imlunestrant
imlunestrant: sourced relationships with 1 company · 6 clinical trials tracked · 1 FDA decision.
imlunestrant evidence translation
What we can confirm
1 FDA record · 6 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 evidence5 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| ELI LILLY & Co (LLY) Reported 2025-09-25 · Current development: unknownSource For the treatment of adults with ER-positive HER2-negative, … | Approved |
Clinical Trial Registry Records (6)
A Phase II Trial of Imlunestrant/Abemaciclib/Selinexor in Low Grade Serous Ovarian Cancer and in Endometrioid Endometrial Cancer
Primary endpoint: Objective Response Rate (ORR)
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)
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with imlunestrant?
imlunestrant has dated SEC/FDA relationship records for ELI LILLY & Co.
How many clinical trials involve imlunestrant?
BioSniper tracks 6 clinical trials involving imlunestrant.
What is imlunestrant's latest FDA decision?
The most recent tracked FDA decision for imlunestrant is Approval for 1 INDICATIONS AND USAGE INLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: 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 ( 1 ), dated September 25, 2025.