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OPA-15406
OPA-15406 is a selective JAK1 inhibitor that reduces inflammatory signaling to treat immune-mediated skin diseases.
OPA-15406 is a selective JAK1 inhibitor that reduces inflammatory signaling to treat immune-mediated skin diseases. Used for Atopic dermatitis, Other inflammatory skin conditions.
At a glance
| Generic name | OPA-15406 |
|---|---|
| Also known as | difamilast |
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | JAK1 inhibitor |
| Target | JAK1 |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Immunology |
| Phase | Phase 3 |
Mechanism of action
OPA-15406 selectively inhibits Janus kinase 1 (JAK1), a key enzyme in the JAK-STAT signaling pathway that drives inflammatory and immune responses. By blocking JAK1, the drug suppresses the production of pro-inflammatory cytokines and reduces pathogenic T-cell activation, thereby ameliorating symptoms in conditions like atopic dermatitis and other inflammatory skin disorders.
Approved indications
- Atopic dermatitis
- Other inflammatory skin conditions
Common side effects
- Nasopharyngitis
- Upper respiratory tract infection
- Headache
- Application site reactions
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)
- A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis (PHASE2)
- Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis (PHASE3)
- Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis (PHASE3)
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 |