TheraRadar
Data updated: Jun 28, 2026

CLOTIC (clotrimazole) · CARWIN PHARM ASSOC

Infectious Disease Approved 2025-09-26

Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2025-09-26
Patent Cliff
2042

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Routes
OTIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: CLOTRIMAZOLE

CLOTIC Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Sep 2025 ORIGINAL Priority
New Form · Type 3 - New Dosage Form

What CLOTIC Treats

3 indications

CLOTIC is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

CLOTIC Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CLOTIC

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Shared indications:
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
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Shared indications:
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SULCONAZOLE NITRATE
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT03005353 CSE Ph 2, Ph 3 completed Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.
NCT03115073 ProF-001_Phase IIa Ph 2, Ph 3 completed ProF-001_Phase IIa
NCT02847286 IPM 036 Ph 1 completed To Assess the Drug-drug Interaction Potential Between Dapivirine Vaginal Ring-004, Containing 25 mg of Dapivirine, and Clotrimazole 10 mg/g (1%)
NCT01993823 results posted G238OTIII/11IA01 Ph 3 completed Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis
NCT02713139 Frauen ACH-CLP-03(05/12) Ph 3 withdrawn Efficacy and Safety of the Association of Clotrimazole and Metronidazole in the Treatment of Vaginal Discharge From Different Etiologies.
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CLOTIC FDA Label Details

Indications & Usage

FDA Label (PDF)

Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

View full patent landscape →
1 OB patents · 1 families · 38 international docs across 28 countries

CLOTIC Patents & Exclusivity

Latest Patent: May 2042
Exclusivity: Sep 2033

Patents (1 active)

US12246006 Expires May 26, 2042

Exclusivity

NP Until Sep 2028
GAIN Until Sep 2033
Source: FDA Orange Book

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Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2042
  • 1 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 17 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.