NDAORALPELLETSPriority Review
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
ORLADEYO (berotralstat hydrochloride) by BioCryst Pharmaceuticals is activity. First approved in 2025.
Drug data last refreshed Yesterday · AI intelligence enriched 2w 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.
Launch14.0 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.
Why This Matters for Your Career
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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.