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Last Updated: January 7, 2025

CLINICAL TRIALS PROFILE FOR TAPAZOLE


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All Clinical Trials for TAPAZOLE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02727738 ↗ Treatment of Graves' Hyperthyroidism With Selenium Plus Methimazole Completed University of Pisa N/A 2014-01-01 Evaluation of the efficacy of the combined treatment (methimazole plus selenium) in the control of hyperthyroidism as compared to methimazole alone in 30 Graves' disease (GD) untreated patients.
NCT05017610 ↗ Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma Not yet recruiting Emory University Early Phase 1 2021-12-31 This early phase I trial studies the safety and feasibility of inducing a hypothyroxinemic state in patients with glioblastoma or gliosarcoma that has come back (recurrent). This trial aims to see if giving a specific thyroid hormone, such as methimazole and liothyronine, is safe and could benefit cancer treatment.
NCT05607407 ↗ A Phase 2 Study of Methimazole in Patients With Progressive Glioblastoma Not yet recruiting Case Comprehensive Cancer Center Phase 2 2024-01-01 The purpose of this study is to test the effectiveness, safety, and tolerability of a drug called Methimazole. The investigational drug, Methimazole is not FDA approved for brain tumors, but it is used to treat thyroid illnesses. Different doses of Methimazole will be given to several study participants with glioblastoma. The first several study participants will receive the lowest dose. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. The doses will continue to increase for every group of study participants until the side effects occur that require the dose to be lowered. The procedures in this study are research blood draws, physical exams, collection of medical history, MRI scans, and study drug administration.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TAPAZOLE

Condition Name

Condition Name for TAPAZOLE
Intervention Trials
Glioblastoma 1
Glioma 1
Graves' Disease 1
Recurrent Glioblastoma 1
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Condition MeSH

Condition MeSH for TAPAZOLE
Intervention Trials
Glioblastoma 2
Graves Disease 1
Gliosarcoma 1
Hyperthyroidism 1
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Clinical Trial Locations for TAPAZOLE

Trials by Country

Trials by Country for TAPAZOLE
Location Trials
Italy 1
United States 1
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Trials by US State

Trials by US State for TAPAZOLE
Location Trials
Georgia 1
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Clinical Trial Progress for TAPAZOLE

Clinical Trial Phase

Clinical Trial Phase for TAPAZOLE
Clinical Trial Phase Trials
Phase 2 1
N/A 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for TAPAZOLE
Clinical Trial Phase Trials
Not yet recruiting 2
Completed 1
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Clinical Trial Sponsors for TAPAZOLE

Sponsor Name

Sponsor Name for TAPAZOLE
Sponsor Trials
University of Pisa 1
Emory University 1
Case Comprehensive Cancer Center 1
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Sponsor Type

Sponsor Type for TAPAZOLE
Sponsor Trials
Other 3
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TAPAZOLE Market Analysis and Financial Projection

Tapazole (Methimazole): Clinical Trials, Market Analysis, and Projections

Introduction to Tapazole (Methimazole)

Tapazole, commonly known by its generic name methimazole, is a small-molecule drug that has been a cornerstone in the treatment of hyperthyroidism and hyperparathyroidism for over seven decades. Here, we will delve into the current clinical trials, market analysis, and future projections for this essential medication.

Mechanism of Action and Drug Targets

Methimazole primarily targets the enzyme thyroid peroxidase (TPO), which is crucial for the synthesis of thyroid hormones. By inhibiting TPO, methimazole reduces the production of thyroid hormones, thereby alleviating symptoms associated with hyperthyroidism[2].

Current Clinical Trials

Several clinical trials are ongoing or recently completed to evaluate the efficacy and safety of methimazole in various contexts:

  • Thyroid Storm Treatment: A recent comparative effectiveness study published in JAMA Network Open compared outcomes between propylthiouracil and methimazole for the treatment of thyroid storm. The study found no significant differences in mortality rates, duration of organ support, or hospitalization costs between the two treatments[4].
  • Phase 2 and Phase 3 Trials: Various institutions, such as the Case Comprehensive Cancer Center and the First Affiliated Hospital of Xiamen University, are conducting Phase 2 and Phase 3 trials to further evaluate the efficacy and safety of methimazole in different patient populations[5].

Market Analysis

Global Market Size and Growth

The global market for hyperthyroidism treatments, which includes methimazole, is projected to grow steadily. This growth is driven by the increasing prevalence of thyroid disorders and advancements in drug development.

