NDAORALTABLET
Approved
Jul 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
8
Data completeness
5/8 — Partial
EKTERLY (sebetralstat) by KalVista Pharmaceuticals is kallikrein inhibitors [moa]. First approved in 2025.
Drug data last refreshed 34m ago · AI intelligence enriched Yesterday
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, a key enzyme in the contact system pathway that drives angioedema attacks. This small-molecule tablet represents a new oral treatment option in a historically injectable-dominated HAE market.
Growth12.2 years to LOE
Early-stage growth product with minimal competitive pressure creates opportunity for field teams to establish market presence and define the oral HAE treatment category.
Mechanism of Action
Kallikrein Inhibitors
Pharmacologic Class:
Plasma Kallikrein Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)
Started Aug 2026
100 enrolled
Hereditary Angioedema
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
Started Aug 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
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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.