Imlunestrant Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple Phase 1, 2, and 3 clinical trials, sponsored by Eli Lilly and Company alongside academic collaborators, evaluate the clinical efficacy and pharmacokinetic profile of imlunestrant. These studies target estrogen receptor-positive, HER2-negative breast cancers across early to metastatic stages, adult solid tumors, and healthy or hepatically impaired cohorts for drug interaction assessments. Recruitment status across this research portfolio ranges from completed pharmacokinetic evaluations to active, recruiting, and planned investigations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05768139	RECRUITING	Breast Cancer; Solid Tumors, Adult	Eli Lilly and Company	2023-04-17	PHASE1; PHASE2
NCT07191717	RECRUITING	Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Invasive Breast Carcinoma; Localized Estrogen Receptor-Positive Breast Carcinoma; Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma	Jonsson Comprehensive Cancer Center	2026-05-18	PHASE2
NCT07410559	NOT_YET_RECRUITING	Breast Cancer	Fudan University	2026-07-01	PHASE2
NCT07287098	RECRUITING	Breast Neoplasms	Eli Lilly and Company	2026-05-13	PHASE2
NCT05514054	ACTIVE_NOT_RECRUITING	Breast Neoplasms	Eli Lilly and Company	2022-10-04	PHASE3
NCT05307705	RECRUITING	Breast Cancer	Eli Lilly and Company	2022-05-11	PHASE1
NCT04975308	ACTIVE_NOT_RECRUITING	Breast Neoplasms; Neoplasm Metastasis	Eli Lilly and Company	2021-10-04	PHASE3
NCT05440344	COMPLETED	Hepatic Insufficiency; Healthy	Eli Lilly and Company	2022-07-05	PHASE1
NCT05509816	COMPLETED	Healthy	Eli Lilly and Company	2022-09-12	PHASE1
NCT05444556	COMPLETED	Healthy	Eli Lilly and Company	2022-07-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-07)

Check the Imlunestrant product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Imlunestrant is an orally bioavailable selective estrogen receptor degrader (SERD) that binds to estrogen receptor alpha (ERα) and acts as a pure antagonist, thereby inhibiting ER-dependent gene transcription and cellular proliferation in estrogen-sensitive cells. By inducing target receptor degradation and suppressing downstream estrogen signaling pathways, imlunestrant blocks tumor growth, providing a mechanistically targeted therapeutic approach for estrogen receptor-positive breast cancers and advanced solid tumors currently evaluated in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).