CLINICAL TRIALS PROFILE FOR OLANZAPINE

All Clinical Trials for Olanzapine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
NCT00000373 ↗	Treatment of Obsessive-Compulsive Disorder	Completed	University of Florida	Phase 4	1992-09-01	The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and involuntary body movements (tics). There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on type of OCD, determined by medical history and family member interviews. In Part 2, patients are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone, either haloperidol or an inactive placebo will be added to the FVX regimen; patients will take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
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.

Clinical Trial Conditions for Olanzapine

Condition Name

Condition Name for Olanzapine
Intervention	Trials
Schizophrenia	237
Bipolar Disorder	55
Schizoaffective Disorder	54

Condition MeSH

Condition MeSH for Olanzapine
Intervention	Trials
Schizophrenia	255
Psychotic Disorders	90
Disease	83

Clinical Trial Locations for Olanzapine

Trials by Country

Trials by Country for Olanzapine
Location	Trials
Canada	73
China	51
Germany	43
Spain	39
India	35

Trials by US State

Trials by US State for Olanzapine
Location	Trials
New York	84
California	79
Texas	63
Ohio	57
Florida	53

Clinical Trial Progress for Olanzapine

Clinical Trial Phase

Clinical Trial Phase for Olanzapine
Clinical Trial Phase	Trials
Phase 4	166
Phase 3	131
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for Olanzapine
Clinical Trial Phase	Trials
Completed	349
Terminated	39
Recruiting	37

Clinical Trial Sponsors for Olanzapine

Sponsor Name

Sponsor Name for Olanzapine
Sponsor	Trials
Eli Lilly and Company	86
National Institute of Mental Health (NIMH)	33
Merck Sharp & Dohme Corp.	17

Sponsor Type

Sponsor Type for Olanzapine
Sponsor	Trials
Other	476
Industry	279
NIH	53

Olanzapine: Clinical Trials Update, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Olanzapine

Olanzapine is an atypical antipsychotic medication widely used to treat schizophrenia, bipolar I disorder, and major depressive disorder. It works by affecting the naturally occurring chemical messengers in the brain, such as dopamine and serotonin. Here, we will delve into the latest updates on clinical trials, market analysis, and future projections for olanzapine.

Clinical Trials Update

Olanzapine Long-Acting Injectable (LAI)

One of the significant developments in the olanzapine landscape is the ongoing clinical trials for Olanzapine Long-Acting Injectable (LAI). Medincell and its partner Teva are conducting a pivotal Phase 3 clinical trial known as the SOLARIS study.

• Safety Profile: The trial has shown promising results, with no Post-Injection Delirium/Sedation Syndrome (PDSS) observed after completing approximately 95% of the targeted injections. This is a critical differentiation from other LAIs of olanzapine, which carry an FDA black box warning for PDSS[1][4].
• Efficacy and Tolerability: The SOLARIS trial has demonstrated a positive efficacy, safety, and tolerability profile for Olanzapine LAI. Full Phase 3 safety results are expected in the second half of 2024, with positive efficacy results already announced in May 2024[1][4].
• Future Milestones: The ongoing open-label Period 2 of the SOLARIS study is assessing long-term safety and the incidence of PDSS, with topline results anticipated in the first half of 2025[4].

Market Analysis

Global Market Size and Growth

The global olanzapine market has been growing steadily and is expected to continue this trend.

• Current Market Size: As of 2021, the global olanzapine market was valued at $1.8 billion[2].
• Projected Growth: The market is projected to reach $2.2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 2.3% from 2022 to 2031[2].
• Alternative Projections: Another forecast suggests the market could reach $1.9 billion by 2030, with a CAGR of 2.1% from 2024 to 2030[5].

Regional Breakdown

The market is segmented regionally, with varying growth rates and market shares.

• North America: This region holds a significant market share due to the high prevalence of schizophrenia and the presence of key market players. It is expected to remain the largest region over the forecast period[2][5].
• Asia-Pacific: This region is anticipated to witness the highest growth rate due to increasing government initiatives to promote a healthy lifestyle and a rise in the number of drug stores and retail pharmacies[2].

Key Market Drivers

Several factors are driving the growth of the olanzapine market.

