Sebetralstat: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: November 27, 2025🚩 Report this page

Sebetralstat

Drugs Used In Hereditary Angioedema

Sold as Ekterly

GB MHRAEU EMA

Drug class: Drugs Used In Hereditary Angioedema
Availability: See label
Markets covered: 2
Products on record: 2

B06ACDrugs Used In Hereditary Angioedema

Overview

Sebetralstat is an active pharmaceutical ingredient in the Drugs Used In Hereditary Angioedema group (B06AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	November 27, 2025
EU European Union	EMA	1	October 8, 2025

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised November 27, 2025[1]

Ekterly is indicated for the treatment of hereditary angioedema (HAE) attacks in adult and adolescents aged 12 years and older.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised October 8, 2025[2]

Ekterly is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 years and older.

How to take

Sources & citations

[1]MHRA (UK) · PL463260001 · revised November 27, 2025
[2]European Medicines Agency · EMEA/H/C/006211 · revised October 8, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised November 27, 2025[1]

Summary of the safety profile Ekterly has been administered to a total of 411 healthy subjects and 239 hereditary angioedema patients. In clinical studies used for registration, 1,945 HAE attacks have been treated with Ekterly. 2% of patients).
The reported events of headache were generally mild to moderate in severity, non-serious and resolved without any further intervention. Tabulated list of adverse reactions The frequency of all adverse reactions listed in the table below is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Table 1. Summary of adverse reactions by system organ class and frequency System organ class Adverse Reaction Frequency Nervous system disorders Headache Common Dyspepsia Common Nausea Uncommon Gastrointestinal disorders Abdominal pain Uncommon General disorders and administration site conditions Fatigue Uncommon Musculoskeletal and connective tissue disorders Back pain Uncommon Vascular disorders Hot flush Uncommon Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised November 27, 2025[1]

Laryngeal attacks:
Following treatment of laryngeal attacks with Ekterly, advise patients to seek immediate medical attention. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”.
Sebetralstat is an in vitro inhibitor of MATE1, MATE2-K and OCT2 and co- administration may raise exposure to substrates of these transporters such as metformin. Clinicians should consider monitoring blood lactate and renal function in patients who carry a higher risk for lactic acidosis.

This is not medical advice. Consult a qualified healthcare professional.