COMPANY
Soleno Therapeutics
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start —: Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome source ↗
- Raise Follow-on offering: $200M (total, as published), announced Jul 10, 2025. Source: SEC filing. source ↗
- FDA FDA Original approval: VYKAT XR (diazoxide choline) — NDA216665, Mar 26, 2025. Applicant at approval: Soleno Therapeutics, Inc. source ↗
- Debt Debt: $200M (not counted as a raise), announced Dec 17, 2024. Source: SEC filing. source ↗
- Trial start Phase 3: Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome source ↗
- Trial start Phase 2: An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities source ↗
- Trial start Phase 3: An Open-Label Study of DCCR Tablet in Patients With PWS source ↗
- Trial start —: PWS Outcomes Assessment Study source ↗
- Trial start Phase 3: Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period source ↗
- Trial start Phase 3: A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome source ↗
Upcoming milestones
- 2028-03 (ESTIMATED) · · Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome · NCT07450664
- 2028-06 (ESTIMATED) · Phase 3 · Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome · NCT05701774
Funding
Clinical trials (lead sponsor) 7
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07450664 | Observational Study of VYKAT™ XR in Patients With Prader-Willi Syndrome | Not listed | Enrolling by invitation | Nov 26, 2025 | 2028-03 (estimated) |
| NCT05701774 | Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome | Phase 3 | Active, not recruiting | Jan 31, 2023 | 2028-06 (estimated) |
| NCT04102839 | PWS Outcomes Assessment Study | Not listed | Completed | Jul 15, 2019 | Jun 8, 2021 (actual) |
| NCT03714373 | Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period | Phase 3 | Completed | Oct 1, 2018 | Aug 17, 2023 (actual) |
| NCT03440814 | A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome | Phase 3 | Completed | May 9, 2018 | May 1, 2020 (actual) |
| NCT05532020 | An Open-Label Study of Diazoxide Choline in Patients With Genetic Obesities | Phase 2 | Unknown status (ClinicalTrials.gov) | 2023-01 | 2024-01 (estimated) |
| NCT04086810 | An Open-Label Study of DCCR Tablet in Patients With PWS | Phase 3 | Withdrawn | 2019-10 | 2019-10 (estimated) |
FDA records (last 2 years)
- FDA Original approval: VYKAT XR (diazoxide choline) — NDA216665, Mar 26, 2025. Applicant at approval: Soleno Therapeutics, Inc. source ↗
NIH awards 3
- NIH award 5R44HL126469-03 FY2018: $1,018,885 awarded for that fiscal year; activity R44 (SBIR); PI BHATNAGAR, ANISH; recipient as written: SOLENO THERAPEUTICS, INC., REDWOOD CITY, CA. Point of Care Breath Test to Scr source ↗
- NIH award 2R44HL126469-02A1 FY2017: $1,057,282 awarded for that fiscal year; activity R44 (SBIR); PI BHATNAGAR, ANISH; recipient as written: SOLENO THERAPEUTICS, INC., REDWOOD CITY, CA. Point of Care Breath Test to S source ↗
- NIH award 1R43HL126469-01 FY2015: $219,917 awarded for that fiscal year; activity R43 (SBIR); PI BHATNAGAR, ANISH; recipient as written: SOLENO THERAPEUTICS, INC., REDWOOD CITY, CA. Point-of-Care End-Tidal Carbon Mon source ↗
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