NDAORALCAPSULEPriority Review
Approved
Jan 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
DIBENZYLINE (phenoxybenzamine hydrochloride) by Pfizer is clinical pharmacology phenoxybenzamine hydrochloride is a long-acting, adrenergic, alpha -receptor-blocking agent, which can produce and maintain "chemical sympathectomy" by oral administration. Approved for the treatment of pheochromocytoma, to control episodes of hypertension, sweating and 1 more indications. First approved in 1953.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIBENZYLINE (phenoxybenzamine HCl) is a long-acting alpha-adrenergic receptor blocker approved in 1953 for treatment of pheochromocytoma and its associated hypertensive episodes, sweating, and cardiovascular symptoms. It works by producing 'chemical sympathectomy' through oral administration, blocking catecholamine effects on alpha-adrenergic receptors. Only 20-30% of oral dose is absorbed, but effects persist 3-4 days with IV dosing and cumulate over a week with daily dosing.
LOE Approaching
Product is approaching loss of exclusivity with minimal commercial investment signals; teams are typically lean and focused on niche indication management.
Mechanism of Action
CLINICAL PHARMACOLOGY Phenoxybenzamine hydrochloride is a long-acting, adrenergic, alpha -receptor-blocking agent, which can produce and maintain "chemical sympathectomy" by oral administration. It increases blood flow to the skin, mucosa and abdominal viscera, and lowers both supine and erect…
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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.