CLINICAL TRIALS PROFILE FOR CHLORPROMAZINE

All Clinical Trials for CHLORPROMAZINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00140179 ↗	Valnoctamide in Mania	Completed	Stanley Medical Research Institute	Phase 3	2004-09-01	Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00140179 ↗	Valnoctamide in Mania	Completed	Beersheva Mental Health Center	Phase 3	2004-09-01	Valproic acid is a leading mood stabilizer for the treatment of bipolar disorder. Its well-known teratogenicity limits its use in young women of childbearing age. According to toxicologic studies the teratogenicity of valproate stems from its free carboxylic group. Valnoctamide is an isomer and an analog of valpromide. Unlike valpromide, valnoctamide does not undergo a biotransformation to the corresponding free acid. It is also likely or at least possible that valnoctamide is anti-bipolar. In mice valnoctamide has been shown to be distinctly less teratogenic than valproate. An injection at day 8 of gestation produced only 1% exencephaly (as compared to 0-1% in control mice and 53% in valproate treated mice). The investigators are performing a double-blind controlled trial of valnoctamide as an anti-bipolar drug. If shown to be anti-bipolar, valnoctamide could be an important valproate substitute for young women with bipolar disorder who are at risk of pregnancy. Patients newly admitted to the Beersheva Mental Health Center may participate if they meet Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for mania or schizoaffective disorder, manic type. Patients admitted to the study are treated with risperidone at doses of the physicians' discretion beginning with 2 mg daily on days 1 and 2. Valnoctamide or placebo is begun at doses of 600 mg per day (200 mg three times daily) and increased to 1200 mg (400 mg three times daily) after four days. Weekly ratings by a psychiatrist blind to the study drug are conducted using the Brief Psychiatric Rating Scale (BPRS), the Young Mania Rating Scale (YMS), and the Clinical Global Impression (CGI). Weekly blood is drawn for drug levels of valnoctamide to be measured by gas chromatography. Each patient receives valnoctamide or placebo for 5 weeks. Low teratogenic mood stabilizers are a high priority for current research.
NCT00169039 ↗	Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia	Terminated	Commonwealth Research Center, Massachusetts	Phase 4	1994-12-01	This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
NCT00169039 ↗	Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia	Terminated	Dartmouth-Hitchcock Medical Center	Phase 4	1994-12-01	This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
NCT00169039 ↗	Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia	Terminated	National Institute of Mental Health (NIMH)	Phase 4	1994-12-01	This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.

Clinical Trial Conditions for CHLORPROMAZINE

Condition Name

Condition Name for CHLORPROMAZINE
Intervention	Trials
Schizophrenia	13
Schizoaffective Disorder	6
Bipolar Disorder	3
Schizophreniform Disorder	3

Condition MeSH

Condition MeSH for CHLORPROMAZINE
Intervention	Trials
Schizophrenia	16
Psychotic Disorders	10
Mental Disorders	6
Disease	6

Clinical Trial Locations for CHLORPROMAZINE

Trials by Country

Trials by Country for CHLORPROMAZINE
Location	Trials
United States	32
China	13
Spain	9
Canada	3
Italy	3

Trials by US State

Trials by US State for CHLORPROMAZINE
Location	Trials
Texas	4
New York	4
Ohio	2
Iowa	1
Washington	1

Clinical Trial Progress for CHLORPROMAZINE

Clinical Trial Phase

Clinical Trial Phase for CHLORPROMAZINE
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	9

Clinical Trial Status

Clinical Trial Status for CHLORPROMAZINE
Clinical Trial Phase	Trials
Completed	21
Not yet recruiting	5
Unknown status	5

Clinical Trial Sponsors for CHLORPROMAZINE

Sponsor Name

Sponsor Name for CHLORPROMAZINE
Sponsor	Trials
Stanley Medical Research Institute	2
Capital Medical University	2
Centre for Addiction and Mental Health	2

Sponsor Type

Sponsor Type for CHLORPROMAZINE
Sponsor	Trials
Other	65
Industry	7
NIH	4

Chlorpromazine: Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

Chlorpromazine is a first-generation antipsychotic approved for decades and marketed as both branded and generic products. Patent coverage in major markets has long expired for the core drug, shifting the commercial focus to generic pricing dynamics, regional regulatory status, and ongoing clinical research in new indications and formulations.

What is the current clinical-trials landscape for chlorpromazine?

Global interventional and key research signal

Chlorpromazine has a persistent presence in clinical research as a comparator, as background standard of care, and in studies that investigate dose-response, relapse prevention, or off-label targets (notably nausea and vomiting, hiccups, agitation, and certain pediatric psychiatric indications). Trial activity tends to be fragmented, and many studies are small, single-center, or observational.

Trial types seen in the chlorpromazine pipeline

Most chlorpromazine “updates” fall into four buckets:

• Generic-era clinical studies: small interventional studies focusing on safety, tolerability, or comparative efficacy versus other agents.
• Supportive-care trials: studies in acute care settings where chlorpromazine is used for symptom control (e.g., agitation, nausea/vomiting, hiccups).
• Pharmacology and formulation work: trials evaluating different routes or controlled-release approaches, where available.
• Comparator roles: studies where chlorpromazine is included as a reference arm rather than the primary investigational product.

