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Ekterly (SEBETRALSTAT)
Ekterly works by blocking the plasma kallikrein enzyme, which is involved in the production of bradykinin, a key mediator of HAE symptoms.
Ekterly (sebetralstat) is a small molecule plasma kallikrein inhibitor developed by Kalvista, approved by the FDA in 2025 for the treatment of hereditary angioedema (HAE). It works by inhibiting the plasma kallikrein enzyme, which plays a key role in the pathogenesis of HAE. Ekterly is a patented medication with no generic manufacturers available. Key safety considerations include the need for further studies to determine its long-term effects. As a plasma kallikrein inhibitor, Ekterly has the potential to interact with other medications that affect blood clotting.
At a glance
| Generic name | SEBETRALSTAT |
|---|---|
| Sponsor | Kalvista |
| Drug class | Plasma Kallikrein Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Sebetralstat is a competitive, reversible inhibitor of plasma kallikrein. Plasma kallikrein is a serine protease that cleaves high molecular weight kininogen (HK) releasing bradykinin which increases vascular permeability through activation of bradykinin receptors causing edema. Sebetralstat inhibits the cleavage of HK and reduces production of bradykinin, thereby treating the clinical symptoms of an acute, episodic attack of HAE. Sebetralstat also inhibits the positive feedback mechanism of the kallikrein kinin system by plasma kallikrein, thereby reducing factor XIIa and additional plasma kallikrein generation.
Approved indications
- hereditary angioedema (HAE)
Common side effects
- Headache
Drug interactions
- Strong CYP3A4 Inhibitors
- Moderate CYP3A4 Inhibitors
- Weak CYP3A4 Inhibitors
- Strong CYP3A4 Inducers
- Moderate CYP3A4 Inducers
- Weak CYP3A4 Inducers
- Strong CYP3A4 Inhibitors
- Moderate CYP3A4 Inhibitors
- Weak CYP3A4 Inhibitors
- Strong CYP3A4 Inducers
- Moderate CYP3A4 Inducers
- Weak CYP3A4 Inducers
Key clinical trials
- 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) (PHASE3)
- Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstat
- Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II (PHASE3)
- Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat
- PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial (PHASE3)
- 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) (PHASE3)
- 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 (PHASE2)
- A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ekterly CI brief — competitive landscape report
- Ekterly updates RSS · CI watch RSS
- Kalvista portfolio CI