PT2385 Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 297

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile and pharmacokinetics of PT2385 in early-phase development, encompassing Phase I and Phase II studies for clear cell renal cell carcinoma, Von Hippel-Lindau disease-associated neoplasms, recurrent glioblastoma, and healthy volunteer food-effect evaluations. Sponsored by commercial entities like Peloton Therapeutics (a Merck & Co., Inc. subsidiary) and academic institutions such as the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, recruitment statuses range from completed to active, not recruiting, and actively recruiting. Key investigations include Phase I dose-escalation, exploratory imaging, and Phase II studies in VHL-associated lesions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04989959	RECRUITING	Renal Cell Carcinoma; Clear Cell Renal Cell Carcinoma	Orhan Kemal Oz	2021-08-18	PHASE1
NCT03108066	COMPLETED	VHL Gene Mutation; VHL; VHL Syndrome; VHL Gene Inactivation; Von Hippel; Von Hippel-Lindau Disease; Von Hippel's Disease; Von Hippel-Lindau Syndrome, Modifiers of; Clear Cell Renal Cell Carcinoma; Clear Cell RCC; ccRCC	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2017-04-24	PHASE2
NCT03216499	COMPLETED	Recurrent Glioblastoma	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2017-09-14	PHASE2
NCT02293980	ACTIVE_NOT_RECRUITING	ccRCC; RCC; Kidney Cancer; Clear Cell Renal Cell Carcinoma; Renal Cell Carcinoma	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2014-11-25	PHASE1
NCT02553356	COMPLETED	Healthy	Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	2015-09	PHASE1
NCT02553356	Completed	Healthy	Peloton Therapeutics Inc. a subsidiary of Merck & Co. Inc. (Rahway New Jersey USA)	2015-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-12-04)

Check the PT2385 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PT2385 selectively acts as a hypoxia-inducible factor 2 alpha (HIF-2α) antagonist with an EC50 of 27 nM, blocking its interaction with HIF-1β and thereby inhibiting downstream transcription of pro-angiogenic and proliferative target genes. This molecular inhibition suppresses hypoxia-mediated tumor growth and survival, providing direct clinical relevance for HIF-2α-driven malignancies such as clear cell renal cell carcinoma, Von Hippel-Lindau disease, and recurrent glioblastoma.

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>).