NDAORALPELLETSPriority Review
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
ORLADEYO (berotralstat hydrochloride) by BioCryst Pharmaceuticals is activity. First approved in 2025.
Drug data last refreshed 2h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLADEYO (berotralstat hydrochloride) is an oral plasma kallikrein inhibitor approved for hereditary angioedema (HAE) patients with C1-inhibitor deficiency or dysfunction. It works by decreasing plasma kallikrein activity to control excess bradykinin generation, thereby preventing angioedema attacks characterized by swelling and pain.
Launch13.9 years to LOE
As a newly launched product in a rare disease space with minimal competitive pressure, the brand team is positioned for rapid market development and team expansion.
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.
Career Relevance
ORLADEYO is at product launch with 18 linked career opportunities, offering entry points across R&D, Medical Affairs, Regulatory Affairs, and IT. Working on this product as a newly approved rare disease therapy provides exposure to specialty pharma commercial build-out, clinical expansion strategy, and long-term franchise development in a focused patient population.
Director
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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.