TWYNEO (benzoyl peroxide)
TWYNEO is indicated for the treatment of Acne Vulgaris.
How TWYNEO Works
This medication works by combining the bactericidal and skin-clearing properties of benzoyl peroxide with the cellular effects of tretinoin. Tretinoin binds to specific receptors to modify cell growth and decrease the stickiness of skin cells, which helps prevent new clogs from forming. Additionally, it increases the turnover of skin cells to help clear out existing acne lesions.
Details
- Status
- Prescription
- First Approved
- 2021-07-26
- Patent Cliff
- 2041
- Routes
- TOPICAL
- Dosage Forms
- CREAM
TWYNEO Approval History
What TWYNEO Treats
1 indicationsTWYNEO is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
TWYNEO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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 TWYNEO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05536882 | IRB# 14663 | Ph 3 | withdrawn | MC RCT - BPO vs Adapalene |
| NCT04548349 results posted | 2020P000595 | Ph 4 | completed | Profiling the Skin Microbiome in Response to Altreno in Acne Patients |
| NCT02589405 Benzac results posted | RD.03.SPR.105041 | Ph 4 | completed | Benzac 5% Gel in Combination With Cosmetic Products in Acne Vulgaris |
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.
TWYNEO FDA Label Details
Indications & Usage
FDA Label (PDF)TWYNEO is indicated for the treatment of Acne Vulgaris.
TWYNEO Patents & Exclusivity
Patents (13 active)
Pro Intelligence Preview
Deep insights for TWYNEO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 13 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.