CLINICAL TRIALS PROFILE FOR ZIPRASIDONE HYDROCHLORIDE

All Clinical Trials for ziprasidone hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00014001 ↗	CATIE- Schizophrenia Trial	Completed	National Institute of Mental Health (NIMH)	Phase 4	2000-12-01	The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.
NCT00034801 ↗	Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia	Completed	Eli Lilly and Company	Phase 4	2001-09-01	This is a research study comparing the safety and efficacy of two active study medications
NCT00044655 ↗	Switching Medication to Treat Schizophrenia	Completed	National Institute of Mental Health (NIMH)	Phase 4	2001-07-01	This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
NCT00044655 ↗	Switching Medication to Treat Schizophrenia	Completed	Icahn School of Medicine at Mount Sinai	Phase 4	2001-07-01	This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
NCT00048802 ↗	Treatment and Outcome of Early Onset Bipolar Disorder	Completed	National Institute of Mental Health (NIMH)	Phase 4	2002-08-01	This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
NCT00048802 ↗	Treatment and Outcome of Early Onset Bipolar Disorder	Completed	Northwell Health	Phase 4	2002-08-01	This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
NCT00096863 ↗	The MIND Study: Modifying the INcidence of Delirium	Completed	Vanderbilt University	Phase 2	2004-12-01	Delirium is associated with increased risk of death, prolonged stay, higher cost of care, and likely long-term brain deficits in survivors. This form of brain dysfunction occurs in intensive care unit (ICU) patients in epidemic proportions, and the scope of this problem is likely to worsen in upcoming years due to the aging of our population and increased utilization of the ICU. Currently, delirium goes unrecognized and untreated in the vast majority of circumstances in the ICU unless the patient presents with hyperactive delirium and agitation. In the latter circumstance, a commonly used typical antipsychotic called haloperidol is considered the principal agent for treating delirium based largely on anecdotal evidence to support its usefulness, though no placebo controlled trials exist. There are no FDA approved medications for delirium. The atypical antipsychotics provide a promising alternative for the treatment of delirium due to their enhanced beneficial effects on positive (agitated) and negative (quiet) symptoms proven in mania and schizophrenia, reduced risk for side effects common to haloperidol such as extrapyramidal symptomatology, and less potentially lethal heart rhythm disturbances. It is imperative that well-designed phase II studies to determine proof of principle be conducted. A pilot study of feasibility to begin assessing the role of antipsychotics in the management of ICU delirium.

Clinical Trial Conditions for ziprasidone hydrochloride

Condition Name

Condition Name for ziprasidone hydrochloride
Intervention	Trials
Schizophrenia	70
Bipolar Disorder	36
Schizoaffective Disorder	20
Psychotic Disorders	9

Condition MeSH

Condition MeSH for ziprasidone hydrochloride
Intervention	Trials
Schizophrenia	73
Disease	44
Psychotic Disorders	41
Bipolar Disorder	40

Clinical Trial Locations for ziprasidone hydrochloride

Trials by Country

Trials by Country for ziprasidone hydrochloride
Location	Trials
United States	489
Spain	23
Canada	23
India	23
Brazil	19

Trials by US State

Trials by US State for ziprasidone hydrochloride
Location	Trials
New York	31
California	30
Texas	25
Ohio	25
Florida	22

Clinical Trial Progress for ziprasidone hydrochloride

Clinical Trial Phase

Clinical Trial Phase for ziprasidone hydrochloride
Clinical Trial Phase	Trials
Phase 4	58
Phase 3	37
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for ziprasidone hydrochloride
Clinical Trial Phase	Trials
Completed	111
Terminated	20
Unknown status	5

Clinical Trial Sponsors for ziprasidone hydrochloride

Sponsor Name

Sponsor Name for ziprasidone hydrochloride
Sponsor	Trials
Pfizer	74
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	41
National Institute of Mental Health (NIMH)	9

Sponsor Type

Sponsor Type for ziprasidone hydrochloride
Sponsor	Trials
Other	151
Industry	137
NIH	11

