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. It is available as tablets for oral use. MedsAcross supplies Sebetralstat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Sebetralstat is a competitive, reversible inhibitor of plasma kallikrein. Plasma kallikrein is a serine protease that cleaves high molecular weight kininogen (HK) releasing bradykinin which increases vascular permeability through activation of bradykinin receptors causing edema. Sebetralstat inhibits the cleavage of HK and reduces production of bradykinin, thereby treating the clinical symptoms of an acute, episodic attack of HAE. Sebetralstat also inhibits the positive feedback mechanism of the kallikrein kinin system by plasma kallikrein, thereby reducing factor XIIa and additional plasma kallikrein generation.
Source: US FDA prescribing information
Recommended Dosage: one dose of 600 mg (2 tablets) taken orally at the earliest recognition of an HAE attack. A second dose of 600 mg (2 tablets) may be taken 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur. Maximum Recommended Dosage: 1,200 mg in any 24-hour period. See full prescribing information for dosage modification for concomitant use with CYP3A4 inhibitors and inducers. See full prescribing information for recommended dosage for patients with hepatic impairment.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
The most common adverse reaction (incidence ≥2%) is headache.
Source: US FDA prescribing information
Strong and Moderate CYP3A4 Inhibitors: Avoid use with strong CYP3A4 inhibitors. In patients taking moderate CYP3A4 inhibitors, take one dose of 300 mg. A second dose of 300 mg may be taken at least 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur. CYP3A4 Inducers: Avoid use with moderate or strong CYP3A4 inducers.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C and 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Sebetralstat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ekterly 300 mg tabletOral | KalVista Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Sebetralstat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Sebetralstat, including Ekterly.
Yes. The US FDA first approved Sebetralstat on 3 July 2025, according to Drugs@FDA.
Yes. Sebetralstat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Sebetralstat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Sebetralstat is classified under ATC code B06AC08 (Sebetralstat).
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