DS-1001b (DS 1001) Clinical Trials

Size	Price	Qty
5mg	USD 217

Clinical Trials

Multiple clinical trials evaluate DS-1001b for the targeted treatment of central nervous system malignancies, specifically investigating IDH1-mutated gliomas and chemotherapy- and radiotherapy-naive WHO Grade II gliomas. Sponsored by Daiichi Sankyo, these studies span Phase I safety evaluations to Phase II efficacy trials. Current recruitment statuses across these protocols include both completed studies and active, non-recruiting trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04458272	ACTIVE_NOT_RECRUITING	WHO Grade II Glioma	Daiichi Sankyo Co., Ltd.	2020-07-08	PHASE2
NCT03030066	COMPLETED	Glioma	Daiichi Sankyo	2017-01-19	PHASE1
NCT04458272	Active not recruiting	WHO Grade II Glioma	Daiichi Sankyo Co. Ltd.\|Daiichi Sankyo	2020-07-08	Phase 2
NCT03030066	Active not recruiting	Glioma	Daiichi Sankyo	2017-01-19	Not Applicable

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the DS-1001b (DS 1001) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DS-1001b selectively binds to and inhibits mutant isocitrate dehydrogenase 1 (IDH1 R132X), blocking the abnormal cellular accumulation of the oncometabolite 2-hydroxyglutarate to promote cell differentiation and suppress malignant growth. By penetrating the blood-brain barrier to attenuate mutant IDH1 biochemical activity, this targeted inhibitor provides direct therapeutic relevance for halting tumor progression in patients with IDH1-mutated WHO Grade II 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>).