PROAMATINE
LOE ApproachingNDAORALTABLETPriority Review
Approved
Sep 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
PROAMATINE by Takeda is clinical pharmacology mechanism of action: proamatine forms an active metabolite, desglymidodrine, that is an alpha 1 -agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of blood pressure. Approved for symptomatic orthostatic hypotension (oh). First approved in 1996.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROAMATINE (midodrine) is an oral alpha-1 agonist prodrug approved in 1996 for symptomatic orthostatic hypotension across multiple etiologies. The drug is rapidly converted to its active metabolite desglymidodrine, which increases vascular tone and blood pressure by stimulating alpha-adrenergic receptors without central nervous system penetration. It elevates standing systolic blood pressure by 15–30 mmHg within 1 hour, with effects persisting 2–3 hours.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity; brand team likely focused on managed decline, cost optimization, and retention of remaining market share.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action: ProAmatine forms an active metabolite, desglymidodrine, that is an alpha 1 -agonist, and exerts its actions via activation of the alpha-adrenergic receptors of the arteriolar and venous vasculature, producing an increase in vascular tone and elevation of…
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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.