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Efficacy
and Safety

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EKTERLY halts HAE attacks fast for rapid symptom relief1,2

KONFIDENT EFFICACY

Primary Endpoint: median time to the beginning of symptom relief1,2

  • Ekterly

    1.8

    hours*

  • Timer icon

  • Placebo

    6.7

    hours

Explore the primary endpointlink

*Based on prespecifying that attacks with incomplete data were censored at timepoint zero. Analysis included in label assigns these attacks a value of 12 hours, resulting in a median of 2.0 hours.1,2

One-dose symptom relief

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96% of attacks
that reached the primary
endpoint achieved
symptom relief
with only 1 dose3

Patients reported rapid time to symptom relief with EKTERLY1,2

Time to Beginning of Symptom Relief Within 12 Hours of Dosing1,2,4*

Time to symptom relief within 12 hours of EKTERLY® (sebetralstat) dosing

• Some patients experienced symptom relief as early as 30 minutes after administration4

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Time to symptom relief was
consistent across
attack locations,
severities, and
patient demographics2

KONFIDENT study design link

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.2,3

Learn more about the KONFIDENT trial

KONFIDENT SAFETY

Safety events with EKTERLY were similar to placebo1

Adverse Events Observed in ≥2% of Patients and More Common Than Placebo1

Adverse
Events		 EKTERLY PLACEBO
600 mg
(n=93) 		n=83
no. (%) no. (%)
Headache 3 (3.2) 1 (1.2)
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discontinuations

due to adverse events2

KONFIDENT-S 2-YEAR, OPEN-LABEL EXTENSION5

1700+ attacks were treated with EKTERLY6,7†

Primary attack locations EKTERLY-treated
attacks, no. (%)
Abdomen 645 (37.8)
Arms/hands 490 (28.7)
Legs/feet 403 (23.6)
Head/face/neck 129 (7.6)
Torso 99 (5.8)
Genitals 84 (4.9)
Larynx/throat‡ 32 (1.9)
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Laryngeal attacks had a median time
to beginning of symptom
relief of 1.3 hours, with no reports of difficulty swallowing EKTERLY8,‡

95%

of attacks achieved beginning
of symptom relief
with only one dose.7

Safety in KONFIDENT-S (N=134)9

Treatment-Related TEAEs Participants, no. (%)
Any treatment-related TEAE 12 (9.0)
Vomiting 3 (2.2)
Nausea 2 (1.5)
Abdominal discomfort 1 (0.7)
Diarrhea 1 (0.7)
Influenza-like illness 1 (0.7)
Arthralgia 1 (0.7)
Myalgia 1 (0.7)
Headache 5 (3.7)
Tremor 1 (0.7)
Skin burning sensation 1 (0.7)
Urticaria 1 (0.7)
Hypothetical EKTERLY® (sebetralstat) patient socializing in an indoor setting Hypothetical EKTERLY® (sebetralstat) patient socializing in an indoor setting
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Study Design Right arrow
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†KONFIDENT-S is a multicenter, open-label extension trial of 134 adult and adolescent (≥12 years of age) patients. 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.5,6

‡Patients with laryngeal attacks were instructed to treat immediately with conventional on-demand treatment if laryngeal attack symptoms worsened after initial treatment with EKTERLY. 10

HAE=hereditary angioedema; PGI-C=Patient Global Impression of Change scale; TEAE=treatment-emergent adverse event.

References:

1. EKTERLY. Package insert. KalVista Pharmaceuticals, Inc.; 2025.
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. 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 4. Data on File. KalVista Pharmaceuticals, Inc. 2024. 5. Data on File. KalVista Pharmaceuticals, Inc. 2024. 6. Data on File. KalVista Pharmaceuticals, Inc. 2024. 7. Data on File. KalVista Pharmaceuticals, Inc. 2024. 8. Bernstein J, Aygören-Pürsün E, Grivcheva-Panovska V, et al. Effectiveness of sebetralstat for the on-demand treatment of laryngeal hereditary angioedema attacks: interim analysis from KONFIDENT-S. J Allergy Clin Immunol. 2025;155(2)Supplement:AB432. 9. Data on File. KalVista Pharmaceuticals, Inc. 2024. 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.

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.