IDH-305 Clinical Trials

Size	Price	Qty
5mg	USD 649
25mg	USD 1,947

Clinical Trials

A Phase 2 clinical trial sponsored by the University of Texas Southwestern Medical Center investigated the therapeutic potential of the small molecule inhibitor IDH-305. The study was designed to evaluate the intervention in patients with glioma harboring target isocitrate dehydrogenase 1 mutations and presenting with measurable 2-hydroxyglutarate levels. According to clinical registry records, the trial's recruitment status was formally documented as withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02987010	Withdrawn	Glioma	University of Texas Southwestern Medical Center	2017-01	Phase 2

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

Check the IDH-305 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IDH-305 selectively binds to mutant forms of isocitrate dehydrogenase 1 (IDH1 R132), inhibiting its enzymatic activity and blocking the downstream production and aberrant accumulation of the oncometabolite 2-hydroxyglutarate. By suppressing intracellular 2-hydroxyglutarate levels, IDH-305 promotes normal cellular differentiation and inhibits tumor cell proliferation, demonstrating clinical relevance for targeted therapy in IDH1-mutated 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>).