NDAORALCAPSULE, EXTENDED RELEASE
Approved
Nov 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
5/8 — Partial
EMROSI (minocycline hydrochloride extended-release) by Journey Medical is 12. Approved for inflammatory lesions (papules, pustules) of rosacea in adults, development of drug-resistant bacteria and 2 more indications. First approved in 2024.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMROSI is an extended-release oral capsule formulation of minocycline hydrochloride approved for treating inflammatory lesions (papules and pustules) of rosacea in adults. The mechanism of action and pharmacodynamics for rosacea treatment remain unknown, though minocycline is lipid-soluble and distributes into skin and sebum with a ~15-hour half-life. This represents a novel delivery approach for an established antibiotic class.
Growth12.5 years to LOE
As a newly approved (Nov 2024) product in growth phase with no direct competitors yet listed, the brand team is positioned to build market presence and establish clinical adoption in dermatology.
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of EMROSI for the treatment of rosacea is unknown. 12.2 Pharmacodynamics The pharmacodynamics of EMROSI for the treatment of rosacea are unknown. 12.3 Pharmacokinetics EMROSI is not bioequivalent to any other minocycline products. The…
Indications (5)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.