Overview
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Indication
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Associated Conditions
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Research Report
Comprehensive Report on PF-07905428: An Investigational Topical Agent for Acne Vulgaris
1. Executive Summary
PF-07905428 is an investigational drug candidate under development by Pfizer Inc. for the topical treatment of acne vulgaris. Currently in Phase 1 clinical trials, its primary evaluation centers around safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical effects in both healthy volunteers and individuals with acne. The sole publicly identified clinical trial is NCT06671834 (C5441001), a randomized, double-blind, placebo-controlled, dose-escalation study being conducted in Canada, with an estimated primary completion date of October 15, 2025.
Significant information gaps exist regarding PF-07905428, most notably its precise mechanism of action and chemical structure, which are currently reported as "Unknown" or "N/A" in available databases. However, it is also stated that the compound does not possess a "Novel Mechanism," suggesting that its intended biological target or pathway may be established, even if its application in acne or the specific molecular entity is new. The drug is administered as a topical solution in low (0.08%) and high (0.24%) strengths. Given its early stage of development, the likelihood of approval is currently estimated at 4%, a figure typical for Phase 1 assets. Future disclosures from Pfizer regarding the compound's properties and clinical trial outcomes will be critical in assessing its therapeutic potential and position within the acne treatment landscape.
2. Introduction to PF-07905428
Overview
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/04 | Phase 1 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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