PF-04418948 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 497

Clinical Trials

The clinical trial landscape for PF-04418948 consists of a clinical trial sponsored by Pfizer. This completed Phase 1 study evaluated the compound in healthy subjects through a randomized, dose-escalating protocol to assess overall safety, tolerability, and pharmacokinetics. Consequently, available clinical data remain limited to early-stage safety profiling in healthy volunteers, with no trials currently targeting specific disease conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01002963	COMPLETED	Healthy	Pfizer	2009-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2010-10-25)

Check the PF-04418948 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-04418948 acts as a potent and selective prostaglandin EP₂ receptor antagonist with an IC50 of 16 nM, binding specifically to the receptor to block G-protein-coupled signaling and downstream intracellular cyclic AMP generation. This inhibition attenuates EP₂-mediated cellular activation and inflammatory signaling cascades, providing the mechanistic rationale for its clinical evaluation in Phase 1 trials assessing safety and tolerability in healthy volunteers.

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>).