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 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLADEYO (berotralstat hydrochloride) is an oral, once-daily plasma kallikrein inhibitor approved for hereditary angioedema (HAE) prophylaxis. It works by decreasing plasma kallikrein activity to control excess bradykinin generation, thereby reducing the frequency and severity of angioedema attacks in patients with C1-inhibitor deficiency or dysfunction.
Growth13.7 years to LOE
Product is in launch phase with typical commercial infrastructure build-out underway; team size expected to expand with field and sales operations.
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 in active launch phase with career opportunities concentrated in cross-functional leadership and specialized medical affairs roles. Working on this product offers exposure to rare disease commercialization, long-term brand building, and medical education in a high-unmet-need therapeutic area.
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.