Carbetapentane Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Several clinical trials are evaluating interventions across various development stages—including Early Phase 1, Phase 1/Phase 2, and Not Applicable—for conditions such as esophageal squamous cell carcinoma, mild cognitive impairment, depression, COVID long-haul, post-traumatic stress disorder, and cognitive decline. Featuring recruitment statuses ranging from recruiting and not yet recruiting to withdrawn, these investigations are supported by pharmaceutical entities such as Servier alongside academic and government institutions, including Johns Hopkins University, the Medical University of South Carolina, the University of Utah, Ohio State University, and the National Institute on Aging.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05312372	Withdrawn	Esophageal Squamous Cell Carcinoma	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2025-05	Phase 1\|Phase 2
NCT05992831	Recruiting	Mild Cognitive Impairment\|Depression	Medical University of South Carolina\|National Institute on Aging (NIA)	2024-07-15	Not Applicable
NCT06223971	Recruiting	COVID Long-Haul	Johns Hopkins University\|Radiological Society of North America	2024-05-20	Early Phase 1
NCT06135064	Not yet recruiting	PTSD	University of Utah	2024-04	Phase 1\|Phase 2
NCT06223672	Recruiting	Cognitive Decline\|Cognitive Impairment	Ohio State University\|United States Department of Agriculture (USDA)\|The California Walnut Commission	2024-02-07	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carbetapentane functions as a nonselective sigma-1 receptor agonist that modulates intracellular calcium mobilization and downstream neurochemical signaling within the central nervous system. By suppressing central cough reflex pathways and dampening excessive neuronal excitability, this agent exerts antitussive and anticonvulsant activity relevant to clinical indications and ongoing investigations in cognitive and neurological disorders.

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>).