Aklief

(Trifarotene)

Small molecule

GGalderma R&D

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Acne Vulgaris

NCT07186413

Clinical

Trials by Indication[1]

Acne Vulgaris2 trials

A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris

Recruiting·GGalderma R&D·Phase 3·NCT07186413·561 enrolled

Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris

Completed·GGalderma R&D·Phase 3·NCT03915860·47 enrolled

Hyperpigmentation1 trial

AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation

Completed·GGalderma R&D·Phase 4·NCT05089708·123 enrolled

Scar Formation1 trial

Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation

Completed·GGalderma R&D·Phase 4·NCT04856904·121 enrolled

Efficacy and Safety1 trial

A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)

Completed·GGalderma R&D·Phase 4·NCT04451330·202 enrolled

Regulatory

FDA Approval Timeline[3]

Oct 4, 2019

AKLIEF

NDA NDA211527

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Trifarotene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trifarotene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA211527). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Aklief. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Galderma R&D company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: GGalderma R&D

Patent Landscape[4]

Patent Cliff

Jul 19, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7807708Jul 19, 2031

9084778May 30, 2033

9498465May 30, 2033