Drugs / Sebetralstat
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ekterly | — | 2025-09-17 | europa.eu ↗ |
| Approved | US (FDA) | EKTERLY | — | 2025-07-03 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04349800 | Jan → Sep 2018 | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04208412 | Jul 2019 → Dec 2020 | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Completed | Met primary |
| Phase 34 trials · 1 met primary | ||||||
| Phase 3 | NCT06467084 | Jun 2024 → Jan 2026 | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05511922 | Oct 2022 → May 2026 | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05505916 | Oct 2022 → May 2026 | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05259917 | Feb 2022 → Dec 2023 | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT07654829 | Jul 2026 → Nov 2027 expected | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Not yet recruiting | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT06628713 | — | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Approved for marketing | No outcome recorded |
| — | NCT07216378 | — | hereditary angioedema | KalVista Pharmaceuticals, Ltd. | Available | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sebetralstat | “This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary...” NCT05511922 ↗4“Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)” NCT07654829 ↗ “A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers” NCT04349800 ↗ |
| Known as | KVD900 | “Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)” NCT07654829 ↗ |
| Action | Inhibit | “KVD900, an orally administered inhibitor of PKa in healthy adults.” PMID 35086692 ↗ Jan 2022 |
| Modality | Small molecule | — CHEMBL5095248 ↗ |
| Route | Oral | “KVD900, an orally administered inhibitor of PKa in healthy adults.” PMID 35086692 ↗ Jan 2022 |