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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLADEYO (berotralstat hydrochloride) is an oral small-molecule plasma kallikrein inhibitor approved for hereditary angioedema (HAE) prophylaxis. It works by suppressing plasma kallikrein activity to prevent excess bradykinin generation, thereby reducing the frequency and severity of angioedema attacks in patients with C1-inhibitor deficiency or dysfunction.
$0.052BPart D
Peak13.7 years to LOEProduct is at peak commercial maturity with 1,293 Part D claims in 2023, indicating established market penetration in a niche rare disease category with stable small team requirements.
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
Roles linked to ORLADEYO span commercial operations, medical affairs, and quality oversight, reflecting a mature product requiring strong operational execution and specialist engagement in a rare disease setting. Career positions emphasize leadership, data management, and regional MSL expertise rather than broad commercial sales expansion.
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.