Padnarsertib (KPT-9274, ATG-019) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 270

Clinical Trials

Multiple Phase 1, open-label clinical trials have evaluated padnarsertib in patients with advanced solid tumors and Non-Hodgkin's lymphoma to assess its safety, tolerability, and preliminary therapeutic activity. Sponsored by Karyopharm Therapeutics Inc and Antengene Therapeutics Limited, these oncology studies have all reached a terminated recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04281420	TERMINATED	Solid Tumor, Non-Hodgkin's Lymphoma	Antengene Therapeutics Limited	2020-04-13	PHASE1
NCT02702492	Terminated	Solid Tumors\|NHL	Karyopharm Therapeutics Inc	2016-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-04-30)

Check the Padnarsertib (KPT-9274, ATG-019) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Padnarsertib acts as a non-competitive dual inhibitor of p21-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase (NAMPT), blocking cellular NAD+ biosynthesis and downstream PAK4 signaling pathways to induce metabolic stress and apoptosis. This dual disruption of metabolic maintenance and oncogenic survival signaling suppresses tumor growth, providing the underlying rationale for investigating padnarsertib in patients with advanced solid tumors and Non-Hodgkin's lymphoma.

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>).