Current registrational posture

Chlorpromazine has a long-established regulatory history and does not behave like a modern “pipeline candidate.” Its clinical-trials activity is better read as:

• ongoing clinical practice validation in specific populations and settings,
• and targeted research rather than broad phase-3 development.

Where to expect the next meaningful clinical signal

Because chlorpromazine is off-patent in most major markets, the most commercially relevant clinical updates usually come from:

• new route/formulation approvals (if any),
• label expansions tied to guideline adoption,
• and competitive differentiation for branded generics in regulated tenders.

How large is the chlorpromazine market and what drives it?

Market characterization

Chlorpromazine is a mature, off-patent CNS drug with commercialization dominated by:

• generic supply across multiple manufacturers,
• hospital procurement pricing pressure,
• and regional reimbursement and formulary decisions.

Commercial demand is influenced by:

• the size of the antipsychotic-treated patient base,
• acute care utilization (agitation, nausea/vomiting, hiccups),
• and guideline positioning relative to newer antipsychotics.

Pricing and margin structure

For off-patent antipsychotics, economics typically compress around:

• lowest-cost generic tender wins,
• supply reliability and manufacturing footprint,
• and switching friction (formulary inertia).

Competitive set

In practice, chlorpromazine competes for line-item use against:

• other first-generation antipsychotics,
• and second-generation antipsychotics for many chronic indications,
• with chlorpromazine retaining niche use in specific symptom-control contexts and settings.

Regulatory and safety constraints

Chlorpromazine carries well-known safety limitations (sedation, hypotension, anticholinergic effects, movement disorders). This affects:

• adoption in outpatient settings versus inpatient,
• and restrictions or preference for alternative agents in some jurisdictions.

What is the near-term market projection for chlorpromazine?

Projection framework (mature, off-patent drug)

A realistic projection for chlorpromazine must assume:

• no meaningful new exclusivity from the core drug substance,
• continued generic penetration,
• and steady demand tied to residual guideline and hospital use.

Base-case directional outlook (2025–2029)

• Volume: stable to slightly declining in chronic psychotic disorders as second-generation agents remain preferred in many formularies, with partial offset from supportive-care use.
• Value: gradually declining or flat in USD terms due to price erosion in generic markets.
• Geographic: relative stability is more likely in markets where hospital formularies maintain first-generation options and procurement supports multiple suppliers at low prices.

What do clinical updates change for commercialization?

Clinical-trials outcomes matter less for near-term pricing (genericized drug) and more for:

• maintaining guideline inclusion in targeted symptom-control indications,
• supporting new formulation or route adoption,
• and sustaining hospital formulary placement against competitor generics.

If trials improve evidence for specific acute-use populations, the commercial effect typically shows up first as:

• broader hospital adoption,
• and more consistent procurement volumes.

Competitive and business implications for R&D decision-makers

If you are evaluating new chlorpromazine development

Commercial differentiation generally requires at least one of:

• a new formulation (route, release profile, stability),
• a new approved indication with guideline traction,
• or a superior safety/tolerability strategy supported by clinical endpoints.

Without one of these, chlorpromazine behaves like a commodity:

• price pressure dominates,
• and returns depend on scale and tender access rather than exclusivity.

If you are an investor

The dominant value drivers are:

• generic market share and supply reliability,
• tender wins in key hospitals and procurement networks,
• and regional reimbursement/formulary stability.

Key Takeaways

• Chlorpromazine’s clinical-trials activity is ongoing but typically fragmented and centered on supportive-care, population-specific questions, or comparator roles rather than large phase-3 exclusivity-building programs.
• Commercial demand is stable-to-modestly pressured by generic competition and substitution by newer antipsychotics in chronic indications.
• Market value trends are likely flat-to-declining in USD terms due to persistent generic price erosion, with partial resilience where chlorpromazine retains acute-care or symptom-control positioning.
• Differentiation for any new entrant relies on formulation/route innovation or label expansions that translate into guideline and hospital procurement adoption.

FAQs

1) Is chlorpromazine still being developed in large late-stage trials?

Chlorpromazine generally does not run as a conventional late-stage “pipeline” drug. Clinical activity is more common as smaller studies, supportive-care research, and comparator roles.

2) What indications drive most ongoing chlorpromazine use?

Real-world use is anchored in acute symptom management and supportive-care contexts, with some ongoing antipsychotic utility in settings where first-generation agents remain acceptable on formularies.

3) Will new clinical trial results materially change chlorpromazine pricing?

For the core drug, pricing typically follows generic market dynamics. Clinical results influence adoption indirectly through guideline and formulary effects rather than through new exclusivity.

4) What is the biggest commercial risk for chlorpromazine?

The biggest risk is continued procurement-driven price compression paired with ongoing substitution by second-generation antipsychotics in many formularies.

5) What is the highest-impact strategy for a chlorpromazine “next-gen” product?

A strategy that changes how patients receive the drug (route or formulation) or secures a label expansion with strong guideline uptake and measurable hospital adoption.

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References

[1] NHS. “Chlorpromazine.” NHS Medicines A to Z.
[2] EMA. “Chlorpromazine.” European Medicines Agency product information and public assessment resources.
[3] FDA. “Chlorpromazine.” Drugs@FDA database and labeling references.
[4] NCBI Bookshelf. “Chlorpromazine.” StatPearls (Harrisons guidance and pharmacology summary).
[5] ClinicalTrials.gov. Search results for chlorpromazine (interventional and observational studies).