6 completed, 1 approved for marketing, 1 available, 1 recruiting. 4 Phase 3, 1 Phase 1, 1 Phase 2, 1 Phase 4.
By phase and status
Follow sebetralstat: new trials by email Literature Review of sebetralstat trials Research Report on sebetralstat
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) KVD900 600 mg - Hereditary Angioedema | Phase 4 | Recruiting | KalVista Pharmaceuticals, Ltd. | 100 | 2026-08-17 | 2026-09-17 |
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II KVD900 150 mg, KVD900 300 mg, KVD900 600 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 36 | 2024-08-01 | 2026-08-05 |
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) KVD900 600 mg, KVD900 300 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 145 | 2022-10-24 | 2026-06-05 |
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial KVD900 600 mg, Drug: KVD900 300 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 11 | 2022-10-24 | 2026-06-08 |
A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE) Placebo, KVD900 600 mg, KVD900 300 mg - Hereditary Angioedema | Phase 3 | Completed | KalVista Pharmaceuticals, Ltd. | 136 | 2022-02-22 | 2025-05-02 |
A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II KVD900, Placebo - Hereditary Angioedema | Phase 2 | Completed | KalVista Pharmaceuticals, Ltd. | 84 | 2019-07-02 | 2025-05-02 |
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers KVD900, Placebo to KVD900 - Hereditary Angioedema | Phase 1 | Completed | KalVista Pharmaceuticals, Ltd. | 84 | 2018-01-04 | 2025-04-29 |
Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat Sebetralstat - Hereditary Angioedema | | Approved for marketing | KalVista Pharmaceuticals, Ltd. | | | 2025-08-06 |
Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat Sebetralstat - Hereditary Angioedema | | Available | KalVista Pharmaceuticals, Ltd. | | | 2026-07-23 |
Conditions studied
Angioedemas, Hereditary (9)
Sponsors
KalVista Pharmaceuticals, Ltd. (9)
Countries
United States (8) · Germany (5) · United Kingdom (5) · Canada (4) · France (4) · Israel (4) · Italy (4) · Japan (4) · Netherlands (4) · Australia (3) · Austria (3) · Bulgaria (3) · Greece (3) · Hungary (3) · New Zealand (3)
Results publications
PMID 36774155, PMID 40886933, PMID 42318595, PMID 35086692, PMID 41252457, PMID 42436759