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Real EKTERLY® (sebetralstat) patient Cari sitting on a dock with children laughing Real EKTERLY® (sebetralstat) patient Cari sitting on a dock with children laughing

Study
Design

Real EKTERLY patient

TRIAL DETAILS

EKTERLY was studied in the largest on‑demand HAE trial1,2

The KONFIDENT phase 3 trial reflected the broad population of patients with HAE who continue to live with attacks2,3

  • Adult and adolescents
    Adults & adolescents Ages 12 years and older3
  • Attack
    ≥2 attacks in the 3 months prior to the study for all patients, including those treating with prophylaxis2
  • Shield
    23% treated with long-term prophylaxis* + on‑demand treatment2
  • Warning
    77% treated with on-demand treatment only2

Attacks in all locations were eligible for treatment2

Locations of HAE attacks on the body

*Prophylaxis treatments included berotralstat (38%), lanadelumab (33%), and C1 inhibitor replacement (25%).2

Patients treated 3 attacks with either EKTERLY 300 mg, 600 mg, or placebo2,3

  • KONFIDENT trial

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    • KONFIDENT was a multinational, randomized, double-blind, placebo-controlled, phase 3, crossover study of 136 patients from 17 countries. Study participants were randomized to receive either placebo, EKTERLY 300 mg, or EKTERLY 600 mg to treat 3 attacks in a 3-way crossover design using 1 of 6 treatment sequences.2,4

KONFIDENT study design schematic KONFIDENT study design schematic
Adapted from Riedl NEJM 20242,4
  • Participants assessed their posttreatment symptoms every half hour or hour through 12 hours5

PRIMARY ENDPOINT

KONFIDENT: Setting the new standard for on‑demand trials
in HAE6,7

The primary endpoint was designed with input from patients with HAE6,7

Primary endpoint: time to beginning of symptom relief2,3

Defined as a rating of at least “a little better” for at least 2 consecutive timepoints on the Patient Global Impression of Change (PGI-C) scale within 12 hours of first dose

PGI-C (7-Point Scale)4

PGI-C 7-point scale
PGI-C 7-point scale

Patients who reported at least “a little better” had clinically meaningful improvement in attack symptoms6

Mechanism of Action

KONFIDENT-S study design

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  • KONFIDENT-S is a multicenter, open-label extension trial of adult and adolescent patients
(≥12 years of age; N=134). Study participants had a confirmed diagnosis of HAE and ≥2 attacks within 3 months and were enrolled after completing the KONFIDENT phase 3 trial or de novo.9

ATTACK SEVERITY & TIME TO TREATMENT

EKTERLY enables rapid treatment within minutes of recognizing an attack2

Median Time to Treatment From Attack Onset2,8

  • KONFIDENT phase 3 study

    (93 attacks)

    41

    minutes

  • KONFIDENT-S open-label extension*

    (1706 attacks)

    10

    minutes

Severity of HAE attacks in KONFIDENT trial All attacks were eligible for treatment2,† 44.1%
of treated attacks were mild2 36.6%
of treated
attacks were moderate2 19.4%
of treated attacks were severe/very severe2

*KONFIDENT-S is a multicenter, open-label extension trial of adult and adolescent patients (≥12 years of age; N=134). Study participants had a confirmed diagnosis of HAE and ≥2 attacks within 3 months and were enrolled after completing the KONFIDENT phase 3 trial or de novo.9

†For severe laryngeal attacks, patients were directed to treat with their conventional on-demand medication.10

HAE=hereditary angioedema.

Real EKTERLY® (sebetralstat) patient Cari enjoying time on a boat Real EKTERLY® (sebetralstat) patient Cari enjoying time on a boat Real EKTERLY patient
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References:
1. Valerieva A, Longhurst HJ. Treatment of hereditary angioedema—single or multiple pathways to the rescue. Front Allergy. 2022;3:952233. doi:10.3389/ falgy.2022.952233 2. Riedl MA, Farkas H, Aygören-Pürsün E, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391(1):32-43. doi:10.1056/NEJMoa2314192
3. EKTERLY. Package insert. KalVista Pharmaceuticals, Inc.; 2025. 4. Riedl MA, Farkas H, Aygören-Pürsün E, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391(1)(suppl 1):1-33. doi:10.1056/NEJMoa2314192 5. Riedl MA, Farkas H, Aygören-Pürsün E, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391(1)(protocol):1-263. doi:10.1056/NEJMoa2314192 6. Cohn DM, Aygören-Pürsün E, Bernstein JA, et al. Evaluation of patient-reported outcome measures for on-demand treatment of hereditary angioedema attacks and design of KONFIDENT, a phase 3 trial of sebetralstat. Clin Transl Allergy. 2023;13(9):e12288. doi:10.1002/clt2.12288 7. Cohn DM, Soteres DF, Craig TJ, et al. Interplay between on-demand treatment trials for hereditary angioedema and treatment guidelines. J Allergy Clin Immunol. 2025;155(3):726-739. doi:10.1016/j.jaci.2024.12.1079
8. Data on File. KalVista Pharmaceuticals, Inc.; 2025.
9. Bernstein JA, Aygören-Pürsün E, Cancian M, et al. Sebetralstat for on-demand treatment of mucosal hereditary angioedema attacks in KONFIDENT-S. Clin Transl Allergy. 2025;15(11):e70118. doi: 10.1002/clt2.70118 10. Data on File. KalVista Pharmaceuticals, Inc.; 2024.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

EKTERLY® (sebetralstat) 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.

IMPORTANT SAFETY INFORMATION

Adverse reactions: The most commonly reported adverse reaction was headache (3.2%).

Drug interactions: EKTERLY is a substrate of CYP3A4. Concomitant use of EKTERLY with a strong CYP3A4 inhibitor increases sebetralstat exposure, which may increase the risk of sebetralstat adverse reactions. Avoid use of EKTERLY with strong CYP3A4 inhibitors and reduce the dose of EKTERLY to one dose of 300 mg (one tablet) with moderate CYP3A4 inhibitors. Concomitant use of EKTERLY with a strong or moderate CYP3A4 inducer decreases sebetralstat exposure, which may decrease efficacy. The use of EKTERLY with strong or moderate CYP3A4 inducers is not recommended.

Use in specific populations: Avoid use of EKTERLY in patients with severe hepatic impairment (Child-Pugh Class C). The recommended dosage of EKTERLY is one dose of 300 mg (one tablet) in patients with moderate hepatic impairment (Child-Pugh Class B).

There are no available data on EKTERLY in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are no data on the presence of sebetralstat or its metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.

The safety and effectiveness of EKTERLY in pediatric patients aged under 12 years of age have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.