Oncology. 40 (16_suppl): 1021. doi:10.1200/JCO.2022.40.16_suppl.1021. S2CID 249445691.
- Jhaveri, Komal; O'Shaughnessy, Joyce; Andre, Fabrice; Goetz, Matthew P.; Harbeck, Nadia; Martín, Miguel; et al. (March 2023). "Abstract OT1-01-02: EMBER-4: A phase 3 adjuvant trial of imlunestrant vs standard endocrine therapy (ET) in patients with ER+, HER2- early breast cancer (EBC) with an increased risk of recurrence who have previously received 2 to 5 years of adjuvant ET". Cancer Research. 83 (5_Supplement): OT1–01–02-OT1-01–02. doi:10.1158/1538-7445.SABCS22-OT1-01-02.
- Neven, P.; Stahl, N.; Losada, M.J. Vidal; Jimenez, M. Martin; Kaufman, P.A.; Harbeck, N.; et al. (October 2023). "273P A preoperative window-of-opportunity (WOO) study of imlunestrant in ER+, HER2- early breast cancer (EBC): Final analysis from EMBER-2". Annals of Oncology. 34: S292 – S293. doi:10.1016/j.annonc.2023.09.470. S2CID 264385454.
External links
[edit]- Clinical trial number NCT04975308 for "A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer (EMBER-3)" at ClinicalTrials.gov
 | This pharmacology-related article is a stub. You can help Wikipedia by expanding it. |