CABTREO (adapalene)
Cabtreo is a fixed-dose, triple-combination topical gel containing clindamycin phosphate (a lincosamide antibacterial), adapalene (a retinoid), and benzoyl peroxide. It is indicated for the topical treatment of acne vulgaris in adult and pediatric patients aged 12 years and older. By combining three distinct active ingredients, Cabtreo addresses multiple pathogenic factors of acne, including bacterial proliferation, follicular hyperkeratinization, and inflammation.
How CABTREO Works
Cabtreo utilizes three components with different mechanisms of action: * **Adapalene:** A retinoid that binds to specific retinoic acid nuclear receptors to modulate cellular differentiation, keratinization, and inflammatory processes. * **Clindamycin:** A lincosamide antibacterial that suppresses the growth of *Cutibacterium acnes*. * **Benzoyl Peroxide:** An oxidizing agent with bactericidal and keratolytic effects. While these biochemical profiles are established, the FDA label notes that the precise significance of these findings and the exact mechanism of action in the treatment of acne are not fully known.
Details
- Status
- Prescription
- First Approved
- 2023-10-20
- Patent Cliff
- 2040
- Routes
- TOPICAL
- Dosage Forms
- GEL
CABTREO Approval History
What CABTREO Treats
1 indicationsCABTREO is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
CABTREO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 CABTREO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01213199 results posted | RD.03.SPR.29088 | Ph 2 | completed | Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars |
| NCT00660985 results posted | RD.06.SPR.18115 | Ph 4 | completed | Pharmacokinetic Study to Compare the Systemic Exposure of Differin® Gel, 0.3% or Differin® Gel, 0.1% |
| NCT03626298 | PapulexPaper1 | Ph 4 | completed | Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia |
| NCT01406080 FOTEN | BR.10.002 | Ph 3 | completed | A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CABTREO FDA Label Details
Indications & Usage
FDA Label (PDF)CABTREO is indicated for the treatment of Acne Vulgaris.
CABTREO Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for CABTREO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.