CLINICAL TRIALS PROFILE FOR TIMOLOL MALEATE

All Clinical Trials for Timolol Maleate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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).

Clinical Trial Conditions for Timolol Maleate

Condition Name

Condition Name for Timolol Maleate
Intervention	Trials
Ocular Hypertension	38
Glaucoma	19
Open-angle Glaucoma	14
Primary Open Angle Glaucoma	5

Condition MeSH

Condition MeSH for Timolol Maleate
Intervention	Trials
Glaucoma	49
Ocular Hypertension	43
Hypertension	36
Glaucoma, Open-Angle	36

Clinical Trial Locations for Timolol Maleate

Trials by Country

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Trials by Country for Timolol Maleate
Location	Trials
United States	123
Spain	8
United Kingdom	4
Canada	4
Germany	4

Trials by US State

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Trials by US State for Timolol Maleate
Location	Trials
California	12
New York	8
Georgia	8
Massachusetts	8
New Jersey	6

Clinical Trial Progress for Timolol Maleate

Clinical Trial Phase

Clinical Trial Phase for Timolol Maleate
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	17
Phase 2	16

Clinical Trial Status

Clinical Trial Status for Timolol Maleate
Clinical Trial Phase	Trials
Completed	47
Recruiting	9
Active, not recruiting	5

Clinical Trial Sponsors for Timolol Maleate

Sponsor Name

Sponsor Name for Timolol Maleate
Sponsor	Trials
Alcon Research	8
Aerie Pharmaceuticals	5
Allergan	5

Sponsor Type

Sponsor Type for Timolol Maleate
Sponsor	Trials
Industry	50
Other	27
NIH	3

Timolol Maleate: Clinical Trials, Market Analysis, and Projections

Introduction

Timolol maleate is a non-selective beta adrenergic blocker widely used in the treatment of elevated intraocular pressure in ocular hypertension and open-angle glaucoma. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Completed Trials

Timolol maleate has been a benchmark in glaucoma treatment for decades, and it continues to be a reference point in newer clinical trials. For instance, in the trials conducted by Aerie Pharmaceuticals, timolol maleate was used as a comparator for the new drug Rhopressa. In the Rocket 1 trial, Rhopressa did not demonstrate noninferiority to timolol at all pressure ranges above 20 mm Hg to below 27 mm Hg, although it did show noninferiority at ranges below 26 mm Hg[3].

Safety and Efficacy

Clinical trials have consistently shown that timolol maleate rapidly reduces intraocular pressure when administered via the ophthalmic route. The drug has a fast onset of action, typically within 20 minutes, and its effects can last up to 24 hours with doses of 0.5% or 0.25%[4].

Adverse Effects

While effective, timolol maleate can have adverse effects, including hyperemia, which was reported in 35% of patients in the Rocket 1 trial, with 80% of cases being mild[3]. Other potential adverse effects include dizziness, headache, shortness of breath, bradycardia, and bronchospasm, especially in cases of overdose[4].

Market Analysis

Global Market Size and Forecast

The global market for pharmaceutical-grade timolol maleate is significant and growing. In 2023, the market was valued at several million USD and is forecasted to reach a readjusted size by 2030, with a Compound Annual Growth Rate (CAGR) during the forecast period of 2024-2030[2][5].

Regional Market Breakdown

The market is segmented by region, with North America, Europe, and the Asia-Pacific region being key markets. Each of these regions is expected to see growth, with the North American market, for example, valued at millions of USD in 2023 and projected to reach millions by 2030[2].

Key Players

The global market for timolol maleate is dominated by several key players, including Micro Labs Ltd, Syn-Tech Chem And Pharm Co Ltd, Fareva La Vallee, Pcas, Centaur Pharmaceuticals Pvt Ltd, Excella Gmbh And Co Kg, Fdc Ltd, Teva Pharmaceutical Industries Ltd, and Olon Spa. These companies hold a significant share of the market revenue[2][5].

Market Segmentation

By Application

Timolol maleate is primarily used in eye drops for the treatment of glaucoma and ocular hypertension. The market segmentation by application includes eye drops and other minor applications. The sales volume and revenue by application are closely monitored, with eye drops being the dominant segment[2][5].

By Type

The market is also segmented by the type of timolol maleate API, which includes different concentrations and formulations. This segmentation helps in understanding the demand for specific types of the drug[5].

Market Trends and Growth Factors

Increasing Prevalence of Glaucoma

The growing prevalence of glaucoma and ocular hypertension is a major driver for the timolol maleate market. As the global population ages, the incidence of these conditions is expected to rise, thereby increasing the demand for effective treatments like timolol maleate[3].

Advancements in Formulations

Continuous advancements in formulations, such as the development of combination therapies (e.g., Xalacom which combines latanoprost and timolol maleate), are also driving the market. These combination therapies offer improved efficacy and patient compliance[1].

Regulatory Environment

Regulatory approvals and priority reviews, such as the Priority Review designation in China, can significantly impact the market growth of timolol maleate. These designations can expedite the approval process, making the drug available to patients sooner[1].

Projections and Future Outlook

Market Growth Projections

The global timolol maleate market is expected to grow steadily over the next few years, driven by increasing demand and advancements in formulations. The market is forecasted to reach a significant value by 2030, with a CAGR that reflects the growing need for glaucoma treatments[2][5].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, are expected to contribute significantly to the growth of the timolol maleate market. These regions have large populations with increasing access to healthcare, which will drive the demand for glaucoma treatments[2].

Key Takeaways

• Clinical Trials: Timolol maleate continues to be a benchmark in glaucoma treatment trials, with ongoing studies comparing its efficacy to newer drugs.
• Market Size and Forecast: The global market for timolol maleate is valued in millions of USD and is expected to grow with a significant CAGR by 2030.
• Regional Markets: North America, Europe, and the Asia-Pacific region are key markets, each expected to see substantial growth.
• Key Players: Major pharmaceutical companies dominate the market, with a significant share of revenue.
• Market Segmentation: The market is segmented by application (primarily eye drops) and type (different concentrations and formulations).
• Growth Factors: Increasing prevalence of glaucoma, advancements in formulations, and favorable regulatory environments are driving the market.

FAQs

What is the primary use of timolol maleate?

Timolol maleate is primarily used in the treatment of elevated intraocular pressure in ocular hypertension and open-angle glaucoma.

What are the common adverse effects of timolol maleate?

Common adverse effects include hyperemia, dizziness, headache, shortness of breath, bradycardia, and bronchospasm.

Which companies are the key players in the timolol maleate market?

Key players include Micro Labs Ltd, Syn-Tech Chem And Pharm Co Ltd, Fareva La Vallee, Pcas, Centaur Pharmaceuticals Pvt Ltd, Excella Gmbh And Co Kg, Fdc Ltd, Teva Pharmaceutical Industries Ltd, and Olon Spa.

What is the forecasted growth rate of the global timolol maleate market?

The global market is forecasted to grow with a significant CAGR during the period of 2024-2030.

What are the main drivers for the growth of the timolol maleate market?

The main drivers include the increasing prevalence of glaucoma, advancements in formulations, and favorable regulatory environments.

Sources

1. Synapse: Timolol Maleate - Drug Targets, Indications, Patents.
2. QYResearch: Pharmaceutical Grade Timolol Maleate - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
3. Glaucoma Today: Industry News and Innovations.
4. DrugBank: Timolol: Uses, Interactions, Mechanism of Action.
5. Valuates Reports: Global Timolol Maleate API Market Research.