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imlunestrant 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| estrogen antagonists, including estrogen receptor down-regulators | 5783 | 2408840-26-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Imlunestrant is an estrogen receptor (ER) antagonist and selective estrogen receptor degrader (SERD). Imlunestrant binds to ER, blocks estrogen-mediated signaling, and induces ER degradation.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 25, 2025 | FDA | ELI LILLY AND CO | |
| Jan. 9, 2026 | EMA | Eli Lilly Nederland B.V. | |
| Dec. 22, 2026 | PMDA | Eli Lilly Japan K.K. |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| FDA MoA | N0000000145 | Estrogen Receptor Antagonists |
| FDA EPC | N0000175582 | Estrogen Receptor Antagonist |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004965 | Estrogen Antagonists |
| MeSH PA | D006727 | Hormone Antagonists |
| MeSH PA | D018931 | Antineoplastic Agents, Hormonal |
| MeSH PA | D065171 | Estrogen Receptor Antagonists |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Malignant neoplasm of breast | indication | 254837009 | DOID:1612 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE | INLURIYO | ELI LILLY AND CO | N218881 | Sept. 25, 2025 | RX | TABLET | ORAL | 10654866 | July 11, 2039 | 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 |
| EQ 200MG BASE | INLURIYO | ELI LILLY AND CO | N218881 | Sept. 25, 2025 | RX | TABLET | ORAL | 11117902 | July 11, 2039 | 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 200MG BASE | INLURIYO | ELI LILLY AND CO | N218881 | Sept. 25, 2025 | RX | TABLET | ORAL | Sept. 25, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Estrogen receptor | Nuclear hormone receptor | ANTAGONIST | Ki | 9.19 | DRUG LABEL | DRUG LABEL | |||
| Estrogen receptor beta | Nuclear hormone receptor | ANTAGONIST | Ki | 9.96 | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| CHEMBL5095183 | ChEMBL_ID |
| C000719756 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4044290 | VANDF |
| C5565130 | UMLSCUI |
| CHEBI:747442 | CHEBI |
| CHEMBL5095397 | ChEMBL_ID |
| 12039 | INN_ID |
| D12216 | KEGG_DRUG |
| 146603228 | PUBCHEM_CID |
| 398152 | MMSL |
| d10325 | MMSL |
| 020257 | NDDF |
| 12896 | IUPHAR_LIGAND_ID |
| 9CXQ3PF69U | UNII |
| 2725912 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Inluriyo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-1717 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 30 sections |