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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR ZAROXOLYN


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All Clinical Trials for Zaroxolyn

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00649051 ↗ Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg Completed Mylan Pharmaceuticals Phase 1 2002-12-01 The objective of this study was to investigate the bioequivalence of Mylan metolazone 2.5 mg tablets to Celltech Zaroxolyn® 2.5 mg tablets following a single, oral 10 mg (4 x 2.5 mg) dose administration under fasting conditions.
NCT00649181 ↗ Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg Completed Mylan Pharmaceuticals Phase 1 2003-10-01 The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose administration under fasting conditions.
NCT00650195 ↗ Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg Completed Mylan Pharmaceuticals Phase 1 2004-02-01 The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zaroxolyn

Condition Name

Condition Name for Zaroxolyn
Intervention Trials
Healthy 3
Heart Failure 2
Heart Failure Acute 2
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Condition MeSH

Condition MeSH for Zaroxolyn
Intervention Trials
Heart Failure 4
Cardiovascular Diseases 1
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Clinical Trial Locations for Zaroxolyn

Trials by Country

Trials by Country for Zaroxolyn
Location Trials
United States 7
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Trials by US State

Trials by US State for Zaroxolyn
Location Trials
West Virginia 2
Maryland 1
Virginia 1
Tennessee 1
North Carolina 1
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Clinical Trial Progress for Zaroxolyn

Clinical Trial Phase

Clinical Trial Phase for Zaroxolyn
Clinical Trial Phase Trials
Phase 4 4
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Zaroxolyn
Clinical Trial Phase Trials
Completed 4
Terminated 3
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Clinical Trial Sponsors for Zaroxolyn

Sponsor Name

Sponsor Name for Zaroxolyn
Sponsor Trials
Mylan Pharmaceuticals 3
University of North Carolina, Chapel Hill 1
Vanderbilt University 1
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Sponsor Type

Sponsor Type for Zaroxolyn
Sponsor Trials
Other 7
Industry 3
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Zaroxolyn: Clinical Trials, Market Analysis, and Projections

Introduction

Zaroxolyn, known generically as metolazone, is a thiazide-like diuretic used primarily in the treatment of edema and hypertension. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Studies

One of the notable recent studies involving metolazone is the comparison with dapagliflozin in patients with heart failure resistant to loop diuretics. This multi-center, open-label, randomized clinical trial was conducted by the Heart Failure Research Group at the University of Glasgow.

  • Study Design and Outcomes: The trial compared the efficacy and safety of dapagliflozin versus metolazone. Patients assigned to dapagliflozin received a larger cumulative dose of furosemide but experienced less biochemical upset compared to those assigned to metolazone. The study highlighted that patients on dapagliflozin had better outcomes in terms of kidney function and electrolyte balance[5].

Regulatory Framework

As of January 2023, all initial clinical trial applications in the EU/EEA must be submitted through the Clinical Trials Information System (CTIS). This update ensures that clinical trials are conducted under a unified and more efficient regulatory framework[1].

Market Analysis

Current Market Size and Forecast

The global market for metolazone was valued at approximately $453 million in 2023. It is projected to grow to $642.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.1% during the forecast period of 2024-2030[2].

Market Segmentation

The metolazone market is segmented based on type and application. The types include 2.5mg, 5mg, and 10mg formulations. The primary applications are in the treatment of edema, mild hypertension, and moderate hypertension[3].

Regional Framework

The market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country, providing a detailed overview of the market dynamics and growth opportunities[3].

Market Drivers and Restraints

Drivers

  • Increasing Prevalence of Hypertension and Edema: The rising incidence of hypertension and edema, particularly in aging populations, drives the demand for effective diuretics like metolazone.
  • Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure and access to medical services in developing regions contribute to the growth of the metolazone market[3].

Restraints

  • Side Effects and Adverse Events: Metolazone can cause significant side effects such as hypokalemia, hyperglycemia, and renal impairment, which can limit its use and impact market growth.
  • Competition from Alternative Treatments: The availability of other diuretics and antihypertensive drugs can pose a competitive challenge to metolazone[5].

Key Players and Competitive Landscape

Major Manufacturers

The metolazone market is dominated by several key players, including Mylan, Novartis, Lannett, Gd Searle, Mylan Pharmaceuticals, Roxane Laboratories, Teva Pharmaceuticals, Watson Laboratories, and UCB. These companies play a crucial role in the production, distribution, and marketing of metolazone[2].

Competitive Strategies

Companies are focusing on expanding their product portfolios, enhancing distribution networks, and investing in research and development to improve the efficacy and safety of metolazone. Strategic partnerships and collaborations are also common strategies to maintain market competitiveness[3].

Future Projections

Market Growth

The metolazone market is expected to continue its growth trajectory, driven by increasing demand for effective diuretics and antihypertensive medications. The forecasted CAGR of 5.1% indicates a steady and significant growth over the next several years[2].

Emerging Trends

  • Personalized Medicine: There is a growing trend towards personalized medicine, which could lead to more targeted and effective use of metolazone based on individual patient profiles.
  • Combination Therapies: Research into combination therapies involving metolazone and other medications could offer new treatment options and enhance market growth[5].

Key Takeaways

  • Clinical Trials: Recent studies have compared metolazone with other treatments, highlighting its efficacy and safety profile.
  • Market Size and Forecast: The global metolazone market is projected to grow from $453 million in 2023 to $642.9 million by 2030.
  • Market Segmentation: The market is segmented by type and application, with a focus on edema and hypertension treatment.
  • Key Players: Major manufacturers include Mylan, Novartis, and Lannett, among others.
  • Future Projections: The market is expected to grow with a CAGR of 5.1%, driven by increasing demand and emerging trends.

FAQs

What is the current market size of metolazone?

The global market for metolazone was valued at approximately $453 million in 2023[2].

What is the projected market size of metolazone by 2030?

The market is forecasted to reach $642.9 million by 2030[2].

What are the primary applications of metolazone?

The primary applications of metolazone are in the treatment of edema, mild hypertension, and moderate hypertension[3].

Who are the key players in the metolazone market?

Key players include Mylan, Novartis, Lannett, Gd Searle, Mylan Pharmaceuticals, Roxane Laboratories, Teva Pharmaceuticals, Watson Laboratories, and UCB[2].

What are the major drivers of the metolazone market?

The increasing prevalence of hypertension and edema, along with advancements in healthcare infrastructure, are major drivers of the metolazone market[3].

Sources

  1. EU Clinical Trials Register: EudraCT Number: 2022-003314-37.
  2. Valuates Reports: Metolazone - Market, Report Size, Worth, Revenue, Growth, Industry.
  3. The Insight Partners: Metolazone Market Developments by 2031.
  4. ClinicalTrials.gov: A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel.
  5. European Heart Journal: Dapagliflozin vs. metolazone in heart failure resistant to loop diuretics.

More… ↓

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