NDAORALCAPSULE
Approved
Dec 2020
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
ORLADEYO (berotralstat hydrochloride) by BioCryst Pharmaceuticals is activity. First approved in 2020.
Drug data last refreshed 5h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLADEYO (berotralstat hydrochloride) is an oral, first-in-class plasma kallikrein inhibitor approved for hereditary angioedema (HAE) prophylaxis. It works by decreasing plasma kallikrein activity to control excess bradykinin generation, reducing the frequency and severity of angioedema attacks in HAE patients with C1-inhibitor deficiency or dysfunction.
$0.052BPart D
PeakGrowing
unknown
13.5 years to LOEPeak-stage oral therapy with established Medicare presence and growing patient adoption supports sustained commercial infrastructure 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 offers 22 linked job opportunities across senior commercial and cross-functional leadership roles, reflecting peak-stage product maturity and sustained organizational headcount. Roles emphasize sales execution, data analytics, and regulatory strategy in a stable, competitive-moat environment.
VP
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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.