Ekterly FDA Approval History
Last updated by Melisa Puckey, BPharm on July 8, 2025.
FDA Approved: Yes (First approved July 3, 2025)
Brand name: Ekterly
Generic name: sebetralstat
Dosage form: Tablets
Company: KalVista Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema
Ekterly (sebetralstat) is an oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older.
- Hereditary angioedema (HAE) is a genetic disease characterized by a deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. Symptoms of an HAE attack include painful and debilitating attacks of tissue swelling in the hands, feet, limbs, face, intestinal tract, and airways.
- Ekterly contains sebetralstat which works in the treatment of HAE by targeting the kallikrein-kinin system (KKS) cascade and selectively inhibiting plasma kallikrein which drives HAE attacks. Sebetralstat is administered orally to readily treat HAE attacks on-demand, including at the earliest signs before the HAE attack fully develops. It is the first and only oral on-demand treatment for HAE; all other approved on-demand treatment options require either intravenous or subcutaneous administration.
- The FDA approval was based on clinical trial results, including data from the KONFIDENT phase 3 clinical trial and the KONFIDENT-S extension trial. Sebetralstat met the primary endpoint in the phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief significantly faster than placebo. The median time to beginning of symptom relief was 1.61 hours with sebetralstat 300 mg, 1.79 hours with sebetralstat 600 mg, and 6.72 hours with placebo.
- Ekterly tablets are administered orally at the earliest sign of an acute attack of hereditary angioedema and may be repeated after at least 3 hours after the first dose if the symptoms return, worsen, or you do not feel better.
- Common adverse reactions include headache.
Development timeline for Ekterly
Further information
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