Imlunestrant
Highest phase reached
Phase 3
Drug type
Small molecule
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Small molecule
- Drug name
- Imlunestrant
- Molecular weight
- 524.51
- Structure (SMILES)
- Oc1ccc2c3c(cnc2c1)-c1ccc(C(F)(F)F)cc1O[C@@H]3c1ccc(OCCN2CC(CF)C2)cc1
- imlunestrant
- Imlunestrant
- imlunestrant [INN]
- IMLUNESTRANT [USAN]
- Imlunestrant [WHO-DD]
- imlunestrant inn
- imlunestrant usan
- imlunestrant who dd
- ly 3484356
- Ly 3484356
- LY-3484356
- ly3484356
- LY3484356
- ATC classification codes
- L02BA
- CAS registry numbers
- 2408840-26-4
- ChEMBL ID
- CHEMBL5095183
- InChIKey
- UVBQMXOKKDCBJN-MUUNZHRXSA-N
- PubChem compound IDs
- 146603228
- RxNorm IDs (RxCUI)
- 2725912
- FDA ingredient codes (UNII)
- 9CXQ3PF69U
- 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
- 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 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
- 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
- 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
- NCT04647487
- NCT05307705
- NCT05509790
- NCT05514054
- 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
- 0002-1717
- Recorded assays
- 13
- Active assays
- 11
Active assay types
- Confirmatory
- Antineoplastic Agents, Hormonal
- Estrogen Receptor Antagonists
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
- A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
- 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
- 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
- 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 Phase 3
- Breast neoplasm Phase 3
- Neoplasm Phase 2