Enasidenib(AG-221) Mesylate Clinical Trials

Size	Price	Qty
5mg	USD 117
25mg	USD 357

Clinical Trials

Several clinical trials evaluate Enasidenib (AG-221) across Phase I and Phase I/II development for IDH-mutated hematologic malignancies—such as acute myeloid leukemia, myeloproliferative neoplasms, and chronic myelomonocytic leukemia—and advanced solid tumors including glioma, chondrosarcoma, intrahepatic cholangiocarcinoma, and angioimmunoblastic T-cell lymphoma. Led by industry sponsors including Celgene Corporation and Agios Pharmaceuticals alongside academic medical centers such as Massachusetts General Hospital and the University of Chicago, these studies range from completed safety and pharmacokinetic evaluations in healthy volunteers to active recruitment for combination therapies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04955938	Recruiting	IDH Mutation\|IDH1 Mutation\|IDH2 Gene Mutation\|Blood Cancer\|Myeloproliferative Neoplasm	University of Chicago	2021-10-29	Phase 1
NCT03515512	Completed	Acute Myeloid Leukemia\|Chronic Myelomonocytic Leukemia	Massachusetts General Hospital\|Celgene	2018-07-17	Phase 1
NCT02273739	Completed	Solid Tumor\|Glioma\|Angioimmunoblastic T-cell Lymphoma\|Intrahepatic Cholangiocarcinoma\|Chondrosarcoma	Celgene\|Celgene Corporation	2014-12-08	Phase 1\|Phase 2
NCT02218346	Completed	Healthy Volunteers	Agios Pharmaceuticals Inc.\|Celgene Corporation	2014-08	Phase 1

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

Check the Enasidenib(AG-221) Mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Enasidenib (AG-221) mesylate selectively binds to and inhibits the mutant isocitrate dehydrogenase 2 (IDH2) enzyme, preventing the aberrant reduction of alpha-ketoglutarate to the oncometabolite 2-hydroxyglutarate (2-HG) and thereby reversing hypermethylation-induced blockades in cellular differentiation. By suppressing 2-HG accumulation and restoring normal cell maturation, Enasidenib promotes myeloid differentiation and suppresses tumor cell proliferation, delivering target-directed therapeutic efficacy in IDH2-mutated hematologic malignancies such as acute myeloid leukemia.

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>).