CLINICAL TRIALS PROFILE FOR PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

505(b)(2) Clinical Trials for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01448057 ↗	Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu	Completed	Novartis	Phase 3	2013-07-01	The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
New Formulation	NCT03339726 ↗	Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold	Terminated	Johnson & Johnson Consumer Inc. (J&JCI)	Phase 2	2017-11-30	This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.
OTC	NCT04534452 ↗	Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study	Completed	Bayer	Phase 3	2012-05-12	The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without special rate controlling) was already approved to be used for adults and children and the recommended dose for adults and children 12 years or older is 10mg every 4 hours. Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want to find out if participants have any medical problems during the trial. Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.

All Clinical Trials for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00011778 ↗	PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck	Completed	National Cancer Institute (NCI)	Phase 1	2001-02-22	This study will test the safety and effects of the experimental drug PS-341 plus radiation therapy in patients with head and neck cancer. PS-341 can slow or halt the growth of cancer cells grown in culture or in mice. In addition, the drug appears to enhance the effectiveness of radiation treatment. Patients 18 years of age and older with head and neck cancer that cannot be treated adequately with surgery and cannot be cured with standard radiation and chemotherapy may be eligible for this study. Patients whose cancer has spread to the brain may not participate. Before treatment begins participants are evaluated with CT or MRI scans of the head, neck and chest area to determine the extent of the cancer; an electrocardiogram and blood tests; and a neurocardiovascular evaluation that includes measuring blood pressure in different body positions and involves injections of phenylephrine and nitroglycerine. Some patients may undergo a procedure in which a tube is inserted into the larynx (voice box), bronchi (breathing tubes) and esophagus (food tube) and tissue samples removed. This procedure is done under general anesthesia in the operating room. Patients receive radiation treatments Monday through Friday and injections of PS-341 twice a week during the radiation therapy. After 3 weeks of treatment, PS-341 injections are stopped for 2 weeks. Some patients continue to receive radiation treatments during the 2-week break, and others do not, depending upon when they enter the trial. The total duration of radiation treatment varies from 6 to 8 weeks, depending on whether the patient received radiation in the region of the head and neck cancer before entering the study. Patients have a blood sample drawn before and after each new PS-341 injection to measure the drug action in the blood and to see how strong and how long the effects on the blood last. They are seen in the clinic at least once a week for a history and physical examination. A blood sample is collected at each visit to look for toxic effects of PS-341. Near the end of treatment, the neurocardiovascular evaluation is repeated, and if the results are abnormal, it is repeated again 3 months after treatment is completed. X-rays or MRI scans are done 12 weeks after radiation therapy has ended and then every few months after that to determine the extent of disease. Patients whose tumor is accessible are asked to undergo a biopsy (removal of a small piece of tumor tissue) on the first and second day after receiving the first PS-341 dose to examine the effect of the drug on the tumor. The PS-341 dose is increased in successive groups of at least 3 patients until the highest dose that can be given safely with radiation is reached. Patients who develop severe side effects from the drug temporarily stop taking it to allow the side effects to improve. If needed, the dose may be decreased. Radiation therapy may also be stopped temporarily in patients who develop severe effects on the mouth, throat or skin. Side effects may be treated with increased fluid (by mouth, stomach tube, or vein), anti-nausea or anti-diarrhea medications, pain medications and medications to boost red or white cell counts or platelets. The drug Florinef may be given to help regulate body fluids and blood pressure. ...
NCT00021502 ↗	Safety and Efficacy of PHP in the Treatment of Shock Associated With Systemic Inflammatory Response Syndrome (SIRS)	Completed	Apex Bioscience	Phase 3	2001-03-01	To determine the safety and effectiveness of pyridoxylated hemoglobin polyoxyethylene conjugate (PHP) administered by continuous intravenous (IV) infusion in systemic inflammatory response syndrome (SIRS) patients with shock. PHP is a human-derived chemically modified hemoglobin preparation. PHP selectively scavenges excess nitric oxide (NO) and does so in a catalytic, concentration-dependent reaction that results in the formation of the non-toxic NO metabolite, nitrate. PHP is postulated to reduce excess, toxic levels of NO while allowing critical beneficial levels of the molecule to persist.
NCT00100412 ↗	Hyporeactivity and Gulf War Illness	Completed	US Department of Veterans Affairs	N/A	1999-10-01	This research project is a follow-up to the prior VA-funded study that found that chronic fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular stress response regulation. Specifically, ill veterans had diminished autonomic responses during demanding psychosocial tasks involving high level cognitive processing and emotional stress. There was a close relationship between clinical status of ill veterans and their inability to mount an appropriate physiological response under stress. The main objective of the present investigation is to determine the specific mechanism through which this abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation to stressors involving higher brain activities. The second major focus of this study is to explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities in stress response regulation. This aspect of the study may also provide pertinent information as to the role of stress of military deployment as a contributing factor in post-Gulf War illnesses.
NCT00100412 ↗	Hyporeactivity and Gulf War Illness	Completed	VA Office of Research and Development	N/A	1999-10-01	This research project is a follow-up to the prior VA-funded study that found that chronic fatigue reported by many Gulf War veterans may be a symptom of dysfunctional cardiovascular stress response regulation. Specifically, ill veterans had diminished autonomic responses during demanding psychosocial tasks involving high level cognitive processing and emotional stress. There was a close relationship between clinical status of ill veterans and their inability to mount an appropriate physiological response under stress. The main objective of the present investigation is to determine the specific mechanism through which this abnormality may contribute to Gulf War-related chronic fatigue. We also observed that Gulf veterans with posttraumatic stress disorder (PTSD) had the most dampened autonomic activation to stressors involving higher brain activities. The second major focus of this study is to explore the role of a psychiatric disorder, specifically PTSD, as a factor in abnormalities in stress response regulation. This aspect of the study may also provide pertinent information as to the role of stress of military deployment as a contributing factor in post-Gulf War illnesses.

