NDAORALTABLET
Approved
Jul 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
6/8 — Strong
EKTERLY (sebetralstat) by KalVista Pharmaceuticals is kallikrein inhibitors [moa]. Approved for hereditary angioedema. First approved in 2025.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EKTERLY (sebetralstat) is an oral plasma kallikrein inhibitor approved July 2025 for hereditary angioedema (HAE). It works by inhibiting kallikrein, an enzyme that triggers bradykinin release and causes the characteristic swelling and pain attacks in HAE patients. This is the first oral on-demand therapy in its class, offering a convenient alternative to IV and subcutaneous options.
Launch12.7 years to LOE
Early-stage launch with zero documented competitive pressure creates significant upside opportunity for commercial teams to establish market position in a niche rare disease indication.
Mechanism of Action
Kallikrein Inhibitors
Pharmacologic Class:
Plasma Kallikrein Inhibitor
Indications (1)
Clinical Trials (7)
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
Started Jun 2024
36 enrolled
Hereditary Angioedema
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)
Started Oct 2022
145 enrolled
Hereditary Angioedema
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)
Started Feb 2022
136 enrolled
Hereditary Angioedema
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
Started Jul 2019
84 enrolled
Hereditary Angioedema
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
Started Jan 2018
84 enrolled
Hereditary Angioedema
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.