TheraRadar
Data updated: May 26, 2026

CARVEDILOL PHOSPHATE

Cardiovascular Approved 2017-10-25

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

Source: FDA Label • Sun Pharma

How CARVEDILOL PHOSPHATE Works

Carvedilol is a racemic mixture that provides dual-action adrenergic blockade. Nonselective beta-adrenoreceptor blocking activity is present in the S(−) enantiomer, while alpha-1 adrenergic blocking activity is present in both the R(+) and S(−) enantiomers at equal potency. Carvedilol does not possess intrinsic sympathomimetic activity (ISA).

Source: FDA Label
2
Indications
--
Phase 3 Trials
8
Years on Market

Details

Status
Prescription
First Approved
2017-10-25
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: CARVEDILOL PHOSPHATE

CARVEDILOL PHOSPHATE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2017 to 2025
Jun 2025 SUPPL
Label · Labeling
Apr 2024 SUPPL
Label · Labeling
May 2018 ORIGINAL
Update

What CARVEDILOL PHOSPHATE Treats

4 indications

CARVEDILOL PHOSPHATE is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

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

CARVEDILOL PHOSPHATE 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 CARVEDILOL PHOSPHATE

3 of 20

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

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
DIOVAN
VALSARTAN
4 shared
Novartis
🔬

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.

CARVEDILOL PHOSPHATE FDA Label Details

Indications & Usage

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

Looking for the branded version?

COREG CR

Full clinical data, patents, trials, and competitive landscape for carvedilol phosphate.

See COREG CR

Data Sources

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