Brilanestrant (GDC-0810) Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Genentech Inc. sponsored several clinical trials evaluating brilanestrant (GDC-0810) across Phase 1, Phase 2, and combined Phase 1/2 designs. Early-stage Phase 1 studies assessing pharmacokinetics and drug interactions in healthy female subjects successfully reached completion. In contrast, clinical evaluations in advanced breast cancer patient populations, including Phase 2 and Phase 1/2 combination studies, were terminated prior to full completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02802670	Completed	Healthy Volunteers	Genentech Inc.	2016-05	Phase 1
NCT02621957	Completed	Breast Cancer	Genentech Inc.	2015-12	Phase 1
NCT02569801	Terminated	Breast Cancer	Genentech Inc.	2015-12-04	Phase 2
NCT01823835	Terminated	Breast Cancer	Genentech Inc.	2014-12-29	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Brilanestrant (GDC-0810) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brilanestrant (GDC-0810) functions as a selective estrogen receptor degrader that directly binds to estrogen receptor-alpha with nanomolar affinity to act as a full transcriptional antagonist. By inducing target receptor degradation and suppressing downstream estrogen-mediated gene transcription, the compound impairs tumor cell viability, directly suppressing proliferation in estrogen receptor-positive breast cancer models investigated 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>).