AG-120 (racemic) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials evaluate AG-120 across oncology indications and clinical pharmacology studies to establish its therapeutic efficacy and safety. Prominent Phase 3 research targets newly diagnosed acute myeloid leukemia and advanced or metastatic cholangiocarcinoma, whereas Phase 1 studies examine its utility in recurrent glioma as well as its pharmacokinetic and metabolic profiles in healthy volunteers. Sponsored primarily by Agios Pharmaceuticals Inc. and Institut de Recherches Internationales Servier, these studies encompass active, non-recruiting, and completed trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03343197	Active not recruiting	Glioma	Institut de Recherches Internationales Servier\|Servier	2018-03-20	Phase 1
NCT03173248	Active not recruiting	Newly Diagnosed Acute Myeloid Leukemia (AML)\|Untreated AML\|AML Arising From Myelodysplastic Syndrome (MDS)\|Leukemia Myeloid Acute	Institut de Recherches Internationales Servier\|Servier	2017-06-26	Phase 3
NCT02989857	Completed	Advanced Cholangiocarcinoma\|Metastatic Cholangiocarcinoma	Institut de Recherches Internationales Servier\|Servier	2017-02-20	Phase 3
NCT02831972	Completed	Healthy	Agios Pharmaceuticals Inc.	2016-06	Phase 1
NCT02489513	Completed	Healthy Volunteers	Agios Pharmaceuticals Inc.	2015-06	Phase 1

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

Check the AG-120 (racemic) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AG-120 (racemic) functions as a selective inhibitor of isocitrate dehydrogenase type 1 (IDH1), preventing the NADPH-dependent reduction of alpha-ketoglutarate to the oncometabolite D-2-hydroxyglutarate. This reduction in D-2-hydroxyglutarate levels restores normal cellular differentiation and suppresses tumor proliferation, providing a mechanistically targeted approach for treating IDH1-mutated malignancies such as acute myeloid leukemia, cholangiocarcinoma, and glioma.

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>).