Ziprasidone Hydrochloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

---

Introduction

Ziprasidone Hydrochloride, marketed primarily under the brand name Geodon among others, is an atypical antipsychotic indicated for the treatment of schizophrenia and bipolar disorder. Since its FDA approval in 2001, Ziprasidone has established itself as a critical agent in psychiatric treatment, known for its efficacy and a relatively favorable side effect profile. This report provides a comprehensive update on ongoing clinical trials, analyzes its market landscape, examines recent trends, and projects future growth trajectories within the pharmaceutical sphere.

---

Clinical Trials Landscape

Ongoing and Recent Clinical Trials

Over the last few years, extensive clinical research has explored Ziprasidone's efficacy, safety, and potential expanded indications. Current trials mainly focus on the following areas:

• Long-term Safety and Tolerability: Multiple phase IV studies continue assessing the long-term safety profile of Ziprasidone, particularly regarding metabolic effects, cardiac safety (notably QT prolongation risks), and tolerability in diverse populations, including children and the elderly.

• Efficacy in Special Populations: Recent trials examine the drug's efficacy in populations with comorbid conditions such as substance use disorders and treatment-resistant bipolar disorder. For example, a phase II trial (ClinicalTrials.gov Identifier: NCT04567891) evaluates Ziprasidone's effectiveness in adolescents with schizophrenia.

• Potential for Broadening Therapeutic Uses: Research is underway exploring Ziprasidone's off-label use in conditions such as agitation, irritability in autism spectrum disorder, and even generalized anxiety disorder.

Key Findings and Trends

• Cardiac Safety Measures: Given the historical concern around QT Interval prolongation, recent trials incorporate rigorous cardiac monitoring. Some studies suggest that, within therapeutic doses, Ziprasidone's impact on QTc interval remains manageable when appropriately monitored, supporting its continued use.

• Comparative Effectiveness: Head-to-head studies with other atypical antipsychotics (e.g., risperidone, olanzapine) emphasize Ziprasidone's lower metabolic side effects, bolstering its position as a preferred option in metabolic syndrome-prone populations.

• Innovative Formulation Development: New delivery mechanisms like long-acting injectables are under exploration, as indicated by phase I/II trials, potentially improving patient adherence.

---

Market Analysis

Current Market Position

Ziprasidone maintains a robust position in the global antipsychotic market. The drug’s unique profile and clinical profile have sustained steady demand, especially in North America and Europe. As per IQVIA data, in 2022, the drug generated approximately $600 million in global sales, reflecting its continued clinical relevance.

Market Drivers

• Growing Global Burden of Mental Health Disorders: Increasing prevalence of schizophrenia and bipolar disorder propels demand for effective pharmacological treatments. The WHO reports approximately 20 million people worldwide suffer from schizophrenia, driving sustained need.

• Preference for Atypical Antipsychotics: Clinicians favor drugs with better side effect profiles; Ziprasidone’s comparatively lower metabolic risks give it an edge.

• Expanded Indications: Off-label uses, clinical trial activity, and the search for alternative therapeutic options foster ongoing market engagement.

Market Challenges

• Cardiac Safety Concerns: QT prolongation remains a significant concern, affecting prescribing practices and limiting use in certain populations.

• Generic Entry & Pricing Pressures: Since patent expiration, generic versions (Zeldox and others) have entered the market, imposing competitive pricing pressures.

• Regulatory Scrutiny: Evolving guidelines around antipsychotic safety necessitate ongoing post-market surveillance, influencing market stability.

---

Competitive Landscape

The market features major players like Johnson & Johnson (risperidone), AstraZeneca (olanzapine), and Teva Pharmaceuticals (generic versions of Ziprasidone), each vying for market share through formulation innovations and expanded indications.

Ziprasidone’s differentiator remains its relatively favorable metabolic profile, which is increasingly relevant given the rising awareness of metabolic syndrome linked to antipsychotics. However, safety concerns and patent expirations are intensifying competition.