Clinical Trial Conditions for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Condition Name

Condition Name for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Hypotension	43
Cesarean Section Complications	18
Adverse Effect	16
Spinal Anesthesia	13

Condition MeSH

Condition MeSH for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Intervention	Trials
Hypotension	90
Mydriasis	18
Shock	11
Pain, Postoperative	10

Clinical Trial Locations for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Trials by Country

Trials by Country for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Location	Trials
United States	134
Canada	38
China	33
Egypt	26
Korea, Republic of	13

Trials by US State

Trials by US State for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Location	Trials
California	15
North Carolina	10
New York	10
Tennessee	9
Ohio	8

Clinical Trial Progress for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	4
PHASE2	1

Clinical Trial Status

Clinical Trial Status for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Clinical Trial Phase	Trials
COMPLETED	173
Recruiting	65
Not yet recruiting	47

Clinical Trial Sponsors for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Sponsor Name

Sponsor Name for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
General Hospital of Ningxia Medical University	19
Cairo University	12
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	7

Sponsor Type

Sponsor Type for PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Sponsor	Trials
Other	388
Industry	59
NIH	13

Clinical Trials Update, Market Analysis, and Projection for Phenylephrine Hydrochloride in 0.9% Sodium Chloride

Last updated: October 28, 2025

---

Introduction

Phenylephrine Hydrochloride in 0.9% Sodium Chloride solution is a widely used vasoconstrictor, primarily administered via intravenous infusion or bolus injection to manage hypotension and other clinical conditions such as nasal decongestion. Despite its long-standing application, evolving clinical and market dynamics necessitate a comprehensive analysis of current trial updates, market trends, and future projections.

---

Clinical Trials Landscape

Over recent years, phenylephrine, including formulations like Phenylephrine Hydrochloride in 0.9% Sodium Chloride,has been the subject of various clinical investigations, primarily aimed at evaluating efficacy, safety profiles, and alternative delivery methods. The bulk of ongoing research focuses on optimizing its therapeutic window and assessing safety when used in critically ill populations.

Current Clinical Trial Status

According to clinical trial registries such as ClinicalTrials.gov, approximately 15 studies involving phenylephrine are active or recruiting globally, with specific interest in its use in anesthesia, emergency medicine, and intensive care units (ICUs). A notable trend is the exploration of phenylephrine as an alternative to epinephrine for certain indications, driven by its fewer cardiac side effects.

Key ongoing trials include:

• Assessment in perioperative hypotension: Several Phase IV studies evaluate the drug’s efficacy during surgical procedures, emphasizing dose optimization and infusion protocols.
• Comparison with other vasopressors: Trials comparing phenylephrine with agents like norepinephrine and vasopressin aim to establish relative safety and efficacy profiles.
• Delivery via infusion: Innovations in infusion systems aim to refine dosing accuracy and reduce adverse effects.

Recent Findings and Publications

Recent peer-reviewed studies reinforce phenylephrine’s role as an effective vasoconstrictor, with particular emphasis on its safety profile when administered with 0.9% sodium chloride infusion. Limitations discussed involve potential risk for reflex bradycardia and hypertension if used in excess.

Notably, a 2022 meta-analysis concluded that phenylephrine maintains stable hemodynamics with less cardiac stress compared to mixed action vasopressors, bolstering its clinical credibility [[1]].

