TheraRadar
Data updated: May 26, 2026

TRANDOLAPRIL

Angiotensin-converting Enzyme Inhibitors
Cardiovascular Approved 2006-12-12

TRANDOLAPRIL is indicated for the treatment of Hypertension; Heart Failure; Left Ventricular Dysfunction; Myocardial Infarction.

Source: FDA Label • WATSON LABS
5
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Discontinued
First Approved
2006-12-12
Routes
ORAL
Dosage Forms
TABLET

TRANDOLAPRIL Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
147 FDA actions from 2006 to 2025
May 2025 SUPPL
Label · Labeling
Feb 2025 SUPPL
Label · Labeling
Apr 2020 SUPPL
Label · Labeling

What TRANDOLAPRIL Treats

4 indications

TRANDOLAPRIL is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Heart Failure
  • Left Ventricular Dysfunction
  • Myocardial Infarction
Source: FDA Label

TRANDOLAPRIL Boxed Warning

FETAL TOXICITY When pregnancy is detected, discontinue trandolapril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (See WARNINGS: Fetal Toxicity .)...

TRANDOLAPRIL Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to TRANDOLAPRIL

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CARVEDILOL PHOSPHATE
CARVEDILOL PHOSPHATE
4 shared
Sun Pharma
Shared indications:
Heart FailureLeft Ventricular DysfunctionMyocardial Infarction +1 more
COREG
CARVEDILOL
4 shared
WAYLIS THERAP
Shared indications:
Heart FailureLeft Ventricular DysfunctionMyocardial Infarction +1 more
COREG CR
CARVEDILOL PHOSPHATE
4 shared
WAYLIS THERAP
Shared indications:
Heart FailureLeft Ventricular DysfunctionMyocardial Infarction +1 more
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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

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.

TRANDOLAPRIL FDA Label Details

Indications & Usage

TRANDOLAPRIL is indicated for the treatment of Hypertension; Heart Failure; Left Ventricular Dysfunction; Myocardial Infarction.

⚠️ BOXED WARNING

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue trandolapril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (See WARNINGS: Fetal Toxicity .)...

Looking for the branded version?

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE

Full clinical data, patents, trials, and competitive landscape for trandolapril.

See TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE

Data Sources

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