Drugs / Trifarotene
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AKLIEF | — | 2019-10-04 | fda.gov ↗ |
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06733402 | Jun 2024 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06063473 | Feb → Jul 2023 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01804335 | Feb 2013 → Mar 2015 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03738800 | May 2019 → Sep 2021 | lamellar ichthyosis | Mayne Pharma International Pty Ltd | Terminated | No outcome recorded |
| Phase 2 | NCT01616654 | Jun 2012 → Jul 2013 | acne | Galderma R&D | Completed | Mixed |
| Phase 36 trials | ||||||
| Phase 3 | NCT07186413 | Sep 2025 → Dec 2026 expected | acne | Galderma R&D | Recruiting | No outcome recorded |
| Phase 3 | NCT05550337 | Sep 2022 → May 2023 | acne | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 3 | NCT03915860 | Mar → Dec 2019 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02566369 | Nov 2015 → Nov 2017 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02556788 | Nov 2015 → Feb 2017 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02189629 | Feb 2015 → Feb 2017 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 43 trials · 1 met primary | ||||||
| Phase 4 | NCT05089708 | Dec 2021 → Dec 2022 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT04856904 | May 2021 → Feb 2023 | acne | Galderma R&D | Completed | Met primary |
| Phase 4 | NCT04451330 | Jul 2020 → Apr 2021 | acne | Galderma R&D | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-09-17 | Galderma R&D | Results EADV 2024: scientific presentations supported by Galderma galderma.com ↗
Phase 4 Analyses: Trifarotene Reduces Atrophic Acne Scars Across All Skin Types With Greater Effect in Subjects with Higher Baseline Acne and Acne Scarring Severity |
| 2024-02-28 | Galderma R&D | Results Galderma to showcase latest updates from its broad, innovative and leading dermatology portfolio at the 2024 American Academy of Dermatology annual meeting galderma.com ↗
Alexis, A, et al. Trifarotene shown to improve acne and related sequelae. |
| 2024-02-28 | Galderma R&D | Results AAD 2024: scientific presentations supported by Galderma galderma.com ↗
Phase IV studies show trifarotene is efficacious and suitable for broad range of patient types |
| 2023-10-04 | Galderma R&D | Results EADV 2023: Galderma to present new data showcasing its continued leadership in dermatology galderma.com ↗
New data on trifarotene from the phase IV START study showing positive outcomes, patient satisfaction and patient compliance for risk of atrophic acne scarring will be presented. |
| 2022-10-07 | Galderma R&D | Results Galderma study paves the way for an effective, new acne treatment combination galderma.com ↗
The Journal of Clinical and Aesthetic Dermatology recently published results from a Galderma-sponsored DUAL Phase 4 study demonstrating the effectiveness of a new treatment combination in improving quality of life for severe acne patients1. |
| 2022-03-25 | Galderma R&D | Results Galderma to highlight latest science and innovation across its product portfolio at the 2022 AAD Annual meeting galderma.com ↗
DUAL Study: Trifarotene Plus Doxycycline Has Proven Efficacy and Safety in Severe Acne Vulgaris |
| 2019-12-20 | Galderma R&D | Regulatory Galderma receives a positive outcome through the European Decentralised Procedure for AKLIEF® (trifarotene 50 mcg/g cream), the first new retinoid molecule for acne in the European Union in 25 years galderma.com ↗
Galderma today announced that AKLIEF® (trifarotene 50 mcg/g cream) has concluded its European decentralised procedure resulting in the approval of its summary of product characteristics, package leaflet, and labelling, by all involved European member states. |
| 2019-10-07 | Galderma R&D | Regulatory Galderma Receives FDA Approval for AKLIEF® (trifarotene) Cream, 0.005%, the First New Retinoid Molecule for the Treatment of Acne in Over 20 Years galderma.com ↗
Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. |
| 2019-03-01 | Galderma R&D | Results Galderma Announces Publication of Pivotal Phase 3 PERFECT 1 and PERFECT 2 Clinical Trials of Trifarotene in Patients with Moderate Facial and Truncal Acne in the Journal of the American Academy of Dermatology galderma.com ↗
The two identical multicenter, randomized, 12-week clinical trials of more than 2,400 patients met all primary and secondary efficacy endpoints, including Investigator Global Assessment (IGA/facial acne), changes in inflammatory and non-inflammatory lesion counts and Physician Global Assessment (PGA/truncal acne). |
| 2016-06-09 | Galderma R&D | Results Galderma Trifarotene Development Program Meets Key Milestone for Lamellar Ichthyosis Orphan Disease galderma.com ↗
Galderma today announced that its trifarotene development program targeting lamellar ichthyosis, a debilitating orphan disease resulting in the formation of scales covering the skin, was demonstrated to be safe and well-tolerated in a phase I study. |
All press releases naming this drug 10 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | trifarotene | “CD5789 (trifarotene) 50µg/g Cream” NCT02556788 ↗ |
| Known as | AKLIEF | “AKLIEF® (Trifarotene Cream, 0.005%), Apply to the affected areas of the face once daily for 84 days.” NCT05550337 ↗2“AKLIEF® Cream (Trifarotene 0.005%) US REFERENCE LISTED DRUG” NCT06733402 ↗ “AKLIEF® Cream (Trifarotene 0.005%, Galderma Laboratories)” NCT06063473 ↗ |
| Known as | CD5789 | “Assessment of the efficacy and safety of CD5789 (trifarotene) 50μg/g cream applied once daily for 12 weeks in subjects with acne vulgaris.” NCT02566369 ↗7“Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks” NCT04856904 ↗ “Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks” NCT05089708 ↗ “Trifarotene (CD5789) Cream HE1” NCT03738800 ↗ “CD5789 (trifarotene)” NCT02189629 ↗ |
| Known as | Trifaroteno | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707313 ↗ |
| Action | Activate | “Retinoic acid receptor gamma agonist” CHEMBL3707313 ↗ |
| Modality | Small molecule | — CHEMBL3707313 ↗ |
| Route | Topical | “CD5789 25 µg/g cream applied once daily” NCT01616654 ↗ |
| Target | RARG | “Retinoic acid receptor gamma agonist” CHEMBL3707313 ↗ |