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Last Updated: February 10, 2025

CLINICAL TRIALS PROFILE FOR ZYPREXA


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All Clinical Trials for Zyprexa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000374 ↗ Treatment for First-Episode Schizophrenia Completed National Institute of Mental Health (NIMH) Phase 4 1998-09-01 This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
NCT00000374 ↗ Treatment for First-Episode Schizophrenia Completed The Zucker Hillside Hospital Phase 4 1998-09-01 This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
NCT00000374 ↗ Treatment for First-Episode Schizophrenia Completed Northwell Health Phase 4 1998-09-01 This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.
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.
NCT00048802 ↗ Treatment and Outcome of Early Onset Bipolar Disorder Completed National Institute of Mental Health (NIMH) Phase 4 2002-08-01 This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zyprexa

Condition Name

Condition Name for Zyprexa
Intervention Trials
Schizophrenia 49
Schizoaffective Disorder 15
Bipolar Disorder 12
Healthy 6
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Condition MeSH

Condition MeSH for Zyprexa
Intervention Trials
Schizophrenia 51
Psychotic Disorders 22
Disease 16
Bipolar Disorder 16
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Clinical Trial Locations for Zyprexa

Trials by Country

Trials by Country for Zyprexa
Location Trials
United States 238
Canada 20
Spain 7
Russian Federation 6
China 6
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Trials by US State

Trials by US State for Zyprexa
Location Trials
New York 27
California 18
Pennsylvania 13
Illinois 12
Ohio 12
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Clinical Trial Progress for Zyprexa

Clinical Trial Phase

Clinical Trial Phase for Zyprexa
Clinical Trial Phase Trials
Phase 4 40
Phase 3 29
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Zyprexa
Clinical Trial Phase Trials
Completed 93
Terminated 16
Recruiting 6
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Clinical Trial Sponsors for Zyprexa

Sponsor Name

Sponsor Name for Zyprexa
Sponsor Trials
Eli Lilly and Company 30
National Institute of Mental Health (NIMH) 17
Dr. Reddy's Laboratories Limited 4
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Sponsor Type

Sponsor Type for Zyprexa
Sponsor Trials
Other 131
Industry 67
NIH 21
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Zyprexa (Olanzapine): Clinical Trials Update, Market Analysis, and Projections

Introduction to Zyprexa (Olanzapine)

Zyprexa, commonly known by its generic name olanzapine, is a widely used antipsychotic medication approved by the US Food and Drug Administration for the treatment of schizophrenia, bipolar disorder, and other neurological disorders. Here, we will delve into the latest clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update: TEV-749 Olanzapine

Phase 3 SOLARIS Trial

One of the most significant recent developments in the clinical trials of olanzapine is the Phase 3 Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS) trial conducted by Teva Pharmaceuticals and Medincell. This trial evaluated TEV-749, a once-monthly subcutaneous long-acting injectable formulation of olanzapine, in adult patients with schizophrenia.

  • Efficacy Results: The trial met its primary endpoint, demonstrating clinically meaningful and statistically significant reductions in the Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8 compared to placebo. This indicates a significant improvement in the symptoms of schizophrenia[1][4].
  • Safety Profile: The systemic safety profile of TEV-749 was consistent with other approved oral formulations of olanzapine, with no new safety signals identified and no Post-Injection Delirium/Sedation Syndrome (PDSS) events reported to date[1][4].
  • Social Functioning and Quality of Life: TEV-749 also showed significant improvements in social functioning and quality of life across multiple validated measures from baseline to week 8[4].

Ongoing and Future Studies

  • Long-term Safety: The long-term safety of TEV-749 and the incidence of PDSS are being evaluated in the SOLARIS open-label study, with safety data topline readout expected in the second half of 2024[1].
  • Real-World Analyses: Real-world analyses of UZEDY (risperidone), another long-acting injectable, have also been presented, highlighting high adherence rates and utilization in adults with schizophrenia who have barriers to treatment[4].

Market Analysis

Global Antipsychotic Drugs Market

The global antipsychotic drugs market, which includes olanzapine, is projected to grow significantly.