  • Market Size: The global tachycardia drugs market, which includes treatments for hyperthyroidism, is expected to reach USD 19.18 billion by 2029, growing at a CAGR of 5.50% from 2022 to 2029[3].
  • Competitive Landscape: The market is characterized by the presence of several key players, including Pfizer Inc., Takeda Pharmaceutical Co., Ltd., and ASKA Pharmaceutical Holdings Co., Ltd. These companies are actively involved in research and development, contributing to the market's growth[2].

Distribution Channels and End-Users

  • Distribution Channels: Methimazole is available through various distribution channels, including hospital pharmacies, online pharmacies, and retail pharmacies. The rise in the number of retail pharmacies, particularly in highly developed countries, is expected to boost market growth[3].
  • End-Users: The primary end-users of methimazole include hospitals, homecare settings, specialty centers, and other healthcare facilities. The increasing demand for convenient and accessible treatment options is driving the growth in these segments[3].

Market Projections

Increasing Demand for Oral Drugs

The preference for oral drugs is expected to accelerate the market growth for methimazole. As most products, including methimazole, are available in capsule and tablet form, this route of administration remains highly feasible and preferred by patients[3].

Growing Prevalence of Thyroid Disorders

The global prevalence of thyroid disorders is on the rise, which is expected to drive the demand for methimazole. According to various studies, the increasing incidence of hyperthyroidism and other thyroid-related conditions will continue to fuel the market growth[5].

Advancements in Drug Development

Advancements in drug development and the ongoing clinical trials are expected to enhance the efficacy and safety profile of methimazole. New formulations and delivery methods could further expand the market for this drug[2].

Key Players and Competitive Landscape

  • Pfizer Inc.: As the original developer of methimazole, Pfizer Inc. remains a significant player in the market. The company's long-standing presence and continuous R&D efforts have solidified methimazole's position as a treatment option for hyperthyroidism[2].
  • Other Key Players: Companies like Takeda Pharmaceutical Co., Ltd., and ASKA Pharmaceutical Holdings Co., Ltd. are also making significant contributions to the market through their R&D activities and product offerings[2].

Challenges and Opportunities

Challenges

  • Generic Competition: The availability of generic versions of methimazole can pose a challenge to branded products. However, the ongoing clinical trials and advancements in drug development can help maintain market share[5].
  • Side Effects and Adverse Events: While methimazole is generally well-tolerated, it can have side effects such as liver damage and agranulocytosis. Continuous monitoring and improvement in safety profiles are essential[4].

Opportunities

  • Retail Pharmacies: The increasing number of retail pharmacies and their accessibility create opportunities for the market growth of methimazole. Patients prefer retail pharmacies due to their convenience and ease of access[3].
  • Emerging Markets: Expanding into emerging markets where thyroid disorders are increasingly being diagnosed and treated presents a significant opportunity for growth[2].

Key Takeaways

  • Clinical Trials: Ongoing and recent clinical trials are evaluating the efficacy and safety of methimazole in various contexts, including thyroid storm treatment.
  • Market Growth: The global market for hyperthyroidism treatments is projected to grow steadily, driven by the increasing prevalence of thyroid disorders and advancements in drug development.
  • Distribution Channels: Methimazole is available through multiple distribution channels, with retail pharmacies expected to play a significant role in market growth.
  • Competitive Landscape: Key players like Pfizer Inc., Takeda Pharmaceutical Co., Ltd., and ASKA Pharmaceutical Holdings Co., Ltd. are driving the market through R&D and product offerings.

FAQs

What is the primary mechanism of action of methimazole?

Methimazole primarily targets the enzyme thyroid peroxidase (TPO), inhibiting the synthesis of thyroid hormones.

Which companies are key players in the methimazole market?

Key players include Pfizer Inc., Takeda Pharmaceutical Co., Ltd., and ASKA Pharmaceutical Holdings Co., Ltd.

What is the projected market size for hyperthyroidism treatments by 2029?

The global market for hyperthyroidism treatments is expected to reach USD 19.18 billion by 2029.

What are the main distribution channels for methimazole?

Methimazole is available through hospital pharmacies, online pharmacies, and retail pharmacies.

Are there any ongoing clinical trials for methimazole?

Yes, several clinical trials are ongoing to evaluate the efficacy and safety of methimazole in different patient populations.

Sources

  1. Clinical Research News Online: "New Treatment Option for Graves' Disease Finally 'On the Horizon'".
  2. Patsnap Synapse: "Methimazole: Detailed Review on its Transformative R&D Success, Mechanism of Action, and Drug Targets".
  3. Data Bridge Market Research: "Global Tachycardia Drugs Market – Industry Trends and Forecast to 2029".
  4. JAMA Network Open: "Propylthiouracil vs Methimazole for Thyroid Storm in Critically Ill Patients".
  5. Drug Patent Watch: "METHIMAZOLE - Generic Drug Details".

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