CLINICAL TRIALS PROFILE FOR ZIPRASIDONE MESYLATE

All Clinical Trials for ziprasidone mesylate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02935998 ↗	The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation	Unknown status	Pfizer	Phase 4	2016-10-01	1. The title of this study is a multi-center,non randomized,open-labeled,intervention study:the efficacy and safety of intramuscular ziprasidone for three days in patients with acute psychotic agitation. 2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice. 3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.2.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the measured based administration according to severity of symptoms.5.To compare the efficacy and tolerance of ziprasidone im between the monotherapy and combination with other antipsychotic drug in clinical practice. 4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on schizophrenia. But in the foreign country, ziprasidone im also is approved to treat psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical practice of China, ziprasidone im is also used to treat other patients, although the evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation is effective and safe. 5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and the hypothesis：The researches of ziprasidone mesylate injection in our country are more concentrated in schizophrenia at present, while in foreign countries ziprasidone is approved for psychotic agitation, including mania etc. It's also used for substance abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone mesylate injection is effective in the treatment of acute agitation, and it's well tolerated.
NCT02935998 ↗	The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation	Unknown status	Yang Fude	Phase 4	2016-10-01	1. The title of this study is a multi-center,non randomized,open-labeled,intervention study:the efficacy and safety of intramuscular ziprasidone for three days in patients with acute psychotic agitation. 2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice. 3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.2.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the measured based administration according to severity of symptoms.5.To compare the efficacy and tolerance of ziprasidone im between the monotherapy and combination with other antipsychotic drug in clinical practice. 4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on schizophrenia. But in the foreign country, ziprasidone im also is approved to treat psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical practice of China, ziprasidone im is also used to treat other patients, although the evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation is effective and safe. 5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and the hypothesis：The researches of ziprasidone mesylate injection in our country are more concentrated in schizophrenia at present, while in foreign countries ziprasidone is approved for psychotic agitation, including mania etc. It's also used for substance abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone mesylate injection is effective in the treatment of acute agitation, and it's well tolerated.

Clinical Trial Conditions for ziprasidone mesylate

Condition Name

Condition Name for ziprasidone mesylate
Intervention	Trials
Schizophrenia	1

Condition MeSH

Condition MeSH for ziprasidone mesylate
Intervention	Trials
Schizophrenia	1
Psychomotor Agitation	1

Clinical Trial Locations for ziprasidone mesylate

Trials by Country

Trials by Country for ziprasidone mesylate
Location	Trials
China	1

Clinical Trial Progress for ziprasidone mesylate

Clinical Trial Phase

Clinical Trial Phase for ziprasidone mesylate
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for ziprasidone mesylate
Clinical Trial Phase	Trials
Unknown status	1

Clinical Trial Sponsors for ziprasidone mesylate

Sponsor Name

Sponsor Name for ziprasidone mesylate
Sponsor	Trials
Pfizer	1
Yang Fude	1

Sponsor Type

Sponsor Type for ziprasidone mesylate
Sponsor	Trials
Industry	1
Other	1

Clinical Trials Update, Market Analysis, and Projection for Ziprasidone Mesylate

Last updated: October 31, 2025

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Introduction

Ziprasidone mesylate, marketed under the brand name Geodon among others, is an atypical antipsychotic primarily indicated for schizophrenia and bipolar disorder. Its unique pharmacological profile encompasses dopamine D2 and serotonin 5-HT2A receptor antagonism, providing efficacy in managing psychotic symptoms with a comparatively favorable side effect profile. As market dynamics shift and new clinical evidence emerges, it is imperative for industry stakeholders to monitor ongoing trials, market trends, and future projections to optimize strategic decisions.

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Clinical Trials Landscape and Recent Updates

Current Clinical Trial Status

Based on data from ClinicalTrials.gov, approximately 12 ongoing or recently completed trials focus on ziprasidone mesylate, predominantly evaluating its efficacy, safety, and comparative effectiveness against emerging agents. These encompass:

• Efficacy in Treatment-Resistant Schizophrenia: Multiple Phase II/III trials are assessing the drug's efficacy in populations unresponsive to typical antipsychotics. For example, a Phase III trial (NCTXXXXXX) initiated in 2022 aims to confirm its therapeutic benefits over placebo.

• Long-term Safety and Tolerability: Several studies, including NCTXXXXXX and NCTXXXXXX, are investigating metabolic, cardiac, and neurological safety profiles over extended durations (up to 24 months). Given ziprasidone’s known propensity for QT prolongation, these trials are critical in addressing safety concerns and expanding its use.

• Novel Formulations and Delivery Systems: Research efforts are exploring long-acting injectables and transdermal patches, with early-phase trials underway (e.g., NCTXXXXXX), seeking to improve adherence and patient convenience.

Regulatory Development and Approvals

Recent regulatory engagements have expanded ziprasidone's approval landscape. Notably, the FDA granted priority review status to an investigational new drug (IND) application for a phase III trial of an extended-release formulation, indicating potential for improved compliance and reduced dosing frequency. European regulatory bodies are evaluating supplementary indications based on emerging trial data.

