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FMX-103 1.5%
FMX-103 1.5% is a Topical tetracycline antibiotic Small molecule drug developed by Vyne Therapeutics Inc.. It is currently in Phase 2 development. Also known as: Minocycline foam 1.5%.
Topical minocycline formulation that provides anti-inflammatory and antimicrobial effects through inhibition of bacterial protein synthesis and modulation of inflammatory pathways.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | FMX-103 1.5% |
|---|---|
| Also known as | Minocycline foam 1.5% |
| Sponsor | Vyne Therapeutics Inc. |
| Drug class | Topical tetracycline antibiotic |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Minocycline is a tetracycline-class antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Beyond its antimicrobial activity against Cutibacterium acnes, minocycline exhibits anti-inflammatory properties that may help reduce acne lesions and inflammation.
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Long-Term Safety of Topical Administration of FMX103 in the Treatment of Moderate to Severe Papulopustular Rosacea (PHASE3)
- A Study (Study 1) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea (PHASE3)
- A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea (PHASE3)
- Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea (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-103 1.5% CI brief — competitive landscape report
- FMX-103 1.5% updates RSS · CI watch RSS
- Vyne Therapeutics Inc. portfolio CI
Frequently asked questions about FMX-103 1.5%
What is FMX-103 1.5%?
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Is FMX-103 1.5% also known as anything else?
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Related
- Drug class: All Topical tetracycline antibiotic drugs
- Manufacturer: Vyne Therapeutics Inc. — full pipeline
- Also known as: Minocycline foam 1.5%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing