Trifarotene

Overview

Trifarotene is a topical retinoid cream used in the treatment of acne vulgaris that was first approved for use in the United States in October 2019. Retinoids are a class of medications structurally and functionally analogous to vitamin A, though later generation retinoids such as trifarotene and adapalene bear little structural resemblance to vitamin A and are analogous only in function. Trifarotene is considered the first of the "fourth-generation" retinoids due to its uniquely selective activity - this selectivity appears to confer improved efficacy and reduced side effects as compared to older, less selective retinoids.

Indication

Trifarotene is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Associated Conditions

Acne Vulgaris

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
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	2024/12/13	NCT06733402	Phase 1	Completed	Taro Pharmaceuticals USA
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris	2023/10/02	NCT06063473	Phase 1	Completed	Taro Pharmaceuticals USA
Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris	2022/09/22	NCT05550337	Phase 3	Completed	Teva Pharmaceuticals USA
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation	2021/10/22	NCT05089708	Phase 4	Completed	Galderma R&D
Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation	2021/04/23	NCT04856904	Phase 4	Completed	Galderma R&D
A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)	2020/06/30	NCT04451330	Phase 4	Completed	Galderma R&D
Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris	2019/04/16	NCT03915860	Phase 3	Completed	Galderma R&D

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
AKLIEF	Galderma Laboratories, L.P.	0299-5935	TOPICAL	50 ug in 1 g	1/25/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AKLIEF CREAM 50mcg/g	Laboratoires GALDERMA	SIN16571P	CREAM	50 mcg/g	8/17/2022

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
AKLIEF trifarotene 50 microgram/g cream tube	340375	Galderma Australia Pty Ltd	Medicine	A	1/18/2021
AKLIEF trifarotene 50 microgram/g cream bottle	332220	Galderma Australia Pty Ltd	Medicine	A	1/18/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AKLIEF	galderma canada inc	02494175	Cream - Topical	50 MCG / G	11/28/2019

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Novel Topical Acne Therapies Show Promising Results in Clinical Trials

5 months ago

Triple combination therapy containing clindamycin, adapalene, and benzoyl peroxide achieved clear or near-clear skin in over 50% of patients with a 70% reduction in lesion counts.

Clascoterone, Trifarotene, and Tazarotene Show Comparable Efficacy in Acne Treatment: Meta-Analysis

9 months ago

• A meta-analysis of randomized controlled trials reveals that clascoterone, trifarotene, and tazarotene demonstrate similar efficacy in treating moderate to severe acne vulgaris. • The study, involving over 5,400 patients, found no statistically significant differences in reducing inflammatory and non-inflammatory lesion counts among the three treatments. • Odds ratios for treatment success were comparable, suggesting clinicians can select treatments based on individual patient needs and potential side effects. • Further research is needed to compare the safety profiles of these agents to inform comprehensive treatment decisions.

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