EKTERLY Ref.[115734] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product description

The active ingredient of EKTERLY is sebetralstat, a plasma kallikrein inhibitor. The chemical name of sebetralstat is N-[(3-fluoro-4-methoxypyridin-2-yl) methyl]-3-(methoxymethyl)-1-({4-[(2-oxo-1,2-dihydropyridin-1-yl) methyl]phenyl}methyl)-1H-pyrazole-4-carboxamide. The chemical structure of sebetralstat is:

The molecular formula is C26H26FN5O4 and molecular weight is 491.5. Sebetralstat is a white to off-white crystalline powder. It is slightly soluble in ethanol, acetone and isopropanol, and practically insoluble in water.

EKTERLY is supplied as 300 mg film-coated tablets for oral administration. Each tablet contains the active ingredient sebetralstat. The inactive ingredients include croscarmellose sodium, glycerol mono and dicaprylocaprate, guar gum/guar galactomannan, hypromellose, iron oxide black, iron oxide yellow, macrogol polyvinyl alcohol graft copolymer, magnesium stearate, maltodextrin, medium chain triglycerides, microcrystalline cellulose, polyvinyl alcohol, povidone, talc and titanium dioxide.

Dosage Forms and Strengths

Tablets: 300 mg, yellow, oval, biconvex, film-coated tablets debossed with ?renderMultiMedia?on one side and "300" on the other side.

How Supplied

EKTERLY (sebetralstat) tablets: 300 mg, yellow, oval, biconvex, film-coated tablets debossed with ?renderMultiMedia?on one side and "300" on the other side.

  • EKTERLY is supplied in a carton containing four child-resistant blister cards. Each child-resistant blister card contains 1 x 300 mg tablet (NDC 82928-300-04).
  • Each carton contains a tamper evident seal. Do not use if tamper evident seal is broken or missing.

Distributed by: KalVista Pharmaceuticals, Inc., 55 Cambridge Parkway Suite 901E, Cambridge, MA 02142

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