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	12
Bipolar Disorder	4
Bipolar I Disorder	3
Schizoaffective Disorder	2

Condition MeSH

Condition MeSH for Iloperidone
Intervention	Trials
Schizophrenia	12
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	102
India	16
Ukraine	2
China	2
United Kingdom	1

Trials by US State

Trials by US State for Iloperidone
Location	Trials
California	9
New Jersey	8
Texas	7
Florida	7
Ohio	6

Clinical Trial Progress for Iloperidone

Clinical Trial Phase

Clinical Trial Phase for Iloperidone
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	4
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Iloperidone
Clinical Trial Phase	Trials
Completed	14
Recruiting	5
Terminated	2

Clinical Trial Sponsors for Iloperidone

Sponsor Name

Sponsor Name for Iloperidone
Sponsor	Trials
Vanda Pharmaceuticals	11
Novartis Pharmaceuticals	7
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for Iloperidone
Sponsor	Trials
Industry	24
Other	8

Iloperidone: Clinical Trials, Market Analysis, and Projections

Introduction to Iloperidone

Iloperidone is a second-generation antipsychotic medication, primarily used for the treatment of schizophrenia and bipolar mania. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Efficacy in Bipolar Mania

Recent clinical trials have demonstrated the efficacy of iloperidone in treating bipolar mania. A study published in the Journal of Clinical Psychiatry involved 414 participants randomized to receive either iloperidone or a placebo. At week 4, patients receiving iloperidone showed significant improvement on the Young Mania Rating Scale (YMRS) compared to those receiving the placebo, with a mean change from baseline of -4.0 (95% CI: -5.70 to -2.25; adjusted P = .000008)[1].

Efficacy in Schizophrenia

Iloperidone has been extensively evaluated in several double-blind, placebo-controlled clinical trials for the treatment of schizophrenia. These trials have shown that iloperidone is effective in reducing the symptoms of acute schizophrenia, particularly at fixed daily doses. For example, in one study, significantly more patients receiving iloperidone (72%) met the response criterion compared to those receiving the placebo (52%)[3].

Safety Profile

The safety profile of iloperidone is generally consistent with other second-generation antipsychotics. Common adverse events include tachycardia, dizziness, dry mouth, increased alanine aminotransferase, nasal congestion, increased weight, and somnolence. Notably, iloperidone has a low incidence of akathisia and extrapyramidal symptoms, and it is essentially free of extrapyramidal side effects[1][3].

Ongoing and Completed Trials

Vanda Pharmaceuticals completed enrollment for a Phase III trial involving 604 patients with schizophrenia in 2006. The trial was designed to assess the efficacy and safety of iloperidone in this patient population. Although the top-line results were expected in 2007, the current status and outcomes of this trial are not specified in recent updates[4].

Market Analysis

Global Market Overview

The global market for iloperidone is part of the broader pharmaceutical market, which was valued at $1,475 billion in 2022 and is expected to grow at a CAGR of 5% over the next six years. The iloperidone market is segmented by type (brand drugs and generic drugs) and application (schizophrenia and other conditions)[2].

Key Market Players

The main players in the iloperidone market include Vanda Pharmaceuticals, Taro Pharmaceutical, Inventia, Alembic Pharmaceuticals, CSPC, and Hansoh Pharma. These companies are driving the market through their production and distribution of both brand and generic versions of iloperidone[2].

Market Share and Forecast

The global market share and ranking of iloperidone are expected to grow as the demand for antipsychotic medications increases. Market research reports forecast the overall sales and demand for iloperidone from 2024 to 2030, highlighting the potential for significant growth in the healthcare and pharma sector[5].

Market Projections

Growth Factors and Trends

The growth of the iloperidone market is driven by several factors, including the increasing prevalence of mental health disorders such as schizophrenia and bipolar mania, advancements in healthcare infrastructure, and the expanding reach of pharmaceutical companies. Additionally, the development of depot formulations and potential genetic biomarkers for iloperidone could further enhance its market position[3][5].

Regional Market Analysis

The market for iloperidone is expected to grow across various regions, with significant contributions from the United States, Europe, and Asia-Pacific. The regional growth is influenced by the local healthcare policies, regulatory environments, and the presence of key market players[5].

Competitive Landscape

The competitive landscape of the iloperidone market is characterized by the presence of both brand and generic drug manufacturers. Companies like Vanda Pharmaceuticals and Taro Pharmaceutical are key players, and the entry of generic versions is expected to increase competition and drive market growth[2].

Key Takeaways

• Efficacy: Iloperidone has demonstrated significant efficacy in treating bipolar mania and schizophrenia in clinical trials.
• Safety: The drug has a tolerable safety profile with common adverse events such as tachycardia, dizziness, and dry mouth.
• Market Growth: The global market for iloperidone is expected to grow at a CAGR of 5% over the next six years, driven by increasing demand and advancements in healthcare.
• Key Players: Vanda Pharmaceuticals, Taro Pharmaceutical, and other companies are leading the market through their production and distribution efforts.
• Future Prospects: The development of depot formulations and genetic biomarkers could further enhance the market position of iloperidone.

FAQs

What is iloperidone used for?

Iloperidone is primarily used for the treatment of schizophrenia and bipolar mania.

What are the common adverse events associated with iloperidone?

Common adverse events include tachycardia, dizziness, dry mouth, increased alanine aminotransferase, nasal congestion, increased weight, and somnolence.

Which companies are the main players in the iloperidone market?

The main players include Vanda Pharmaceuticals, Taro Pharmaceutical, Inventia, Alembic Pharmaceuticals, CSPC, and Hansoh Pharma.

What is the expected growth rate of the iloperidone market?

The global market for iloperidone is expected to grow at a CAGR of 5% over the next six years.

Are there any ongoing clinical trials for iloperidone?

While recent updates on specific ongoing trials are not available, past trials have been completed, and new trials may be initiated to explore additional applications or formulations of iloperidone.

References

1. Efficacy and Safety of Iloperidone in Bipolar Mania - Psychiatrist.com
2. Iloperidone Drugs - Market, Report Size, Worth, Revenue, Growth - Valuates Reports
3. Iloperidone for schizophrenia: a review of the efficacy and safety profile - Wiley Online Library
4. Vanda Pharmaceuticals Completes Enrollment for Iloperidone and VEC-162 Trials - Vanda Pharmaceuticals
5. Iloperidone Drugs - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030 - Market Research Reports Inc.