D-Cycloserine Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials evaluate D-cycloserine across Phase 1, Phase 3, and Phase 4 stages for neuropsychiatric and substance use conditions, including major depressive disorder, schizophrenia, smoking cessation, and nicotine addiction. Sponsored by academic and government research institutions such as Massachusetts General Hospital, the University of Calgary, Baylor College of Medicine, the National Institute of Mental Health, and the National Institute on Drug Abuse, these studies report both completed and withdrawn statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05731323	Completed	Major Depressive Disorder	University of Calgary	2022-10-12	Phase 1
NCT01399866	Completed	Smoking Cessation	Massachusetts General Hospital	2011-05	Phase 3
NCT00964041	Withdrawn	Schizophrenia	Massachusetts General Hospital\|National Institute of Mental Health (NIMH)	2009-07	Phase 4
NCT01062932	Completed	Nicotine Addiction	Baylor College of Medicine\|National Institute on Drug Abuse (NIDA)	2009-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a structural analog of D-alanine, D-cycloserine competitively inhibits L-alanine racemase and D-alanylalanine synthetase, thereby blocking the formation of D-alanine and its incorporation into the bacterial peptidoglycan precursor pentapeptide. This enzymatic block disrupts cell wall assembly to induce osmotic lysis, providing the foundation for its antibiotic action and its clinical evaluation in neurological conditions such as major depressive disorder and schizophrenia.

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>).