Data updated: May 26, 2026
SORIATANE (acitretin)
Trial Activity: Mature 3 active trials
Immunology
Approved 1996-10-28
Development Insights
Singapore General Hospital conducting 2 trials (17%)
10 indications explored (Broad Platform)
→ plaque psoriasis (2 trials)
→ psoriasis (2 trials)
→ lichen planus (1 trials)
1
Indication
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1996-10-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SORIATANE Approval History
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
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2024
2025
2026
Original
New Indication
New Form
Label Update
88 FDA actions from 1996 to 2023
Oct 2014 SUPPL
Mfg
Jan 2003 SUPPL
Mfg
Sep 2002 SUPPL
Mfg
Jan 2001 SUPPL
Mfg
Dec 1999 SUPPL
Mfg
Jun 1997 SUPPL
Label
Oct 1996 ORIGINAL
New Ingredient
What SORIATANE Treats
1 FDA approvalsOriginally approved for its first indication in 1996 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 1996)
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06739551 | SheikhZMC/H | Ph 2 | not yet recruiting | Systemic Treatment Options for Generalized Lichen Planus |
| NCT04239859 | PsO1 | Ph 4 | not yet recruiting | Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis |
| NCT04537689 | PsO_IXE | Ph 4 | recruiting | Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis |
| NCT05203354 | 288/9/18 | Ph 4 | completed | Omentin-1 Level in Psoriatic Patients Treated With Narrowband Ultraviolet B Phototherapy Versus Acitretin |
| NCT02181790 results posted | GCO 14-0580 PD14-01323 | Ph 4 | terminated | Addition of Excimer Laser to Treatment With Acitretin Tablets for Psoriasis of the Palms and Soles |
| NCT03753867 | 2018 0639 | Ph 1 | withdrawn | RA Effect on Cell Surface Molecules in Vivo |
| NCT02050321 results posted | 1312167559 | Ph 2 | terminated | A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma |
| NCT01078168 ADAM results posted | ADAM 2009-011881-27 | Ph 2 | completed | Alzheimer's Disease Acitretin Medication |
| NCT01545284 | Inno-6022 | Ph 2, Ph 3 | completed | Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis |
| NCT01299220 | PRO10020317 | Ph 4 | withdrawn | Study of Acitretin to Treat Skin Rash Caused by Erlotinib (a Chemotherapy Drug) |
| NCT00936065 results posted | 0881A6-4625 B1801065 | Ph 4 | completed | Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis |
| NCT01039142 | 12345 | Ph 4 | completed | Dose Ranging Study to Assess the Efficacy and Safety of Acitretin in Severe Plaque Type Psoriasis |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SORIATANE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment