Berotralstat

Chemical formula: C₃₀H₂₆F₄N₆O  Molecular mass: 562.573 g/mol 

Active ingredient description

Berotralstat is an inhibitor of plasma kallikrein. In patients with hereditary angioedema (HAE) due to C1-INH deficiency or dysfunction, normal regulation of plasma kallikrein activity is impaired, which leads to uncontrolled increases in plasma kallikrein activity and bradykinin release, resulting in HAE attacks consisting of swelling (angioedema).

Medicine classification

This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:

ATC code Group title Classification
B06AC06 B Blood and blood forming organs → B06 Other hematological agents → B06A Other hematological agents → B06AC Drugs used in hereditary angioedema
Discover more medicines within B06AC06

Product monographs

Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):

Title Information Source Document Type  
ORLADEYO Hard capsule European Medicines Agency (EU) MPI, EU: SmPC

Structural formula

Graphic representation of the active ingredient's molecular structure

External identifiers

CAS Substance: 1809010-50-1
DrugBank Drug: DB15982
RxNorm Ingredient: 2467540
UNII Identifier: XZA0KB1BDQ
BEROTRALSTAT

Medicines

Berotralstat is an active ingredient of these brands:

Austria (AT)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Croatia (HR)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Estonia (EE)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

France (FR)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Ireland (IE)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Israel (IL)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Italy (IT)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Japan (JP)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Lithuania (LT)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Poland (PL)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Spain (ES)

  • ORLADEYO as BEROTRALSTAT HYDROCHLORIDE

Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide.

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