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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.

Development timeline for Ekterly

DateArticle
Jul  8, 2025Approval FDA Approves Ekterly (sebetralstat) the First and Only Oral On-demand Treatment for Hereditary Angioedema (HAE)
Jun 13, 2025KalVista Pharmaceuticals Announces FDA Will Not Meet PDUFA Goal Date for Sebetralstat NDA for Hereditary Angioedema Due to FDA Resource Constraints
Sep  3, 2024KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema
Jun 18, 2024KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary Angioedema
Feb 13, 2024KalVista Pharmaceuticals Reports Phase 3 KONFIDENT Trial Meets All Endpoints for Sebetralstat as First Oral On-demand Therapy for Hereditary Angioedema
Oct 31, 2022KalVista Pharmaceuticals Announces Positive Phase 1 Data for Orally Disintegrating Tablet Formulation of Sebetralstat for Use in Hereditary Angioedema

Further information

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