TheraRadar
Data updated: May 26, 2026

ACEON (perindopril erbumine)

Cardiovascular Approved 1993-12-30
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
32
Years on Market

Details

Status
Discontinued
First Approved
1993-12-30
Routes
ORAL
Dosage Forms
TABLET

Companies

SYMPLMED PHARMS LLC
Active Ingredient: PERINDOPRIL ERBUMINE

ACEON Approval History

1994
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Original
New Indication
New Form
Label Update
57 FDA actions from 1993 to 2017 · 1 indication expansions
Sep 2017 SUPPL
Label · Labeling
FDA Letter Label
Mar 2015 SUPPL
Label · Labeling
FDA Letter Label
Feb 2013 SUPPL
Label · Labeling
FDA Letter Label

What ACEON Treats

2 FDA approvals

Originally approved for its first indication in 1993 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT07547878 RAPID-CKD 026-271 Ph 4 not yet recruiting Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
NCT01556997 PATH results posted X985400 Ph 3 completed Perindopril Amlodipine for the Treatment of Hypertension
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ACEON FDA Label Details

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Data Sources

FDA Approval: NDA020184 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.