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NCT01770600 ↗	Impulsivity and Thought Process Disorder in Patients With Active Suicidal Ideation and Depression	Withdrawn	University of Alabama at Birmingham	N/A	2010-04-01	This study is dedicated to achieving a better understanding of how the brain processes information.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	313
Schizoaffective Disorder	65
Bipolar Disorder	51
Psychotic Disorders	42

Condition MeSH

Condition MeSH for RISPERIDONE
Intervention	Trials
Schizophrenia	340
Psychotic Disorders	134
Disease	117
Mental Disorders	76

Clinical Trial Locations for RISPERIDONE

Trials by Country

Trials by Country for RISPERIDONE
Location	Trials
China	72
Canada	57
India	43
Spain	42
Germany	37

Trials by US State

Trials by US State for RISPERIDONE
Location	Trials
California	109
New York	90
Texas	76
Florida	61
Ohio	60

Clinical Trial Progress for RISPERIDONE

Clinical Trial Phase

Clinical Trial Phase for RISPERIDONE
Clinical Trial Phase	Trials
Phase 4	186
Phase 3	132
Phase 2/Phase 3	9

Clinical Trial Status

Clinical Trial Status for RISPERIDONE
Clinical Trial Phase	Trials
Completed	405
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)	40
Janssen, LP	39

Sponsor Type

Sponsor Type for RISPERIDONE
Sponsor	Trials
Other	523
Industry	364
NIH	63

RISPERIDONE Market Analysis and Financial Projection

Risperidone: Clinical Trials, Market Analysis, and Projections

Introduction

Risperidone, an antipsychotic medication, is a cornerstone in the treatment of psychiatric disorders such as schizophrenia, bipolar disorder, and certain mood disorders. This article delves into the latest clinical trials, market analysis, and projections for risperidone, highlighting its evolving role in psychiatric care.

Recent Clinical Trials: Lyndra Therapeutics' Weekly Risperidone

Lyndra Therapeutics has made significant strides with its weekly formulation of risperidone, known as LYN-005. The STARLYNG-1 (LYN-005-C-301) study, a pivotal Phase 3 trial, compared the pharmacokinetic (PK) profile of oral weekly risperidone to daily immediate-release Risperdal in adults with schizophrenia and schizoaffective disorder.

• Key Findings: The study demonstrated that Lyndra's weekly risperidone maintained comparable medication levels to Johnson and Johnson's daily Risperdal, establishing pharmacokinetic bio-comparability. Participants on the weekly formulation maintained stable Positive And Negative Symptom Scale (PANSS) scores throughout the study[1][4].
• Study Outcome: The trial was stopped early due to positive results at the interim analysis. Following this success, Lyndra plans to conduct the STARLYNG-2 study, a six-month, double-blind pivotal safety study, in the second half of 2024[1][4].

ROVI's Risperidone ISM®: A New Frontier in Drug Delivery

ROVI has introduced Risperidone ISM®, a product based on its innovative drug delivery technology, ISM®. This formulation is indicated for the treatment of schizophrenia in adults who have established tolerability and effectiveness with oral risperidone.

• Market Approval: Risperidone ISM®, marketed as Okedi® in Europe and Risvan® in the U.S., Canada, and Australia, has seen significant market approval and expansion. The product was launched in several European countries in 2022 and 2023 and received FDA approval in the U.S. in March 2024[2].
• Sales Performance: Sales of Okedi® increased by 42% in the fourth quarter of 2023 compared to the third quarter, with total sales reaching 14.4 million euros in 2023. ROVI forecasts potential sales of between 200 and 300 million euros globally in the upcoming years[2].

Market Analysis: Global Risperidone Market

The global risperidone market is a substantial segment of the pharmaceutical industry, driven by the increasing demand for effective treatments of psychiatric disorders.

• Market Size and Growth: The global risperidone market was valued at USD 545.10 million in 2022 and is anticipated to grow at a CAGR of 5.13% from 2023 to 2028. This growth is fueled by the soaring prevalence of psychiatric disorders and advancements in treatment approaches[3].
• Key Drivers: The market is driven by factors such as the increasing disease burden, modern lifestyles contributing to mental health issues, and advancements in pharmacogenomics and diagnostic precision. These advancements enable personalized treatment plans, optimizing outcomes for patients[3].

Advancements in Treatment Approaches

The risperidone market benefits significantly from ongoing advancements in psychiatric treatment.

