Product Dossier
EKTERLY
Product Dossier for EKTERLY (sebetralstat, JACE Pharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: JACE Pharma
- Active ingredient: sebetralstat
- Therapeutic area: Rare Disease
- Same area: ORKAMBI
- Same area: BYLVAY
What it is EKTERLY is a sebetralstat 300 mg film coated tablet .
Approved indications
— Treatment of hereditary angioedema (HAE) attacks caused by C1 inhibitor deficiency or dysfunction in patients aged 12 years and older.
Key safety warnings
Embryofetal toxicity and malformations in rats at higher doses have been identified as a key safety concern.
Regulatory history
EKTERLY was approved on 2025-10-09. The product was first listed on the ARTG on 2025-11-19.