CLOTIC

LaunchSM

clotrimazole

NDAOTICSOLUTION/DROPSPriority Review
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
6

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

Clinical Trials (5)

NCT03599323N/ACompleted

Study on the Safety of the Approved Product Empedic L Cream During Its Routine Use (Active Ingredient is Clotrimazole 1%)

Started Jul 2018
1,033 enrolled
Vaginal Candida
NCT02180828Phase 4Completed

Clotrimazole Vaginal Tablet vs Fluconazole for Severe Vulvovaginal Candidiasis

Started Jul 2014
240 enrolled
Candidiasis, Vulvovaginal
NCT01993823Phase 3Completed

Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis

Started May 2013
NCT02184351Phase 3Completed

Clotrimazole vs. Mycelex® in Patients With Human Insufficiency Virus (HIV) Infection for the Treatment of Oropharyngeal Candidiasis

Started May 2001
187 enrolled
Candidiasis, Oral
NCT00002282N/ACompleted

A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS

Candidiasis, OralHIV Infections

Loss of Exclusivity

LOE Date
May 26, 2042
197 months away
Patent Expiry
May 26, 2042
Exclusivity Expiry
Sep 26, 2033

Patent Records (1)

Patent #ExpiryTypeUse Code
12246006
May 26, 2042
Product
U-4276