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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR GEODON


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All Clinical Trials for Geodon

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00141271 ↗ A Six-Week Study Evaluating The Efficacy And Safety Of Geodon In Patients With A Diagnosis Of Bipolar I Depression Completed Pfizer Phase 3 2005-07-01 This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.
NCT00044655 ↗ Switching Medication to Treat Schizophrenia Completed National Institute of Mental Health (NIMH) Phase 4 2001-07-01 This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
NCT00044655 ↗ Switching Medication to Treat Schizophrenia Completed Icahn School of Medicine at Mount Sinai Phase 4 2001-07-01 This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for Geodon

Condition Name

171570024681012141618SchizophreniaBipolar DisorderSchizoaffective Disorder[disabled in preview]
Condition Name for Geodon
Intervention Trials
Schizophrenia 17
Bipolar Disorder 15
Schizoaffective Disorder 7
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Condition MeSH

1717160024681012141618DiseaseSchizophreniaBipolar Disorder[disabled in preview]
Condition MeSH for Geodon
Intervention Trials
Disease 17
Schizophrenia 17
Bipolar Disorder 16
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Clinical Trial Locations for Geodon

Trials by Country

+
Trials by Country for Geodon
Location Trials
United States 181
India 14
Malaysia 5
Ukraine 4
Colombia 4
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Trials by US State

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Trials by US State for Geodon
Location Trials
New York 14
Massachusetts 13
California 12
Texas 11
Ohio 10
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Clinical Trial Progress for Geodon

Clinical Trial Phase

60.0%32.0%8.0%00246810121416Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for Geodon
Clinical Trial Phase Trials
Phase 4 15
Phase 3 8
Phase 2/Phase 3 2
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Clinical Trial Status

80.9%14.9%00510152025303540CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for Geodon
Clinical Trial Phase Trials
Completed 38
Terminated 7
Unknown status 2
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Clinical Trial Sponsors for Geodon

Sponsor Name

trials02468101214161820222426PfizerPfizer's Upjohn has merged with Mylan to form Viatris Inc.Massachusetts General Hospital[disabled in preview]
Sponsor Name for Geodon
Sponsor Trials
Pfizer 25
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 8
Massachusetts General Hospital 6
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Sponsor Type

59.8%34.6%5.6%0010203040506070OtherIndustryNIH[disabled in preview]
Sponsor Type for Geodon
Sponsor Trials
Other 64
Industry 37
NIH 6
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Geodon (Ziprasidone): Clinical Trials Update, Market Analysis, and Projections

Introduction to Geodon (Ziprasidone)

Geodon, known generically as ziprasidone, is an atypical antipsychotic medication used primarily for the treatment of schizophrenia and acute mania or mixed states associated with bipolar disorder. It is also approved for the immediate release intramuscular injection form to treat acute agitation in people with schizophrenia[5].

Clinical Trials Update

Pediatric Clinical Trials

A significant update in the clinical trials of Geodon involves the closure of a Phase 3 pediatric clinical trial. This trial, designated as A1281198, was conducted to evaluate the efficacy and safety of ziprasidone in pediatric subjects (children and adolescents) aged 10-17 with bipolar I disorder. The trial was closed after achieving a sufficient number of participants to establish efficacy and safety objectives.

The primary efficacy endpoint, which was the change from baseline to Week 4 in the Young Mania Rating Scale (YMRS) total score, was met with a statistically significant treatment effect (p=0.005) for ziprasidone compared to placebo. The treatment was found to be safe and generally well tolerated, with no new or unexpected safety concerns observed. The safety data were consistent with the established safety profile of ziprasidone in adults and previous pediatric studies[1][3].

Additional Safety and Efficacy Studies

Several other studies have been conducted to assess the safety and efficacy of Geodon in various populations. For instance, two 6-month open-label studies were conducted to obtain additional data on the tolerability and safety of ziprasidone in pediatric bipolar disorder. These studies involved a total of 201 bipolar patients and provided valuable insights into the long-term safety and efficacy of the drug[3].

Market Analysis

Global Market Size and Forecast

The global market for ziprasidone is analyzed in detail in recent market reports. As of 2023, the global market for ziprasidone was estimated to be worth several million dollars and is forecasted to grow at a certain CAGR during the period from 2024 to 2030. The market size and development potential are analyzed at the global, regional, and country levels, providing a comprehensive overview of the market dynamics[2][5].

