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Trifarotene cream
Trifarotene is a selective retinoid X receptor (RXR) agonist that modulates gene expression to reduce inflammation and normalize skin cell differentiation in acne.
Trifarotene is a selective retinoid X receptor (RXR) agonist that modulates gene expression to reduce inflammation and normalize skin cell differentiation in acne. Used for Acne vulgaris.
At a glance
| Generic name | Trifarotene cream |
|---|---|
| Also known as | AKLIEF, Aklief, AKLIEF® |
| Sponsor | Galderma R&D |
| Drug class | Selective retinoid X receptor (RXR) agonist |
| Target | Retinoid X receptor (RXR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Trifarotene selectively activates retinoid X receptors (RXR), which are nuclear receptors involved in regulating genes associated with inflammation, sebum production, and keratinocyte differentiation. By binding to RXR, it reduces inflammatory cytokines and normalizes follicular keratinization, addressing multiple pathogenic factors in acne. This mechanism differs from traditional retinoids like tretinoin, which bind to retinoic acid receptors (RAR).
Approved indications
- Acne vulgaris
Common side effects
- Erythema
- Scaling/peeling
- Dryness
- Pruritus
Key clinical trials
- A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris (PHASE3)
- A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris (PHASE1)
- Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris (PHASE3)
- Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation (PHASE4)
- AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation (PHASE4)
- A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris (PHASE1)
- A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis (PHASE2)
- A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV) (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trifarotene cream CI brief — competitive landscape report
- Trifarotene cream updates RSS · CI watch RSS
- Galderma R&D portfolio CI