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 4h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRESTALIA is a fixed-dose combination of amlodipine besylate (a dihydropyridine calcium channel blocker) and perindopril arginine (an ACE inhibitor) for oral 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. This combination addresses hypertension through complementary pathways of the renin-angiotensin-aldosterone system and calcium signaling.
Peak3.0 years to LOE
PRESTALIA is at peak commercial maturity with high competitive pressure (score 8/10), suggesting stable but challenged revenue environment and moderate-sized team focused on market share defense.
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.