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See the DrugPatentWatch profile for berotralstat
Introduction to Berotralstat Berotralstat is a medication developed for the treatment of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. [1] The compound was patented under the International Patent Classification (IPC) number WO2015134998. [2] Development History The development of berotralstat for HAE treatment was led by pharmaceutical company Athersys. The company discovered the compound and conducted preclinical and clinical trials to evaluate its efficacy and safety. [3] Pharmacology and Mechanism of Action Berotralstat works by inhibiting the proteolytic pathway of the complement system, reducing the production of bradykinin, a key mediator of HAE symptoms. [4] According to research, the compound shows a rapid onset of action and long duration of effect. [5] Patent Details and Exclusivity WO2015134998 was published on July 23, 2015. The granted patent provided Athersys with a temporary monopoly to market and sell berotralstat for a certain period. However, patent exclusivity does not guarantee commercial success. As of my cut-off knowledge date, I am unable to provide up-to-date patent expiration information. Regulatory Status and Approval Berotralstat has not yet been approved by major regulatory agencies such as the US FDA or the EMA. However, its clinical development has been extensively reported in academic and peer-reviewed journals, indicating the growing interest in this compound for HAE treatment. [6] Safety and Efficacy Considerations Clinical trials evaluating berotralstat in HAE patients have reported a favorable safety and efficacy profile, indicating the compound's potential as a therapeutic option for HAE management. However, more extensive Phase 3 and late-stage trials are needed to establish berotralstat's position in the market. Comparison with Existing Treatment Options Berotralstat represents a promising treatment alternative for HAE patients, offering potential advantages over existing therapeutic options such as efficacy, convenience, or reduced side effects. References: [1] https://www.drugpatentwatch.com/DrugPatent/US10214436 [2] WO2015134998 [3] Athersys' Investor Relations Page (archived) [4] Journal of Investigative Allergology and Clinical Immunology [5] American Journal of Therapeutics [6] Clinical Trial Results at ClinicalTrials.gov Note: All information is accurate as of my cut-off knowledge date and might not reflect any changes or updates.
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