• Personalized Treatment: Modern psychiatric practice emphasizes tailored medications based on individual patient profiles, which has enhanced the efficacy and safety of risperidone. Advancements in pharmacogenomics and diagnostic precision play a crucial role in this personalized approach[3].
• Combination Therapies: Combining risperidone with other medications or therapeutic approaches is a growing trend, fostering more comprehensive treatment regimens. This includes non-pharmacological interventions like psychotherapy and behavioral therapies, which are often used in conjunction with risperidone[3].

Global Expansion and Emerging Markets

The risperidone market is expanding globally, with a focus on emerging markets.

• International Approvals: Regulatory approvals in new regions have facilitated market growth. For instance, ROVI’s Risperidone ISM® has been approved in the U.S., Canada, and Australia, in addition to several European countries[2].
• Emerging Markets: Pharmaceutical companies are adopting strategies to penetrate emerging markets through partnerships, distribution agreements, and pricing models that make risperidone more accessible in developing regions. The aging global population and increased awareness of pediatric psychiatric disorders also present significant opportunities[3].

Route of Administration Insights

The route of administration plays a critical role in the risperidone market.

• Oral Segment Dominance: Oral medications, such as tablets or capsules, remain the most common and familiar form of drug administration. Lyndra’s weekly oral risperidone and ROVI’s Risperidone ISM® are examples of innovative oral formulations that are gaining traction[3].
• Long-Acting Injectables: Long-acting injectables, such as Luye Pharma’s Rykindo, which is an intramuscular injection given every two weeks, also represent a significant segment. These formulations offer convenience and improved adherence for patients[4].

Market Projections

The risperidone market is projected to continue its growth trajectory.

• Sales Forecasts: ROVI expects Risperidone ISM® to achieve sales of between 200 and 300 million euros globally in the upcoming years. The global risperidone market, valued at USD 545.10 million in 2022, is expected to grow at a CAGR of 5.13% through 2028[2][3].
• Market Dynamics: The market will be influenced by factors such as generic erosion in some regions, the launch of new formulations, and expanding indications for risperidone. Regulatory approvals and international expansion will also drive market growth[3][5].

Key Takeaways

• Clinical Trials: Lyndra Therapeutics' weekly risperidone (LYN-005) has shown comparable efficacy to daily Risperdal, paving the way for a new treatment option.
• Market Expansion: ROVI’s Risperidone ISM® has received significant market approvals and is expected to achieve substantial sales globally.
• Advancements in Treatment: Personalized treatment plans, combination therapies, and advancements in pharmacogenomics are driving the risperidone market.
• Global Growth: The risperidone market is expanding globally, with a focus on emerging markets and new formulations.

FAQs

What is the significance of Lyndra Therapeutics' weekly risperidone formulation?

Lyndra Therapeutics' weekly risperidone formulation (LYN-005) has demonstrated comparable efficacy to daily Risperdal, offering a more convenient treatment option for patients with schizophrenia and schizoaffective disorder.

How does ROVI’s Risperidone ISM® differ from traditional risperidone formulations?

ROVI’s Risperidone ISM® uses an innovative drug delivery technology, ISM®, which provides a different pharmacokinetic profile compared to traditional oral risperidone, and has been approved in several countries including the U.S., Canada, and Australia.

What are the key drivers of the global risperidone market?

The global risperidone market is driven by the increasing prevalence of psychiatric disorders, advancements in treatment approaches, and expanding indications for risperidone. Personalized treatment plans and combination therapies also play a significant role.

What are the projections for the global risperidone market?

The global risperidone market is expected to grow at a CAGR of 5.13% from 2023 to 2028, with ROVI forecasting potential sales of between 200 and 300 million euros for its Risperidone ISM®.

How is the risperidone market affected by generic erosion?

Generic erosion is expected to impact the risperidone market, particularly in regions where patents for branded products are expiring. However, innovative formulations and expanding indications are expected to mitigate this impact and drive continued market growth.

Sources

1. Lyndra Therapeutics Announces Positive Data from Pivotal Phase 3 Study with Oral Weekly Risperidone (LYN-005) for Schizophrenia. Biospace.
2. ROVI Forecasts Potential Risperidone ISM® Sales of Between 200 and 300 Million Euros Globally. ROVI.
3. Risperidone Market By Size, Growth, Trends and Forecast 2028. TechSci Research.
4. Phase III Schizophrenia Trial Shows Lyndra's Weekly Risperidone Comparable to J&J's Daily Risperdal. Biospace.
5. Schizophrenia - 5EU Drug Forecast and Market Analysis to 2025. Business Wire.