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Acitretin Capsules.
Acitretin is a retinoid that binds to retinoid receptors to regulate the growth, differentiation, and keratinization of epithelial cells.
Acitretin is a retinoid used primarily for the treatment of severe psoriasis. It is not approved by the FDA and is manufactured by the Army Medical University in China. The drug works by regulating the growth and differentiation of skin cells. Common side effects include dry skin, mucous membrane irritation, and elevated liver enzymes. Due to its teratogenicity, it is contraindicated in pregnant women. Acitretin is not commercially available in the US, but it has a significant presence in other markets.
At a glance
| Generic name | Acitretin Capsules. |
|---|---|
| Sponsor | Army Medical University, China |
| Drug class | Retinoid |
| Target | Retinoid X Receptor (RXR), Retinoid Acid Receptor (RAR) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Acitretin is a second-generation retinoid that acts as a ligand for retinoid X receptors (RXR) and retinoid acid receptors (RAR), modulating gene transcription involved in cell differentiation and proliferation. By normalizing epithelial cell turnover and reducing hyperkeratinization, it is effective in treating disorders characterized by abnormal skin cell growth and differentiation. The drug's effects on epithelial cells make it particularly useful in psoriasis and other keratinization disorders.
Approved indications
- Severe psoriasis
- Lichen planus
- Pityriasis rubra pilaris
- Ichthyosis and keratinization disorders
Common side effects
- Dry skin and mucous membranes
- Cheilitis
- Pruritus
- Alopecia
- Nail dystrophy
- Headache
- Elevated triglycerides
- Elevated liver enzymes
- Teratogenicity (if exposed during pregnancy)
Key clinical trials
- A Prospective Cohort Study on Primary Cutaneous Amyloidosis (PHASE4)
- Outcomes With Treatment and Withdraw of Ixekizumab in Patients With Plaque Psoriasis (PHASE4)
- Outcomes With Treatment and Withdraw of Secukinumab in Patients With Plaque Psoriasis (PHASE4)
- Effect of Acitretin Versus Narrowband Ultraviolet B on Neopterin Level in Psoriatic Patients . (PHASE4)
- Combined Effect of Acitretin and Narrow Band Ultraviolet B on Vitiligo Repigmentation (NA)
- Acitretin or Tazarotene Gel and Excimer Laser for Treatment of Psoriasis (NA)
- Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules (PHASE2)
- Trial of an Injectable Biologic and U0279 as Combination Therapy for Severe Plaque-Type Psoriasis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Acitretin Capsules. CI brief — competitive landscape report
- Acitretin Capsules. updates RSS · CI watch RSS
- Army Medical University, China portfolio CI