PRESTALIA
Peakamlodipine besylate; perindopril arginine
NDAORALTABLET
Approved
Jan 2015
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
4/8 — Partial
PRESTALIA (amlodipine besylate; perindopril arginine) is perindopril, a pro-drug, is hydrolyzed to perindoprilat, which inhibits ace in humans and in animals. Approved for hypertension, to lower blood pressure. First approved in 2015.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRESTALIA is a fixed-dose combination oral tablet containing amlodipine besylate (a dihydropyridine calcium channel antagonist) and perindopril arginine (an ACE inhibitor pro-drug) for the treatment of hypertension. It works through dual mechanisms: perindopril inhibits ACE to reduce angiotensin II-mediated vasoconstriction and aldosterone secretion, while amlodipine blocks calcium influx into vascular smooth muscle to reduce peripheral vascular resistance. The combination targets patients requiring enhanced blood pressure control through complementary pathways in the renin-angiotensin-aldosterone system.
Peak3.4 years to LOE
Product is at peak commercial performance with stable market position; commercial teams focused on defending market share against combination competitors.
Mechanism of Action
Perindopril, a pro-drug, is hydrolyzed to perindoprilat, which inhibits ACE in humans and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of the inactive decapeptide, angiotensin I, to the vasoconstrictor substance angiotensin II. Angiotensin II is a potent peripheral…
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.