EKTERLY Film-coated tablet Ref.[115832] Active ingredients: Sebetralstat

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: KalVista Pharmaceuticals (Ireland) Ltd., Magennis Place, Block C, Dublin 2, D02 FK76, Ireland

Product name and form

Ekterly 300 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Yellow, oval shaped (approximately 15 mm x 9 mm), biconvex tablets debossed with KalVista logo "K" on one side and "300" on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 300 mg of sebetralstat.

For the full list of excipients, see section 6.1.

Active Ingredient

Sebetralstat is a competitive, reversible inhibitor of plasma kallikrein (PKa). By inhibiting PKa, sebetralstat blocks the cleavage of high molecular weight kininogen (HK) and the subsequent generation of bradykinin (BK), thereby halting HAE attack progression which is associated with increased vascular permeability and oedema formation. Sebetralstat also suppresses the activation of positive feedback mechanism of the kallikrein-kinin system (KKS), thereby reducing factor XIIa (FXIIa) and additional PKa production.
List of Excipients

Tablet core:

Microcrystalline cellulose (E460)
Croscarmellose sodium (E468)
Povidone K30 (E1201)
Magnesium stearate (E470b)

Film-coatings:

Macrogol poly(vinyl alcohol) grafted copolymer (E1209)
Talc (E553b)
Titanium dioxide (E171)
Glycerol monocaprylocaprate (Type 1) (E471)
Poly(vinyl alcohol) (E1203)
Iron oxide yellow (E172)
Iron oxide black (E172)
Maltodextrin (E1400)
Guar galactomannan (E412)
Hypromellose (E464)
Triglycerides, medium-chain

Pack sizes and marketing

oPA/Al/PVC with aluminium lidding blisters (1 film-coated tablet per blister).

The film-coated tablets are packed in a blister encased in a child-resistant cardboard wallet. The wallets are contained in a cardboard box.

Pack size: 4 or 6 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

KalVista Pharmaceuticals (Ireland) Ltd., Magennis Place, Block C, Dublin 2, D02 FK76, Ireland

Marketing authorization dates and numbers

EU/1/25/1975/001
EU/1/25/1975/002

Drugs

Drug Countries
EKTERLY Austria, Estonia, Italy, Lithuania, United States
 
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