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FMX-101, 4% minocycline foam
Minocycline, a tetracycline antibiotic, reduces inflammation and bacterial colonization in acne by inhibiting bacterial protein synthesis and suppressing inflammatory mediators.
Minocycline, a tetracycline antibiotic, reduces inflammation and bacterial colonization in acne by inhibiting bacterial protein synthesis and suppressing inflammatory mediators. Used for Acne vulgaris.
At a glance
| Generic name | FMX-101, 4% minocycline foam |
|---|---|
| Sponsor | Vyne Therapeutics Inc. |
| Drug class | Tetracycline antibiotic |
| Target | Bacterial ribosome (30S subunit); also has anti-inflammatory effects on host immune cells |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Minocycline is a broad-spectrum tetracycline antibiotic that works through multiple mechanisms in acne treatment: it inhibits bacterial protein synthesis to reduce Cutibacterium acnes (formerly Propionibacterium acnes) proliferation, and it also has anti-inflammatory properties that suppress cytokine production and neutrophil activation independent of its antimicrobial effects. The 4% foam formulation provides topical delivery to affected skin areas while minimizing systemic absorption.
Approved indications
- Acne vulgaris
Common side effects
- Application site irritation
- Erythema
- Dryness
- Photosensitivity
Key clinical trials
- To Evaluate the Efficacy and Safety of Minocycline Hydrochloride Foam in the Treatment of Moderate-to-severe Acne Vulgaris (PHASE3)
- A Companion Treatment Study for Patients With Moderate to Severe Acne Vulgaris (PHASE4)
- A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris (PHASE3)
- A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne (PHASE3)
- A Pharmacokinetic Study of Minocycline in Male and Female Volunteers (PHASE1)
- Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Rosacea Patients (PHASE2)
- Study to Evaluate the Safety and Efficacy of Topical Minocycline FXFM244 in Impetigo Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FMX-101, 4% minocycline foam CI brief — competitive landscape report
- FMX-101, 4% minocycline foam updates RSS · CI watch RSS
- Vyne Therapeutics Inc. portfolio CI