CLINICAL TRIALS PROFILE FOR ILOPERIDONE

All Clinical Trials for iloperidone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00254202 ↗	Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia	Completed	Vanda Pharmaceuticals	Phase 3	2005-11-01	The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.
NCT00833976 ↗	Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia	Completed	GlaxoSmithKline	Phase 4	2009-07-01	This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
NCT00833976 ↗	Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia	Completed	Massachusetts General Hospital	Phase 4	2009-07-01	This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.
NCT01207414 ↗	Switching to Iloperidone From Other Antipsychotics in Schizophrenia	Completed	Novartis	Phase 4	2010-08-01	Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.
NCT01291511 ↗	Relapse Prevention Study in Patients With Schizophrenia	Completed	Vanda Pharmaceuticals	Phase 3	2011-02-01	The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia
NCT01348100 ↗	Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients	Completed	Vanda Pharmaceuticals	Phase 1/Phase 2	2011-04-01	This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.
NCT01348100 ↗	Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients	Completed	Novartis Pharmaceuticals	Phase 1/Phase 2	2011-04-01	This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.

Clinical Trial Conditions for iloperidone

Condition Name

Condition Name for iloperidone
Intervention	Trials
Schizophrenia	14
Bipolar Disorder	4
Bipolar I Disorder	4
Schizoaffective Disorder	2

Condition MeSH

Condition MeSH for iloperidone
Intervention	Trials
Schizophrenia	14
Disease	6
Bipolar Disorder	4
Psychotic Disorders	3

Clinical Trial Locations for iloperidone

Trials by Country

Trials by Country for iloperidone
Location	Trials
United States	107
India	16
China	2
Ukraine	2
United Kingdom	1

Trials by US State

Trials by US State for iloperidone
Location	Trials
California	11
New Jersey	9
Texas	8
Florida	7
New York	6

Clinical Trial Progress for iloperidone

Clinical Trial Phase

Clinical Trial Phase for iloperidone
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for iloperidone
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	2

Clinical Trial Sponsors for iloperidone

Sponsor Name

Sponsor Name for iloperidone
Sponsor	Trials
Vanda Pharmaceuticals	14
Novartis Pharmaceuticals	7
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for iloperidone
Sponsor	Trials
Industry	27
Other	8

Clinical Trials Update, Market Analysis, and Projection for Iloperidone

Last updated: October 31, 2025

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Introduction

Iloperidone (brand name Fanapt) is an atypical antipsychotic developed primarily for the treatment of schizophrenia. Since its FDA approval in 2009, iloperidone has sought to carve a niche in the psychiatric treatment landscape, characterized by its unique receptor-binding profile aiming to mitigate side effects commonly associated with first-generation antipsychotics. This article provides an in-depth analysis of the latest clinical trial developments, current market dynamics, and projections for iloperidone’s future within the global therapeutic and commercial arena.

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Clinical Trials Update

Recent Developmental Activities

Over the past three years, iloperidone's clinical pipeline has remained relatively stable, with limited new indications explored outside its primary use in schizophrenia. The drug's dose optimization, pharmacokinetics, and safety profile remain central to ongoing studies.

• Post-approval Studies: Post-marketing surveillance continues to focus on long-term safety, particularly concerning metabolic and cardiovascular outcomes. Notably, data from the Post-Authorisation Safety Study (PASS) indicates a manageable adverse event profile when used as prescribed.

• New Indications: Limited investigations to expand iloperidone’s use beyond schizophrenia—such as in schizoaffective disorder or bipolar disorder—have yielded inconclusive results or have been deprioritized by the sponsor, Vanda Pharmaceuticals.

Key Clinical Trials

1. Phase IV Safety and Efficacy Studies: Conducted worldwide, these trials reaffirm iloperidone’s efficacy in symptom control, with a focus on metabolic and EPS (extrapyramidal symptoms) profiles.

2. Pharmacovigilance: Data collected from post-marketing environments supports ongoing safety monitoring, with a specific concern over QT prolongation, which necessitates caution in patients with known cardiac risks.

3. Combination Therapy Trials: Preliminary data is emerging around using iloperidone adjunctively with other psychotropics; however, these are in early phases with limited published results.

Emerging Research and Limitations

While no major new clinical trials have been initiated recently, ongoing pharmacovigilance and real-world evidence studies underscore the importance of individualized dosing strategies to optimize tolerability.

Overall, the clinical landscape for iloperidone remains stable, with the focus on refining dosing, safety profiles, and understanding its role amidst novel antipsychotics.

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Market Analysis

Current Market Position

Iloperidone’s market presence is primarily confined to North America, where it secures a moderate penetration in schizophrenia treatment owing to its favorable side effect profile relative to older antipsychotics.

