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Last Updated: April 7, 2025

CLINICAL TRIALS PROFILE FOR TIMOLOL


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505(b)(2) Clinical Trials for Timolol

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 NCT05857267 ↗ Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety Recruiting Laboratorios Poen Phase 4 2023-03-07 The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.
New Formulation NCT02973880 ↗ Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Completed Sintesi Research Srl Phase 3 2017-10-15 Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success. Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation. After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative. NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time. The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
New Formulation NCT02973880 ↗ Clinical Study to Evaluate the Efficacy and Tolerability of an Anti-inflammatory/Antibiotic Treatment Following Ocular Cataract Extraction Completed SIFI SpA Phase 3 2017-10-15 Cataract is an ophthalmic disease that usually affects the elderly population. Cataract surgery with phaco-emulsification is now the most frequently performed intraocular surgical procedure in the developed world. However, differences in surgical technique impact the severity of surgical trauma and post-operative recovery. The amount of post-operative ocular pain and inflammation plays a significant role in the Patient's perception of the surgical success. Several ophthalmic products have been studied in the management of post-surgery ocular inflammation and pain following cataract surgery. Corticosteroids are considered the gold standard for the treatment of ocular inflammation, and their most commonly used route of administration is the topical instillation as eye drops formulation. After topical administration of Dexamethasone, the concentration in the anterior chamber increases and declines within hours, necessitating frequent daily instillations of eye drops for several weeks. This might be associated with compliance issues, particularly in elderly Patients or in individuals with disabilities. A pharmaceutical formulation allowing for a less frequent administration could therefore be an attractive alternative. NETILDEX™ eye drops solution, containing Netilmicin Sulfate 4.55 mg (3mg/ml) and Dexamethasone Disodium Phosphate 1.32 mg (1mg/ml), is already available for Patients. A new ophthalmic gel, preservative-free formulation has been developed. This new formulation has been tested in pre-clinical animal studies and in a clinical trial. The new formulation contains Xanthan gum, a high molecular mass polysaccharide approved by the FDA in 1969 for food products. It is used in the product as viscosity enhancer and to give to the product pseudo-plastic characteristics and prolonged ocular retention time. The purpose of this trial is to show that the administration of a reduced dose of NETILDEX ™ gel 2 times a day starting on the day of cataract extraction by means of phaco-emulsification and administered until 14 days after surgery is sufficient to obtain a non-inferior efficacy of the NETILDEX ™ eye drops solution administered 4 times a day for the same period.
New Formulation NCT01426113 ↗ A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma Terminated Allergan Phase 3 2011-09-01 The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for Timolol

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00004641 ↗ Prevention of Esophageal Varices by Beta-Adrenergic Blockers Completed Yale University Phase 3 1993-08-01 The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
NCT00004641 ↗ Prevention of Esophageal Varices by Beta-Adrenergic Blockers Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1993-08-01 The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
NCT00006398 ↗ Prevention of Esophageal Varices by Beta-Adrenergic Blockers Completed Yale University Phase 3 1993-08-01 The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
NCT00006398 ↗ Prevention of Esophageal Varices by Beta-Adrenergic Blockers Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 1993-08-01 The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed US Department of Veterans Affairs 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗ Hypertension Screening and Treatment Program Completed VA Office of Research and Development 1989-06-01 Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for Timolol

Condition Name

1197139200020406080100120Ocular HypertensionGlaucomaOpen-angle GlaucomaGlaucoma, Open-Angle[disabled in preview]
Condition Name for Timolol
Intervention Trials
Ocular Hypertension 119
Glaucoma 71
Open-angle Glaucoma 39
Glaucoma, Open-Angle 20
[disabled in preview] 0
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Condition MeSH

1711361181130020406080100120140160180GlaucomaOcular HypertensionHypertensionGlaucoma, Open-Angle[disabled in preview]
Condition MeSH for Timolol
Intervention Trials
Glaucoma 171
Ocular Hypertension 136
Hypertension 118
Glaucoma, Open-Angle 113
[disabled in preview] 0
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Clinical Trial Locations for Timolol

