ORLADEYO

Peak

berotralstat hydrochloride

BioCryst Pharmaceuticals

NDAORALCAPSULE

Approved

Dec 2020

Lifecycle

Peak

Competitive Pressure

0/100

Data completeness

5/8 — Partial

ORLADEYO (berotralstat hydrochloride) by BioCryst Pharmaceuticals is activity. First approved in 2020.

Drug data last refreshed 23h ago · AI intelligence enriched 3w ago

AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data

ORLADEYO (berotralstat hydrochloride) is an oral plasma kallikrein inhibitor approved in December 2020 for the treatment of hereditary angioedema (HAE). It works by decreasing plasma kallikrein activity to control excess bradykinin generation, which is the underlying cause of angioedema attacks in HAE patients with C1-inhibitor deficiency or dysfunction. ORLADEYO represents the first oral on-demand and prophylactic treatment option for HAE, addressing a historically underserved patient population previously dependent on subcutaneous or intravenous therapies.

$0.1BPart D

14.0 years to LOE

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Mechanism of Action

activity. Plasma kallikrein is a protease that cleaves high-molecular-weight kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor…

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Career Relevance

ORLADEYO supports approximately 18 open professional roles across brand management, medical science liaisons, specialty pharmacy representatives, and rare disease field teams focused on HAE patient education and physician engagement. Key skills include rare disease expertise, patient advocacy coordination, medical writing for a niche indication, and understanding of prophylactic treatment paradigms. The specialized nature of HAE creates demand for deep disease knowledge and relationships with the limited number of HAE specialists and genetics centers.