COMPANY
Satsuma Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
Timeline
- FDA FDA Original approval: ATZUMI (dihydroergotamine mesylate) — NDA217901, Apr 30, 2025. Applicant at approval: Satsuma Pharmaceuticals, Inc. source ↗
- Trial start Phase 3: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine source ↗
- Trial start Phase 1: A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects source ↗
- Trial start Phase 3: A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine source ↗
- Trial start Phase 3: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine source ↗
- Trial start I: A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects source ↗
Clinical trials (lead sponsor) 5
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04940390 | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine | Phase 3 | Completed | Jun 30, 2021 | Oct 13, 2022 (actual) |
| NCT04406649 | A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine | Phase 3 | Completed | Sep 14, 2020 | Jan 16, 2023 (actual) |
| NCT03901482 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine | Phase 3 | Completed | Jun 24, 2019 | Jul 31, 2020 (actual) |
| NCT05337254 | A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects | Phase 1 | Completed | Mar 5, 2021 | Jun 4, 2021 (actual) |
| NCT03874832 | A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects | I | Completed | Sep 11, 2018 | Nov 7, 2018 (actual) |
FDA records (last 2 years)
- FDA Original approval: ATZUMI (dihydroergotamine mesylate) — NDA217901, Apr 30, 2025. Applicant at approval: Satsuma Pharmaceuticals, Inc. source ↗