imlunestrant

Small moleculeapproved

Approved

Sep 25, 2025

Clinical trial activity

13 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
4
Phase 3
2
Phase 4
0

Earliest trial started Dec 4, 2019 (NCT04188548)

Timeline

2010s

  1. Jan 1, 2019

    Eli Lilly — Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2021

    Eli Lilly — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2025

    Eli Lilly — Earliest Phase 2 Sponsor(trial)

  3. Sep 25, 2025

    Earliest FDA Approval

  4. Sep 25, 2025

    Eli Lilly — Marketing Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedSep 25, 2025

Chemistry & pharmacology

Loading structure…

SMILES

Oc1ccc2c3c(cnc2c1)-c1ccc(C(F)(F)F)cc1O[C@@H]3c1ccc(OCCN2CC(CF)C2)cc1
Mol. weight
524.51 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07191717Phase 2Apr 30, 2026University of California, Los Angeles
NCT07287098Phase 2Dec 31, 2025Eli Lilly
NCT05509790Phase 1Oct 9, 2022Eli Lilly
NCT05514054Phase 3Oct 4, 2022Eli Lilly
NCT05509816Phase 1Sep 12, 2022Eli Lilly
NCT05444556Phase 1Jul 7, 2022Eli Lilly
NCT05440344Phase 1Jul 5, 2022Eli Lilly
NCT05307705Phase 1May 11, 2022Eli Lilly, Loxo Oncology
NCT04975308Phase 3Oct 4, 2021Eli Lilly
NCT04991766Phase 1Aug 13, 2021Eli Lilly
NCT04840888Phase 1Apr 26, 2021Eli Lilly
NCT04647487Phase 1Dec 21, 2020Eli Lilly
NCT04188548Phase 1Dec 4, 2019Eli Lilly
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Eli LillyFor profit121232019
Loxo OncologyFor profit1012022
University of California, Los AngelesAcademic/Hospital1112026
3 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Eli LillyFor profitMKTGSep 25, 2025