• Sales Performance: According to IQVIA data, annual US sales hovered around $60-80 million pre-pandemic peaks. Post-2019, sales plateaued with modest declines attributed to increased competition.

• Competitive Landscape: Dominated by risperidone, olanzapine, quetiapine, and newer agents like brexpiprazole and cariprazine. Iloperidone’s competitive edge lies in its lower metabolic side effects, but this is counterbalanced by concerns over QT prolongation and a less aggressive marketing push.

• Market Challenges:

  • Limited indication scope.
  • A relatively complex titration schedule compared to other agents.
  • Competition from long-acting injectable formulations which appeal to adherence issues.

Market Opportunities

• Untapped Demographics: Elderly patients with schizophrenia or bipolar disorder who benefit from a lower risk of metabolic syndrome.

• Global Expansion: Emerging markets exhibit growing psychiatric treatment needs, but iloperidone’s regulatory approval has yet to be secured outside the US and Europe.

• Formulation Advancements: Recent efforts to develop easier-to-administer formulations (e.g., transdermal patches) could enhance adherence and expand market share.

Regulatory and Patent Outlook

Iloperidone’s patent life extends into the mid-2030s, providing a window for market presence. Patent challenges or biosimilar incursions are unlikely in the immediate future but could impact pricing strategies.

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Market Projection and Future Outlook

Forecast for 2023–2030

Analysts project a compound annual growth rate (CAGR) of 3-4% in the unorphaned schizophrenia drug market, with iloperidone poised to retain a niche segment due to its tolerability profile.

• Market Penetration: With targeted marketing and the expansion into new indications or formulations, iloperidone could see moderate growth, potentially reaching $100 million annually in key markets by 2025.

• Impact of Competition: The influx of generic formulations of established antipsychotics could exert pricing pressures, limiting iloperidone’s revenue growth unless differentiation is emphasized.

• Potential Game-Changer: Demonstrating significant benefits in special populations or obtaining regulatory approval for additional indications (e.g., bipolar disorder mono-therapy) could enhance the drug's marketability.

Strategic Recommendations

• Focus on Post-market Data: Leveraging real-world evidence to substantiate safety and efficacy can bolster prescriber confidence.

• Formulation Innovation: Development of alternative delivery systems might address adherence issues and attract a broader patient base.

• Geographic Expansion: Pursuing regulatory approvals in Asia and Latin America could diversify revenue streams amidst stagnant growth in mature markets.

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Key Takeaways

• Stable Clinical Profile: Iloperidone continues to demonstrate efficacy and tolerability in schizophrenia, with ongoing safety monitoring emphasizing QT prolongation management.

• Niche Market Position: Its competitive advantage lies in metabolic safety; however, its market share remains constrained by competition, administration complexity, and safety concerns.

• Growth Opportunities: Expansion into underserved demographics, new formulations, and geographic markets could elevate its commercial performance.

• Strategic Focus: Emphasizing real-world evidence, innovating delivery methods, and seeking new therapeutic indications are critical for growth.

• Long-term Outlook: With patent protection until 2035 and a stable clinical profile, iloperidone holds moderate growth potential, especially if regulatory and marketing strategies align with evolving market needs.

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FAQs

1. What are the primary advantages of iloperidone over other antipsychotics?
Iloperidone offers a favorable metabolic profile with a lower risk of weight gain and lipid abnormalities, which are common with other atypical antipsychotics like olanzapine.

2. Are there significant safety concerns associated with iloperidone?
Yes, QT prolongation is a notable safety concern. Proper cardiac assessment and monitoring are essential, particularly in patients with pre-existing cardiac conditions.

3. Has iloperidone been approved for indications beyond schizophrenia?
Currently, its primary FDA approval is for schizophrenia. Limited studies are underway to explore other indications, but no major regulatory approvals have been granted outside its initial indication.

4. What is the outlook for iloperidone's market share in schizophrenia treatment?
While it maintains a niche, its market share has remained relatively flat due to competition and administration complexities. Future growth hinges on formulation innovations and expanded indications.

5. How might upcoming patent expirations affect iloperidone’s market?
Patent lifecycle until the mid-2030s provides a window for sustained sales. Patent expirations or biosimilar threats are unlikely in the near term but could influence pricing and market share moving forward.

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References

[1] Vanda Pharmaceuticals. (2009). FDA approval for Fanapt (iloperidone).
[2] IQVIA, Pharmaceutical Market Data, 2022.
[3] FDA Post-Marketing Safety Data, 2021.
[4] MarketResearch.com. (2022). Global schizophrenia treatment market analysis.
[5] ClinicalTrials.gov. (2023). Ongoing studies involving iloperidone.

Note: Data and projections are based on publicly available sources and industry analyses as of early 2023.