Trials by Country

+
Trials by Country for Timolol
Location Trials
United States 383
Italy 24
China 22
Canada 21
Germany 21
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Trials by US State

+
Trials by US State for Timolol
Location Trials
California 33
Texas 26
Pennsylvania 19
New York 18
Georgia 18
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Clinical Trial Progress for Timolol

Clinical Trial Phase

38.4%35.1%24.2%001020304050607080Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Timolol
Clinical Trial Phase Trials
Phase 4 81
Phase 3 74
Phase 2/Phase 3 5
[disabled in preview] 51
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Clinical Trial Status

70.8%9.2%6.3%13.8%0020406080100120140160180CompletedRecruitingUnknown status[disabled in preview]
Clinical Trial Status for Timolol
Clinical Trial Phase Trials
Completed 170
Recruiting 22
Unknown status 15
[disabled in preview] 33
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Clinical Trial Sponsors for Timolol

Sponsor Name

trials0510152025303540Alcon ResearchAllerganPfizer[disabled in preview]
Sponsor Name for Timolol
Sponsor Trials
Alcon Research 37
Allergan 35
Pfizer 15
[disabled in preview] 31
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Sponsor Type

57.4%39.6%0020406080100120140160180IndustryOtherNIH[disabled in preview]
Sponsor Type for Timolol
Sponsor Trials
Industry 174
Other 120
NIH 5
[disabled in preview] 4
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Timolol: Clinical Trials, Market Analysis, and Projections

Introduction

Timolol, a non-selective beta-blocker, is widely used in the treatment of various conditions, including glaucoma, high blood pressure, and superficial infantile hemangiomas. This article delves into the recent clinical trials, market analysis, and future projections for timolol.

Clinical Trials and Efficacy

Topical Timolol for Infantile Hemangiomas

A significant clinical study published in 2017 involved the topical application of 0.5% timolol maleate hydrogel for treating superficial infantile hemangiomas (IHs). The study treated 321 patients and observed satisfactory efficacy, with an average Visual Analog Scale (VAS) improvement of 76.4%. Clinical responses were noted in 318 patients, with only three patients showing poor responses without further complications[1].

Microdrops of Timolol Maleate

A recent trial by Nannodropper evaluated the effectiveness of microdrops of timolol maleate 0.5% compared to standard-size drops. The study found no clinically significant difference in intraocular pressure (IOP) reduction between the two, suggesting that microdrops could reduce waste, cost, and side effects while maintaining efficacy[4].

Glaucoma Treatment

In the context of glaucoma, timolol is often used in combination with other drugs. For instance, the fixed-dose combination of tafluprost and timolol maleate has been introduced, which is expected to drive market growth. Clinical trials, such as those involving Rhopressa and Roclatan, have also shown that new formulations and combinations can be as effective as, or even superior to, traditional timolol treatments[3].

Market Analysis

Global Market Size and Growth

The global timolol market has been growing steadily. As of 2023, the market size was valued at millions of dollars, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is segmented by type (e.g., 5ml:12.5mg, 5ml:25mg) and application (high blood pressure, glaucoma, others)[2].

Regional Analysis

The market is geographically segmented into North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. North America, particularly the United States, is expected to remain a dominant market for glaucoma treatment, driven by an aging population and the introduction of new products[2][3].

Key Players

Major competitors in the timolol market include Pfizer, Merck and Co Inc, Kissei, Allergan plc, STA PHARMACEUTICALS, AKORN, OAK PHARMS INC, WATSON LABS INC, SANDOZ, and BAUSCH AND LOMB. In the API market, key players are Teva api, Seqens, Fairdeal Corporation, Medilux Laboratories, Bhavna Laboratories, and others[2][5].

