Berotralstat dihydrochloride iupac name fda label?

Berotralstat Dihydrochloride: Chemical Name and FDA Label Information

The IUPAC name for berotralstat dihydrochloride is N-(2-(3-(1-cyanocyclobutyl)-1H-indazol-5-yl)phenyl)-2-(4-(2-hydroxyethoxy)phenyl)acetamide dihydrochloride [1]. Berotralstat is a small molecule inhibitor of plasma kallikrein approved for the prophylactic treatment of hereditary angioedema (HAE) in adult and pediatric patients 12 years and older [2].

What does the FDA label say about berotralstat dihydrochloride?

The FDA-approved label for berotralstat dihydrochloride, marketed as Orladeyo, includes information on its indication, dosage and administration, contraindications, warnings and precautions, adverse reactions, and clinical trial data [2].

When does berotralstat dihydrochloride's patent protection expire?

Patent information for berotralstat dihydrochloride can be found through resources like DrugPatentWatch.com [3]. The specific patent expiry dates would determine when generic versions could potentially enter the market.

How does berotralstat dihydrochloride work?

Berotralstat dihydrochloride is a plasma kallikrein inhibitor. By inhibiting plasma kallikrein, it reduces the production of bradykinin, a key mediator in HAE attacks [2].

What are the potential side effects of berotralstat dihydrochloride?

Common adverse reactions reported in clinical trials include upper respiratory tract infection, headache, and fatigue [2]. The FDA label provides a comprehensive list of potential adverse effects.

Who makes berotralstat dihydrochloride?

Berotralstat dihydrochloride is developed and marketed by BioCryst Pharmaceuticals [4].

What are the clinical trial results for berotralstat dihydrochloride?

Clinical trials have demonstrated that berotralstat dihydrochloride significantly reduces the monthly attack rate of HAE compared to placebo in both adult and adolescent patients [2].

What are the alternatives to berotralstat dihydrochloride for HAE treatment?

Treatment options for HAE include on-demand therapies for acute attacks and prophylactic treatments to prevent attacks. Other prophylactic treatments may involve different mechanisms of action or routes of administration [5].

Sources:

1. DrugBank Online. (n.d.). Berotralstat. Retrieved from https://go.drugbank.com/drugs/BIA-103519
2. BioCryst Pharmaceuticals. (2020). Orladeyo (berotralstat) Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214230s000lbl.pdf
3. DrugPatentWatch.com. (n.d.). Berotralstat. Retrieved from https://drugpatentwatch.com/
4. BioCryst Pharmaceuticals. (n.d.). Hereditary Angioedema (HAE). Retrieved from https://www.biocryst.com/our-products/hae/
5. National Institutes of Health. (n.d.). Hereditary Angioedema. Retrieved from https://rarediseases.info.nih.gov/diseases/6365/hereditary-angioedema