PH-797804 Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials, primarily sponsored by Pfizer, have evaluated PH-797804 to assess its safety, pharmacokinetics, and therapeutic efficacy. These investigations focused on healthy volunteers as well as patients with inflammatory and pain-related conditions, including rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), osteoarthritis, and postherpetic neuralgia. Although a small number of studies were withdrawn prior to evaluation, most of the trials have reached completed status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01924650	WITHDRAWN	Healthy	Pfizer	2014-03	PHASE1
NCT01543919	COMPLETED	Pulmonary Disease, Chronic Obstructive	Pfizer	2012-04	PHASE2
NCT01862887	COMPLETED	Healthy	Pfizer	2013-04	PHASE1
NCT01589614	COMPLETED	Healthy	Pfizer	2012-06	PHASE1
NCT01321463	COMPLETED	Pulmonary Disease, Chronic Obstructive	Pfizer	2011-05	PHASE2
NCT01479647	COMPLETED	Healthy Volunteers	Pfizer	2011-12	PHASE1
NCT01314885	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Pfizer	2011-01	PHASE1
NCT01226693	COMPLETED	Healthy	Pfizer	2010-11	PHASE1
NCT01217918	COMPLETED	Healthy	Pfizer	2010-10	PHASE1
NCT01102660	COMPLETED	Osteoarthritis	Pfizer	2010-05	PHASE2
NCT01217918	Completed	Healthy	Pfizer	2010-10	Phase 1
NCT00559910	COMPLETED	Chronic Obstructive Pulmonary Disease	Pfizer	2008-02	PHASE2
NCT00827515	WITHDRAWN	Pain	Pfizer	2009-02	PHASE1
NCT00827515	Withdrawn	Pain	Pfizer	2009-02	Phase 1
NCT00614705	COMPLETED	Neuralgia, Postherpetic	Pfizer	2008-04	PHASE2
NCT00620685	COMPLETED	Arthritis, Rheumatoid	Pfizer	2008-03	PHASE2
NCT00383188	COMPLETED	Arthritis, Rheumatoid	Pfizer	2006-12-15	PHASE2
NCT00614705	Completed	Neuralgia Postherpetic	Pfizer	2008-04	Phase 2
NCT00620685	Completed	Arthritis Rheumatoid	Pfizer	2008-03	Phase 2
NCT02084485	COMPLETED	Healthy	Pfizer	2006-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2013-12-20)

Check the PH-797804 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PH-797804 is a potent, ATP-competitive inhibitor that reversibly binds to the alpha isoform of p38 mitogen-activated protein (MAP) kinase, thereby suppressing downstream signaling and preventing the cellular production of key proinflammatory cytokines, such as tumor necrosis factor and prostaglandin E2. By suppressing these cytokine-driven inflammatory cascades, the compound attenuates chronic systemic and localized joint inflammation, providing the biochemical basis for its clinical evaluation in inflammatory and pain conditions such as rheumatoid arthritis, chronic obstructive pulmonary disease, and postherpetic neuralgia.

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>).