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Last Updated: February 15, 2025

CLINICAL TRIALS PROFILE FOR LATUDA


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All Clinical Trials for Latuda

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT01143077 ↗ A Study Evaluating Lurasidone for The Treatment of Schizophrenia or Schizoaffective Disorder in Subjects Switched From Other Antipsychotic Agents Completed Sunovion Phase 3 2010-06-01 Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.
NCT01284517 ↗ Lurasidone HCI - A 6-week Phase 3 Study of Patients With Bipolar I Depression Completed Sunovion Phase 3 2010-11-01 Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.
NCT01421134 ↗ Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose Completed Sunovion Phase 3 2011-09-01 Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
NCT01423240 ↗ Major Depressive Disorder With Mixed Features Withdrawn Sunovion Phase 3 2012-01-01 Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features.
NCT01423253 ↗ Major Depressive Disorder With Mixed Features - Extension Completed Sunovion Phase 3 2011-09-01 Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive disorder with mixed features over time.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Latuda

Condition Name

Condition Name for Latuda
Intervention Trials
Schizophrenia 13
Bipolar Depression 4
Schizoaffective Disorder 4
Bipolar Disorder 3
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Condition MeSH

Condition MeSH for Latuda
Intervention Trials
Schizophrenia 13
Disease 8
Depressive Disorder 7
Bipolar Disorder 7
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Clinical Trial Locations for Latuda

Trials by Country

Trials by Country for Latuda
Location Trials
United States 207
China 11
India 8
Ukraine 7
Korea, Republic of 6
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Trials by US State

Trials by US State for Latuda
Location Trials
New York 16
Texas 13
California 13
Florida 11
Georgia 11
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Clinical Trial Progress for Latuda

Clinical Trial Phase

Clinical Trial Phase for Latuda
Clinical Trial Phase Trials
Phase 4 6
Phase 3 14
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Latuda
Clinical Trial Phase Trials
Completed 21
Withdrawn 2
Recruiting 1
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Clinical Trial Sponsors for Latuda

Sponsor Name

Sponsor Name for Latuda
Sponsor Trials
Sunovion 15
Massachusetts General Hospital 2
New York State Psychiatric Institute 2
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Sponsor Type

Sponsor Type for Latuda
Sponsor Trials
Industry 19
Other 14
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Latuda (Lurasidone HCl): Clinical Trials, Market Analysis, and Projections

Introduction to Latuda

Latuda, or lurasidone hydrochloride, is an oral atypical antipsychotic belonging to the chemical class of benzoisothiazol derivatives. It is primarily used for the treatment of schizophrenia and bipolar depression. Developed by Sunovion Pharmaceuticals, a subsidiary of Dainippon Sumitomo Pharma, Latuda was approved by the US FDA on October 28, 2010, for the treatment of schizophrenia[1][3].

Clinical Trials Overview

Phase III Clinical Trials for Schizophrenia

The clinical trials for Latuda were extensive and involved multiple phases. The first phase III clinical trials, conducted from October 2007 to October 2010, enrolled 489 participants across 48 study centers in several countries. These trials assessed the drug's efficacy on various symptoms of schizophrenia, including grandiosity, delusions, and weak impulse control[1].

The PEARL 3 study, another significant phase III trial, was conducted from October 2008 to July 2010 across 65 study centers. This study involved 488 patients with acutely psychotic chronic schizophrenia and compared the safety and efficacy of Latuda with a placebo. The results showed that Latuda doses of 80mg/day and 160mg/day were significantly more effective than placebo after six weeks, with 65% and 79% of patients, respectively, showing a 20% improvement on the Positive and Negative Syndrome Scale (PANSS)[1].

Adverse Events and Tolerability

The clinical trials also evaluated the safety and tolerability of Latuda. The most common adverse events reported were akathisia, parkinsonism, dizziness, somnolence, and nausea. However, the discontinuation rates due to adverse events were comparable to those of the placebo group, indicating that Latuda was generally well-tolerated[1].

Systematic Review and Meta-Analysis

A recent systematic review and meta-analysis of eight short-term, randomized, double-blind, placebo-controlled clinical trials further supported the efficacy and safety of lurasidone. The study found that while the 40mg dose showed no significant difference from placebo, the 80mg, 120mg, and 160mg doses demonstrated significant improvements in PANSS and Clinical Global Impression of Severity (CGI-S) scores. However, higher doses were associated with increased incidence of adverse reactions such as akathisia, nausea, somnolence, and extrapyramidal disorders[4].

Market Analysis

Current Market Scenario

The global antipsychotic drugs market, which includes Latuda, is projected to grow significantly. By 2025, the market is expected to reach $19.74 billion, growing at a CAGR of 4.0% during the forecast period 2019-2025[5].

