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.
NCT02582736 ↗	Antipsychotics and Risk of Hyperglycemic Emergencies	Completed	Canadian Network for Observational Drug Effect Studies, CNODES		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.
NCT07152184 ↗	Study Comparing Antipsychotic Dose Reduction vs. Maintenance Treatment in Patients With Schizophrenia Spectrum Disorder: a Personalized Medicine Approach	NOT_YET_RECRUITING	University Hospital, Strasbourg, France	PHASE2	2026-01-01	The objective of this study is to respond to frequent requests from patients who wish to reduce or even stop their antipsychotic treatment once they have achieved clinical stability. Psychiatrists are reluctant to respond to these requests because the method for safely reducing or stopping antipsychotic treatment remains poorly understood. The investigators want to verify the existence of an interaction between treatment strategy and psychotic phenotype (cycloid psychosis vs. non-CP), i.e., in terms of functional remission, the benefit of the dose reduction strategy compared to the maintenance strategy will be greater in the CP group than in the non-CP group. To this end, patients will be randomly assigned to four groups based on their phenotype and treatment strategy (CP-dose reduction; CP-dose maintenance; non-CP-dose reduction; and non-CP-dose maintenance). Several hospitals throughout France are participating in this study, in which a random draw (called randomization) will be conducted to determine whether the physician will propose reducing the antipsychotic dose or maintaining it at the same dose for the patient. Patients included in this study will be adults aged 18 to 60 who have been diagnosed with a schizophrenic spectrum disorder (SS): schizophrenia, schizophreniform disorder, schizoaffective disorder, or brief psychotic episode. The antipsychotics studied are: * second-generation antipsychotics: amisulpride, aripiprazole, olanzapine, quetiapine, risperidone; * first-generation antipsychotics: chlorpromazine, flupentixol, haloperidol, levomepromazine, loxapine, pipotiazine, zuclopenthixol. 288 patients will be included and followed for 24 months. The inclusion period is 48 months. Fourteen follow-up visits are planned, every month for four months and then every two months. During these visits, self-questionnaires or cognitive tests will have to be completed by the patient, the caregiver, and/or the treating psychiatrist. Three blood samples will be taken at inclusion, at 6 months, and at the end of the study, in particular to measure the level of medication in the blood.

Clinical Trial Conditions for levomepromazine

Condition Name

Condition Name for levomepromazine
Intervention	Trials
Schizophrenia	2
Psychosis Nos/Other	1
Psychosomatic Disorders	1
Psychotic Disorders	1

Condition MeSH

Condition MeSH for levomepromazine
Intervention	Trials
Disease	2
Psychotic Disorders	2
Mental Disorders	2
Schizophrenia	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
Unknown status	1
Completed	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for levomepromazine

Sponsor Name

Sponsor Name for levomepromazine
Sponsor	Trials
Fundación Pública Andaluza Progreso y Salud	1
Hannover Medical School	1
Canadian Institutes of Health Research (CIHR)	1

Sponsor Type

Sponsor Type for levomepromazine
Sponsor	Trials
Other	7

Last updated: May 14, 2026

Levomepromazine clinical trials update and market projection (2025-2035)

Levomepromazine’s clinical-trials footprint is light and concentrated in older, mostly non-U.S. development and symptom-management studies, with limited visibility of current late-stage programs. Commercially, the market is best characterized as a niche, off-patent antipsychotic/antiemetic in multiple geographies where generic supply and local formularies dominate pricing. Near-term growth depends primarily on (1) regional guideline inclusion and (2) replacement dynamics versus other phenothiazines and newer antiemetics/antipsychotics, not on proprietary pipeline expansion.
Bottom line: absent new phase 3 registrational trials, the most credible 2025-2035 outlook is steady-to-modest growth in real terms in markets with constrained branded supply, flat unit demand, and continued margin pressure from generic competition.

Are there any active or recent clinical trials for levomepromazine?

Answer: Public-trials visibility for levomepromazine is intermittent and skewed toward older studies, with no clear signal of active global phase 3 registrational programs.

What trial types have most often been used for levomepromazine?

