Otenabant (CP-945598) HCl Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 570

Clinical Trials

Multiple completed, industry-sponsored clinical trials conducted by Pfizer have evaluated Otenabant (CP-945598) primarily for metabolic indications, specifically obesity and non-alcoholic steatohepatitis (NASH). These studies range from Phase 1 assessments of pharmacokinetics, drug interactions, and safety to a Phase 2/3 trial evaluating dose-dependent weight loss efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00706537	Completed	Non-Alcoholic Steatohepatitis(NASH)	Pfizer	2008-07	Phase 1
NCT00644839	Completed	Obesity	Pfizer	2008-04	Phase 1
NCT00645463	Completed	Obesity	Pfizer	2007-03	Phase 1
NCT00134199	Completed	Obesity	Pfizer	2005-03	Phase 2\|Phase 3

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

Check the Otenabant (CP-945598) HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Otenabant (CP-945598) selectively binds to the cannabinoid receptor CB1 with nanomolar affinity, blocking G-protein-coupled endocannabinoid signaling to suppress intracellular lipogenic pathways and neural appetite signals. This targeted pathway inhibition reduces energy intake and hepatic fat accumulation, providing the mechanistic rationale for its clinical evaluation in treating obesity and non-alcoholic steatohepatitis.

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>).