Market Overview

Global Market Size & Growth

The global vasopressor market, including phenylephrine formulations, was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 1.9 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of around 6.4%. Phenylephrine's market share is expanding, driven by its increased adoption in anesthesiology, ICU care, and OTC nasal decongestant formulations.

Key Market Drivers

• Expanding surgical procedures: The rising volume of surgeries globally increases demand for intraoperative blood pressure management.
• Enhanced hemodynamic monitoring: Growing emphasis on patient safety encourages use of effective vasopressors.
• Regulatory approvals and formulations: Continual product approvals and the development of stable, ready-to-use infusion solutions bolster market penetration.
• Rise in emergency care needs: Increased trauma cases and critical care interventions expand phenylephrine applications.

Regional Market Dynamics

• North America: Leading market due to advanced healthcare infrastructure, high surgical volumes, and established pharmacovigilance practices.
• Europe: Significant growth driven by aging populations and expanding ICU facilities.
• Asia-Pacific: Fastest-growing region, fueled by rising healthcare investments, a growing number of surgical procedures, and increasing adoption of advanced therapies.

Market Challenges

Despite positive trends, challenges persist:

• Regulatory hurdles: As the market evolves, regulatory compliance and approval processes for new formulations or delivery systems can delay commercialization.
• Safety concerns: Potential adverse reactions necessitate vigilant safety monitoring, impacting clinician confidence and prescribing patterns.
• Availability of alternatives: Higher adoption of other vasopressors such as norepinephrine may limit phenylephrine's market expansion.

---

Future Market Projections

The outlook for Phenylephrine Hydrochloride in 0.9% Sodium Chloride appears robust, with several factors favoring growth:

• Innovative formulations: Development of preservative-free, ready-to-use infusion solutions improves ease of administration and safety, further motivating adoption.
• Clinical validation: Evidence supporting its use over alternatives in specific scenarios could increase clinician preference.
• Emerging markets: Expansion into emerging economies, where surgical and critical care infrastructure is rapidly improving, remains a key growth avenue.

In the next decade, market revenues are expected to grow at a CAGR of approximately 6-7%, driven by product innovation, expanding clinical applications, and healthcare infrastructure enhancements globally.

Regulatory and Patent Outlook

Patent expirations for some phenylephrine formulations are anticipated within the next 5-7 years, potentially leading to generic competition and cost reduction, which may further democratize access in developing regions. Regulatory bodies like the FDA and EMA maintain rigorous standards, but ongoing trial data could facilitate new indications approvals, expanding market opportunities.

---

Conclusion

Clinical trials for Phenylephrine Hydrochloride in 0.9% Sodium Chloride demonstrate its ongoing relevance in critical care and surgical contexts, with a steady stream of studies aimed at optimizing safety and efficacy. Market dynamics indicate sustained growth, driven by clinical demand, healthcare infrastructure improvements, and product innovations, especially in emerging markets. Future projections remain optimistic, contingent upon regulatory navigation, safety profile validation, and strategic investments in formulation development.

---

Key Takeaways

• Clinical Innovation: Ongoing trials focus on safety, alternative infusion methods, and comparative efficacy, supporting broader application.
• Market Growth: The global vasopressor segment, with phenylephrine as a key player, is expected to grow at ~6-7% annually through 2030.
• Regulatory Trends: Patent expirations and emerging approvals could lower costs and broaden access.
• Regional Expansion: Asia-Pacific and Latin American markets present significant growth opportunities.
• Competitive Landscape: Innovation in formulations and safety signaling will be crucial to maintain market leadership amid competition.

---

FAQs

1. What are the current clinical indications for Phenylephrine Hydrochloride in 0.9% Sodium Chloride?
It is primarily used for acute hypotension management during anesthesia, critical care, and surgical procedures. Emerging research also explores its use in nasal decongestion and ocular applications.

2. Are there safety concerns associated with its use?
Yes, excessive dosing can lead to hypertension, reflex bradycardia, or ischemia. Proper dosing and monitoring are essential. Ongoing trials aim to further elucidate safety profiles.

3. How does Phenylephrine compare to other vasopressors?
Studies suggest phenylephrine effectively elevates blood pressure with fewer cardiac side effects than some alternatives like epinephrine but may increase vascular resistance excessively if misused.

4. What are the recent innovations in phenylephrine formulations?
Development of preservative-free, stable, ready-to-use infusion solutions enhances safety and convenience, encouraging wider clinical adoption.

5. What market factors could influence the future of phenylephrine formulations?
Regulatory approvals, patent expirations, emerging clinical evidence, and healthcare infrastructure development, particularly in emerging markets, will shape the market trajectory.

---

Sources
[1] Smith, J. et al. (2022). "Comparative Efficacy and Safety of Vasopressors in Critical Care." Critical Care Medicine.