• Symptom control trials in psychiatry and behavioral disturbance settings (often phenothiazine comparisons).
• Antiemetic and supportive-care studies (post-operative nausea and vomiting, chemotherapy-related nausea in historical programs).
• Dosing/tolerability and regimen optimization studies, frequently in inpatient or palliative-care contexts.

What does “recent” mean in practice for levomepromazine?

For market planning, “recent” typically means:

• Phase 3 trials with endpoints tied directly to FDA/EMA labeling expansion, or
• Bioequivalence-related studies if new generics are being launched in a regulated region.

For levomepromazine, the publicly traceable pattern is more consistent with the latter (regional generic launches and local formulation work) than with new multinational late-stage trials.

How does levomepromazine market performance compare with other phenothiazines and antiemetics?

Answer: Levomepromazine sits in the same prescribing ecosystem as older phenothiazines and antiemetics, but it is usually not differentiated as a “winner take most” molecule. Market share tends to be driven by local formulary status, clinician familiarity, and pack availability rather than differentiated efficacy.

Key competitive set

• Other phenothiazines with overlapping use: e.g., promethazine-class antiemetics and similar first-generation agents used for nausea and agitation in some jurisdictions.
• Newer antiemetic standards in high-acuity settings: NK1 antagonists, 5-HT3 antagonists, and dopamine antagonists with broader branded penetration.
• Antipsychotic comparators for agitation/psychosis use cases: second-generation antipsychotics dominate many markets, constraining volume for older agents outside specific guideline pockets.

Competitive implication for pricing and unit demand

• Pricing: Generic supply keeps ASP compression high where multiple manufacturers operate.
• Demand: demand is “treatment-option” driven. It can remain stable or grow modestly in pockets where patients are treated in settings comfortable with first-generation phenothiazines or where cost controls favor older agents.

What is the FDA and EMA status of levomepromazine?

Answer: In most global contexts, levomepromazine is treated as an established medicine with generic availability. U.S. visibility is typically limited and often associated with local-market availability rather than a broad branded regimen.

Orange Book status and FDA approval

• Public U.S. exclusivity and patent-listing dynamics apply primarily where an FDA-approved listed drug exists with patent coverage.
• For planning purposes, if a robust Orange Book estate is absent, it generally signals that generic entry pathways are open or near-open.

(A full Orange Book mapping requires drug-specific Orange Book query results, which are not present in the inputs here.)

EMA marketing authorization and generics

• In Europe, levomepromazine is usually distributed as a generic or locally authorized product where historical originators have aged out of patent protection.
• Regulatory updates are more likely formulation-specific (new salts, new presentations, line extensions) than new clinical-drug substance.

When does levomepromazine lose exclusivity or key patent protection?

Answer: For a mature, largely off-patent product class, the decisive constraint is not new exclusivity. The constraint is whether any late-filed formulation or method-use patents exist in a given territory.

How to think about exclusivity risk for market projection

• If no active patent thickets exist in major markets, the limiting factor becomes supply capacity and price erosion, not regulatory blockage.
• Where any remaining local formulation IP exists, it affects only the specific presentation (oral tablets vs drops vs injections), not the active ingredient’s total market.

(No territory-specific patent expiration dataset is included in the provided context.)

What formulations of levomepromazine are marketed and how does that affect revenue?

Answer: Revenue is presentation-dependent. Injection and oral forms may track different reimbursement patterns and different clinical use cases.

Presentation-level market drivers

• Oral forms: often volume-driven through chronic or recurring use where clinicians prefer low-cost options.
• Parenteral forms: constrained by hospital formularies and use in acute symptom control pathways.
• Pediatric vs adult restrictions: can shift demand between markets depending on local labeling and safety controls.

What are the biggest clinical and safety issues that influence prescribing and uptake?

Answer: First-generation phenothiazines are limited by tolerability and safety monitoring needs. For prescribing, the dominant issues are:

• Sedation and anticholinergic effects (driving clinician caution, especially in older populations)
• Extrapyramidal symptoms risk
• QT prolongation concerns in at-risk patients
• Hyperprolactinemia-related effects that can constrain use in some psychiatric or antiemetic populations

Impact on market growth

Safety-driven prescribing boundaries typically cap incremental uptake. Market expansion tends to be gradual and localized rather than rapid.

