CLINICAL TRIALS PROFILE FOR PHENYLEPHRINE HYDROCHLORIDE

505(b)(2) Clinical Trials for PHENYLEPHRINE HYDROCHLORIDE

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

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

Condition Name

Condition Name for PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Hypotension	43
Cesarean Section Complications	18
Adverse Effect	16
Spinal Anesthesia	13

Condition MeSH

Condition MeSH for PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Hypotension	92
Mydriasis	18
Shock	11
Rhinitis	10

Clinical Trial Locations for PHENYLEPHRINE HYDROCHLORIDE

Trials by Country

Trials by Country for PHENYLEPHRINE HYDROCHLORIDE
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
Location	Trials
California	15
North Carolina	10
New York	10
Tennessee	9
Ohio	8

Clinical Trial Progress for PHENYLEPHRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	4
PHASE2	2

Clinical Trial Status

Clinical Trial Status for PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	175
Recruiting	65
Not yet recruiting	47

Clinical Trial Sponsors for PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for PHENYLEPHRINE HYDROCHLORIDE
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
Sponsor	Trials
Other	389
Industry	59
NIH	13

Phenylephrine Hydrochloride Clinical Trials Update, Market Outlook, and Patent/Generic Risk Assessment

Last updated: July 27, 2026

Phenylephrine hydrochloride is an established, off-patent vasopressor/bronchodilator-adjacent active used in emergency medicine, perioperative settings, and certain pediatric respiratory indications. Current decision-making risk is driven less by late-stage development and more by (1) regulatory status by dosage form, (2) supply continuity and manufacturing constraints, and (3) any remaining use-of-drug protections in specific labeled indications and formulations.

What is the current clinical trials pipeline for phenylephrine hydrochloride?

Phenylephrine hydrochloride’s clinical development footprint is heavily indication- and formulation-specific, with limited signal for new registrational trials that would materially change the competitive landscape of the legacy drug.

Where trials show up most often

• Formulation and delivery optimization: nasal decongestion formulations, oral liquids/syrups, injectable stability, and alternatives targeting onset/PK variability.
• Pediatric and perioperative cohorts: dose finding, monitoring endpoints (blood pressure, heart rate), and safety assessments.
• Comparative effectiveness: head-to-head comparisons against other sympathomimetics and vasopressors in perioperative or emergency protocols.
• Device or workflow trials: administration protocols, infusion regimens, and perioperative care pathways.

Clinical development reality check

• Phenylephrine hydrochloride is an older active ingredient and is widely available as generic and compounded product. As a result, many “trials” are either small, formulation-focused, or protocol-adjacent rather than large-scale, regulatory-defining Phase 3 programs.
• Practical pipeline value is therefore tied to: (a) whether any late-stage program targets a regulated new formulation with a distinct clinical label, and (b) whether any pediatric labeling expansion is pursued with regulatory data packages.

Actionable interpretation for business planning

• Treat the near-term pipeline as incremental unless an RCT is explicitly designed for label expansion under FDA (or parallel regulators) and the endpoints map to the labeled claim being sought (hemodynamic stability, congestion symptom relief window, or pediatric efficacy/safety).

Which phenylephrine hydrochloride clinical trials are enrolling or recently reported?

A precise “recently reported and enrolling” list requires live registry querying. No trial list can be produced accurately from the information available in this chat.

What is the phenylephrine hydrochloride market by segment (hospital vs retail, injectable vs oral/nasal)?

Market structure is dominated by dosage form and site of care, not by proprietary status.

Hospital / acute care

• Injectable phenylephrine hydrochloride is used as a vasopressor and for hemodynamic support in perioperative settings and emergency medicine.
• Value drivers are clinical protocol adoption, availability, and procurement contract stability rather than brand-led promotion.

Retail / consumer

• Oral and OTC nasal decongestant products are driven by seasonal demand, OTC shelf competition, and regulatory labeling constraints.
• Generic turnover is fast; differentiation comes from formulation attributes and distribution.

Key commercial factors

• WAC vs net pricing compression: generic and hospital formularies pressure pricing.
• Supply risk: sterile injectable supply interruptions can drive short-term scarcity pricing.
• Contracting: group purchasing organization (GPO) and IDN formularies dominate injectable tender outcomes.

How is phenylephrine hydrochloride expected to grow through 2030?

A defensible projection cannot be generated without current-year market size, historical CAGR, and validated channel shares. No dataset is available in this chat to support numeric forecasting.

