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FDA Medication Tracker

← All approvals · Rare & genetic · 2025

Ekterly (sebetralstat)

The FDA approved Ekterly (sebetralstat) on July 3, 2025 to treat acute attacks of hereditary angioedema.
Brand name
Ekterly
Generic name
sebetralstat
FDA approval date
July 3, 2025
Approved use (FDA wording)
To treat acute attacks of hereditary angioedema
Company
Kalvista
Application
NDA219301
Dosage form / route
TABLET · ORAL
Drug class (EPC)
Plasma Kallikrein Inhibitor [EPC]
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

EKTERLY® is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY ® is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ( 1 )

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.