Drugs / Difamilast
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ADQUEY | — | 2026-02-12 | fda.gov ↗ |
Trials 14 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02334787 | Jan → Feb 2015 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01702181 | Aug 2012 → Dec 2013 | atopic eczema | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03018691 | Jan → Jun 2017 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02914548 | Sep 2016 → Jun 2017 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT02068352 | Jun 2014 → Jan 2015 | atopic eczema | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT07173478 | Oct 2025 → Dec 2026 expected | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07184645 | Sep 2025 → Feb 2027 expected | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05650320 | Feb 2023 → Jul 2024 | atopic eczema | Otsuka Beijing Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT05667623 | Feb 2023 → Jun 2024 | atopic eczema | Otsuka Beijing Research Institute | Completed | No outcome recorded |
| Phase 3 | NCT05571943 | Sep 2022 → Jul 2024 | atopic eczema | Acrotech Biopharma Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05372653 | May → Dec 2022 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03961529 | May 2019 → Nov 2020 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03911401 | May → Dec 2019 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03908970 | Mar → Dec 2019 | atopic eczema | Otsuka Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05608343 Comparator | Oct 2022 → Oct 2023 | atopic eczema | Acrotech Biopharma Inc. | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-09-28 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Has Filed an Application in Japan for Approval of Difamilast (OPA-15406) as an Atopic Dermatitis Drug otsuka.co.jp ↗ |
| 2020-03-26 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Announces Top-line Results from Two Phase 3 Studies in Japan for Atopic Dermatitis Drug Candidate Difamilast (OPA-15406) otsuka.co.jp ↗ |
| 2016-02-09 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka and Medimetriks Sign Licensing Agreement for Development and Commercialization of OPA-15406 in the U.S. for Atopic Dermatitis otsuka.co.jp ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Difamilast | “Difamilast is a new selective PDE4 inhibitor.” PMID 34289086 ↗ Nov 2021 |
| Known as | OPA 15406 | “OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor.” NCT02068352 ↗ |
| Action | Inhibit | “OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor.” NCT02068352 ↗ |
| Modality | Small molecule | — CHEMBL3989968 ↗ |
| Route | Topical | “0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days” NCT01702181 ↗ |