Aklief

(Trifarotene)

Phase 3Small molecule

GGalderma R&D

Aklief is one of 5 small molecule programs targeting Acne Vulgaris. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Acne VulgarisActive, not recruiting

Acne VulgarisPhase 3

Active, not recruiting

Competition

Competitive Landscape

5 competitors in Acne Vulgaris

#DrugCompanyPhaseTrials

Experimental Drug

MMedesis Pharma SA

Phase 3

1 2

Aklief

GGalderma R&D

Phase 3

2 3

Secretome

BBaermed

Phase 2

1 4

N-Acetyl-GED-0507-34-Levo

PPPM Services S.A.

Phase 3

3 5

Dihydroartemisinin

KKunming Pharmaceuticals, Inc.

Phase 1

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Acne Vulgaris

NCT07186413

Clinical

Trials by Indication[1]

Acne Vulgaris2 trials

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

A Multicenter, Randomized, Double-blinded, Parallel-group, Vehicle-controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris

Active, not recruiting·GGalderma R&D·Phase 3·NCT07186413·561 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[4]

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]
Open Targets Platform — Drug–disease associations for Trifarotene. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA211527). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Aklief. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Galderma R&D company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GGalderma R&D

Patent Landscape[5]

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

Aklief

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Acne Vulgaris2 trials

Hyperpigmentation1 trial

Scar Formation1 trial

Efficacy and Safety1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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