Sirpiglenastat (DRP-104) Clinical Trials

Size	Price	Qty
5mg	USD 597
25mg	USD 1,790

Clinical Trials

A clinical trial sponsored by Dracen Pharmaceuticals Inc. investigated the therapeutic application of Sirpiglenastat (DRP-104) in patients affected by advanced solid tumors and metastatic non-small cell lung cancer. This Phase 1/2a study served as a first-in-human assessment of the compound's safety, dosage, and early therapeutic responses. However, official records indicate that recruitment for the study has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04471415	Terminated	Advanced Solid Tumor\|Non Small Cell Lung Cancer Metastatic	Dracen Pharmaceuticals Inc.	2020-08-31	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Sirpiglenastat (DRP-104) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sirpiglenastat (DRP-104) acts as a broad-spectrum glutamine antagonist that directly inhibits metabolic pathways essential for tumor energetics, thereby disrupting glutamine-dependent metabolic flux and impairing cell survival mechanisms. This targeted metabolic inhibition suppresses cancer cell proliferation while simultaneously stimulating host immunomodulatory responses, providing a therapeutic rationale for targeting tumor growth in advanced solid tumors and metastatic non-small cell lung cancer.

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>).