FMX103 minocycline foam 1.5% — Competitive Intelligence Brief

FMX103 minocycline foam 1.5% (FMX103 minocycline foam 1.5%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Tetracycline antibiotic. Area: Dermatology.

phase 3 Tetracycline antibiotic Bacterial ribosome (30S subunit); also has anti-inflammatory effects on host immune mediators Dermatology Small molecule

Target snapshot

FMX103 minocycline foam 1.5% (FMX103 minocycline foam 1.5%) — Vyne Therapeutics Inc.. Minocycline, a tetracycline antibiotic, reduces inflammation and bacterial colonization in acne by inhibiting bacterial protein synthesis and suppressing inflammatory mediators.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
FMX103 minocycline foam 1.5% TARGET	FMX103 minocycline foam 1.5%	Vyne Therapeutics Inc.	phase 3	Tetracycline antibiotic	Bacterial ribosome (30S subunit); also has anti-inflammatory effects on host immune mediators
Vibramycin	doxycycline	Generic (originally Pfizer)	marketed	Tetracycline antibiotic	72 kDa type IV collagenase, Stromelysin-1, Collagenase 3	1967-01-01
Minocycline HCl Microspheres	Minocycline HCl Microspheres	OraPharma	marketed	Tetracycline antibiotic	Bacterial 30S ribosome
Minocycline HCl	Minocycline HCl	OraPharma	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
Doxycycline Hyclate Enteric-Coated Capsules	Doxycycline Hyclate Enteric-Coated Capsules	The Third Xiangya Hospital of Central South University	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit
Minocycline plus tretinoin	Minocycline plus tretinoin	Derm Research @ 888 Inc.	marketed	Tetracycline antibiotic + retinoid combination	Bacterial ribosome (minocycline); retinoic acid receptors (tretinoin)
Omadacycline Injection	Omadacycline Injection	Wake Forest University Health Sciences	marketed	Tetracycline antibiotic	Bacterial 30S ribosomal subunit

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2027-12-19 — Vibramycin · 7749532 · Formulation · US

Sponsor landscape (Tetracycline antibiotic class)

1. OraPharma · 2 drugs in this class
2. Vyne Therapeutics Inc. · 2 drugs in this class
3. Beijing Tiantan Hospital · 1 drug in this class
4. Clinica Universidad de Navarra, Universidad de Navarra · 1 drug in this class
5. Darier · 1 drug in this class
6. Edward Lain, MD · 1 drug in this class
7. Generic (originally Pfizer) · 1 drug in this class
8. Galderma R&D · 1 drug in this class
9. Johns Hopkins University · 1 drug in this class
10. Chinese University of Hong Kong · 1 drug in this class