Imlunestrant
Also known as Inluriyo, Imlunestrant tosylate
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
NDA218881,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ELI LILLY & Co LLY Source: Company record for ELI LILLY & Co (opens in a new tab)
- Indications
- Breast Neoplasms; Neoplasm Metastasis Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 218881 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218881 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 4 Oct 20212 linked trials
- Filed Completed
- Approved Current stageFirst approval 25 Sep 2025
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Imlunestrant. Editors add each one with its source.
Filed application
No filed application is on record for Imlunestrant. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Imlunestrant.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05514054ClinicalTrials.gov record for NCT05514054 (opens in a new tab)EMBER-4 | A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer | Phase 3 | Active, not recruiting | 8,000 (estimated) | Oct 2027 (estimated) | No |
| NCT04975308ClinicalTrials.gov record for NCT04975308 (opens in a new tab)EMBER-3 | A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer | Phase 3 | Active, not recruiting | 874 (actual) | 24 Jun 2024 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04975308 (opens in a new tab) |
Posted results on ClinicalTrials.gov for EMBER-3
Serious adverse events (Baseline up to 28 months): Arm A: Imlunestrant 46 of 327; Arm B: Investigator's Choice of Endocrine Therapy - Exemestane 6 of 32; Arm B: Investigator's Choice of Endocrine Therapy - Fulvestrant 49 of 292; Arm C: Imlunestrant + Abemaciclib 42 of 208 Source: ClinicalTrials.gov results for NCT04975308 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing EMBER-3 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA218881Action letter for NDA218881 (opens in a new tab) | Supplement 1 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA218881Action letter for NDA218881 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Inluriyo (EMEA/H/C/006184)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Eli Lilly Nederland B.V.
- Active substance (INN)
- imlunestrant
- ATC code
- L02BA
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Inluriyo (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 218881 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05514054 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04975308 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA218881 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.