CARVEDILOL PHOSPHATE · IMPAX LABS
Carvedilol phosphate is an extended-release alpha/beta-adrenergic blocker indicated for the treatment of essential hypertension and mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin. It is also indicated to reduce cardiovascular mortality in clinically stable patients following the acute phase of a myocardial infarction who have a left ventricular ejection fraction (LVEF) ≤40%. It is frequently used in combination with other standard-of-care therapies, such as ACE inhibitors and diuretics, to improve survival and reduce the risk of hospitalization.
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).
Details
- Status
- Prescription
- First Approved
- 2006-10-20
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
CARVEDILOL PHOSPHATE Approval History
What CARVEDILOL PHOSPHATE Treats
4 indicationsCARVEDILOL 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
CARVEDILOL PHOSPHATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in CARVEDILOL PHOSPHATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications CARVEDILOL PHOSPHATE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to CARVEDILOL PHOSPHATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. left ventricular dysfunction following myocardial infarction in clinically stable patients. hypertension 1.1 Heart Failure Carvedilol phosphate extended-release capsules are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions...
Looking for the branded version?
COREG CR
Full clinical data, patents, trials, and competitive landscape for carvedilol phosphate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.