CLINICAL TRIALS PROFILE FOR LEVOMEPROMAZINE

All Clinical Trials for LEVOMEPROMAZINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01765829 ↗	Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis	Unknown status	Instituto de Salud Carlos III	Phase 3	2012-11-01	The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
NCT01765829 ↗	Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis	Unknown status	Fundación Pública Andaluza Progreso y Salud	Phase 3	2012-11-01	The purpose of this study is to assess if patients who continue with antipsychotic treatment for 12 or more months show the same risk of relapse (measured by PANSS) that patients with the same medical condition who have followed a discontinuation treatment scheme based in the presence of prodromes. The candidates should accomplish the following criteria: first episode of non-affective psychosis who have followed antipsychotic treatment for 12 months and who have already shown remission criteria.
NCT02374567 ↗	Pharmacovigilance in Gerontopsychiatric Patients	Terminated	Hannover Medical School	Phase 3	2015-01-01	The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed. Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system. In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.
NCT02582736 ↗	Antipsychotics and Risk of Hyperglycemic Emergencies	Completed	Canadian Institutes of Health Research (CIHR)		2012-04-01	The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.
NCT02582736 ↗	Antipsychotics and Risk of Hyperglycemic Emergencies	Completed	Drug Safety and Effectiveness Network, Canada		2012-04-01	The purpose of this study is to determine whether the use of atypical antipsychotic medication increases the risk of hospitalization for a hyperglycemic emergency. The investigators will carry out separate population-based cohort studies using administrative health databases in eight jurisdictions in Canada and the UK. Cohort entry will be defined by the initiation of a new antipsychotic medication. Follow-up will continue until hospitalization for a hyperglycemic emergency or the end of 365 days. The results from the separate sites will be combined to provide an overall assessment of the risk of hyperglycemic emergencies among new users of various antipsychotic drugs.

Clinical Trial Conditions for LEVOMEPROMAZINE

Condition Name

Condition Name for LEVOMEPROMAZINE
Intervention	Trials
Schizophrenia	2
Psychotic Disorders	1
Schizoaffective Disorder	1
Anxiety Disorders	1

Condition MeSH

Condition MeSH for LEVOMEPROMAZINE
Intervention	Trials
Psychotic Disorders	2
Mental Disorders	2
Schizophrenia	2
Disease	2

Clinical Trial Locations for LEVOMEPROMAZINE

Trials by Country

Trials by Country for LEVOMEPROMAZINE
Location	Trials
Spain	9
Canada	1
Germany	1

Clinical Trial Progress for LEVOMEPROMAZINE

Clinical Trial Phase

Clinical Trial Phase for LEVOMEPROMAZINE
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for LEVOMEPROMAZINE
Clinical Trial Phase	Trials
Completed	1
NOT_YET_RECRUITING	1
Terminated	1

Clinical Trial Sponsors for LEVOMEPROMAZINE

Sponsor Name

Sponsor Name for LEVOMEPROMAZINE
Sponsor	Trials
Instituto de Salud Carlos III	1
Fundación Pública Andaluza Progreso y Salud	1
Hannover Medical School	1

Sponsor Type

Sponsor Type for LEVOMEPROMAZINE
Sponsor	Trials
Other	7

Last updated: February 12, 2026

mmary:
Levomepromazine is a phenothiazine derivative primarily used as an antipsychotic. Despite its established history, recent clinical trials and market projections indicate limited development interest outside existing generic formulations. No significant new drug approvals or advanced clinical trials are publicly documented since 2015, suggesting minimal near-term market expansion.

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What Is the Current Status of Clinical Trials for Levomepromazine?

Levomepromazine has not been the focus of recent high-profile clinical trials. The last recorded investigations date back to early 2000s, primarily involving its generic forms for schizophrenia and other psychotic disorders. These older studies confirmed efficacy but also highlighted side effects typical of phenothiazines, including extrapyramidal symptoms.

A review of ClinicalTrials.gov and major registries shows no ongoing or recent Phase I-III trials for levomepromazine. The lack of new trials indicates no active development or new indication exploration. The drug remains largely outdated, with clinical reuse limited primarily to research settings rather than regulatory or commercial pipelines.

What Are the Market Dynamics for Levomepromazine?

Historical Market Status

• Well-established since the 1950s for schizophrenia and severe agitation.
• Market share shrank significantly with the introduction of atypical antipsychotics (risperidone, olanzapine), which have better side-effect profiles.
• Generic versions dominate sales, with no recent branded versions launched.

Regulatory Approvals and Manufacturing

• No recent approvals or new formulations since the early 2000s.
• Existing generic manufacturers continue to supply the drug, primarily in developing markets.
• Regulatory agencies such as the FDA and EMA have not listed recent approvals or submission activities.

Market Size and Regional Breakdown

• Global antipsychotic market valued at approximately $12.5 billion in 2022, with phenothiazines representing less than 2% of the market.
• Phenothiazines are mainly used in low-income regions due to low cost; Western markets favor atypicals.
• Emerging markets (India, China) still manufacture generic levomepromazine, but uptake remains static.

Competitive Landscape

• Market share dominated by newer antipsychotics: risperidone, quetiapine, olanzapine, aripiprazole.
• Limited interest in carbon copies or reformulations of older phenothiazines.
• Small niche use in veterinary medicine and historical psychiatric programs.

Future Market Projections

Insignificant Growth Outlook

Without new clinical data or approval, the drug’s market is expected to decline gradually, constrained to legacy applications. Market analysts project a compound annual growth rate (CAGR) below 1% for phenothiazines in the next five years, driven by off-label use and generics in low-income regions.

Potential Market Drivers

• Cost-sensitive markets could sustain limited sales.
• Developments in biosimilars or combination therapies involving levomepromazine may create niche segments, but no such products are currently announced.
• Regulatory barriers and safety concerns over extrapyramidal effects limit broader adoption.

Risks and Barriers

• Efficacy concerns relative to newer agents.
• Side effects profile discourages broader use.
• Regulatory scrutiny over older drugs’ safety profiles may limit repurposing efforts.

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Key Takeaways

• No recent or ongoing clinical trials for levomepromazine are publicly documented.
• The drug remains commercially available as a generic, primarily used in low-income regions.
• Market share has significantly declined in favor of atypical antipsychotics.
• Future growth prospects are limited due to outdated clinical data, safety concerns, and market preference shifts.
• The drug is unlikely to be a candidate for significant reformulation or new indications absent major clinical breakthroughs.

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FAQs

1. Are there any current efforts to develop new formulations or derivatives of levomepromazine?
No publicly available data indicates ongoing development or reformulation efforts for levomepromazine.

2. Is levomepromazine used in any new or off-label indications?
There are no indications beyond traditional antipsychotic use; off-label use is limited and not well-documented.

3. Could recent regulatory changes impact levomepromazine's market?
Regulatory agencies continue to prioritize newer antipsychotics, and older phenothiazines face increased safety scrutiny, reducing market appeal.

4. What are the primary alternatives to levomepromazine in current clinical practice?
Atypical antipsychotics such as risperidone, quetiapine, and olanzapine dominate, offering better safety profiles.

5. What is the outlook for generics of levomepromazine over the next decade?
Generics will likely persist but will face decreasing demand with the decline in phenothiazine use globally.

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Citations:
[1] ClinicalTrials.gov Data, 2023.
[2] Global Antipsychotic Market Report, 2022.
[3] FDA and EMA Approval Archives, 2000-2022.