Stiripentol (BCX 2600) Clinical Trials

Size	Price	Qty
10mg	USD 147
100mg	USD 449

Clinical Trials

Numerous clinical trials evaluate stiripentol across Phase 1 through Phase 4 protocols, comprising completed, recruiting, and expanded access studies sponsored by pharmaceutical entities (e.g., Biocodex, Jazz Pharmaceuticals) and research institutions including the Mayo Clinic and Assistance Publique - Hôpitaux de Paris. These investigations focus on severe pediatric and refractory neurological conditions—such as Dravet syndrome, pharmacoresistant focal epilepsies, status epilepticus, and SCN1A mutation-associated epileptic encephalopathies—as well as primary hyperoxaluria and chronic renal insufficiency. Additionally, trials assess pharmacokinetic profiles, drug-drug interaction safety, and monotherapy or adjunctive treatment regimens across diverse patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06465472	NOT_YET_RECRUITING	Primary Hyperoxaluria Type 1; Primary Hyperoxaluria Type 2; Primary Hyperoxaluria Type 3	Biocodex	2024-08	PHASE3
NCT07176832	COMPLETED	Dravet Syndrome; Epilepsy; Childhood; Epileptic Encephalopathy; Pediatric Epilepsy	Biocodex	2025-06-01	PHASE1
NCT05735951	COMPLETED	Chronic Renal Insufficiency	Biocodex	2023-07-24	PHASE1
NCT05419180	COMPLETED	Pharmacoresistant Focal Epilepsies	Biocodex	2022-10-13	PHASE4
NCT05735951	Recruiting	Chronic Renal Insufficiency	Biocodex	2023-07-24	Phase 1
NCT05419180	Unknown status	Pharmacoresistant Focal Epilepsies	Biocodex	2022-10-13	Phase 4
NCT03819647	COMPLETED	Primary Hyperoxaluria	Biocodex	2019-05-21	PHASE2
NCT02607904	COMPLETED	Epilepsy	Jazz Pharmaceuticals	2016-12-15	PHASE2
NCT03819647	Completed	Primary Hyperoxaluria	Biocodex	2019-05-21	Phase 2
NCT03866928	COMPLETED	Healthy Volunteers	Biocodex	2019-02-12	PHASE1
NCT02607891	COMPLETED	Epilepsy	Jazz Pharmaceuticals	2016-11-09	PHASE2
NCT02926898	COMPLETED	Dravet Syndrome	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.	2017-01-27	PHASE3

(data from https://clinicaltrials.gov, updated on 2024-06-18)

Check the Stiripentol (BCX 2600) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Stiripentol enhances central GABAergic neurotransmission and functions as an inhibitor of cytochrome P450 enzymes, which suppresses repetitive high-frequency neuronal firing by augmenting inhibitory synaptic activity. This dual mechanism of central inhibition and altered hepatic drug clearance decreases pathological seizure activity, offering critical therapeutic benefit in clinical conditions such as Dravet syndrome, pharmacoresistant focal epilepsies, and status epilepticus.

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>).