Market Segmentation

The market is segmented by type and application to help identify the most promising market segments. The application segments include the treatment of schizophrenia, acute mania, and mixed states associated with bipolar disorder, as well as acute agitation in people with schizophrenia. The regional analysis covers various regions, including their market size, development potential, and future prospects[5].

Competitive Landscape

The competitive landscape of the ziprasidone market is characterized by several key players. The market report provides detailed analysis of these manufacturers, including their competitive strategies, price, sales, and revenue market share. It also covers the latest development plans, mergers, and acquisitions in the industry[2][5].

Market Projections

Growth Drivers and Restraints

The growth of the ziprasidone market is driven by several factors, including the increasing prevalence of mental health disorders such as schizophrenia and bipolar disorder. Additionally, advancements in healthcare infrastructure and the availability of effective treatment options contribute to market growth. However, the market also faces certain restraints, such as regulatory challenges, side effects associated with the drug, and competition from other antipsychotic medications[5].

Regional Market Outlook

The regional market outlook for ziprasidone varies significantly. The market size and development potential are analyzed for each region, including North America, Europe, Asia-Pacific, and other regions. The report provides quantitative data on sales value, sales volume, and average price by region, helping to identify the most lucrative markets[5].

Future Development Prospects

The future development prospects for the ziprasidone market look promising, driven by ongoing research and development activities. The market is expected to benefit from the increasing awareness of mental health issues and the need for effective treatment options. However, the market will also need to navigate challenges such as regulatory approvals, patent expirations, and competitive pressures[2][5].

Key Takeaways

  • Clinical Trials: The Phase 3 pediatric clinical trial for Geodon was successfully closed, demonstrating efficacy and safety in children and adolescents with bipolar I disorder.
  • Market Size: The global market for ziprasidone is forecasted to grow at a significant CAGR from 2024 to 2030.
  • Market Segmentation: The market is segmented by type and application, with a focus on schizophrenia, bipolar disorder, and acute agitation.
  • Competitive Landscape: The market is characterized by several key players, with detailed analysis of their competitive strategies and market share.
  • Growth Drivers: The market is driven by the increasing prevalence of mental health disorders and advancements in healthcare infrastructure.
  • Regional Outlook: The regional market outlook varies, with detailed analysis of sales value, volume, and average price by region.

FAQs

What is Geodon (ziprasidone) used for?

Geodon (ziprasidone) is used for the treatment of schizophrenia, acute mania, and mixed states associated with bipolar disorder. It is also approved for the immediate release intramuscular injection form to treat acute agitation in people with schizophrenia[5].

What were the findings of the Phase 3 pediatric clinical trial for Geodon?

The Phase 3 pediatric clinical trial for Geodon demonstrated statistically significant efficacy and safety in children and adolescents with bipolar I disorder. The primary efficacy endpoint was met, and the treatment was generally well tolerated with no new safety concerns[1][3].

What is the forecasted growth rate of the global ziprasidone market?

The global ziprasidone market is forecasted to grow at a certain CAGR during the period from 2024 to 2030, although the exact CAGR is not specified in the available sources[2][5].

Who are the key players in the ziprasidone market?

The key players in the ziprasidone market include several pharmaceutical companies, with detailed analysis provided in market reports. However, specific company names are not listed in the available sources[2][5].

What are the main drivers of the ziprasidone market growth?

The main drivers of the ziprasidone market growth include the increasing prevalence of mental health disorders and advancements in healthcare infrastructure. Regulatory approvals and the availability of effective treatment options also contribute to market growth[5].

What are the potential restraints for the ziprasidone market?

The potential restraints for the ziprasidone market include regulatory challenges, side effects associated with the drug, and competition from other antipsychotic medications. Additionally, patent expirations and competitive pressures can impact market growth[5].

Sources

  1. Pfizer Statement on Geodon (ziprasidone) Trial Closure in the United States. Pfizer, November 10, 2020.
  2. Ziprasidone Market Report 2024 (Global Edition). Cognitive Market Research, September 9, 2022.
  3. Geodon®-ziprasidone HCL. FDA, April 29, 2009.
  4. Comparison of Efficacy and Safety Between Low-Dose Ziprasidone and Usual Dose in Combination with Sertraline. Frontiers in Pharmacology, April 25, 2022.
  5. Ziprasidone - Global Market Share and Ranking, Overall Sales and Revenue. QY Research, January 16, 2024.

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