CLINICAL TRIALS PROFILE FOR RISPERIDONE

505(b)(2) Clinical Trials for risperidone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Indication	NCT01770600 ↗	Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression	Withdrawn	University of Alabama at Birmingham	N/A	2010-04-01	This study is dedicated to achieving a better understanding of how the brain processes information. Specifically, the investigators are studying cognitive function, thought process, and impulsivity in people with and without suicidal thoughts. You are being asked to participate in a research study to learn how the use of a medication, risperidone, improves your symptoms of depression. Specifically the investigators are studying the effectiveness of reducing the thought of suicide and other symptoms of severe depression. Risperidone is approved by FDA for the treatment of schizophrenia and bipolar mania, and clinical practice suggests that it might benefit patients with major depressive disorder. During clinical trials with 2607 patients, risperidone was proved to be safe. This is a pilot study to test a new indication of risperidone for treatment of severe depression. The study medication will be given in addition to usual psychiatric care.

All Clinical Trials for risperidone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000267 ↗	Risperidone Treatment in Dually-Diagnosed Individuals - 2	Completed	New York State Psychiatric Institute	Phase 2	1969-12-31	The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine dependence in individuals with schizophrenia/schizoaffective illness.
NCT00000267 ↗	Risperidone Treatment in Dually-Diagnosed Individuals - 2	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1969-12-31	The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine dependence in individuals with schizophrenia/schizoaffective illness.
NCT00000272 ↗	Early Phase II Trials for Cocaine Medication Development - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1996-08-01	The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
NCT00000272 ↗	Early Phase II Trials for Cocaine Medication Development - 1	Completed	New York State Psychiatric Institute	Phase 2	1996-08-01	The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
NCT00000272 ↗	Early Phase II Trials for Cocaine Medication Development - 1	Completed	Research Foundation for Mental Hygiene, Inc.	Phase 2	1996-08-01	The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
NCT00000309 ↗	Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1	Terminated	National Institute on Drug Abuse (NIDA)	Phase 2	1994-08-01	The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Clinical Trial Conditions for risperidone

Condition Name

Condition Name for risperidone
Intervention	Trials
Schizophrenia	316
Schizoaffective Disorder	66
Bipolar Disorder	51
Psychotic Disorders	42

Condition MeSH

Condition MeSH for risperidone
Intervention	Trials
Schizophrenia	346
Psychotic Disorders	137
Disease	117
Mental Disorders	76

Clinical Trial Locations for risperidone

Trials by Country

Trials by Country for risperidone
Location	Trials
China	73
Canada	58
India	44
Spain	42
Germany	37

Trials by US State

Trials by US State for risperidone
Location	Trials
California	109
New York	91
Texas	76
Florida	61
Ohio	60

Clinical Trial Progress for risperidone

Clinical Trial Phase

Clinical Trial Phase for risperidone
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	5

Clinical Trial Status

Clinical Trial Status for risperidone
Clinical Trial Phase	Trials
Completed	409
Terminated	51
Unknown status	48

Clinical Trial Sponsors for risperidone

Sponsor Name

Sponsor Name for risperidone
Sponsor	Trials
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	47
National Institute of Mental Health (NIMH)	41
Janssen, LP	39

Sponsor Type

Sponsor Type for risperidone
Sponsor	Trials
Other	537
Industry	366
NIH	64

Risperidone Clinical Trials Update, Market Analysis and Projection

Last updated: April 27, 2026

What is risperidone and where is it used commercially?

Risperidone is a first-generation atypical (second-generation) antipsychotic marketed globally for schizophrenia and bipolar disorder indications, with broad adoption across inpatient and outpatient psychiatry. In 2024-2025, risperidone remains a high-volume branded-and-generic molecule in major markets, with ongoing lifecycle activity focused on reformulations (long-acting injectables and pediatric label expansions historically) rather than new fundamental mechanisms.

Key commercial reality: risperidone is now largely generic in most developed markets, so the “market” is shaped by manufacturing capacity, price compression, and branded tendering dynamics rather than patent exclusivity in many jurisdictions.

What is the current clinical-trials landscape for risperidone (latest update view)?

A full “latest” clinical-trials update requires live registry data per cut date. The provided source set here does not include a trial-by-trial, cut-dated registry extract for risperidone, so a complete and accurate “clinical trials update” cannot be produced without risking omission or misstatement.

How big is the risperidone market today?

Risperidone’s market is best treated as a legacy antipsychotic segment with:

• high total volume,
• strong generic penetration,
• price pressure,
• uneven branded persistence where local marketing retains value (formulations, pack sizes, and tendering).

Because the source set here does not include a credible, cut-dated industry market estimate for the risperidone molecule or specific formulations (oral vs. long-acting), a complete market sizing and projection cannot be produced accurately.

What market drivers shape risperidone pricing and demand?

Even without a numeric forecast, the demand drivers and constraints are structurally clear in mature antipsychotic markets:

• Formulation mix: oral tablets drive core volume; long-acting injectable formulations (where available in-country) drive adherence-based use-cases.
• Generic competition: most developed markets price risperidone aggressively, limiting revenue per patient even where usage is stable.
• Clinical guideline inertia: risperidone remains embedded in schizophrenia and bipolar treatment pathways, supporting demand stability even as newer agents expand.
• Safety and switching patterns: metabolic and prolactin-related tolerability concerns influence patient selection, dose titration, and switching, but they do not eliminate baseline use.

What is a realistic market projection approach for risperidone?

A proper projection requires baseline market size and segmentation (US/EU/Rest of World, oral vs. LAI, branded vs. generic). Those inputs are not present in the supplied material, so any numeric projection would be speculative.

What can be projected without making up numbers?

If you need an actionable projection framework that can be parameterized once you plug in market size by geography and formulation, the risperidone projection can be modeled as:

1. Volume growth (population-level and diagnosis prevalence)
2. Price decay (generic erosion and tender cycles)
3. Mix shift (oral to LAI where reimbursement favors adherence and where administration capacity exists)
4. Competitive substitution (share loss to other antipsychotics, including SGAs and LAIs)
5. Policy impacts (formularies, step therapy, and national health system procurement)

This framework produces a defensible forecast once a credible baseline is inserted.

Regulatory and patent reality (what it implies for market growth)

Risperidone’s broad availability strongly limits upside from exclusivity-led expansion in most regions. Growth tends to come from:

• managed care coverage persistence,
• stable incidence-driven demand,
• procurement cycles that preserve low-cost supply,
• substitution patterns across antipsychotics.

Any projection that assumes “pipeline-driven” growth for the risperidone molecule itself would be inconsistent with typical lifecycle economics for an established genericized drug.

Actionable market positioning (how companies win in risperidone)

In mature generic antipsychotic markets, commercial advantage comes from execution, not novelty:

• Supply reliability: uninterrupted manufacturing and compliance.
• Cost of goods: margin protection under tender competition.
• Formulation execution: stability, bioavailability consistency, and pack economics.
• Contracting: formulary access, hospital procurement inclusion, pharmacy benefit outcomes.
• Substitution readiness: line extensions and complementary SKUs that match payer preferences.

Key Takeaways

• Risperidone is a mature, high-volume antipsychotic whose market performance is dominated by generic pricing dynamics and formulation mix rather than exclusivity-driven growth.
• A complete, cut-dated “clinical trials update” and a numeric market sizing and projection cannot be produced accurately from the provided source set.
• The defensible projection method is a volume-price-mix model parameterized by geography and formulation (oral vs. long-acting), with substitution and procurement policy as key sensitivities.
• Commercial wins in risperidone markets come from supply, cost, contracting, and formulation execution.

FAQs

1. Is risperidone still brand-protected in major markets?
   Risperidone is widely genericized in developed markets, so pricing and growth are primarily driven by generic availability and procurement rather than patent exclusivity.

2. What drives risperidone revenue changes year to year?
   Generic price decay, tender cycles, and formulation mix (oral versus long-acting injectable where applicable) dominate.

3. Does risperidone have active development that could materially change its market?
   Development is typically lifecycle oriented (reformulations and label refinements) and tends not to reset molecule-level market growth expectations once generic penetration is established.

4. What is the most practical forecasting structure for risperidone?
   Model demand as volume (diagnosis prevalence and treatment rates) minus substitution impacts, multiplied by an evolving net price curve and adjusted for oral versus LAI mix.

5. What factors most affect whether patients stay on risperidone?
   Tolerability (including prolactin-related effects and metabolic considerations), dosing practicality, clinician familiarity, and payer coverage conditions.

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References

[1] FDA. Drug Approval Reports and labeling resources for risperidone (access via Drugs@FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
[2] EMA. Public assessment documents and product information for risperidone in the European Union (access via European Medicines Agency). https://www.ema.europa.eu/
[3] ClinicalTrials.gov. Risperidone search results and trial registry records. https://clinicaltrials.gov/