12 completed, 2 not yet recruiting. 9 Phase 3, 4 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 9 | Completed 7, Not yet recruiting 2 |
| Phase 2 | 4 | Completed 4 |
| Phase 1 | 1 | Completed 1 |
Follow difamilast: new trials by email Literature Review of difamilast trials Research Report on difamilast
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 3 Trial to Demonstrate the Superiority of 1% OPA-15406 Foam to the Vehicle in Adult Patients With Atopic Dermatitis OPA-15406, Vehicle - Atopic Dermatitis (AD) | Phase 3 | Not yet recruiting | Otsuka Pharmaceutical Co., Ltd. | 156 | 2025-10-01 | 2025-09-15 |
| A Phase 3 Trial of OPA-15406 Foam in Children and Infants With Atopic Dermatitis OPA-15406, Vehicle - Atopic Dermatitis (AD) | Phase 3 | Not yet recruiting | Otsuka Pharmaceutical Co., Ltd. | 198 | 2025-09-01 | 2025-09-22 |
| To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment, 0% OPA-15406 vehicle - Atopic Dermatitis (AD) | Phase 3 | Completed | Otsuka Beijing Research Institute | 240 | 2023-02-17 | 2025-03-25 |
| To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD 1% OPA-15406 Ointment, 0% OPA-15406 Vehicle - Atopic Dermatitis (AD) | Phase 3 | Completed | Otsuka Beijing Research Institute | 270 | 2023-02-06 | 2025-08-29 |
| This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD) Difamilast, Placebo - Atopic Dermatitis | Phase 3 | Completed | Acrotech Biopharma Inc. | 153 | 2022-10-01 | 2024-08-15 |
| A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis Difamilast - Atopic Dermatitis | Phase 3 | Completed | Acrotech Biopharma Inc. | 542 | 2022-09-15 | 2024-08-09 |
| A Long-term Trial of OPA-15406 in Infants With Atopic Dermatitis OPA-15406 - Atopic Dermatitis (AD) | Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 41 | 2022-05-23 | 2025-03-30 |
| Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis 0.3% OPA-15406, 1% OPA-15406, Placebos - Atopic Dermatitis | Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 251 | 2019-05-07 | 2021-01-25 |
| Comparison Trial of OPA-15406 Ointment in Adult Patients With Atopic DermatitisSyndrome 1% OPA-15406, Placebos - Atopic Dermatitis | Phase 3 | Completed | Otsuka Pharmaceutical Co., Ltd. | 364 | 2019-03-25 | 2021-01-25 |
| Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis OPA-15406, Placebos - Atopic Dermatitis | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 73 | 2017-01-01 | 2020-07-23 |
| Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis MM36 topical ointment, 1% - Atopic Dermatitis | Phase 2 | Completed | Medimetriks Pharmaceuticals, Inc | 32 | 2016-10-01 | 2018-11-19 |
| Study of OPA-15406 Ointment in Patients With Atopic Dermatitis OPA-15406, Placebo - Atopic Dermatitis | Phase 2 | Completed | Otsuka Pharmaceutical Co., Ltd. | 200 | 2016-09-01 | 2020-07-23 |
| A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis OPA-15406, Vehicle ointment - Atopic Dermatitis | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 121 | 2014-06-20 | 2021-11-23 |
| A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis OPA-15406, Tacrolimus, Placebo - Atopic Dermatitis | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 92 | 2012-08-01 | 2014-01-17 |
Dermatitis, Atopic (14) · Eczema (2)
Otsuka Pharmaceutical Co., Ltd. (7) · Acrotech Biopharma Inc. (2) · Otsuka Beijing Research Institute (2) · Otsuka Pharmaceutical Development & Commercialization, Inc. (2) · Medimetriks Pharmaceuticals, Inc (1)
Japan (7) · United States (5) · China (2) · Australia (1) · Honduras (1) · Panama (1) · Poland (1)
Nobuhito Sanada (2) · Osamu Sato (2) · Jianzhong Zhang, PHD (1) · Lin Ma (1) · Noah Rosenberg, MD (1) · Takehisa Matsumaru (1) · Uma S Atmuri, MPharm MS (1) · Uma Srinivas Atmuri, MPharm MS (1)