Prescription medicine

Sebetralstat Brand names: Ekterly

Sebetralstat (Ekterly) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the sebetralstat FDA label on DailyMed (effective April 1, 2026, KalVista Pharmaceuticals Ltd); the NDA 219301 record on Drugs@FDA; every sebetralstat label on DailyMed.

Highlights of the record

FDA label of April 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
EKTERLY® is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

Forms and strengths

300 mg

Tablet.

On the market

Earliest approval on file: July 3, 2025 Ekterly, Kalvista; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: January 26, 2039 Ekterly tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 368 through July 30, 2026

What is sebetralstat used for?

From the label: indications and usage
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.

FDA pharmacologic class: Plasma Kallikrein Inhibitor.

Source: FDA drug label (EKTERLY), KalVista Pharmaceuticals Ltd, effective April 1, 2026 (SPL set 1d145e2f-8e7e-2e90-e063-6294a90a4449), via openFDA; the full label on DailyMed

Is there a generic for sebetralstat (Ekterly)?

No generic sebetralstat is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 8 patents for Ekterly tablets: the compound patent runs to December 25, 2037, and the last listed entry to January 26, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2025 earliest approval on file
2039 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for sebetralstat?

The FDA Adverse Event Reporting System holds 368 reports that list sebetralstat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 69 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Hereditary Angioedema (a use or a product term, not a reaction)123
Drug Ineffective (a use or a product term, not a reaction)70
Headache (named in the label)27
Incorrect Dose Administered (a use or a product term, not a reaction)19
Product Dose Omission Issue (a use or a product term, not a reaction)17
Stress16
Weight Increased14
Vomiting13

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other plasma kallikrein inhibitors: the pharmacologic class, with prices and generics
Sebetralstat side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other