Luxdegalutamide (ARV-766) Clinical Trials

Size	Price	Qty
5mg	USD 790
25mg	USD 1,970

Clinical Trials

Multiple clinical trials are currently evaluating the proteolysis targeting chimera luxdegalutamide (ARV-766) in patients with metastatic prostate cancer. These early-phase, Phase 1 and Phase 2 studies focus on establishing the drug's safety profile, tolerability, pharmacokinetics, and pharmacodynamics through dose-escalation and cohort-expansion protocols. Sponsored by industry leaders including Arvinas Inc., Arvinas Androgen Receptor Inc., and Novartis Pharmaceuticals, these studies are currently listed as actively recruiting and active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05067140	ACTIVE_NOT_RECRUITING	Prostate Cancer Metastatic	Novartis Pharmaceuticals	2021-09-02	PHASE1; PHASE2
NCT05067140	Recruiting	Prostate Cancer Metastatic	Arvinas Androgen Receptor Inc.\|Arvinas Inc.	2021-09-02	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-18)

Check the Luxdegalutamide (ARV-766) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Luxdegalutamide (ARV-766) is an orally active proteolysis targeting chimera (PROTAC) that selectively binds to and induces degradation of wild-type androgen receptors as well as point mutants including L702H, H875Y, and T878A. Target degradation blocks downstream androgen receptor-mediated transcriptional activation, suppressing key survival and growth pathways in androgen-dependent cells. This depletion of functional androgen receptor variants ultimately leads to anti-proliferative effects, providing clinical relevance for the treatment of metastatic prostate cancer.

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>).