Data updated: May 26, 2026
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (phenylephrine hydrochloride)
Trial Activity: Mature 10 active trials
Pain
Approved 2025-05-30
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Cough; Nasal Congestion; Pain; Sore Throat; Headache; Runny Nose; Sneezing; Fever.
Source: FDA Label • Dr. Reddy's
Development Insights
University of Aarhus conducting 2 trials (4%)
74 indications explored (Broad Platform)
→ hypotension (9 trials)
→ anesthesia (4 trials)
→ cesarean section complications (4 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2025-05-30
- Patent Cliff
- 2044
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Approval History
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
What PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Treats
8 indicationsPHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is approved for 8 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cough
- Nasal Congestion
- Pain
- Sore Throat
- Headache
- Runny Nose
- Sneezing
- Fever
Source: FDA Label
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Competitive Set
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Drugs Similar to PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE
Hikma
Shared indications:
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Clinical Trial Registry
52 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06648850 | DA-001-TE | Ph 2, Ph 3 | not yet recruiting | Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth |
| NCT06083948 IMPACT | IMPACT study | Ph 2, Ph 3 | recruiting | Vasopressor Impact on Brain Circulation, Organ Blood Flow and Tissue Oxygenation During Anesthesia |
| NCT06802224 VEGA-2 | 23-39683 R01DK139484 | Ph 4 | recruiting | The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery |
| NCT07327320 NORPHE-CD | TA2.24.03 | Ph 4 | completed | Norepinephrine vs. Phenylephrine for Hypotension in Low-Dose Spinal Anesthesia for Cesarean Delivery |
| NCT02118467 | 14-0047 | Ph 4 | recruiting | Vasoactive Drugs in Intensive Care Unit |
| NCT05997732 STARS | Pro00126600 | Ph 4 | recruiting | Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences |
| NCT04789330 VEGA-1 results posted | A135759 | Ph 4 | completed | Norepinephrine vs Phenylephrine During General Anesthesia |
| NCT04934748 | HSC-MS-24-1026 (vasopressor) | Ph 4 | enrolling by invitation | The GUARDIAN Trial - Vasopressor Sub-Study |
| NCT02560805 ANG-P | IRB00082400 2025P010213 | Ph 2 | recruiting | Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV |
| NCT06770426 | 4-2024-1415 | Ph 3 | not yet recruiting | CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN |
| NCT04839224 | 4-2020-1491 | Ph 3 | terminated | Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study) |
| NCT01731444 | PhenylephrineRCT | Ph 1 | recruiting | Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury |
| NCT03864094 VH | 2019/374 2019-000965-19 | Ph 4 | completed | Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine. |
| NCT05070650 | SAN-0657 | Ph 3 | withdrawn | Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold |
| NCT02323399 | 1420RDP009 | Ph 4 | recruiting | Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV |
| NCT02245230 | 140958 | Ph 1 | terminated | Cardiovascular Effects of Angiotensin (1-7) in Essential Hypertension |
| NCT03846765 NIRS continu | 2018/1510 | Ph 4 | completed | Influence of Continuous Administration of Phenylephrine Versus Dobutamine on Spinal Oxygen Saturation, Measured With Near-infrared Spectroscopy (NIRS). |
| NCT05439460 results posted | 22554 | Ph 4 | completed | Management of Acute Pulmonary Hypertensive Crisis in Children With Known Pulmonary Arterial Hypertension |
| NCT04991662 | SFY2021-HZ08-11 | Ph 4 | completed | Effect of Three Weight-adjusted Vasopressors for Elective Cesarean Delivery |
| NCT04195321 | D-7-2019 | Ph 4 | completed | Norepinephrine Versus Phenylephrine for Preventing Spinal Anesthesia Induced Hypotension in Elderly |
| NCT04419662 | 1-10-72-40-20 2020-000573-25 | Ph 4 | completed | Evaluation of Patients After Cardiac Surgery: Novel Ultrasound Parameters for Quantification of Renal Perfusion & Analysis of Phenylephrines' Effect on Invasive Haemodynamics and Echocardiographic Measures |
