TheraRadar
Data updated: May 26, 2026

VAZCULEP (phenylephrine hydrochloride)

Cardiovascular Approved 2014-06-27
1
Indication
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-06-27
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE

VAZCULEP Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2014 to 2020
Mar 2020 SUPPL
Label · Labeling
Oct 2019 SUPPL
Label · Labeling
Oct 2015 SUPPL
Mfg · Manufacturing (CMC)

What VAZCULEP Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
🔬

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.

VAZCULEP FDA Label Details

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Data Sources

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