COMPANY
Priovant Therapeutics
FDA-approved therapeutic company Clinical Phase 3
Timeline
- FDA FDA New drug/biologic (novel): LISRAYA (brepocitinib tosylate) — NDA220106, Aug 27, 2026. Applicant at approval: Priovant Therapeutics, Inc. source ↗
- Trial start 2: A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris source ↗
- Trial start Phase 2/Phase 3: A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis source ↗
- Trial start Phase 3: A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis source ↗
- Trial start Phase 2: A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis source ↗
- Trial start Phase 2: A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis source ↗
- Trial start Phase 3: A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis source ↗
Upcoming milestones
- Dec 31, 2028 (ESTIMATED) · Phase 2/Phase 3 · A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis · NCT06978725
- Dec 31, 2028 (ESTIMATED) · 2 · A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris · NCT07532603
Clinical trials (lead sponsor) 6
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT05437263 | A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis | Phase 3 | Completed | Oct 31, 2022 | Jul 17, 2025 (actual) |
| NCT06978725 | A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis | Phase 2/Phase 3 | Recruiting | Apr 9, 2025 | Dec 31, 2028 (estimated) |
| NCT07532603 | A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris | 2 | Recruiting | Mar 19, 2026 | Dec 31, 2028 (estimated) |
| NCT06431373 | A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis | Phase 3 | Active, not recruiting | Sep 11, 2024 | Sep 11, 2026 (estimated) |
| NCT05523765 | A Study of Brepocitinib in Adults With Active Non-Infectious Non-Anterior Uveitis | Phase 2 | Completed | Nov 14, 2022 | Jul 30, 2024 (actual) |
| NCT06433999 | A 12-Week Open-Label Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Skin-Predominant Dermatomyositis | Phase 2 | Completed | Aug 28, 2024 | Feb 28, 2025 (actual) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): LISRAYA (brepocitinib tosylate) — NDA220106, Aug 27, 2026. Applicant at approval: Priovant Therapeutics, Inc. source ↗