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FMX101
FMX101 is a topical foam formulation of minocycline that reduces bacterial colonization and inflammation in acne-prone skin.
FMX101 is a topical foam formulation of minocycline that reduces bacterial colonization and inflammation in acne-prone skin. Used for Moderate acne vulgaris.
At a glance
| Generic name | FMX101 |
|---|---|
| Sponsor | Vyne Therapeutics Inc. |
| Drug class | Topical tetracycline antibiotic |
| Target | Bacterial ribosome (30S subunit); inflammatory mediators |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
FMX101 delivers minocycline, a tetracycline antibiotic, in a novel foam vehicle designed for enhanced skin penetration and reduced systemic absorption. The drug works by inhibiting bacterial protein synthesis to reduce Cutibacterium acnes (formerly Propionibacterium acnes) and by suppressing inflammatory pathways involved in acne pathogenesis. The foam formulation improves patient compliance and tolerability compared to traditional oral or topical formulations.
Approved indications
- Moderate acne vulgaris
Common side effects
- Application site irritation
- Erythema
- Dryness
- Photosensitivity
Key clinical trials
- Minocycline as Adjunctive Treatment for Treatment Resistant Depression (PHASE3)
- Optimization of Minocycline for Helicobacter Pylori Rescue Treatment (PHASE4)
- Minocycline in Stroke Study at Maimonides (PHASE2, PHASE3)
- Comparing Two Medicines for Healing Jaw Bone Infections After Root Canal Treatment (NA)
- Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (PHASE2)
- Topical Minocycline for CARP (EARLY_PHASE1)
- Minocycline Efficacy in Improving Neurological Outcome of Patients Who Undergo Endovascular Revascularization for Acute Ischemic Stroke (PHASE2)
- Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories (NA)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |