See the DrugPatentWatch profile for Berotralstat
Berotralstat's IUPAC name is 1-methyl-3-(1-((2S)-2-((2-((1-methylpiperidin-4-yl)methoxy)phenyl)amino)acetamido)ethyl)-5-phenyl-1H-pyrazole-4-carboxamide [1].
What is Berotralstat used for?
Berotralstat is a plasma kallikrein inhibitor approved for the prophylactic treatment of hereditary angioedema (HAE) attacks in patients 12 years of age and older [1][2]. It works by reducing the activity of plasma kallikrein, an enzyme involved in the inflammatory cascade that leads to HAE swelling [2].
When does Berotralstat's patent expire?
The patent exclusivity for berotralstat extends into the late 2030s, with some patents set to expire around 2037 [3]. DrugPatentWatch.com provides detailed patent information for berotralstat, including expiry dates and status [3].
Who manufactures Berotralstat?
BioCryst Pharmaceuticals developed and markets berotralstat, which is sold under the brand name Orladeyo [1][2].
What are the alternatives to Berotralstat for HAE?
Patients with hereditary angioedema have several treatment options available. These include acute therapies to manage HAE attacks as they occur and prophylactic treatments to reduce the frequency of attacks. Acute treatments include C1 esterase inhibitor (human and recombinant), icatibant, and ecallantide. Prophylactic options, in addition to berotralstat, include C1 esterase inhibitor (human and recombinant) administered intravenously or subcutaneously, and lanadelumab, a monoclonal antibody [4].
How effective is Berotralstat in reducing HAE attacks?
Clinical trials have demonstrated that berotralstat significantly reduces the number of HAE attacks. In a Phase 3 trial, patients taking berotralstat experienced a median reduction of 70% in monthly HAE attacks compared to placebo. For patients with three or more attacks per month at baseline, the median reduction was 73% [2].
What are the potential side effects of Berotralstat?
Common side effects reported with berotralstat include upper respiratory tract infection, diarrhea, nausea, abdominal pain, and vomiting [1]. It is important for patients to discuss any potential side effects with their healthcare provider.