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Last Updated: April 3, 2025

CLINICAL TRIALS PROFILE FOR PHENYLEPHRINE HYDROCHLORIDE


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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 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).
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

All Clinical Trials for Phenylephrine Hydrochloride

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00154037 ↗ Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone. Completed Technische Universität Dresden N/A 2005-10-01 The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.
NCT00120432 ↗ Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation Completed Khon Kaen University Phase 3 2004-12-01 The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.
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.
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. ...
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for Phenylephrine Hydrochloride

Condition Name

411616130051015202530354045HypotensionCesarean Section ComplicationsAdverse EffectSpinal Anesthesia[disabled in preview]
Condition Name for Phenylephrine Hydrochloride
Intervention Trials
Hypotension 41
Cesarean Section Complications 16
Adverse Effect 16
Spinal Anesthesia 13
[disabled in preview] 0
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Condition MeSH

8617111000102030405060708090HypotensionMydriasisShockRhinitis[disabled in preview]
Condition MeSH for Phenylephrine Hydrochloride
Intervention Trials
Hypotension 86
Mydriasis 17
Shock 11
Rhinitis 10
[disabled in preview] 0
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Clinical Trial Locations for Phenylephrine Hydrochloride

Trials by Country

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Trials by Country for Phenylephrine Hydrochloride
Location Trials
United States 129
Canada 37
China 27
Egypt 24
Korea, Republic of 13
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Trials by US State

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Trials by US State for Phenylephrine Hydrochloride
Location Trials
California 14
New York 10
North Carolina 9
Tennessee 9
Ohio 8
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Clinical Trial Progress for Phenylephrine Hydrochloride

Clinical Trial Phase

49.3%23.6%5.8%21.3%0102030405060708090100110120Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Phenylephrine Hydrochloride
Clinical Trial Phase Trials
Phase 4 111
Phase 3 53
Phase 2/Phase 3 13
[disabled in preview] 48
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Clinical Trial Status

49.4%16.1%14.0%20.5%0406080100120140160CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for Phenylephrine Hydrochloride
Clinical Trial Phase Trials
Completed 166
Recruiting 54
Not yet recruiting 47
[disabled in preview] 69
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Clinical Trial Sponsors for Phenylephrine Hydrochloride

Sponsor Name

trials024681012141618General Hospital of Ningxia Medical UniversityCairo UniversityVanderbilt University[disabled in preview]
Sponsor Name for Phenylephrine Hydrochloride
Sponsor Trials
General Hospital of Ningxia Medical University 18
Cairo University 12
Vanderbilt University 6
[disabled in preview] 18
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Sponsor Type

84.2%12.5%0050100150200250300350OtherIndustryNIH[disabled in preview]
Sponsor Type for Phenylephrine Hydrochloride
Sponsor Trials
Other 357
Industry 53
NIH 12
[disabled in preview] 2
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Phenylephrine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Phenylephrine Hydrochloride

Phenylephrine hydrochloride is a widely used pharmaceutical compound, primarily known for its decongestant properties. It is commonly found in over-the-counter (OTC) and prescription medications aimed at relieving nasal congestion caused by colds, allergies, and sinusitis. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Recent Findings and Controversies

A recent FDA advisory committee concluded that phenylephrine does not provide significant relief compared to a placebo, suggesting that the drug may not be as effective as previously thought[1].

  • This finding does not immediately impact the availability of phenylephrine, as the FDA will likely take time to review and potentially implement policy changes.
  • Clinical trials have not found phenylephrine to be dangerous at recommended doses, but rather ineffective.

Ongoing and Future Trials

There are ongoing clinical trials aimed at evaluating the efficacy and safety of new formulations of phenylephrine hydrochloride. For example:

  • A multicenter study by Bayer is investigating the use of a 30mg extended-release tablet of phenylephrine hydrochloride to provide relief from nasal congestion due to allergic rhinitis. This formulation is designed to release the drug slowly over time, aiming to provide relief for up to 8 hours[4].

Market Analysis

Current Market Size and Growth

The global phenylephrine hydrochloride market was valued at USD 777.6 million in 2022 and is projected to reach USD 1.6 billion by 2032, with a compound annual growth rate (CAGR) of 7.7% during the forecast period[3].

  • The market is driven by the consistent demand for decongestant medications, particularly for seasonal and year-round respiratory ailments such as the common cold, allergies, and sinus congestion.

Market Segmentation

The market is segmented based on application, formulation, distribution channel, and end-user.

By Application

  • The nasal decongestion segment dominated the market in 2022, with a market share of 29.5%. Phenylephrine hydrochloride is a key ingredient in nasal decongestant medications, providing relief by constricting blood vessels in the nasal passages[3].

By Formulation

  • The drug is available in various formulations, including nasal sprays, oral tablets, eye drops, and intravenous injections. This versatility contributes to its widespread use and market growth[2][3].

