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 · a red edge is where a trial was stopped
| 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 | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 4 | NCT04451330 | Jul 2020 → Apr 2021 | acne | Galderma R&D | Completed | No outcome recorded |
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 ↗ |