Clinical Trials

PF-05175157 has been evaluated in numerous Pfizer-sponsored Phase 1 and Phase 2 clinical trials across metabolic and dermatological conditions, including type 2 diabetes mellitus, glucose metabolism disorders, acne vulgaris, and healthy volunteer cohorts. Early Phase 1 studies assessing safety, tolerability, and pharmacokinetics successfully achieved completed recruitment status. In contrast, several mid-stage Phase 2a efficacy trials in patients with type 2 diabetes or moderate-to-severe acne vulgaris were terminated or withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02100527 WITHDRAWN
Acne Vulgaris
Pfizer
 2014-04 PHASE2
NCT01792635 TERMINATED
Diabetes Mellitus, Type 2
Pfizer
 2012-12 PHASE2
NCT02100527 Withdrawn
Acne Vulgaris
Pfizer
 2014-04 Phase 2
NCT02053116 TERMINATED
Type 2 Diabetes Mellitus
Pfizer
 2014-03 PHASE2
NCT02053103 TERMINATED
Type 2 Diabetes Mellitus
Pfizer
 2014-03 PHASE2
NCT02053116 Terminated
Type 2 Diabetes Mellitus
Pfizer
 2014-03 Phase 2
NCT02053103 Terminated
Type 2 Diabetes Mellitus
Pfizer
 2014-03 Phase 2
NCT01819922 COMPLETED
Healthy
Pfizer
 2013-04 PHASE1
NCT01807377 COMPLETED
Diabetes Mellitus Type 2
Pfizer
 2013-04 PHASE1
NCT01807377 Completed
Diabetes Mellitus Type 2
Pfizer
 2013-04 Phase 1
NCT01821079 COMPLETED
Healthy
Pfizer
 2013-03 PHASE1
NCT01792635 Terminated
Diabetes Mellitus Type 2
Pfizer
 2012-12 Phase 2
NCT01757756 COMPLETED
Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
Pfizer
 2012-10 PHASE1
NCT01537497 COMPLETED
Diabetes Mellitus, Type 2
Pfizer
 2012-03 PHASE1
NCT01433380 COMPLETED
Diabetes Mellitus, Type 2
Pfizer
 2011-07 PHASE1
NCT01537497 Completed
Diabetes Mellitus Type 2
Pfizer
 2012-03 Phase 1
NCT01396161 COMPLETED
Diabetes Mellitus, Type 2
Pfizer
 2011-07 PHASE1
NCT01469468 COMPLETED
Type 2 Diabetes Mellitus
Pfizer
 2011-11 PHASE1
NCT01274663 COMPLETED
Diabetes Mellitus, Type 2
Pfizer
 2010-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2014-05-13)

Check the PF-05175157 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-05175157 acts as a broad-spectrum inhibitor of acetyl-CoA carboxylase 1 (ACC1) and ACC2, blocking the carboxylation of acetyl-CoA to malonyl-CoA and thereby suppressing cellular de novo lipogenesis. By decreasing lipid accumulation and altering lipid metabolic flux, this targeted enzymatic inhibition provides the therapeutic rationale for its evaluation in clinical trials for type 2 diabetes mellitus and acne vulgaris.

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.