By Distribution Channel

  • The market is distributed through hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility of these channels support the drug's market presence[2].

By End User

  • The primary end users are patients with nasal congestion, patients with eye conditions, and healthcare professionals. The diverse applications of phenylephrine hydrochloride cater to a broad range of medical needs[2].

Market Trends

Diversifying Applications

Beyond its traditional role as a decongestant, phenylephrine hydrochloride has found increasing relevance in other medical domains:

  • Ophthalmic Applications: It is used as a mydriatic agent in ophthalmic solutions to facilitate pupil dilation during eye examinations and surgeries, enhancing the visibility of the eye's internal structures[3].

Regional Market Analysis

The global market is segmented by region, including North America, Europe, South America, Asia Pacific, and the Middle East and Africa. Each region has its own growth dynamics driven by local healthcare needs and market conditions[2][3].

Key Players in the Market

The phenylephrine hydrochloride API market includes several major players:

  • DIVI'S LABOTATORIES LTD
  • CHENG FONG CHEMICAL CO LTD
  • SYN-TECH CHEM AND PHARM CO LTD
  • NOVUS FINE CHEMICALS LLC
  • SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH
  • TRANSO PHARM HANDELS GMBH
  • UNICHEM LABORATORIES LTD
  • SHILPA PHARMA LIFESCIENCES LTD
  • Shenzhen Walland Pharmaceutical Co., Ltd.
  • Shandong Keyuan Pharmaceutical
  • Chifeng Aike Pharmaceutical
  • Zhejiang Haixiang Chuannan Pharmaceutical Co., Ltd.[5]

Market Projections

Future Growth

Despite the recent controversy surrounding its efficacy, the phenylephrine hydrochloride market is expected to continue growing:

  • The global market is forecasted to reach USD 1.6 billion by 2032, driven by the ongoing demand for decongestant medications and the adaptability of the drug in various formulations[3].
  • The API market specifically is projected to grow to USD 300.8 million by 2030, with a CAGR of 4.2% during the forecast period[5].

Impact of Recent Findings on Market Projections

The FDA advisory committee's conclusion that phenylephrine is not effective compared to a placebo may have future implications for the market:

  • Potential Policy Changes: While the FDA has not yet made any policy changes, future regulations could impact the market size and growth rate.
  • Consumer Confidence: The efficacy controversy might affect consumer confidence in phenylephrine-based products, potentially influencing market dynamics.

Conclusion

Phenylephrine hydrochloride remains a significant player in the pharmaceutical industry, particularly in the decongestant market. Despite recent questions about its efficacy, the market is projected to continue growing due to its versatility and the ongoing demand for respiratory relief medications.

Key Takeaways

  • Phenylephrine hydrochloride is widely used for its decongestant properties but has been found ineffective in recent clinical trials.
  • The global market is valued at USD 777.6 million in 2022 and is projected to reach USD 1.6 billion by 2032.
  • The drug is available in various formulations and has diverse applications, including ophthalmic uses.
  • Major players in the market include several pharmaceutical companies, contributing to the drug's widespread availability.
  • Future growth is expected, though potential policy changes and consumer confidence issues may impact the market.

FAQs

Q: What is the current status of phenylephrine hydrochloride in clinical trials?

A: Recent clinical trials have raised questions about the efficacy of phenylephrine hydrochloride, with an FDA advisory committee concluding it is no more effective than a placebo. However, ongoing trials are exploring new formulations and uses.

Q: How big is the global phenylephrine hydrochloride market?

A: The global phenylephrine hydrochloride market was valued at USD 777.6 million in 2022 and is projected to reach USD 1.6 billion by 2032.

Q: What are the main applications of phenylephrine hydrochloride?

A: The primary application is as a nasal decongestant, but it is also used in ophthalmic solutions as a mydriatic agent.

Q: Who are the key players in the phenylephrine hydrochloride market?

A: Key players include DIVI'S LABOTATORIES LTD, CHENG FONG CHEMICAL CO LTD, SYN-TECH CHEM AND PHARM CO LTD, and several other pharmaceutical companies.

Q: How might recent findings on phenylephrine's efficacy impact the market?

A: The findings could lead to potential policy changes and may affect consumer confidence, but the market is still projected to grow due to ongoing demand for decongestant medications.

Sources

  1. Encore Docs: FDA Committee Says Phenylephrine Doesn't Work.
  2. Market Research Future: Phenylephrine Hydrochloride Market Size, Growth Report 2032.
  3. GMI Insights: Phenylephrine Hydrochloride Market Size Report, 2032.
  4. Bayer Clinical Trials: Nasal congestion due to allergic rhinitis | Study 18146.
  5. Valuates Reports: Phenylephrine Hydrochloride API - Market Size.

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