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
Schizoaffective Disorder	1
Anxiety Disorders	1
Bipolar Disorder	1

Condition MeSH

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

Clinical Trials Update, Market Analysis, and Projection for Levomepromazine

Last updated: November 13, 2025

Introduction

Levomepromazine, also known by its brand name Neurocil among others, is a longstanding antipsychotic and sedative agent within the phenothiazine class. Historically utilized for schizophrenia, agitation, nausea, and insomnia, its chemical and therapeutic profile has established a niche but declining presence amid evolving psychiatric pharmacotherapy. Recent clinical trials, market dynamics, and technological advancements are shaping its future trajectory. This report provides a comprehensive update on clinical developments, market analysis, and forecasted trends for levomepromazine.

Clinical Trials Landscape

Current Clinical Trial Status

Over the past five years, levomepromazine has experienced limited clinical trial activity. A search in clinical trial registries (ClinicalTrials.gov, WHO ICTRP) indicates sporadic Phase II and Phase III studies primarily centered on its off-label applications, including palliative care and refractory agitation management. Notably:

• Palliative Settings: Multiple trials investigate its efficacy and safety in terminal illness-related agitation management, emphasizing its sedative properties with a focus on quality of life improvements.
• Psychiatric Disorders: Few ongoing studies evaluate its comparative efficacy versus newer atypical antipsychotics, reflecting a shift in clinical preference.

Recent Innovations and Trials

Recent evidence underscores a modest increase in investigational interest around levomepromazine's off-label uses, particularly:

• Refractory Nausea and Vomiting: Trials assess its antiemetic efficacy within palliative medicine, leveraging its dopamine antagonism.
• Behavioral Management in Dementia: Limited pilot studies evaluate its utility in managing neuropsychiatric symptoms, clinician cautioning due to side effects.

However, no pivotal Phase III trials have been launched or announced recently, suggesting a stagnant clinical trial pipeline for levomepromazine, aligned with broader trends favoring newer agents with more favorable safety profiles.

Regulatory and Safety Considerations

Regulatory agencies have expressed increased focus on adverse effects tied to phenothiazines, including extrapyramidal symptoms, QT prolongation, and anticholinergic burden. These safety concerns, coupled with the availability of second-generation antipsychotics, have limited further clinical development and market penetration.

Market Analysis

Historical Market Position

Levomepromazine's global market share has steadily declined. Originally introduced in the mid-20th century, it was widely employed in Europe and other regions for its sedative and antipsychotic effects. Its decline correlates with:

• Introduction of Atypical Antipsychotics: Drugs such as risperidone, olanzapine, and quetiapine offer increased efficacy along with fewer motor side effects.
• Policy and Regulatory Shifts: European and North American guidelines favor newer agents, increasingly restricting phenothiazine use.

Current Market Dynamics

• Regional Preferences: While still utilized in certain European countries, especially within palliative care settings, its use remains limited elsewhere.
• Off-Label and Compassionate Use: In some regions, levomepromazine persists in off-label indications, primarily where access to newer agents is constrained.
• Manufacturing and Patents: No significant patent protections exist for levomepromazine. Many formulations are off-patent, resulting in generic availability and reduced prices.

Market Challenges

• Safety Profile: Increased awareness of adverse effects reduces clinicians' willingness to prescribe.
• Limited New Indications: Lack of recent, compelling clinical data hampers expansion into new therapeutic areas.
• Competitive Landscape: The advent of newer drugs with improved efficacy/safety profiles diminishes levomepromazine’s market relevance.

Emerging Opportunities

Despite decline trends, niche markets remain, particularly:

• Palliative Medicine: Continued acceptance for symptom control where alternatives are limited.
• Region-Specific Markets: Some developing countries continue to rely on older phenothiazines due to cost and availability.

Market Projection

Short-Term Outlook (1-3 Years)

The short-term forecast indicates continued decline in levomepromazine's market share globally. Factors influencing this include:

• Decreased clinical usage.
• Regulatory scrutiny over side effects.
• Persistent availability of newer antipsychotics.

Nevertheless, stable demand in specific niches, like palliative care, offers some ongoing revenue streams.

Medium to Long-Term Outlook (3-10 Years)

Projected trajectories suggest:

• Gradual Phasing Out: As healthcare systems prioritize safety, the use of phenothiazines like levomepromazine is expected to diminish further.
• Potential for Retained Niche Role: Limited clinical utility in palliative and refractory agitation may sustain small markets, particularly in regions with restricted access to newer medications.
• Innovation and Repurposing: Any future clinical trials demonstrating novel benefits could temporarily revive interest; however, recent trends suggest this is unlikely in the near term.

Factors Affecting Market Dynamics

• Regulatory Changes: Stricter safety standards may accelerate discontinuation.
• Molecular Innovations: Development of targeted therapies may render older agents obsolete.
• Manufacturing Trends: A decline in generic production could lead to supply issues, further reducing usage.

Conclusions

Levomepromazine remains a legacy phenothiazine with minimal recent clinical trial activity and a shrinking global market. While some niche applications, such as in palliative care, persist, broader clinical and commercial interest continues to wane. Without new indications or significant safety profile improvements, its market presence is expected to diminish further, though it may retain relevance in specific, resource-limited settings.

Key Takeaways

• Limited Clinical Development: No recent Phase III trials; current studies focus on off-label uses, primarily in palliative care.
• Market Decline: The global market has contracted due to safety concerns and competition from newer agents.
• Niche Applications Persist: Usage remains in select regions and settings, driven by accessibility and cost considerations.
• Future Prospects: Likely to continue its decline unless groundbreaking evidence emerges or new formulations mitigate safety issues.
• Strategic Positioning: Companies considering levomepromazine should focus on niche markets and explore potential repurposing avenues for off-label indications.

FAQs

1. Is levomepromazine still recommended for psychiatric conditions?
   Its use has declined significantly; contemporary guidelines favor newer antipsychotics with better safety profiles, limiting levomepromazine to specific, often off-label, palliative applications.

2. Have any new clinical trials been initiated recently for levomepromazine?
   No notable Phase III or pivotal trials have been launched in recent years; most ongoing research centers on off-label uses in palliative care settings.

3. What are the primary safety concerns associated with levomepromazine?
   Risks include extrapyramidal symptoms, QT prolongation, sedation, and anticholinergic effects, which have contributed to its declining preference.

4. Which regions still utilize levomepromazine actively?
   It remains in use in certain European countries, especially within palliative and hospice care, but is largely obsolete elsewhere.

5. Could levomepromazine be repurposed for newer indications?
   Currently, there is limited evidence supporting repurposing. Future potential depends on clinical trial results demonstrating safety and efficacy for alternative uses.

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Sources:

[1] ClinicalTrials.gov, "Levomepromazine," accessed 2023.
[2] European Medicines Agency (EMA), "Assessment report on phenothiazines," 2020.
[3] Market data reports on phenothiazine market trends, 2022.