Market Projections

Glaucoma Treatment Market

The glaucoma treatment market, which includes timolol, is projected to grow from $2.4 billion in 2013 to approximately $3 billion by 2023 across seven major markets. This growth is driven by the approval of innovative drugs and the introduction of fixed-dose combination products[3].

API Market

The global timolol maleate API market is anticipated to grow significantly from 2023 to 2030, with a notable CAGR. This growth is fueled by increasing demand for eye drops and other applications of timolol maleate[5].

Drivers and Restraints

Drivers

  • Aging Population: The increasing prevalence of glaucoma and other age-related conditions drives the demand for timolol.
  • Innovative Formulations: New formulations like microdrops and combination therapies enhance efficacy and reduce side effects.
  • Market Expansion: Growing markets in Asia-Pacific and Latin America contribute to the overall market growth[2][3].

Restraints

  • Generic Competition: The loss of patent protection for certain timolol formulations, such as the brimonidine and timolol FDC, allows generic products to enter the market, potentially slowing growth[3].
  • Side Effects: Higher frequencies of administration can lead to increased side effects, which may affect patient compliance and market growth[1].

Technological Trends

Microdrops

The development of microdrops is a significant technological trend, as it reduces the volume of the drop administered, thereby minimizing waste and side effects while maintaining therapeutic efficacy[4].

Combination Therapies

The introduction of fixed-dose combination products, such as tafluprost and timolol maleate, is another trend that enhances patient compliance and treatment outcomes[3].

Future Prospects

Clinical Research

Further well-designed prospective studies are needed to analyze the effects of different stages of initiating topical timolol treatment on clinical responses. This research will help in optimizing treatment protocols and improving patient outcomes[1].

Market Growth

The timolol market is expected to continue growing, driven by the increasing demand for effective glaucoma treatments and the introduction of innovative formulations. The API market will also see significant growth, driven by the demand for high-quality active pharmaceutical ingredients[2][5].

Key Takeaways

  • Clinical Efficacy: Timolol, especially in new formulations like hydrogel and microdrops, has shown high efficacy in treating conditions such as infantile hemangiomas and glaucoma.
  • Market Growth: The global timolol market is projected to grow significantly, driven by an aging population and the introduction of innovative products.
  • Technological Trends: Microdrops and combination therapies are key trends that are expected to shape the future of timolol treatment.
  • Drivers and Restraints: While an aging population and innovative formulations drive growth, generic competition and side effects are potential restraints.

FAQs

What is the current market size of the global timolol market?

The global timolol market size was valued at millions of dollars as of 2023, with a projected growth from 2024 to 2031[2].

What are the main applications of timolol?

The main applications of timolol include the treatment of high blood pressure, glaucoma, and superficial infantile hemangiomas[1][2].

Who are the key players in the timolol market?

Major competitors include Pfizer, Merck and Co Inc, Kissei, Allergan plc, and others. In the API market, key players are Teva api, Seqens, Fairdeal Corporation, etc.[2][5].

What are the benefits of microdrops of timolol maleate?

Microdrops reduce waste, cost, and side effects while maintaining therapeutic efficacy, making them a promising innovation in timolol treatment[4].

How does the aging population impact the timolol market?

The aging population drives the demand for timolol, particularly for glaucoma treatment, contributing to market growth[3].

References

  1. Frontiers in Oncology: "Topical Application of 0.5% Timolol Maleate Hydrogel for Superficial Infantile Hemangiomas: A Multicenter, Retrospective Cohort Study"[1].
  2. Cognitive Market Research: "Global Timolol Market Report 2024 Edition"[2].
  3. Glaucoma Today: "Industry News and Innovations"[3].
  4. Ophthalmology Times: "Microdrops of timolol maleate 0.5% show no clinically significant difference in IOP compared to standard size drops"[4].
  5. Valuates Reports: "Global Timolol Maleate API Market Research Report 2024"[5].

More… ↓

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