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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE


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All Clinical Trials for Phenylephrine Hydrochloride; Tropicamide

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00500344 ↗ CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography Completed Genentech, Inc. Phase 1 2007-07-01 CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD
NCT00500344 ↗ CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography Completed Washington University School of Medicine Phase 1 2007-07-01 CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD
NCT00501878 ↗ 2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides Completed Khon Kaen University Phase 4 2007-05-01 To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.
NCT00642135 ↗ CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment Terminated Ioltech Phase 3 2006-01-01 Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.
NCT00642135 ↗ CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment Terminated Assistance Publique - Hôpitaux de Paris Phase 3 2006-01-01 Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.
NCT00877175 ↗ Comparison of Instillation and Packing in Mydriasis for Premature Infants Completed Khon Kaen University Phase 4 2009-03-01 The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Phenylephrine Hydrochloride; Tropicamide

Condition Name

Condition Name for Phenylephrine Hydrochloride; Tropicamide
Intervention Trials
Mydriasis 8
Dilation 4
Retinopathy of Prematurity 3
Cataract 3
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Condition MeSH

Condition MeSH for Phenylephrine Hydrochloride; Tropicamide
Intervention Trials
Mydriasis 13
Dilatation, Pathologic 5
Premature Birth 4
Retinopathy of Prematurity 4
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Clinical Trial Locations for Phenylephrine Hydrochloride; Tropicamide

Trials by Country

Trials by Country for Phenylephrine Hydrochloride; Tropicamide
Location Trials
United States 26
Thailand 3
Greece 2
Egypt 2
Malaysia 1
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Trials by US State

Trials by US State for Phenylephrine Hydrochloride; Tropicamide
Location Trials
Ohio 4
Rhode Island 3
Kansas 3
California 3
Florida 3
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Clinical Trial Progress for Phenylephrine Hydrochloride; Tropicamide

Clinical Trial Phase

Clinical Trial Phase for Phenylephrine Hydrochloride; Tropicamide
Clinical Trial Phase Trials
Phase 4 11
Phase 3 10
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Phenylephrine Hydrochloride; Tropicamide
Clinical Trial Phase Trials
Completed 15
Recruiting 4
Terminated 3
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Clinical Trial Sponsors for Phenylephrine Hydrochloride; Tropicamide

Sponsor Name

Sponsor Name for Phenylephrine Hydrochloride; Tropicamide
Sponsor Trials
Ocuphire Pharma, Inc. 4
Eyenovia Inc. 3
Khon Kaen University 3
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Sponsor Type

Sponsor Type for Phenylephrine Hydrochloride; Tropicamide
Sponsor Trials
Other 21
Industry 9
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Phenylephrine Hydrochloride and Tropicamide: Clinical Trials, Market Analysis, and Projections

Introduction

Phenylephrine hydrochloride and tropicamide are two pharmaceutical ingredients with diverse applications, particularly in the treatment of nasal congestion and ophthalmic conditions. This article delves into the recent clinical trials, market analysis, and future projections for these drugs.

Clinical Trials Update for Phenylephrine Hydrochloride

FDA's Proposal to Remove Oral Phenylephrine

In November 2024, the FDA issued a proposed order to remove oral phenylephrine hydrochloride and phenylephrine bitartrate from the OTC monograph due to a lack of effectiveness as a nasal decongestant. This decision follows a unanimous vote by the Nonprescription Drug Advisory Committee (NDAC) that the current scientific data do not support the efficacy of oral phenylephrine at monograph doses[1][4].

Efficacy Studies

Studies conducted by the National Institutes of Health in 2023 revealed that oral phenylephrine was not more effective than a placebo at doses of 10 to 40 mg every four hours. The FDA's review of data over the past 30 years has reinforced this finding, leading to the proposed removal of oral phenylephrine from OTC medications[4].

Clinical Trials Update for Tropicamide and Phenylephrine Hydrochloride Combination

Mydcombi Update

Eyenovia, Inc. has conducted a Phase IV study on Mydcombi, a fixed-dose combination of tropicamide and phenylephrine hydrochloride ophthalmic spray. This study aimed to determine the efficacy and duration of the lowest deliverable dose for mydriasis (pupil dilation). Mydcombi is the only FDA-approved product of its kind, addressing limitations of current mydriatic eye drops such as cross-contamination and tolerability issues[3].

Market Analysis for Phenylephrine Hydrochloride

Current Market Size and Growth

The phenylephrine hydrochloride market was valued at approximately $1.3 billion in 2023 and is projected to grow at a CAGR of 5.2%, reaching around $2.1 billion by 2030. The market is driven by the increasing prevalence of cold, flu, and respiratory diseases, as well as the growing trend of self-medication and accessible healthcare solutions[2].

Key Drivers of Growth

  • Rising Prevalence of Respiratory Diseases: The growing incidence of seasonal allergies, nasal congestion, and chronic rhinosinusitis drives the demand for phenylephrine hydrochloride-containing medications.
  • Versatility in Therapeutic Applications: Phenylephrine hydrochloride is used not only as a nasal decongestant but also as a vasoconstrictor in eye care and anesthesia, contributing to its market growth[2][5].
  • Global Pharmaceutical Industry Growth: The expansion of the pharmaceutical industry, particularly in regions like North America and Europe, further boosts the market for phenylephrine hydrochloride[5].

