Bavdegalutamide (ARV-110) Clinical Trials

Size	Price	Qty
5mg	USD 199
25mg	USD 597

Clinical Trials

Multiple Phase 1 and Phase 1/2 clinical trials sponsored by industry entities, including Arvinas Inc. and Arvinas Androgen Receptor Inc., have evaluated bavdegalutamide (ARV-110) for the treatment of metastatic prostate cancer. These investigations have assessed dose escalation, safety, and pharmacokinetics of the androgen receptor degrader both as monotherapy and in combination with abiraterone. With recruitment statuses encompassing active, not recruiting, and completed, these trials represent mature clinical evaluations of the agent in advanced oncological settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05177042	COMPLETED	Prostate Cancer Metastatic	Arvinas Androgen Receptor, Inc.	2022-05-13	PHASE1
NCT03888612	COMPLETED	Prostate Cancer Metastatic	Arvinas Inc.	2019-03-01	PHASE1; PHASE2
NCT05177042	Active not recruiting	Prostate Cancer Metastatic	Arvinas Androgen Receptor Inc.\|Arvinas Inc.	2022-02-01	Phase 1
NCT03888612	Active not recruiting	Prostate Cancer Metastatic	Arvinas Androgen Receptor Inc.\|Arvinas Inc.	2019-03-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-04-28)

Check the Bavdegalutamide (ARV-110) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bavdegalutamide (ARV-110) is a targeted proteolysis targeting chimera (PROTAC) that selectively binds the androgen receptor (AR) and recruits E3 ubiquitin ligase to induce AR ubiquitination and subsequent proteasomal degradation. This targeted protein depletion disrupts downstream AR transcriptional signaling and halts tumor cell proliferation, demonstrating therapeutic utility in metastatic prostate cancer models and clinical settings.

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>).