BT2 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Multiple clinical trials involving this research compound encompass Phase 2 and Phase 4 studies targeting diabetes mellitus and acute ischemic stroke. Sponsored by entities such as Dong-A ST Co., Ltd. and the General Hospital of Shenyang Military Region, these investigations evaluate therapeutic efficacy and intervention timing. Recruitment statuses currently range from not yet recruiting to actively recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06010628	RECRUITING	Stroke, Ischemic	General Hospital of Shenyang Military Region	2024-02-01	PHASE4
NCT07239440	NOT_YET_RECRUITING	Diabete Mellitus	Dong-A ST Co., Ltd.	2025-11	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-08-21)

Check the BT2 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BT2 selectively binds to and inhibits branched-chain α-ketoacid dehydrogenase complex kinase (BDK) with an IC50 of 3.19 μM, preventing the phosphorylation and inactivation of the rate-limiting mitochondrial dehydrogenase complex. This biochemical inhibition restores downstream oxidation of branched-chain amino acids, improving cellular metabolic balance and demonstrating potential therapeutic relevance in conditions such as diabetes mellitus and ischemic stroke.

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>).