PF-06840003 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 447

Clinical Trials

A Phase 1 clinical trial sponsored by Pfizer was initiated to assess the safety, tolerability, and dosing of PF-06840003 in patients with malignant neuro-oncological conditions, specifically malignant glioma, astrocytoma, and oligodendroglioma. Although intended to establish the safety profile of the candidate, the study's recruitment status was ultimately reported as terminated. Consequently, clinical evidence for PF-06840003 remains restricted to this early-phase investigation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02764151	TERMINATED	Oligodendroglioma; Astrocytoma; Malignant Glioma	Pfizer	2016-09-09	PHASE1

(data from https://clinicaltrials.gov, updated on 2020-01-27)

Check the PF-06840003 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06840003 is an orally bioavailable, highly selective inhibitor of indoleamine 2,3-dioxygenase 1 that binds the enzyme to block the biochemical catabolism of L-tryptophan into kynurenine. By suppressing kynurenine-mediated immunosuppression and restoring effector T-cell function, PF-06840003 enhances anti-tumor immunity in malignancies such as malignant glioma, astrocytoma, and oligodendroglioma.

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>).