Clinical Trials

The clinical trial landscape for PF-06273340 comprises multiple Phase 1 clinical trials sponsored entirely by Pfizer. These early-stage evaluations enrolled healthy volunteers as well as subjects evaluated for pain conditions to assess safety, tolerability, pharmacokinetics, relative bioavailability, pharmacodynamics, dose escalation, and formulation performance. Having completed recruitment, these trials established the initial clinical characterization of the agent in human subjects.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02260947 COMPLETED
Healthy
Pfizer
 2014-10 PHASE1
NCT01934738 COMPLETED
Healthy
Pfizer
 2013-10 PHASE1
NCT01706796 COMPLETED
Healthy
Pfizer
 2012-11 PHASE1
NCT01601834 COMPLETED
PAIN
Pfizer
 2012-05 PHASE1

(data from https://clinicaltrials.gov, updated on 2015-02-04)

Check the PF-06273340 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06273340 is a potent pan-tropomyosin receptor kinase inhibitor that selectively binds to TrkA, TrkB, and TrkC, thereby suppressing neurotrophin-mediated downstream signaling cascades and nociceptive signal transduction in sensory neurons. By attenuating Trk kinase activity and inhibiting downstream biochemical pathways, the compound blocks primary pain pathway transmission, providing the mechanistic rationale for its clinical evaluation in pain conditions.

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>).

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Note: Technical data last updated: Sep 1, 2026.