Drugs / SAP-001
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06678581 | May → Dec 2023 | gout | Shanton Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03857165 | Sep 2018 → Jun 2019 | gout | Shanton Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06729853 | Apr 2024 → Jan 2025 overdue | gout | Shanton Pharma Pte. Ltd. | Active not recruiting | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT05690204 | Dec 2022 → Jan 2025 overdue | gout | Shanton Pharma Pte. Ltd. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04040816 | Jan 2019 → Aug 2020 | gout | Shanton Pharma Co., Ltd. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-10-27 | Shanton Pharma Co., Ltd. | Regulatory Shanton Pharma Completes EOP2 Meeting with US FDA for Refractory Gout Program shantonpharma.com ↗ |
| 2025-07-28 | Shanton Pharma Co., Ltd. | Regulatory Shanton Receives Fast Track Designation from US FDA for Refractory Gout Program shantonpharma.com ↗
FDA has designated its Investigational New Drug SAP-001 as a Fast Track product for treatment of hyperuricemia in adult patients with gout who are refractory to conventional therapy. |
| 2025-03-29 | Shanton Pharma Co., Ltd. | Results Shanton Reveals Topline Data from Phase 2b Study in Refractory Gout Patients shantonpharma.com ↗
Shanton Pharma, a clinical-stage biotech company developing a novel treatment for gout, today announced topline data of a Phase 2b study in refractory gout patients with its investigational drug SAP-001 that uses a First-in-Class Mechanism of Action targeting a distinct kidney transporter. |
| 2021-02-09 | Shanton Pharma Co., Ltd. | Results Shanton Pharma Meets Primary Endpoint for Phase 2 Study of SAP-001 shantonpharma.com ↗
In the trial, SAP-001 significantly reduce uric acid . |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SAP-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03857165 ↗ |
| Route | Oral | “oral SAP-001 (once daily)” NCT03857165 ↗ |