Is there any biosimilar or biologics risk for levomepromazine?

Answer: No. Levomepromazine is a small-molecule drug and has no biosimilar pathway.

What generic entry risks exist for levomepromazine in major markets?

Answer: Generic entry is the baseline. The main “entry risk” is not regulatory feasibility but supply fragmentation and price competition dynamics.

Where generics usually matter most

• Markets with high hospital usage of older antiemetics/antipsychotics can show rapid substitution if multiple equivalent generics are available.
• Markets with fewer approved presentations may have slower substitution if only one generic controls distribution.

Which companies are supplying levomepromazine and how does that shape competition?

Answer: Competition is typically generic-heavy, with multiple local and regional suppliers. The market structure is usually:

• One or two dominant distributors in a territory
• Multiple generic manufacturers whose products trade through wholesalers and tenders

(A supplier-by-supplier competitive table requires company-level sales and regulatory product listings that are not part of the provided context.)

What is the commercial outlook for levomepromazine from 2025 to 2035?

Answer: Expect modest growth with continued downward pressure on unit pricing where generic competition is dense, and more stable volume where formularies protect established symptom-management options.

Market projection framework (how to model)

Use a three-component model:

1. Base volume trend: stable to slight decline or growth depending on regional prescribing persistence for phenothiazine-based symptom control.
2. Price trend: negative drift from generic competition, slower where supply is constrained.
3. Mix shift: injection vs oral, and adult vs elderly mix depending on local guideline use.

Scenario view (directional)

• Base case: low-single-digit CAGR in revenue globally in real terms where substitution is already saturated; flat-to-low growth in units.
• Bull case: modest incremental growth in regions expanding palliative-support or inpatient symptom-control adoption of older, low-cost phenothiazines.
• Bear case: accelerated price erosion and substitution to newer antiemetics and second-generation antipsychotics in high-acuity settings.

(Numeric forecasts require a market sizing baseline and regional sales distribution that are not provided here.)

How does levomepromazine compare with competing antiemetics and antipsychotics on market dynamics?

Answer: Levomepromazine is more exposed to generic price competition and less exposed to blockbuster-like demand shocks. It competes primarily on cost and clinician practice in niche symptom-management use cases.

Key contrasts

• Newer antiemetics: often higher price, stronger guideline fit in chemo/post-op pathways, which can cap levomepromazine share in those settings.
• Second-generation antipsychotics: strong psychiatric guideline penetration reduces room for older phenothiazines for chronic indications.
• Low-cost equivalence: in constrained budgets, older agents can keep volume steady even without clinical breakthrough differentiation.

What patent litigation or Paragraph IV challenges affect levomepromazine?

Answer: For mature small molecules like levomepromazine, the most common IP friction is not new branded blocking litigation but routine patent certifications around product listings. Any active litigation would typically be territory-specific and presentation-specific.

(No litigation docket mapping is included in the inputs.)

Key Takeaways

• Levomepromazine has limited visibility of active late-stage registrational clinical development; the clinical trial footprint appears mostly historical and supportive-care oriented.
• Commercially, the drug behaves like an established, generic-constrained niche product where formularies and clinician familiarity determine uptake.
• 2025-2035 revenue growth is likely modest, driven by regional mix and supply constraints, with ongoing unit price pressure from generics.
• Patent and exclusivity dynamics are unlikely to be the dominant determinant unless local formulation-specific IP persists in certain territories.

FAQs

1. What therapeutic indications are most associated with levomepromazine prescribing in practice?
2. Does levomepromazine have notable QT prolongation risk that affects market adoption by region?
3. Which dosage forms (oral vs injection) usually show faster generic substitution for levomepromazine?
4. How do hospital formulary tender cycles typically impact levomepromazine revenue in Europe and other regions?
5. What are the main physician switching triggers from levomepromazine to newer antiemetics?

References (APA)

1. No citable sources were provided in the prompt content.