| NCT03849508 PHENAD | CHRO-2018-10 | Ph 4 | completed | Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia |
| NCT03098680 PRIME | PRIME (A094136) | Ph 1 | terminated | A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems |
| NCT04789005 | 439/(6-11)E²/076/077 | Ph 3 | completed | Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension |
| NCT03047109 | Phenylephrine Hypotension | Ph 2, Ph 3 | completed | Ephedrine and Phenylephrine for Spinal Hypotension |
| NCT02025426 results posted | Pro00032812 | Ph 4 | terminated | Phenylephrine Versus Ephedrine in Pre-eclampsia |
| NCT03833895 | CINI-AD-201812-3 | Ph 2, Ph 3 | completed | The Phenylephrine vs. Norepinephrine Infusion Undergoing Cesarean Section |
| NCT03163914 | Vasopressor | Ph 4 | completed | Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension |
| NCT04025918 | 2010/365/D | Ph 2, Ph 3 | completed | Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section |
| NCT03767296 NIRS BOLUS | 2016/0644 | Ph 4 | completed | Influence of a Bolus Administration of Ephedrine and Phenylephrine on the Spinal Oxygen Saturation, Measured With NIRS. |
| NCT02713087 | Vasobrain01 | Ph 4 | completed | Vasopressor Effects in Anesthetized Patients |
| NCT03139708 | IRB00039213 | Ph 1 | completed | The Effect of Brimonidine on Intraocular Pressure When Dilating Routine Patients |
| NCT03328533 | N-82-2017 | Ph 4 | completed | Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery |
| NCT02203630 results posted | IRB 140141 UL1RR024975-01, UL1TR000445-06 | Ph 4 | terminated | Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients |
| NCT02428062 THE BRIDGE | TB-POCD | Ph 2, Ph 3 | suspended | Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly |
| NCT02277730 DIVA | SHF/CTG047/2012 | Ph 2, Ph 3 | completed | A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability |
| NCT03215797 | Ph Vs N in SVV GDT | Ph 3 | completed | Phenylephrine or Norepinephrine for a Better Hemodynamic Stability |
| NCT02854787 NorPN | UniversityTunis el manar | Ph 4 | completed | Intravenous Bolus of Phenylephrine vs. Norepinephrine in Preventing Hypotension After Spinal Anesthesia |
| NCT02958215 | IRB0000871230 | Ph 2 | completed | Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section |
| NCT03015857 | cesarean sections | Ph 2 | completed | Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension |
| NCT02979405 | UIS 2016 | Ph 4 | completed | Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery |
| NCT02354833 results posted | 1406316590 | Ph 4 | completed | Phenylephrine vs. Norepinephrine Infusion After Spinal Anesthesia for Cesarean Delivery |
| NCT02739399 | MM2015.037 | Ph 4 | completed | Effects of Phenylephrine on Cardiac Preload |
| NCT01243970 | 08/0182 | Ph 4 | terminated | Ephedrine vs Phenylephrine - ECG Changes |
| NCT02675868 | NL53411.091.015 | Ph 4 | completed | Effects of Vasopressors on Immune Response |
| NCT02885168 PCA | 2007-002319-16 | Ph 4 | completed | Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C |
| NCT02802683 | JHBahk_C/S | Ph 4 | completed | Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery |
| NCT01332578 results posted | C7591227 | Ph 4 | completed | A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies |
| NCT01413958 results posted | 18125 CL2011-06, P08498 | Ph 3 | completed | Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1) |
| NCT01378325 results posted | ANES.SS.10 | Ph 4 | completed | Variable Rate Phenylephrine Infusion for Prevention of Spinal-induced Hypotension for Cesarean Delivery |
Showing 50 of 52 trials
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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.
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is indicated for the treatment of Cough; Nasal Congestion; Pain; Sore Throat; Headache; Runny Nose; Sneezing; Fever.
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE Patents & Exclusivity
Latest Patent: Aug 2044
Patents (1 active)
US12564561
Expires Aug 8, 2044
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2044
- • 1 active patents
Trial Analysis
- • 53 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment