Sebetralstat

(Ekterly®)

Ekterly®

Drug updated on 7/24/2025

Dosage FormTablet (oral; 200 mg)
Drug ClassPlasma kallikrein inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • Among participants aged >= 12 years with type 1 or type 2 hereditary angioedema, median time to symptom relief was 1.61 hours (interquartile range [IQR], 0.78-7.04) with the 300-mg dose and 1.79 hours (IQR, 1.02-3.79) with the 600-mg dose of sebetralstat, compared to 6.72 hours (IQR, 1.34 to >12) with placebo (P < 0.001 for 300 mg; P = 0.001 for 600 mg).
  • Median time to reduction in attack severity was 9.27 hours (IQR, 1.53 to >12) with the 300-mg dose and 7.75 hours (IQR, 2.19 to >12) with the 600-mg dose, versus >12 hours (IQR, 6.23 to >12) with placebo (P = 0.004 for 300 mg; P = 0.003 for 600 mg).
  • Complete attack resolution within 24 hours occurred in 42.5 % of attacks with the 300-mg dose and 49.5 % with the 600-mg dose, compared to 27.4 % with placebo (P = 0.002 for 300 mg; P < 0.001 for 600 mg).
  • Sebetralstat and placebo had similar safety profiles among participants aged >= 12 years with type 1 or type 2 hereditary angioedema.
  • No serious adverse events related to the trial agents were reported.

Product Monograph / Prescribing Information

Document TitleYearSource
Ekterly (sebetralstat) Prescribing Information2025KalVista Pharmaceuticals, Inc., Cambridge, MA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Oral Sebetralstat for On-Demand Treatment of Hereditary Angioedema Attacks
110Subjects
F: 60%
M: 40%
2024The New England Journal of Medicine

Sex Distribution:

F:60%
M:40%
110Subjects

Year:

2024

Source:The New England Journal of Medicine