LEVOPHED (norepinephrine bitartrate)
Levophed is a catecholamine used to raise blood pressure in adult patients. It helps patients with severe, acute hypotension by restoring blood pressure to safer levels. This medication is used for acute hypotensive states to stabilize a patient's cardiovascular system.
How LEVOPHED Works
This medication works by narrowing peripheral blood vessels through alpha-adrenergic action to increase blood pressure. It also acts as a heart stimulant and widens the coronary arteries through its beta-adrenergic effects. These combined actions help improve heart function and systemic circulation.
Details
- Status
- Prescription
- First Approved
- 1950-07-13
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LEVOPHED Approval History
What LEVOPHED Treats
1 indicationsLEVOPHED is approved for 1 conditions since its original approval in 1950. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypotension
LEVOPHED Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
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.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT05836272 EA-NE-TUN | Tunisian ICUs association | Ph 4 | recruiting | Early Administration of Norepinephrine in Sepsis |
| NCT05521152 | MD-12-2021 | Ph 3 | completed | Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy |
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.
LEVOPHED FDA Label Details
Indications & Usage
FDA Label (PDF)LEVOPHED is indicated for the treatment of Hypotension.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.