PF-04457845 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Several clinical trials sponsored by Pfizer have evaluated the safety, pharmacodynamics, and efficacy of PF-04457845 across Phase 1 and Phase 2 studies. These investigations focused on acute and chronic pain management, polysomnographic sleep endpoints in healthy volunteers, and therapeutic outcomes in knee osteoarthritis flare-ups. Overall, trial recruitment is primarily completed, although a Phase 1 sleep evaluation was terminated prematurely.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01092845	Completed	Healthy\|Sleep	Pfizer	2010-04	Phase 1
NCT01002625	Terminated	Sleep\|Healthy Volunteers	Pfizer	2009-11	Phase 1
NCT00981357	Completed	Osteoarthritis Knee	Pfizer	2009-11	Phase 2
NCT00836082	Completed	Acute Pain\|Chronic Pain	Pfizer	2009-02	Phase 1

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

Check the PF-04457845 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-04457845 functions as a potent, selective inhibitor of fatty acid amide hydrolase (FAAH) by covalently binding to the active-site serine nucleophile, thereby preventing the enzymatic degradation of endogenous endocannabinoids such as anandamide. By elevating endocannabinoid signaling tone, this inhibition dampens nociceptive neurotransmission and modulates central sleep pathways, providing a rationale for its investigation in clinical trials for chronic pain, knee osteoarthritis, and sleep 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>).