imlunestrant
imlunestrant: developed by 1 company · 5 clinical trials tracked · 1 FDA decision.
imlunestrant evidence translation
What we can confirm
1 FDA record · 5 tracked trials
What it means
What to watch
Prepared research question
How could imlunestrant → LLY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| ELI LILLY & Co (LLY) For the treatment of adults with ER-positive HER2-negative, … | Approved |
Clinical Trials (5)
preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Primary endpoint: Change from Baseline in Antigen Kiel (Ki-67) Expression
First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Primary endpoint: Number of participants who experience at least 1 Dose Limiting Toxicity (DLT)
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
Primary endpoint: Invasive Disease-Free Survival (IDFS)
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation
Primary endpoint: Phase 1 a: To determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
Primary endpoint: Investigator-assessed Progression Free Survival (PFS) (Between Arm A and Arm B)
Frequently asked questions
Who is developing imlunestrant?
imlunestrant is being developed by ELI LILLY & Co.
How many clinical trials involve imlunestrant?
BioSniper tracks 5 clinical trials involving imlunestrant.
What is imlunestrant's latest FDA decision?
The most recent tracked FDA decision for imlunestrant is Approval, dated September 25, 2025.