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Moizerto (DIFAMILAST)
Moizerto (DIFAMILAST) is a small molecule drug developed by OTSUKA PHARMACEUTICAL Co., Ltd and currently owned by Acrotech Biopharma. It targets cAMP-specific 3',5'-cyclic phosphodiesterase 4B, a specific enzyme involved in inflammation. Moizerto is approved to treat atopic dermatitis, a chronic skin condition characterized by inflammation and itching. The drug is off-patent, meaning it is no longer protected by patents, and there are currently no generic manufacturers. As a result, its commercial status and availability may be limited.
At a glance
| Generic name | DIFAMILAST |
|---|---|
| Sponsor | OTSUKA PHARMACEUTICAL Co., Ltd |
| Target | cAMP-specific 3',5'-cyclic phosphodiesterase 4B |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Atopic dermatitis
Common side effects
Key clinical trials
- A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis (PHASE3)
- A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis (PHASE3)
- To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD (PHASE3)
- A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis (PHASE3)
- To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD (PHASE3)
- This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD) (PHASE3)
- A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis (PHASE3)
- A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis (PHASE2)
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:
- Moizerto CI brief — competitive landscape report
- Moizerto updates RSS · CI watch RSS
- OTSUKA PHARMACEUTICAL Co., Ltd portfolio CI