Sebetralstat

Treats acute attacks of hereditary angioedema (HAE). Sold as Ekterly. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Sebetralstat (sold as Ekterly), first approved Jul 3, 2025, with 0 new uses approved and 0 published complete response letters.

First approved: Jul 3, 2025
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $17.1M
Orphan exclusivity until: Jul 3, 2032
First approved in the EU: Sep 17, 2025
First approved in Japan: Dec 22, 2025

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Ekterly	Part D	$17.1M	New	115

Who Was in the Trials

110 participants in the largest population FDA reports for the Jul 3, 2025 approval, from FDA's Drug Trials Snapshot; see every snapshot

Women: 60%
65 and older: Not reported
White: 84%
Black: under 1%
Asian: 9%
Hispanic or Latino: 6%

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of bradykinin-mediated angioedemaKalVista Pharmaceuticals Ltd · designated Sep 7, 2021 · approved Jul 3, 2025 · exclusive to Jul 3, 2032

Approvals in the EU (EMA)

First approved in the EU 2 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ekterly, new substanceKalvista Pharmaceuticals (Ireland) Limited · Sep 17, 2025

Approvals in Japan (PMDA)

First approved in Japan 6 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Ekterly, new ingredientA drug with a new active ingredient indicated for the treatment of acute attacks of hereditary angioedema. · KalVista Pharmaceuticals Ltd. · Dec 22, 2025 · Review report

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)Hereditary Angioedema · KalVista Pharmaceuticals, Ltd.	Phase 4	Recruiting	Jun 17, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jul 3, 2025	EkterlyNDA 219301 · New molecular entity	Kalvista	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA