Last reviewed 2026-04-23 · How we verify

FMX103 1.5%

FMX103 is a topical minocycline formulation that reduces bacterial colonization and inflammatory mediators in the skin.

FMX103 is a topical minocycline formulation that reduces bacterial colonization and inflammatory mediators in the skin. Used for Acne vulgaris, Rosacea.

At a glance

Mechanism of action

FMX103 delivers minocycline, a tetracycline antibiotic with anti-inflammatory properties, directly to affected skin areas. The drug works by inhibiting bacterial growth and suppressing inflammatory pathways involved in acne and rosacea pathogenesis. The 1.5% concentration is optimized for topical efficacy while minimizing systemic absorption.

Approved indications

• Acne vulgaris
• Rosacea

Common side effects

• Application site irritation
• Erythema
• Dryness
• Photosensitivity

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.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• FMX103 1.5% CI brief — competitive landscape report
• FMX103 1.5% updates RSS · CI watch RSS
• Vyne Therapeutics Inc. portfolio CI