Qualitative directionality

• Injectable: modest to low single-digit growth is typical for an off-patent vasopressor active unless substitution away from specific dosing practices occurs or supply constraints recur.
• OTC/retail: fluctuates with flu seasons and consumer preferences; long-run growth is constrained by generics and regulatory labeling.
• Formulation niches (stability, pediatric friendliness, alternative delivery): can support share gains for specific SKUs but rarely move the active ingredient market dramatically.

What regulatory status does phenylephrine hydrochloride have (FDA labeling, OTC restrictions, and injectable approvals)?

Regulatory status is dosage-form and route dependent.

Injectables

• Regulatory “ownership” is primarily about which manufacturer holds approved NDAs/ANDAs and which labels are supported for sterile stability, concentration, and dosing instructions.
• In practice, competition is shaped by ANDA approvals and any associated manufacturing process constraints (sterility assurance, container closure system, and dilution guidance).

OTC

• OTC products are shaped by FDA monograph or labeling framework applicable to decongestant products and by evidence requirements for pediatric populations.

Business implication

• If a firm is planning differentiation through formulation or pediatric claims, the most direct pathway is typically an ANDA supplement strategy or an entirely new NDA/505(b)(2) only when the label claim is meaningfully distinct. For phenylephrine hydrochloride, legacy off-patent status makes label expansion difficult to monetize unless the formulation is durable and supply-backed.

What patents protect phenylephrine hydrochloride, and how strong is the patent estate?

No patent landscape can be stated reliably in this chat without Orange Book/NLM identifiers, jurisdiction coverage, or an identified reference product.

When does phenylephrine hydrochloride lose exclusivity for specific brands or formulations?

Exclusivity is product-specific. Without identifying a reference listed drug (RLD) for a given dosage form (injectable, tablet, syrup, nasal), a credible exclusivity timeline cannot be produced.

What patent litigation affects phenylephrine hydrochloride generic entry?

A litigation map (ANDA Paragraph IV suits, settlements, injunctions) cannot be generated accurately without Orange Book RLD mapping and docket-level sourcing.

What generic entry risks exist for phenylephrine hydrochloride?

Generic entry risk is generally low for phenylephrine hydrochloride as an active, but high for particular SKUs if they are tied to:

• sterile manufacturing capacity,
• constrained container closure systems,
• stability-enhancing formulations,
• or specific label formulations that are more difficult to replicate.

The practical risk is often supply- and manufacturing-related rather than IP-driven.

Which companies hold approved phenylephrine hydrochloride products and how competitive is the market?

A company list cannot be produced accurately without pulling current FDA labeling/Orange Book data for each dosage form.

How does phenylephrine hydrochloride compare with alternatives (epinephrine, norepinephrine, pseudoephedrine) in clinical use and procurement?

Competitive positioning depends on the clinical setting:

• Vasopressor choice: phenylephrine is commonly used when clinicians want alpha-1 mediated vasoconstriction with less direct beta-adrenergic chronotropy than norepinephrine or epinephrine, but protocols vary by patient phenotype.
• Perioperative practice: practice patterns drive formulary inclusion more than any patent strategy.
• Nasal/oral decongestant choice: pseudoephedrine and phenylephrine are competing actives in OTC markets; policy and evidence have historically influenced consumer and prescriber preference.

Procurement competition typically favors the most reliable supply at contracted prices.

What manufacturing/IP barriers could limit supply for phenylephrine hydrochloride?

The main barriers for injectables are process and compliance:

• sterile fill-finish capacity,
• stability and concentration-specific requirements,
• extractables/leachables and container closure system performance,
• and quality system robustness.

Where these constraints exist, even generic competition can be temporarily diluted by supply shortfalls.

Key takeaways

• Phenylephrine hydrochloride is predominantly an off-patent active in commercial use, with decision risk shifting to dosage-form specific regulatory, manufacturing, and SKU-level competition rather than active-ingredient patent blocks.
• Clinical development updates are likely incremental unless a late-stage program targets a distinct label claim through a differentiated formulation or pediatric/perioperative indication.
• Near-term market outlook is driven by hospital protocol adoption, procurement contracting, and supply continuity, with OTC demand more seasonal and generic-driven.
• A quantitative market projection and an exclusivity/patent timeline cannot be validated from the information available in this chat.

FAQs

1. Are there any new FDA approvals for phenylephrine hydrochloride in the last 12 months?
2. Which phenylephrine hydrochloride dosage forms have the highest generic substitution risk?
3. Does phenylephrine hydrochloride have different exclusivity timelines for injectable vs oral vs nasal products?
4. What are the most common clinical endpoints used in phenylephrine perioperative trials?
5. How do supply disruptions of phenylephrine hydrochloride injectables affect hospital purchasing and pricing?

References (APA)

1. No sources were cited because registry-level trial, Orange Book, and FDA label data were not provided in the prompt.