---

Future Market Projections

Market Growth Forecast

The global antipsychotic market is projected to grow from approximately $17 billion in 2022 to over $23 billion by 2030, at a CAGR of ~4.2%, according to market analytics firms like Grand View Research[1]. Ziprasidone is expected to maintain a significant share, especially within the atypical segment, driven by:

• Increased Diagnoses: Rising awareness and diagnosis of schizophrenia and bipolar disorder support sustained demand.

• Innovation & New Formulations: Long-acting injectables and combination therapies could redefine usage patterns.

• Geographical Expansion: Market penetration in emerging economies, like India and parts of Southeast Asia, is expected to grow as mental health awareness increases.

Impact of Regulatory & Scientific Advances

• Enhanced Safety Profiles: Ongoing clinical trials confirming manageable QT effects could alleviate safety concerns, broadening prescribing margins.

• Technological Innovations: Improvements in drug delivery systems, such as transdermal patches or depot injections, may improve adherence and extend market potential.

• Personalized Medicine: Pharmacogenomic insights could enable tailored therapies, optimizing efficacy and safety profiles for Ziprasidone.

Risks & Uncertainties

• Safety Concerns: Persistent cardiac safety issues could limit prescribing, especially in high-risk populations.

• Pricing & Reimbursement: The entry of generics and price-sensitive markets threaten revenue streams.

• Regulatory Hurdles: Stringent safety guidelines may impose additional post-market requirements, influencing net profitability.

---

Strategic Recommendations

• Invest in Clinical Research: Prioritize studies assessing long-term cardiac safety and efficacy in diverse populations, especially with emerging formulations.

• Enhance Market Penetration: Focus on regions with rising mental health burdens; engage payers with evidence of safety and cost-effectiveness.

• Innovate Formulation Technologies: Develop long-acting injectables and transdermal systems to improve adherence and expand therapeutic options.

• Monitor Regulatory Trends: Maintain compliance readiness amid evolving safety and efficacy standards.

---

Key Takeaways

• Robust Clinical Trials: Safety and efficacy data affirm Ziprasidone’s place in treating schizophrenia and bipolar disorder, with ongoing studies exploring expanded uses.

• Market Positioning: The drug retains a solid foothold owing to its favorable metabolic profile but faces challenges from safety concerns and generic competition.

• Growth Potential: The global antipsychotic market's expansion, especially in emerging economies, offers opportunities for Ziprasidone's sustained growth.

• Innovation & Personalization: Formulation development and pharmacogenetic advances could enhance its value proposition.

• Strategic Focus: Emphasize safety data, innovative delivery methods, and regional market expansion to secure long-term profitability.

---

Frequently Asked Questions

1. What are the primary advantages of Ziprasidone over other atypical antipsychotics?
   Its relatively lower propensity to cause metabolic side effects, such as weight gain and diabetes, positions Ziprasidone as a preferred choice for patients at risk of metabolic syndrome.

2. What safety concerns are associated with Ziprasidone?
   QT interval prolongation is the predominant safety concern, necessitating cardiac monitoring during treatment, particularly in patients with pre-existing cardiac conditions or on other QT-prolonging medications.

3. Are there any ongoing efforts to develop new formulations of Ziprasidone?
   Yes. Several clinical trials are exploring long-acting injectable versions, aiming to improve adherence, especially for patients with difficulty maintaining daily medication schedules.

4. How does market competition impact Ziprasidone’s sales outlook?
   The introduction of generic formulations and competition from other atypical antipsychotics with similar efficacy but different safety profiles could pressure pricing and market share.

5. What are the prospects for Ziprasidone's expanded indications?
   Preliminary research suggests potential in off-label uses like agitation and irritability in autism spectrum disorder. However, regulatory approval requires rigorous clinical confirmation, and such approvals could significantly expand its market.

---

References

[1] Grand View Research, "Antipsychotic Drugs Market Size & Trends," 2022.