Is Sebetralstat approved by the US FDA?

Drugs@FDA lists 1 application product line for Sebetralstat, including EKTERLY (Prescription).

Is Sebetralstat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Sebetralstat: Ekterly.

Active substance

Sebetralstat

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
EKTERLY	300MG	tablet · oral	KALVISTA	Prescription	3 Jul 2025

EMA European Union — centrally authorised medicines

Ekterly Kalvista Pharmaceuticals (Ireland) Limited · Authorised · authorised 17 Sep 2025 · ATC B06AC08

Therapeutic indication (EMA)

Ekterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.