• Increasing Prevalence of Mental Disorders: The rise in cases of schizophrenia, bipolar disorder, and depression globally is a major driver[2][3][5].
• Government Funding and Initiatives: Growth in government funding for healthcare infrastructure and initiatives to promote mental health awareness also contribute to market growth[5].
• COVID-19 Impact: Although COVID-19 has presented challenges such as delays in clinical trials, it has also highlighted the need for mental health treatments, potentially boosting demand for olanzapine[3].

Key Market Players

The olanzapine market is dominated by several key players.

• Teva Pharmaceuticals: Teva is leading the development and commercialization of Olanzapine LAI and has reaffirmed revenue guidance for UZEDY® (another product) at approximately $80 million for 2024[1].
• Other Players: Other significant players include Alkermes, Apotex Inc., Aurobindo Pharma, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Novartis AG, Sun Pharmaceutical Industries Ltd., and Viatris Inc.[2].

Market Projections and Trends

Future Growth Opportunities

The olanzapine market is expected to see significant growth driven by several factors.

• Increasing Use of Bipolar Therapy: The growing use of bipolar therapy and the rise in neurological conditions are major drivers[5].
• Advancements in Treatment: The development of new therapeutic drugs, including long-acting injectables like Olanzapine LAI, will continue to drive market growth[4].
• Regional Expansion: The Asia-Pacific region is expected to witness high growth due to increasing government initiatives and a rise in the number of drug stores and retail pharmacies[2].

Challenges and Opportunities

While the market is poised for growth, there are also challenges to consider.

• Side Effects: Antipsychotic drugs like olanzapine can have side effects such as weight gain, increased cholesterol levels, and a risk of diabetes, which can hamper market growth[2].
• Investments and Research: Increased investments in new drugs and extensive research in the olanzapine market are expected to create more development opportunities[3].

Commercial Progress and Additional Indications

UZEDY® and Olanzapine LAI

Teva is not only advancing the clinical trials for Olanzapine LAI but also exploring additional indications for its products.

• UZEDY® Revenue Guidance: Teva has reaffirmed the revenue guidance for UZEDY® at approximately $80 million for 2024 and is exploring an additional indication for the treatment of Bipolar I Disorder in adults[1].
• Olanzapine LAI Potential: The potential approval and commercialization of Olanzapine LAI could significantly impact the market, given its favorable safety profile and once-monthly subcutaneous injection regimen[4].

Key Takeaways

• Clinical Trials: The Phase 3 SOLARIS trial for Olanzapine LAI has shown promising results with no PDSS observed and positive efficacy and safety profiles.
• Market Growth: The global olanzapine market is projected to grow from $1.8 billion in 2021 to $2.2 billion by 2031, driven by increasing prevalence of mental disorders and government initiatives.
• Regional Focus: North America remains the largest market, while the Asia-Pacific region is expected to witness the highest growth rate.
• Key Players: Teva Pharmaceuticals, along with other major players, is driving the market forward with new product developments and commercial strategies.

FAQs

What is the current status of the Olanzapine LAI clinical trials?

The Olanzapine LAI clinical trials, specifically the SOLARIS study, have shown positive efficacy, safety, and tolerability profiles with no PDSS observed. Full Phase 3 safety results are expected in the second half of 2024[1][4].

What is the projected market size of the global olanzapine market by 2031?

The global olanzapine market is projected to reach $2.2 billion by 2031, growing at a CAGR of 2.3% from 2022 to 2031[2].

Which region is expected to witness the highest growth rate in the olanzapine market?

The Asia-Pacific region is expected to witness the highest growth rate due to increasing government initiatives and a rise in the number of drug stores and retail pharmacies[2].

What are the key drivers of the olanzapine market growth?

The key drivers include the increasing prevalence of mental disorders, government funding for healthcare infrastructure, and the launch of new therapeutic drugs[2][3][5].

Who are the major players in the olanzapine market?

Major players include Teva Pharmaceuticals, Alkermes, Apotex Inc., Aurobindo Pharma, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Novartis AG, Sun Pharmaceutical Industries Ltd., and Viatris Inc.[2].

Sources

1. Medincell's Partner Teva Provides Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI) and UZEDY® Commercial Progress. Stock Titan.
2. Olanzapine Market Size, Share | Report Forecast By 2031. Allied Market Research.
3. Global Olanzapine Market – Industry Trends and Forecast to 2029. Data Bridge Market Research.
4. MedinCell Partner Teva Delivers Unprecedented Antipsychotic Data. Clinical Trial Vanguard.
5. Olanzapine Market Report: Trends, Forecast and Competitive Landscape. Lucintel.