NDAORALCAPSULE
Approved
Dec 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
SECTRAL (acebutolol hydrochloride) by ANI Pharmaceuticals is clinical pharmacology acebutolol is a cardioselective, β-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (isa) in its therapeutically effective dose range. Approved for hypertension in adults, the management of ventricular premature beats, hypertension and 1 more indications. First approved in 1984.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SECTRAL (acebutolol hydrochloride) is a cardioselective beta-1 adrenergic blocking agent with mild intrinsic sympathomimetic activity, approved in 1984 for treating hypertension and ventricular premature beats. It works by reducing sympathetic nervous system activity, lowering heart rate, cardiac output, and blood pressure with greater selectivity for cardiac beta-1 receptors over bronchial beta-2 receptors, making it safer in respiratory patients than non-selective beta-blockers.
LOE Approaching
As a mature product approaching loss of exclusivity, SECTRAL faces declining market share and minimal team expansion; opportunities lie in defensive strategies and cost optimization rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Acebutolol is a cardioselective, β-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (ISA) in its therapeutically effective dose range. Pharmacodynamics β 1 -cardioselectivity has been demonstrated in experimental animal studies. In…
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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.