Zelavespib (PU-H71) Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 679

Clinical Trials

Multiple clinical trials across Early Phase 1, Phase 1, and Phase 2 have evaluated zelavespib (PU-H71) in hematologic conditions—such as myelofibrosis, accelerated or blast phase myeloproliferative neoplasms, and non-Hodgkin's lymphoma—and advanced metastatic solid tumors. Sponsored by industry, academic, and government entities including Samus Therapeutics, Memorial Sloan Kettering Cancer Center, and the National Cancer Institute, these investigations are completed, active not recruiting, terminated, or withdrawn. Early evaluations established initial clinical feasibility in advanced malignancies, while subsequent studies explored targeted applications in specific myelofibrosis populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01269593	ACTIVE_NOT_RECRUITING	Non-Hodgkin's Lymphoma; Myeloma; Active Solid Malignancy	Memorial Sloan Kettering Cancer Center	2010-12	EARLY_PHASE1
NCT05612633	WITHDRAWN	Accelerated Phase MPN; Blast Phase MPN	Samus Therapeutics, Inc.	2022-06-15	PHASE2
NCT01393509	COMPLETED	Metastatic Solid Tumor; Lymphoma; Myeloproliferative Neoplasms (MPN)	Memorial Sloan Kettering Cancer Center	2011-07-06	PHASE1
NCT03935555	TERMINATED	Primary Myelofibrosis (PMF); Post-Polycythemia Vera Myelofibrosis (Post-PV MF); Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF)	Samus Therapeutics, Inc.	2019-08-12	PHASE1
NCT05612633	Withdrawn	Accelerated Phase MPN\|Blast Phase MPN	Samus Therapeutics Inc.	2022-06-15	Phase 2
NCT03166085	COMPLETED	Metastatic Breast Cancer	Memorial Sloan Kettering Cancer Center	2017-05-23	PHASE1
NCT03373877	TERMINATED	Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis	Samus Therapeutics, Inc.	2018-05-24	PHASE1
NCT03935555	Terminated	Primary Myelofibrosis (PMF)\|Post-Polycythemia Vera Myelofibrosis (Post-PV MF)\|Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF)	Samus Therapeutics Inc.	2019-08-12	Phase 1
NCT03373877	Terminated	Myelofibrosis\|Primary Myelofibrosis\|Post-polycythemia Vera Myelofibrosis\|Post-essential Thrombocythemia Myelofibrosis	Samus Therapeutics Inc.	2018-05-24	Phase 1
NCT01581541	TERMINATED	Solid Tumors; Lymphoma	National Cancer Institute (NCI)	2011-04-26	PHASE1
NCT01393509	Completed	Metastatic Solid Tumor\|Lymphoma\|Myeloproliferative Neoplasms (MPN)	Memorial Sloan Kettering Cancer Center	2011-07-06	Phase 1
NCT01581541	Terminated	Solid Tumors\|Lymphoma	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2011-04-26	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-01-15)

Check the Zelavespib (PU-H71) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zelavespib selectively binds to heat shock protein 90 (HSP90) with an IC50 of 51 nM, inhibiting its ATPase activity and prompting the proteasomal degradation of oncogenic client proteins. This disruption of chaperone function causes cell cycle arrest and apoptosis, directly inhibiting tumor cell survival in clinical target conditions such as myelofibrosis, lymphoma, and solid malignancies.

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>).