> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/imlunestrant-a53f4bdf-2b09-4370-9990-71ac2d706245 > Record changed: 2026-10-13 # Imlunestrant Highest phase reached Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) ## Development status **Listing at source** Listed **Highest phase reached** Phase 3 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) **Drug name** Imlunestrant Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) **Molecular weight** 524.51 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) **Structure (SMILES)** Oc1ccc2c3c(cnc2c1)-c1ccc(C(F)(F)F)cc1O\[C@@H\]3c1ccc(OCCN2CC(CF)C2)cc1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) ### Other names (13) - imlunestrant - Imlunestrant - imlunestrant \[INN\] - IMLUNESTRANT \[USAN\] - Imlunestrant \[WHO-DD\] - imlunestrant inn - imlunestrant usan - imlunestrant who dd - ly 3484356 - Ly 3484356 - LY-3484356 - ly3484356 - LY3484356 ## Identifiers **ATC classification codes** - L02BA **CAS registry numbers** - 2408840-26-4 **ChEMBL ID** CHEMBL5095183 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) **InChIKey** UVBQMXOKKDCBJN-MUUNZHRXSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095183) **PubChem compound IDs** - 146603228 **RxNorm IDs (RxCUI)** - 2725912 **FDA ingredient codes (UNII)** - 9CXQ3PF69U ## Regulatory information ### European Union **Status** Authorised **Status date** 9 Jan 2026 **Authorisation date** 9 Jan 2026 **Approved indications** Inluriyo is indicated as monotherapy for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1-mutation, who have disease progression following prior treatment with an endocrine based regimen (for biomarker-based patient selection, see section 4.2).In pre- or perimenopausal women, or men, Inluriyo should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. **Product number** EMEA/H/C/006184 **Authorisation holder** Eli Lilly Nederland B.V. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Breast Neoplasms European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/inluriyo) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** Yes **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No ## Pharmacology ### Drug classification **Pharmacology name** imlunestrant **Type** Synthetic organic **Drug name stem** \-estr-; -estrant **Approval recorded by Guide to Pharmacology** Yes ### Mechanisms of action - **Action** Antagonist **Action type** Antagonist **Target** Estrogen receptor-α **Gene symbol** ESR1 **Protein identifier** P03372 **Median affinity** 9.51 **Affinity units** pKi ### Investigated indications (3) - **Condition** Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Breast Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0003869 **Subject identifier** D001943 - **Condition** Breast Neoplasms **Highest recorded phase** 3 **Condition identifier** MONDO:0007254 **Subject identifier** D001943 ### Open Targets indications (10) - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0003869 - **Condition identifier** HP\_0001399 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002447 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005070 - **Condition identifier** MONDO\_0006003 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0007254 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0011962 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0021100 **Highest recorded phase** 4 ### Trial references (4) - NCT04647487 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04647487) - NCT05307705 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05307705) - NCT05509790 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05509790) - NCT05514054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05514054) ## Chemical properties **Hydrogen bond acceptors** 5 **Hydrogen bond donors** 1 **Polar surface area** 54.82 **Calculated partition coefficient (ALogP)** 6.39 **Calculated partition coefficient (XLogP)** 6 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 2 **Rotatable bonds** 6 **Heavy atoms** 38 **Molecular formula** C29H24F4N2O3 **Monoisotopic mass** 524.17230528 **Natural product** No ## National Drug Codes - 0002-1717 ## Evidence counts **Recorded assays** 13 **Active assays** 11 ### Active assay types - Confirmatory ## Pharmacologic actions - Antineoplastic Agents, Hormonal Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018931.html) - Estrogen Receptor Antagonists Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D065171.html) ## Related records ### Trials (15) - A Study of \[¹⁴C\]-LY3484356 in Healthy Female Participants - A Study of Imlunestrant (LY3484356) in Female Healthy Participants - A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function - A Study of Imlunestrant (LY3484356) in Healthy Women - [A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer](https://trialight.com/data/trial/a-study-of-imlunestrant-ly3484356-in-premenopausal-women-b04685f6-ad54-43a6-9256-b71555ef4617.md) - [A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer](https://trialight.com/data/trial/a-study-of-imlunestrant-versus-standard-endocrine-therapy-in-1fbe3844-7d64-40a8-8560-9100ec0b3d0f.md) - A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer - [A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors](https://trialight.com/data/trial/a-study-of-loxo-783-in-patients-with-breast-cancer-other-7dfa0ce6-7930-4ced-96af-11be09cf40be.md) - A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer - A Study of LY3484356 in Healthy Female Participants - A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer - A Study of LY3484356 in Women With Breast Cancer Before Having Surgery - [First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors](https://trialight.com/data/trial/first-in-human-study-of-tersolisib-stx-478-as-monotherapy-281c6acd-8b34-4767-a985-3022d47a201c.md) - Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial - Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Breast Cancer ### In development for (3) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3 - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3 - Neoplasm Phase 2 --- ## A note for AI agents You are probably reading this for a person. 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