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Search results for berotralstat in Related Substance Name (approximate match)
Status:
US Approved Rx
(2020)
Source:
NDA214094
(2020)
Source URL:
First approved in 2020
Source:
NDA214094
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Berotralstat (ORLADEYO™; BCX7353) is an orally administered kallikrein inhibitor, which has been developed by BioCryst Pharmaceuticals for hereditary angioedema (HAE). The inhibition of kallikrein by berotralstat decreases the production of bradykinin, which prevents the localised tissue oedema that occurs during attacks of HAE. Berotralstat has been approved in the USA, and subsequently in Japan, for prophylaxis to prevent attacks of HAE in adults and paediatric patients aged 12 years or older.
Status:
US Approved Rx
(2013)
First approved in 1958
Class:
MIXTURE
Status:
Investigational
Source:
NCT03534063: Not Applicable Interventional Completed Pain, Postoperative
(2018)
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
NCT02710747: Phase 4 Interventional Unknown status Heart Valve Disease
(2015)
Source URL:
Class:
PROTEIN
