ACITRETIN
ACITRETIN is indicated for the treatment of Psoriasis.
Details
- Status
- Prescription
- First Approved
- 2013-04-04
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ACITRETIN Approval History
What ACITRETIN Treats
1 indicationsACITRETIN is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Psoriasis
ACITRETIN Boxed Warning
CONTRAINDICATIONS AND WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported ...
CONTRAINDICATIONS AND WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraception while undergoing treatment and for at least 3 years following discontinuation of treatment. Acitretin is a metabolite of etretinate (TEGISON), and major human fetal abnormalities have been reported with the administration of acitretin and etretinate. Potentially, any fetus exposed can be affected. Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin. Because the longer elimination half-life of etretinate would increase the duration of teratogenic potential for female patients, ethanol must not be ingested by female patients of childbearing potential either during treatment with acitretin or for 2 months after cessation of therapy. This allows for elimination of acitretin, thus removing the substrate for transesterification to etretinate. The mechanism of the metabolic process for conversion of acitretin to etretinate has not been fully defined. It is not known whether substances other than ethanol are associated with transesterification. Acitretin has been shown to be embryotoxic and/or teratogenic in rabbits, mice, and rats at oral doses of 0.6, 3, and 15 mg per kg, respectively. These doses are approximately 0.2, 0.3, and 3 times the maximum recommended therapeutic dose, respectively, based on a mg-per-m 2 comparison. Major human fetal abnormalities associated with acitretin and/or etretinate administration have been reported including meningomyelocele; meningoencephalocele; multiple synostoses; facial dysmorphia; syndactyly; absence of terminal phalanges; malformations of hip, ankle, and forearm; low-set ears; high pala
ACITRETIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ACITRETIN
3 of 11FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ACITRETIN FDA Label Details
Indications & Usage
ACITRETIN is indicated for the treatment of Psoriasis.
CONTRAINDICATIONS AND WARNINGS: Pregnancy Acitretin must not be used by females who are pregnant, or who intend to become pregnant during therapy or at any time for at least 3 years following discontinuation of therapy. Acitretin also must not be used by females who may not use reliable contraceptio...
Looking for the branded version?
SORIATANE
Full clinical data, patents, trials, and competitive landscape for acitretin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.