  • Market Size and Growth: The global antipsychotic drugs market was valued at $14.96 billion in 2018 and is forecasted to reach $19.74 billion by 2025, growing at a CAGR of 4.0% during the forecast period 2019-2025[2].
  • Regional Dominance: North America holds the largest revenue share due to the higher prevalence of psychotic disorders and greater availability of advanced healthcare in the region[2].

Olanzapine Market Specifics

  • Market Size: In 2020, the global olanzapine market size was approximately $190 million and is expected to reach $219.9 million by the end of 2027, with a CAGR of around 3%[5].
  • Growth Drivers: The growth of the olanzapine market is driven by the increasing cases of depression and other psychotic disorders globally, as well as significant investments in research and development for new drug formulations[3][5].

Market Projections

Future Growth

  • Forecast Period: The olanzapine market is anticipated to witness healthy growth during the forecast period, driven by the increasing demand for effective treatments for schizophrenia and bipolar disorder[3][5].
  • Research and Development: Increased investments in R&D for new therapeutic drugs, including advanced formulations like long-acting injectables, are expected to boost the market growth. The launch of several advanced therapeutic drugs by major market players will further enhance the growth rate[3].

Opportunities and Challenges

  • Opportunities: The market is expected to benefit from extensive research and the development of new drugs. The COVID-19 pandemic has also highlighted the need for effective treatments, creating opportunities for manufacturers of antipsychotic drugs[3].
  • Challenges: One of the major challenges is the potential for addiction associated with antipsychotic drugs when taken in higher quantities. This necessitates careful prescribing and monitoring practices[2].

Competitive Landscape

  • Key Players: The market is competitive, with key players such as Teva Pharmaceuticals, Medincell, and others investing heavily in research and development. The introduction of new formulations, such as TEV-749, is expected to further intensify competition[1][4][5].

Real-World Impact

Patient Adherence and Outcomes

  • Adherence Rates: Real-world analyses of long-acting injectables like UZEDY (risperidone) have shown high adherence rates and improved outcomes for patients with schizophrenia, particularly those with barriers to treatment[4].
  • Quality of Life: The improvements in social functioning and quality of life observed with TEV-749 highlight the potential for these treatments to significantly impact patients' lives beyond just symptom management[4].

Key Takeaways

  • Clinical Efficacy: TEV-749 has demonstrated significant efficacy in reducing symptoms of schizophrenia and improving social functioning and quality of life.
  • Market Growth: The global antipsychotic drugs market, including olanzapine, is projected to grow due to increasing prevalence of psychotic disorders and investments in R&D.
  • Future Projections: The olanzapine market is expected to grow, driven by the demand for effective treatments and advancements in drug formulations.
  • Challenges and Opportunities: While addiction remains a challenge, the market is poised for growth due to extensive research and the need for effective treatments.

FAQs

What is the current status of the Phase 3 SOLARIS trial for TEV-749 olanzapine?

The Phase 3 SOLARIS trial has met its primary endpoint, showing statistically significant reductions in PANSS total scores from baseline to week 8 compared to placebo[1][4].

How does TEV-749 differ from existing olanzapine formulations?

TEV-749 is a once-monthly subcutaneous long-acting injectable formulation, which differs from existing oral and intramuscular formulations. It has shown no occurrence of PDSS events to date[1][4].

What is the projected market size for the global olanzapine market by 2027?

The global olanzapine market is expected to reach approximately $219.9 million by the end of 2027[5].

What are the main drivers of growth for the antipsychotic drugs market?

The main drivers include the increasing prevalence of psychotic disorders, greater availability of advanced healthcare, and significant investments in research and development for new drug formulations[2][3].

What challenges does the antipsychotic drugs market face?

One of the major challenges is the potential for addiction associated with antipsychotic drugs when taken in higher quantities[2].

Sources

  1. Teva and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-749 Olanzapine. Teva Pharmaceutical Industries Ltd.
  2. Antipsychotic Drugs Market - Forecast(2025 - IndustryARC
  3. Global Olanzapine Market – Industry Trends and Forecast to 2029. Data Bridge Market Research
  4. Teva Presents Latest Schizophrenia Treatment Research, Including Phase 3 SOLARIS Trial Results. BioSpace
  5. Olanzapine Market Size, Growth, Trends & Competitive Landscape. OpenPR

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