Regional Market Outlook

  • North America: Expected to dominate with over 39.7% revenue share by 2037, driven by a diverse array of pharmaceutical companies and the growing adoption of online pharmacies.
  • Europe: Anticipated to experience significant growth due to the increasing prevalence of allergic diseases, partly attributed to climate change[5].

Market Analysis for Tropicamide and Phenylephrine Hydrochloride Combination

Ophthalmic Market

The combination of tropicamide and phenylephrine hydrochloride, as seen in Mydcombi, addresses specific needs in ophthalmic care. This product fills a niche by providing a convenient and safe alternative to traditional mydriatic eye drops, which can have limitations such as potential cross-contamination and tolerability issues[3].

Projections for Phenylephrine Hydrochloride

Future Market Size

The phenylephrine hydrochloride market is estimated to reach USD 2.4 billion by the end of 2037, expanding at a CAGR of 7.9% during the forecast period of 2025-2037. This growth is driven by the increasing prevalence of seasonal allergies and the versatility of phenylephrine hydrochloride in various therapeutic applications[5].

Impact of FDA's Proposal

While the FDA's proposal to remove oral phenylephrine from OTC medications may impact the market, it is important to note that this decision does not affect other forms of phenylephrine hydrochloride, such as nasal sprays and ophthalmic applications. The market is expected to adapt with reformulations or alternative ingredients for oral decongestants[1][4].

Projections for Tropicamide and Phenylephrine Hydrochloride Combination

Ophthalmic Market Growth

The ophthalmic market, particularly for products like Mydcombi, is expected to grow as healthcare providers seek safer and more effective alternatives for mydriasis. The convenience and safety profile of Mydcombi are likely to drive its adoption in clinical settings[3].

Challenges and Opportunities

Challenges

  • Regulatory Changes: The proposed removal of oral phenylephrine from OTC medications presents a challenge for manufacturers, who will need to reformulate their products or seek alternative ingredients.
  • Competition: The market for decongestants and ophthalmic products is competitive, with various alternatives available. Manufacturers must innovate and differentiate their products to maintain market share[1][4].

Opportunities

  • Growing Demand for Self-Medication: The increasing trend of self-medication and accessible healthcare solutions presents an opportunity for growth in the phenylephrine hydrochloride market.
  • Diversification in Therapeutic Applications: The versatility of phenylephrine hydrochloride in various therapeutic applications, including ophthalmic care, offers opportunities for expansion into new markets[2][5].

Key Takeaways

  • Phenylephrine Hydrochloride: Despite the FDA's proposal to remove oral phenylephrine from OTC medications, the market for phenylephrine hydrochloride is expected to grow driven by its use in nasal sprays, ophthalmic applications, and other therapeutic areas.
  • Tropicamide and Phenylephrine Hydrochloride Combination: Mydcombi and similar products are poised for growth in the ophthalmic market due to their safety and efficacy.
  • Market Growth Drivers: Rising prevalence of respiratory diseases, self-medication trends, and the versatility of phenylephrine hydrochloride are key drivers of market growth.

FAQs

What is the current status of oral phenylephrine in OTC medications?

The FDA has proposed to remove oral phenylephrine from OTC medications due to a lack of effectiveness as a nasal decongestant. Comments on this proposal are due by May 7, 2025[1][4].

How does the FDA's proposal affect the phenylephrine hydrochloride market?

The proposal primarily affects oral forms of phenylephrine hydrochloride and does not impact other forms such as nasal sprays and ophthalmic applications. Manufacturers may need to reformulate their oral decongestant products[1][4].

What are the key drivers of growth for the phenylephrine hydrochloride market?

The key drivers include the rising prevalence of cold, flu, and respiratory diseases, the growing trend of self-medication, and the versatility of phenylephrine hydrochloride in various therapeutic applications[2][5].

What is Mydcombi, and how does it differ from traditional mydriatic eye drops?

Mydcombi is a fixed-dose combination of tropicamide and phenylephrine hydrochloride ophthalmic spray. It addresses limitations of traditional mydriatic eye drops such as cross-contamination and tolerability issues[3].

How is climate change impacting the phenylephrine hydrochloride market?

Climate change is expected to increase the prevalence of allergic diseases, which in turn will drive the demand for phenylephrine hydrochloride-containing medications, particularly in regions like Europe[5].

What is the projected market size for phenylephrine hydrochloride by 2037?

The phenylephrine hydrochloride market is estimated to reach USD 2.4 billion by the end of 2037, expanding at a CAGR of 7.9% during the forecast period[5].

Sources

  1. FDA's Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise, but What Is Left Over the Counter? - The FDA Law Blog.
  2. Phenylephrine Hydrochloride Market Size, Potential Scope 2031 - OpenPR.
  3. Eyenovia Provides Clinical and Scientific Update on FDA-Approved Products Mydcombi and Clobetasol Propionate Ophthalmic Suspension - GlobeNewswire.
  4. FDA proposes to remove oral phenylephrine in selected drugs - Regulatory Rapporteur.
  5. Phenylephrine Hydrochloride Market Size, Growth Report 2037 - Research Nester.

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