COMPANY
KalVista Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
KalVista Pharmaceuticals is a global biopharmaceutical company. From company website Source · Oct 12, 2026
Timeline
- Trial start Phase 4: Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) source ↗
- Debt Debt: $125M (not counted as a raise), announced Sep 24, 2025. Source: SEC filing. source ↗
- FDA FDA New drug/biologic (novel): EKTERLY (sebetralstat) — NDA219301, Jul 3, 2025. Applicant at approval: KalVista Pharmaceuticals Limited. source ↗
- Trial start —: A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks source ↗
- Partnership Partnership / licensing: $11M (upfront, as published); deal value up to $11M (kept separate from upfront), announced Apr 8, 2025. Source: SEC filing. source ↗
- Raise Follow-on offering: $55M (total, as published), announced Nov 4, 2024. Source: SEC filing. source ↗
- Debt Debt financing: $184M (up to, as announced), announced Nov 4, 2024. Source: SEC filing. source ↗
- Trial start Phase 3: Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II source ↗
- Trial start Phase 3: PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial source ↗
- Trial start Phase 3: 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 Angioede source ↗
- Trial start III: 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 source ↗
- Trial start Phase 2: A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II source ↗
- Trial start 1: Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations source ↗
- Trial start II: 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 source ↗
- Trial start Phase 1: A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers source ↗
- Trial start Phase 2: Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME) source ↗
- Trial start Phase 1: A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers source ↗
- Trial start I: A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME source ↗
Upcoming milestones
- Nov 29, 2027 (ESTIMATED) · Phase 4 · Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) · NCT07654829
Funding
- Follow-on offering: $55M (total, as published), announced Nov 4, 2024. Source: SEC filing. source ↗
- Debt: $125M (not counted as a raise), announced Sep 24, 2025. Source: SEC filing. source ↗
- Debt financing: $184M (up to, as announced), announced Nov 4, 2024. Source: SEC filing. source ↗
- Partnership / licensing: $11M (upfront, as published); deal value up to $11M (kept separate from upfront), announced Apr 8, 2025. Source: SEC filing. source ↗
Clinical trials (lead sponsor) 15
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT07654829 | Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL) | Phase 4 | Recruiting | Aug 17, 2026 | Nov 29, 2027 (estimated) |
| NCT06467084 | Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II | Phase 3 | Completed | Aug 1, 2024 | Jan 15, 2026 (actual) |
| NCT07216378 | Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat | Not listed | Available | Not listed | Not listed |
| NCT05511922 | PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial | Phase 3 | Completed | Oct 24, 2022 | May 27, 2026 (actual) |
| NCT05505916 | 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) | Phase 3 | Completed | Oct 24, 2022 | May 27, 2026 (actual) |
| NCT05055258 | A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II | Phase 2 | Terminated | Nov 18, 2021 | Oct 27, 2022 (actual) |
| NCT07009262 | A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE Attacks | Not listed | Completed | Apr 21, 2025 | Nov 25, 2025 (actual) |
| NCT06628713 | Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat | Not listed | Approved for marketing | Not listed | Not listed |
| NCT05259917 | 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) | III | Completed | Feb 22, 2022 | Dec 31, 2023 (actual) |
| NCT04208412 | 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 | II | Completed | Jul 2, 2019 | Dec 8, 2020 (actual) |
| NCT04349800 | A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers | Phase 1 | Completed | Jan 4, 2018 | Sep 10, 2018 (actual) |
| NCT05178355 | A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers | Phase 1 | Completed | Feb 12, 2019 | Jun 21, 2019 (actual) |
| NCT05118958 | Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations | 1 | Completed | May 19, 2020 | Dec 1, 2020 (actual) |
| NCT03466099 | Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME) | Phase 2 | Completed | Feb 16, 2018 | Oct 10, 2019 (actual) |
| NCT02193113 | A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME | I | Completed | Jul 18, 2014 | Jun 4, 2015 (actual) |
FDA records (last 2 years)
- FDA New drug/biologic (novel): EKTERLY (sebetralstat) — NDA219301, Jul 3, 2025. Applicant at approval: KalVista Pharmaceuticals Limited. source ↗
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