NDAOTICSOLUTION/DROPSPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
CLOTIC (clotrimazole) by Inpharmus is 12. First approved in 2025.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLOTIC (clotrimazole) is an azole antifungal agent administered as an otic solution for topical ear infections. It works by inhibiting fungal cytochrome P450-dependent enzyme lanosterol 14-α-demethylase, disrupting ergosterol biosynthesis and causing fungal cell membrane damage and lysis. The drug targets Candida and Aspergillus species with minimal systemic absorption.
Launch15.9 years to LOE
Recently approved otic antifungal with no established market share; early-stage launch team focused on market penetration and prescriber education in a narrow indication.
Mechanism of Action
12.1 Mechanism of Action Clotrimazole is an azole antifungal agent [see ] . 12.2 Pharmacodynamics Clotrimazole exposure-response relationships and the time course of pharmacodynamic response are unknown. 12.3 Pharmacokinetics Systemic absorption following topical administration of CLOTIC is…
Pharmacologic Class:
Azole Antifungal
Indications
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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.