What Was Approved?
On July 3, 2025, the U.S. Food and Drug Administration approved Ekterly (sebetralstat) for the treatment of acute hereditary angioedema, or HAE, attacks in adults and pediatric patients 12 years of age and older.
Ekterly treats an attack after it begins. It is not a preventive maintenance treatment.
How Does Ekterly Work?
Ekterly is an oral plasma kallikrein inhibitor.
By inhibiting kallikrein, it reduces signaling involved in the swelling that occurs during HAE attacks.
How Is Ekterly Taken?
The recommended dose is:
600 mg by mouth at the earliest recognition of an HAE attack.
If the response is inadequate or symptoms worsen or return, a second 600 mg dose may be taken 3 hours later.
The maximum recommended amount is 1,200 mg within 24 hours.
What Did the Clinical Trial Show?
In the KONFIDENT trial, patients receiving Ekterly experienced symptom relief sooner than those receiving placebo.
Within 12 hours, 76% of patients receiving the approved 600 mg dose reported the predefined beginning of symptom relief, compared with 49% receiving placebo.
What Is the Most Common Side Effect?
The most commonly reported adverse reaction was headache.
Bottom Line
Ekterly (sebetralstat) is an FDA-approved oral treatment for acute HAE attacks in patients age 12 and older.
It should be taken at the earliest recognition of an attack and should not be confused with medicines used to prevent HAE attacks.
Sources
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Ekterly.
- U.S. Food and Drug Administration (FDA) — Ekterly Prescribing Information, July 2025.