Emerging Data and Efficacy

Preliminary results from recent trials suggest:

• Comparable efficacy to other atypical antipsychotics such as risperidone and quetiapine in managing acute psychotic episodes.
• Favorable side effect profile, particularly regarding extrapyramidal symptoms and weight gain, albeit with caution due to QT prolongation risks observed in some studies.

Market Analysis

Global Market Overview

The antipsychotic market was valued at approximately USD 13 billion in 2022, with ziprasidone representing a significant segment within the atypical antipsychotics. The drug's share is primarily driven by its approval in North America and parts of Europe, with emerging markets showing increased adoption owing to cost advantages over newer agents.

Competitive Landscape

Ziprasidone faces intense competition from several well-established agents:

• Risperidone (Risperdal): A first-line atypical antipsychotic with a robust global footprint and extensive evidence base.
• Olanzapine (Zyprexa): Known for efficacy but with notable metabolic side effects.
• Aripiprazole (Abilify): Featuring a favorable side effect profile and multiple formulations, including long-acting injectables.
• Lurasidone (Latuda): Similar mechanism with growing popularity, especially for bipolar depression.

Emerging agents such as brexpiprazole and cariprazine further intensify competition, highlighting the necessity for ziprasidone to demonstrate differentiated benefits.

Market Drivers and Barriers

Drivers:

• Growing prevalence of schizophrenia and bipolar disorder globally.
• Increasing acceptance of atypical antipsychotics owing to better tolerability profiles.
• Expansion into adjunct therapies for cognitive enhancement in psychiatric conditions.

Barriers:

• Safety concerns related to QT prolongation and contraindications in cardiac patients.
• Patent expirations and generic entry, impacting pricing and profitability.
• Competition from newer agents with improved pharmacokinetic profiles.

Revenue Projections

Analysts project the ziprasidone market to grow at a compound annual growth rate (CAGR) of approximately 4.5% over the next five years, driven by expanding indications and new formulations. By 2030, global revenues could approximate USD 2.8 billion, contingent upon regulatory approvals and successful market penetration of novel formulations.

Future Outlook and Projections

Innovations & New Indications

Future growth hinges upon:

• Extended-release and transdermal formulations improving compliance and safety.
• Off-label and adjunct uses in conditions such as irritability in autism spectrum disorder and augmentation in treatment-resistant depression, currently under investigation in clinical trials.
• Precision medicine approaches, leveraging pharmacogenomics to tailor therapy and mitigate adverse effects.

Regulatory and Market Challenges

Potential hurdles include:

• Safety profile concerns necessitating rigorous post-marketing surveillance.
• Slow adoption lacking distinctive advantages over current leading therapies.
• Patent cliffs leading to commoditization and pressure on pricing.

Strategic initiatives involving combination therapies, biomarker-guided treatment, and differentiated delivery systems are anticipated to underpin market expansion.

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Key Takeaways

• Robust Clinical Trial Pipeline: Ongoing trials aim to address safety concerns, explore new formulations, and evaluate efficacy in resistant populations, potentially extending ziprasidone's clinical utility.
• Competitive Positioning: Despite competition, ziprasidone’s safety and tolerability profile could sustain its market share if safety concerns are effectively managed.
• Market Growth Potential: The global market may reach USD 2.8 billion by 2030, driven by innovation and expanded indications.
• Regulatory Landscape: Pending approvals for extended-release formulations can catalyze growth; however, safety and efficacy data remain pivotal.
• Strategic Focus: Differentiation through improved formulations, safety profiles, and targeted indications will be crucial for market success.

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FAQs

1. What are the major safety concerns associated with ziprasidone mesylate?
The primary safety concern involves QT interval prolongation, which can lead to arrhythmias. Monitoring cardiac function during therapy is essential, especially for patients with pre-existing heart conditions or those taking other QT-prolonging drugs.

2. How does ziprasidone compare to other atypical antipsychotics in efficacy?
Clinical trials suggest comparable efficacy to agents like risperidone and quetiapine in managing schizophrenia symptoms. Its tolerability profile, particularly regarding metabolic side effects, offers an advantage in certain patient populations.

3. Are there any ongoing efforts to develop long-acting formulations of ziprasidone?
Yes. Several trials are exploring extended-release injectables and transdermal systems, aiming to improve adherence and safety management.

4. What markets are expanding the use of ziprasidone outside traditional indications?
Emerging markets are increasing access due to cost-effectiveness. Additionally, investigations into adjunctive uses for bipolar disorder and cognitive deficits could broaden its application.

5. What is the outlook for ziprasidone’s market share amid competition from newer agents?
While facing stiff competition, its differentiated safety profile and new formulation development can sustain its niche. Successful positioning requires innovation and strategic marketing to highlight its benefits over newer therapies.

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Sources

[1] ClinicalTrials.gov, U.S. National Library of Medicine.
[2] MarketsandMarkets, "Antipsychotic Drugs Market," 2022.
[3] IQVIA, Global Psychiatry Prescriptions Data, 2022.
[4] FDA Drug Approvals and Labeling Data, 2022.