PHENYLEPHRINE HYDROCHLORIDE
Phenylephrine hydrochloride helps patients with significant drops in blood pressure that occur while under anesthesia. It is used when blood vessels widen excessively, leading to a condition known as clinically important hypotension. This medication helps stabilize the patient's circulatory system during surgical procedures.
How PHENYLEPHRINE HYDROCHLORIDE Works
This medication works by acting as an alpha-1 adrenergic receptor agonist. By binding to these specific receptors, it triggers a response that counteracts vasodilation to help restore normal blood pressure levels.
Details
- Status
- Prescription
- First Approved
- 2012-12-20
- Patent Cliff
- 2036
- Routes
- INTRAVENOUS, OPHTHALMIC
- Dosage Forms
- SOLUTION, SOLUTION/DROPS
Companies
PHENYLEPHRINE HYDROCHLORIDE Approval History
What PHENYLEPHRINE HYDROCHLORIDE Treats
1 indicationsPHENYLEPHRINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypotension
PHENYLEPHRINE HYDROCHLORIDE 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.
Drugs Similar to PHENYLEPHRINE HYDROCHLORIDE
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
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.
PHENYLEPHRINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)PHENYLEPHRINE HYDROCHLORIDE is indicated for the treatment of Hypotension.
PHENYLEPHRINE HYDROCHLORIDE Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for PHENYLEPHRINE HYDROCHLORIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 22 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 16 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.