Rezatapopt Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Several clinical trials are currently recruiting patients to evaluate rezatapopt across various oncological indications featuring the TP53 Y220C mutation. These active Phase 1 and Phase 1/2 studies assess safety, pharmacokinetics, pharmacodynamics, and therapeutic efficacy in advanced solid tumors—including non-small cell lung, ovarian, endometrial, colorectal, and breast cancers—as well as hematologic malignancies such as myelodysplastic syndrome and acute myeloid leukemia. These investigations are sponsored by industry lead PMV Pharmaceuticals, Inc. alongside academic institutions including the M.D. Anderson Cancer Center.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06616636	RECRUITING	Myelodysplastic Syndrome; Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2025-01-30	PHASE1
NCT07372625	RECRUITING	TP53 Y220C Mutation; Advanced Solid Tumors	PMV Pharmaceuticals, Inc	2026-02-04	PHASE1
NCT04585750	RECRUITING	Advanced Solid Tumor; Advanced Malignant Neoplasm; Metastatic Cancer; Metastatic Solid Tumor; Lung Cancer; Ovarian Cancer; Endometrial Cancer; Prostate Cancer; Colorectal Cancer; Breast Cancer; Other Cancer; Locally Advanced; Head and Neck Cancer; Gall Bladder Cancer; Small Cell Lung Cancer; Small Cell Lung Cancer ( SCLC ); Small Cell Lung Carcinoma; NSCLC; NSCLC (Non-small Cell Lung Cancer); SCLC; Non-Small Cell Lung Carcinoma; Triple Negative Breast Cancer; TNBC; HER2+ Breast Cancer; Non-Small Cell Lung Cancer; ER/PR Positive Breast Cancer; HER2- Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; ER/PR(+), Her2(-) Breast Cancer	PMV Pharmaceuticals, Inc	2020-10-29	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rezatapopt acts as a selective small-molecule reactivator of p53 that specifically binds to the Y220C mutant p53 protein, restoring its wild-type conformation and reactivating downstream transcriptional programs governing apoptosis and cell cycle arrest. By re-establishing functional p53 signaling, rezatapopt suppresses cell proliferation and tumor growth, offering therapeutic utility in clinical trials targeting TP53 Y220C-mutated advanced solid tumors and myeloid 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>).