AG-636 Clinical Trials

Size	Price	Qty
5mg	USD 259
25mg	USD 777

Clinical Trials

A Phase 1 clinical trial sponsored by Agios Pharmaceuticals Inc. evaluated the therapeutic application of AG-636 in patients with advanced lymphoma. Designed to target metabolic vulnerabilities via dihydroorotate dehydrogenase inhibition in hematologic malignancies, the study sought to establish dosage parameters while assessing safety, pharmacokinetics, and preliminary antineoplastic activity. Database records indicate that recruitment for the trial was terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03834584	Terminated	Lymphoma	Agios Pharmaceuticals Inc.	2019-05-24	Phase 1

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

Check the AG-636 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AG-636 selectively binds to and inhibits dihydroorotate dehydrogenase, an enzyme critical for de novo pyrimidine nucleotide synthesis, thereby disrupting cellular pyrimidine pools. This metabolic block suppresses RNA and DNA synthesis, leading to cell cycle arrest and apoptosis in rapidly proliferating cancer cells, which underlies its potential therapeutic relevance in advanced 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>).