Latuda Market Forecast

Specific to Latuda, the market forecast is promising. The drug is expected to maintain its market presence due to its efficacy in treating schizophrenia and bipolar depression. The "LATUDA Market Drug Insight and Market Forecast - 2032" report provides a detailed market assessment, including forecasted sales data from 2023 to 2032. This report highlights that the market scenario for schizophrenia and bipolar depression is set to change due to extensive research and incremental healthcare spending, which will expand the market size and enable drug manufacturers to penetrate deeper into the market[2][3].

Competitive Landscape

The competitive landscape for Latuda includes both marketed therapies and late-stage emerging therapies. Other antipsychotic drugs and emerging therapies are expected to provide tough market competition. However, Latuda's unique mechanism of action, which involves central dopamine D2 and serotonin type 2 (5HT2A) receptor antagonism, positions it favorably in the market[3].

Regulatory Milestones and Development Activities

Latuda has several regulatory milestones, including its FDA approval in 2010. The drug has undergone extensive research and development activities, including phase III clinical trials and ongoing studies to assess its long-term effects and safety profile. These activities continue to support its market presence and future growth[1][3].

SWOT Analysis and Analyst Views

Strengths

  • Efficacy: Latuda has demonstrated significant efficacy in treating schizophrenia and bipolar depression, particularly at doses of 80mg and 160mg.
  • Unique Mechanism of Action: Its mechanism involving dopamine D2 and serotonin 5HT2A receptor antagonism sets it apart from other antipsychotics.
  • Regulatory Approval: FDA approval in 2010 and ongoing regulatory support.

Weaknesses

  • Adverse Events: Higher doses are associated with increased incidence of adverse reactions such as akathisia, nausea, and somnolence.
  • Competition: Emerging therapies and other antipsychotic drugs pose significant market competition.

Opportunities

  • Growing Market: The antipsychotic drugs market is growing, driven by extensive research and increased healthcare spending.
  • Expanding Indications: Potential for approval in additional indications beyond schizophrenia and bipolar depression.

Threats

  • Generic Competition: The tentative approval of a generic version of Latuda in the US could impact market share.
  • Emerging Therapies: New therapies with novel approaches could challenge Latuda's market dominance[2][3].

Future Market Projections

The market for Latuda is expected to grow as the global antipsychotic drugs market expands. Here are some key projections:

  • Forecasted Sales: The report provides forecasted sales data for Latuda from 2023 to 2032, indicating a positive growth trajectory.
  • Market Size: The market size for Latuda in the seven major markets (US, EU4, UK, and Japan) is expected to increase, driven by the growing need for effective antipsychotic treatments[3].

Key Takeaways

  • Efficacy and Safety: Latuda has shown significant efficacy in treating schizophrenia and bipolar depression, with a generally favorable safety profile.
  • Market Growth: The market for Latuda is projected to grow, driven by increasing healthcare spending and the need for effective antipsychotic treatments.
  • Competitive Landscape: Latuda faces competition from emerging therapies but maintains a strong market position due to its unique mechanism of action and regulatory support.
  • Regulatory and Development Activities: Ongoing research and development activities continue to support Latuda's market presence and future growth.

Frequently Asked Questions (FAQs)

1. What is Latuda used for?

Latuda (lurasidone HCl) is used for the treatment of schizophrenia and bipolar depression.

2. When was Latuda approved by the FDA?

Latuda was approved by the US FDA on October 28, 2010, for the treatment of schizophrenia.

3. What are the common adverse events associated with Latuda?

Common adverse events include akathisia, parkinsonism, dizziness, somnolence, and nausea.

4. How does Latuda work?

Latuda works through a combination of central dopamine D2 and serotonin type 2 (5HT2A) receptor antagonism.

5. What is the projected market growth for Latuda?

The market for Latuda is expected to grow, driven by increasing healthcare spending and the need for effective antipsychotic treatments, with forecasted sales data indicating a positive growth trajectory from 2023 to 2032.

Cited Sources:

  1. Clinicaltrialsarena.com: Latuda (lurasidone HCl) for the Treatment of Schizophrenia.
  2. Researchandmarkets.com: United States and Japan LATUDA Market Drug Insight and Market Forecast - 2032.
  3. PRNewswire.com: LATUDA Drug Insight and Market Forecast - 2032.
  4. Spandidos-publications.com: Efficacy and safety of lurasidone for schizophrenia: A systematic review and meta-analysis.
  5. Industryarc.com: Antipsychotic Drugs Market - Forecast(2024 - 2030).

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