AKLIEF (trifarotene)
Aklief is a topical retinoid cream used to manage acne vulgaris. It is suitable for a wide range of patients, including children as young as nine years old and adults. Healthcare providers prescribe this medication to help clear skin by targeting the underlying biological processes that cause acne breakouts.
How AKLIEF Works
This medication works by targeting specific retinoic acid receptors in the skin, specifically the gamma subtype. When it binds to these receptors, it helps regulate genes involved in skin cell differentiation and the inflammatory response. While the precise way it clears acne is not fully understood, these actions help modify the cellular processes that lead to skin lesions.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-10-04
- Patent Cliff
- 2033
- Routes
- TOPICAL
- Dosage Forms
- CREAM
AKLIEF Approval History
What AKLIEF Treats
1 indicationsAKLIEF is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acne Vulgaris
AKLIEF 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 AKLIEF
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07186413 AKLIEF | CD5789.SPR.205101 | Ph 3 | recruiting | A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris |
| NCT03915860 results posted | RD.06.SPR.118295 | Ph 3 | completed | Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal 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.
AKLIEF FDA Label Details
Indications & Usage
FDA Label (PDF)AKLIEF is indicated for the treatment of Acne Vulgaris.
Pro Intelligence Preview
Deep insights for AKLIEF
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 3 active patents
Trial Analysis
- • 3 total trials
- • Stage: Expansion
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment