Risperidone
Regulatory milestones approvals, filings & regulatory actions · 22 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed bipolar disorder 1 milestone | |||||
| Filed | US (FDA) | RISPERDAL CONSTA | bipolar disorder | 2008-04-14 | “submitted a Supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) ((risperidone) Long-Acting Injection) to the U.S. Food and Drug Administration (FDA)” alkermes.com ↗ “Supplemental new drug application for RISPERDAL CONSTA submitted to U.S. Food and Drug Administration.” alkermes.com ↗ “In April 2008, J&JPRD submitted another sNDA for RISPERDAL CONSTA to the FDA” alkermes.com ↗ |
| Filed bipolar I disorder 1 milestone | |||||
| Filed | US (FDA) | RISPERDAL CONSTA | bipolar I disorder | 2008-07-24 | “submitted a supplemental New Drug Application for RISPERDAL CONSTA to the U.S. Food and Drug Administration (FDA)” alkermes.com ↗ |
| Filed schizoaffective bipolar disorder 1 milestone | |||||
| Filed | US (FDA) | Rykindo® | schizoaffective bipolar disorder | 2019-03-28 | “注 射 用 利 培 酮 缓 释 微 球Rykindo®(LY03004)已 于 美 国 东 部 时 间3月28日,正 式 向 美 国 食 品 药 品 监 督 管 理 局(“FDA”)提 交NDA新 药 上 市 申 请” luye.com ↗ |
| Filed schizophrenia 7 milestones | |||||
| Rejected (CRL) | US (FDA) | — | schizophrenia | 2021-09-24 | “On 24 September, 2021, ROVI received a Complete Response Letter from the FDA with outstanding questions on the Risperidone ISM® dossier.” rovi.es ↗ |
| Filed | US (FDA) | — | schizophrenia | 2020-11-24 | “ROVI filed the application for marketing authorisation for Risperidone ISM® with the FDA on 24 November, 2020.” rovi.es ↗ |
| Filed | US (FDA) | — | schizophrenia | 2017-09-28 | “New drug application (NDA) submitted September 28th for RBP-7000 risperidone monthly depot for the treatment of schizophrenia.” indivior.com ↗ |
| Filed | Japan (PMDA) | RISPERDAL CONSTA | schizophrenia | 2006-12-20 | “submitted a new drug application to the Pharmaceuticals and Medical Devices Agency (PMDA) for marketing approval in Japan of RISPERDAL(R) CONSTA(R)” alkermes.com ↗ “submitted a new drug application to the Pharmaceuticals and Medical Devices Agency (PMDA) for marketing approval of RISPERDAL CONSTA in Japan.” alkermes.com ↗ |
| Rejected (CRL) | US (FDA) | Risperdal Consta | schizophrenia | 2002-07-01 | “to fulfill a complete response to the 'non-approvable' letter issued by the FDA regarding the New Drug Application (NDA) for Risperdal Consta(TM) long-acting injection.” alkermes.com ↗ “received a non-approvable letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for Risperdal Consta(TM)” alkermes.com ↗ “Risvan® (Risperidone ISM®) in the United States and reports that it has now filed the final responses to the Complete Response Letter” rovi.es ↗ |
| Filed | US (FDA) | Risperdal Consta | schizophrenia | 2001-08-31 | “Risperdal, currently the most widely prescribed antipsychotic medication in the United States, was submitted to the U.S. Food and Drug Administration on August 31, 2001.” alkermes.com ↗ |
| Filed | EU (EMA) | Doria | schizophrenia | — | “the European health authorities have commenced the assessment process to grant marketing authorisation” rovi.es ↗ “DORIA® Risperidone, monthly Schizophrenia Positive results from Phase III. Filed in Europe.” rovi.es ↗ |
| Approved Indication not stated 6 milestones | |||||
| Label expansion | US (FDA) | UZEDY | — | 2025-10-10 | fda.gov ↗ |
| Label expansion | US (FDA) | PERSERIS KIT | — | 2022-12-15 | fda.gov ↗ |
| Approved | EU (EMA) | Okedi | — | 2022-02-14 | europa.eu ↗ |
| Label expansions (6) | US (FDA) | RISPERDAL | — | 1997-10-17 – 2012-08-02 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | RISPERDAL CONSTA | — | 2007-04-12 – 2009-05-15 | fda.gov ↗ |
| Approved | US (FDA) | RISPERDAL | — | 1993-12-29 | fda.gov ↗ |
Trials 270 · started per year
News releases announcing trial results or a regulatory action · 81
| Date | Issuer | Release |
|---|---|---|
| 2025-10-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Approves Expanded Indication for UZEDY® (risperidone) Extended-Release Injectable Suspension as a Treatment for Adults Living with Bipolar I Disorder tevapharm.com ↗
FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. |
| 2025-09-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Long-term Safety Data from the Completed Phase 3 SOLARIS Trial Support the Potential of Olanzapine LAI (TEV-'749) as the First Long-Acting Olanzapine Treatment Option for Schizophrenia with No PDSS Observed tevapharm.com ↗
No comparisons can be made regarding efficacy, safety, or any other clinical outcomes as this was not studied. |
| 2025-09-04 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension amneal.com ↗
Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta ® . |
| 2025-09-03 | Lupin Limited | Regulatory Lupin Receives U.S. FDA Approval for Risperidone Long-Acting Injectable, with 180-Day CGT Exclusivity, the First Product from its Nanomi’s Long-Acting Injectable Platform lupin.com ↗ |
| 2025-05-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Latest Schizophrenia Portfolio Data Including Real-World Outcomes with UZEDY® (risperidone) Showing Lower Rates of and Longer Time to Relapse Compared to Oral Treatment Options and New Phase 3 SOLARIS Data Showing No Incidence of PDSS with TEV-'749 (olanzapine) to Date tevapharm.com ↗
In the studies, patients receiving UZEDY had lower rates of and longer time to relapse as well as better treatment adherence and persistence rates, fewer inpatient, outpatient and emergency department (ED) visits, shorter hospital length of stay and lower all-cause HCRU. |
| 2025-05-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data from Teva Shows Substantial Rates of Undertreated Tardive Dyskinesia in Long-Term Care Settings at Psych Congress Elevate 2025 tevapharm.com ↗
Of the residents being treated with antipsychotic drugs (APDs), 5.6% had a diagnosis of extrapyramidal syndrome (EPS), – a broad term used to describe any drug-induced movement disorder with no wide-treating therapeutic option – while 1.1% had a specific diagnosis of TD. |
| 2025-04-22 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults with Schizophrenia bms.com ↗
In a post-hoc subgroup analysis there was a notable difference in response between subjects treated with risperidone as a background therapy compared with the remaining subjects treated with other background antipsychotics (non-risperidone). |
| 2025-03-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Strengthens Teva’s Schizophrenia Portfolio, Including Phase 3 SOLARIS Trial Survey Results Demonstrating Patient and Healthcare Professional Satisfaction with TEV-'749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable tevapharm.com ↗
New data from UZEDY® (risperidone) evaluated predictors of response in schizophrenia with efficacy observed across patient demographic and clinical characteristics in the Phase 3 RISE trial |
| 2025-02-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and Medincell Announce FDA Acceptance of Supplemental New Drug Application for UZEDY(R) (risperidone) Extended-Release Injectable Suspension as a Treatment for Patients with Bipolar I Disorder tevapharm.com ↗
Today’s filing demonstrates the potential of UZEDY’s clinical profile as a long-acting treatment for bipolar-I, a complex mental health disorder that significantly affects a person’s mood, behavior, and overall state of mind. |
| 2024-11-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Latest Schizophrenia Treatment Research, Including Phase 3 SOLARIS Trial Results Demonstrating Improvements in Social Functioning and Quality of Life in Adults Receiving TEV-'749 (olanzapine) a Subcutaneous Long-Acting Injectable as well as Results of Real-World Analyses of UZEDY® (risperidone) tevapharm.com ↗
Real-world analyses of UZEDY (risperidone) subcutaneous long-acting injectable reveal high adherence rates and utilization in adults with schizophrenia who have barriers to treatment |
| 2024-09-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Provide Treatment Insights into Options for Switching Adult Patients Diagnosed with Schizophrenia to UZEDY® (risperidone) Extended-Release Injectable Suspension from Perseris® (RBP-7000) tevapharm.com ↗
New data demonstrate switching to UZEDY at four weeks after the last dose of once-monthly RBP-7000 provided the most comparable pharmacokinetic (PK) profile based on relevant simulations, with comparable doses identified |
| 2024-06-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Provide Schizophrenia Treatment Insights into Switching to UZEDY® (risperidone) Extended-Release Injectable Suspension from Invega Sustenna® (paliperidone palmitate) tevapharm.com ↗
No unexpected safety concerns or clinically meaningful trends in adverse events were observed. |
| 2024-04-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Pharmacokinetic Modeling Data Presented by Teva Simulates Clinical Profiles of Schizophrenia Patients Switching to UZEDY® (risperidone) Extended-Release Injectable Suspension at SIRS 2024 tevapharm.com ↗
PK modeling data provide insights into potential dosing conversions and strategies for switching to UZEDY from a long-acting injectable (LAI) formulation of risperidone microspheres (R064766) |
| 2024-04-02 | Rovi Pharmaceuticals Laboratories | Regulatory ROVI receives the FDA’s approval of Risvan® as a treatment for schizophrenia rovi.es ↗
Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults. |
| 2023-11-16 | Delpor, Inc. | Results Delpor’s Investigational Risperidone Implant Product Provides Schizophrenia Therapy for up to One Year after a Single Administration in Phase 1b/2a Patient Study delpor.com ↗
No serious adverse events (AEs) attributed to DLP-114 were reported, and DLP-114 was well tolerated for up to 12 months, including the initial placement and follow-up removal procedures. |
| 2023-11-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Results UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolongs Time to Schizophrenia Relapse in RISE Study Results Published in The Lancet Psychiatry tevapharm.com ↗ |
| 2023-05-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present Data Demonstrating UZEDY™ (risperidone) Extended-Release Injectable Suspension Significantly Prolonged Time to Impending Relapse for Adults with Schizophrenia at the American Psychiatric Association’s 2023 Annual Meeting tevapharm.com ↗
UZEDY significantly reduced the risk of relapse by up to 80% and prolonged the time to impending relapse by up to 5.0 times while having a similar safety profile to other formulations of risperidone1,2 |
| 2023-04-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and MedinCell Announce FDA Approval of UZEDY™ (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced todaythat the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. |
| 2023-02-16 | Rovi Pharmaceuticals Laboratories | Regulatory ROVI informs on the evaluation process to obtain marketing authorisation for Risvan® rovi.es ↗ |
| 2023-01-16 | Luye Pharma Group Ltd. | Regulatory 中国自主研发中枢神经系统新药首次获得美国FDA批准上市,绿叶制药Rykindo® 实现历史突破 luye.com ↗
Rykindo®获 批 意 味 着 我 国 新 药 在 该 领 域 出 海 实 现“零”的 突 破. |
| 2022-11-03 | MedinCell S.A | Regulatory MedinCell’s partner Teva today announced refiling for approval of mdc-IRM and confirmed planned launch in the U.S. in H1 2023 medincell.com ↗
MedinCell’s partner, Teva, today announced that it recently completed the re-submission to a New Drug Application to the U.S. FDA for mdc -IRM, a risperidone subcutaneous Long -Acting Injectable (LAI) for the maintenance treatment of schizophrenia using MedinCell’s proprietary technology. |
| 2022-04-19 | MedinCell S.A | Regulatory Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM medincell.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia. |
| 2022-04-19 | MedinCell S.A | Regulatory MedinCell provides additional information regarding the new drug application for mdc-IRM medincell.com ↗
As announced, Teva recently received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM. |
| 2022-04-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and MedinCell Receive Complete Response Letter for TV-46000/mdc-IRM tevapharm.com ↗ |
| 2022-02-15 | Rovi Pharmaceuticals Laboratories | Regulatory ROVI receives the European Commission’s approval of Okedi® as a treatment for schizophrenia rovi.es ↗
Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the European Commission has authorised the marketing of Okedi ® (Risperidone ISM ® ) for the treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone. |
| 2021-12-17 | Rovi Pharmaceuticals Laboratories | Regulatory ROVI receives the positive opinion of the CHMP on Okedi® as a treatment for schizophrenia rovi.es ↗
The positive opinion of the CHMP is based on the positive results of the PRISMA-3 study on the efficacy and safety of the treatment. |
| 2021-11-01 | MedinCell S.A | Results Phase 3 data of mdc-IRM, first product based on MedinCell’s technology, shows significant improvements in patients with schizophrenia: – Prolonged time to impending relapse – Decreased risk of relapse – Increased chance of clinical stability medincell.com ↗
Phase 3 data of mdc-IRM, first product based on MedinCell’s technology, shows significant improvements in patients with schizophrenia: |
| 2021-10-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Phase 3 Data Presented at Psych Congress 2021 Showed TV-46000/mdc-IRM Significantly Prolonged Time to Impending Relapse Compared to Placebo in Patients with Schizophrenia tevapharm.com ↗
Results showed treatment with TV-46000 (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. |
| 2021-10-21 | Rovi Pharmaceuticals Laboratories | Regulatory The FDA delays its decision on Risperidone ISM® rovi.es ↗
The FDA will be taking a number of actions, including an in-situ inspection of the European production plant where the product is manufactured, located in Madrid (Spain). |
| 2021-08-31 | MedinCell S.A | Regulatory Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia medincell.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration (FDA). |
| 2021-08-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva and MedinCell Announce FDA Acceptance of New Drug Application for TV-46000/mdc-IRM as a Treatment for Patients with Schizophrenia tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL)announced today that the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia has been accepted by the U.S. Food and Drug Administration (FDA). |
| 2021-01-07 | MedinCell S.A | Results Teva and MedinCell Announce Positive Results for Registration Trial of Investigational Extended-Release Subcutaneous Injectable Risperidone for Patients with Schizophrenia medincell.com ↗ |
| 2021-01-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva and MedinCell Announce Positive Results for Registration Trial of Investigational Extended-Release Subcutaneous Injectable Risperidone for Patients with Schizophrenia tevapharm.com ↗
The investigational subcutaneous risperidone injection q1M and q2M demonstrated a reduction of 80.0% and 62.5% in the risk to relapse compared to placebo, respectively. |
| 2020-11-27 | Rovi Pharmaceuticals Laboratories | Results The Journal npj Schizophrenia Publishes the Results of the PRISMA-3 Study of the Efficacy and Safety of Doria® in Schizophrenic Patients rovi.es ↗
Today, Laboratorios Farmacéuticos Rovi, S.A. ( www.rovi.es ) has announced the online publication of the results of the pivotal study PRISMA-3 on the efficacy and safety of Doria® in schizophrenic patients in the journal npj Schizophrenia. |
| 2019-03-29 | Luye Pharma Group Ltd. | Regulatory 重磅!绿叶制药Rykindo®有望成为我国首个在美获批上市的创新药 luye.com ↗
注 射 用 利 培 酮 缓 释 微 球Rykindo®(LY03004)已 于 美 国 东 部 时 间3月28日,正 式 向 美 国 食 品 药 品 监 督 管 理 局(“FDA”)提 交NDA新 药 上 市 申 请,有 望 成 为 我 国 首 个 在 美 获 批 上 市 的 创 新 药. |
| 2019-03-19 | Rovi Pharmaceuticals Laboratories | Results ROVI Announces Positive Topline Results from Phase 3 study of Doria® in Patients with Schizophrenia rovi.es ↗
Laboratorios Farmacéuticos Rovi, S.A. ( www.rovi.es ) today announced topline results from the pivotal study PRISMA-3, a multicenter, randomized, placebo-controlled phase 3 trial of Doria® (Risperidone ISM®), a novel investigational once-monthly injectable antipsychotic for the treatment of schizophrenia. |
| 2018-07-27 | Indivior Inc. | Regulatory Indivior | FDA Approves PERSERIS™ (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults indivior.com ↗
Indivior PLC (LON: INDV) today announced that the U.S. Food and Drug Administration (FDA) has approved PERSERISTM, the first oncemonthly subcutaneous risperidone containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. |
| 2017-12-12 | Indivior Inc. | Regulatory Indivior | Indivior Announces NDA Acceptance of RBP-7000 Risperidone Monthly Depot indivior.com ↗
Indivior PLC (LON: INDV) (the ‘Company’) today announces that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for RBP-7000, an investigational, once-monthly injectable risperidone in the ATRIGEL® delivery system for the treatment of schizophrenia. |
| 2017-10-25 | Rovi Pharmaceuticals Laboratories | Results DORIA® presentation rovi.es ↗
DORIA® has therapeutic levels from the first hours after first administration. |
| 2017-10-02 | Indivior Inc. | Regulatory Indivior | Indivior Submits New Drug Application to U.S. FDA for RBP-7000 Risperidone Monthly Depot for Treatment of Schizophrenia indivior.com ↗
Indivior PLC (LON: INDV) today announced that its U.S. subsidiary, Indivior Inc. successfully submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on September 28, 2017 to seek marketing approval for RBP-7000, Indivior’s investigational, once-monthly injectable risperidone in the ATRIGEL® delivery system for the treatment of schizophrenia. |
| 2017-03-13 | Indivior Inc. | Results Indivior | Indivior RBP-7000 Top-line results indivior.com ↗
Indivior PLC (LON: INDV) today announced positive top-line results from its Phase 3 open-label, long-term safety trial (RB-US-13-0005) of RBP-7000 risperidone monthly depot, an investigational drug candidate in development for the treatment of schizophrenia. |
| 2015-06-26 | Rovi Pharmaceuticals Laboratories | Results ROVI will present positive results of Risperidone ISM® and Bemiparin at the 12th EACPT Congress rovi.es ↗
Thus, the pharmacological profile of Risperidone ISM® not only facilitate better compliance of schizophrenic patients, but may also arise as a suitable medication to treat acute exacerbations of the disease. |
| 2014-12-16 | Rovi Pharmaceuticals Laboratories | Results ROVI announces positive results from a Risperidone-ISM new trial rovi.es ↗
ROVI announces new positive results for the monthly injectable formulation of Risperidone- ISM |
| 2012-07-11 | Eli Lilly and Company | Results Lilly Announces Pomaglumetad Methionil Did Not Meet Primary Endpoint of Clinical Study lilly.com ↗
The active control, risperidone, did separate from placebo in both populations. |
| 2011-01-25 | Sumitomo Pharma America, Inc. | Results Completion of Long-Term Phase 3 Safety Trial for Latuda (lurasidone HCl) sumitomo-pharma.com ↗
The most commonly reported adverse events for risperidone include weight increased (19.8%) and somnolence (17.8%), nausea (10.9%) and akathisia (7.9%). |
| 2009-09-14 | BioLineRx, Ltd. | Results BioLineRx Announces Positive Topline Results for BL-1020, a First in Class GABA Enhanced Antipsychotic for the Treatment of Schizophrenia biolinerx.com ↗
Discontinuations due to AEs (Adverse Events) were similar in the BL-1020 (20-30mg/day) group and in the placebo group (4.3%) but higher in the Risperidone group (8.8%). |
| 2009-05-19 | Alkermes, Inc. | Results RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder alkermes.com ↗
New data demonstrate that maintenance therapy with RISPERDAL® CONSTA® (risperidone) Long-Acting Treatment (RLAT) significantly delayed the time to relapse compared to placebo in patients with bipolar I disorder. |
| 2009-05-19 | Alkermes, Inc. | Results New Data Demonstrate RISPERDAL® CONSTA® (Risperidone) Long-Acting Treatment May Improve Health Outcomes and Reduce Hospitalizations in Patients with Schizophrenia alkermes.com ↗ |
| 2009-05-18 | Alkermes, Inc. | Regulatory FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder alkermes.com ↗
Alkermes, Inc. (NASDAQ: ALKS) today announced that Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has received approval from the U.S. Food and Drug Administration (FDA) for the use of RISPERDAL® CONSTA® (risperidone) Long-Acting Injection as both a monotherapy and adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder. |
| 2009-04-27 | Alkermes, Inc. | Regulatory RISPERDAL(R) CONSTA(R) Approved in Japan alkermes.com ↗
Alkermes, Inc. (NASDAQ: ALKS) today announced that Janssen Pharmaceutica K.K. received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to market RISPERDAL® CONSTA® [(risperidone) long-acting injection] for the treatment of schizophrenia. |
| 2009-02-10 | Alkermes, Inc. | Regulatory FDA Issues Complete Response Letter for RISPERDAL(R) CONSTA(R) for Adjunctive Maintenance Treatment of Bipolar Disorder alkermes.com ↗
The Agency’s complete response outlined questions that need to be addressed prior to granting approval for the new indication, but did not request additional studies. |
| 2009-01-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Generic Risperdal ® Oral Solution tevapharm.com ↗ |
| 2008-10-09 | Alkermes, Inc. | Regulatory FDA Approves New Injection Site for RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment alkermes.com ↗
The U.S. Food and Drug Administration (FDA) has approved a new injection site, the deltoid muscle in the arm, for RISPERDAL CONSTA for the treatment of patients with schizophrenia. |
| 2008-07-24 | Alkermes, Inc. | Regulatory Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to the FDA for the Treatment of Bipolar Disorder alkermes.com ↗
Alkermes, Inc. (NASDAQ: ALKS) today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a supplemental New Drug Application (sNDA) for RISPERDAL(R) CONSTA(R) ((risperidone) Long-Acting Injection) to the U.S. Food and Drug Administration (FDA) for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in adults. |
| 2008-06-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives First U.S. Approval For Generic Risperdal® Tablets; Commences Commercial Launch tevapharm.com ↗
the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Janssen's antipsychotic agent Risperdal® (Risperidone) Tablets |
| 2008-05-06 | Alkermes, Inc. | Results Patients Treated with Risperidone Long-Acting Injection had a Significantly Longer Time to Relapse Compared to Quetiapine in International Clinical Study alkermes.com ↗
Today, data from a new international study showed that patients treated with risperidone long-acting injection (RLAI) had a significantly longer time to relapse compared to patients treated with an oral atypical medication, quetiapine. |
| 2008-04-14 | Alkermes, Inc. | Regulatory Supplemental New Drug Application for RISPERDAL(R) CONSTA(R) Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder alkermes.com ↗ |
| 2008-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Court Ruling Awarding Exclusivity For Generic Risperdal® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Columbia has granted a request of the Company's subsidiary, Teva Pharmaceuticals USA, Inc. that the U.S. Food and Drug Administration (FDA) relist in the Orange Book U.S. Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Janssen Pharmaceutical's Risperdal® (Risperidone) Tablets. |
| 2008-02-05 | ACADIA Pharmaceuticals Inc. | Results ACADIA Pharmaceuticals Announces Presentation of Data on Pimavanserin Co-Therapy at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders acadia.com ↗ |
| 2008-02-04 | Alkermes, Inc. | Results Study Suggests Risperidone Long-Acting Injection Combined with Standard Treatment Helped Delay Time to Relapse in Patients with Bipolar Disorder alkermes.com ↗
The trial showed that time to relapse was significantly longer in patients receiving RLAI compared with placebo (p=0.004) and the relative risk of relapse was 2.4 times higher with placebo. |
| 2007-04-13 | Alkermes, Inc. | Regulatory FDA Approves New Dose of RISPERDAL(R) CONSTA(R) for Schizophrenia Treatment alkermes.com ↗
The U.S. Food and Drug Administration (FDA) approved a 12.5 mg dose of RISPERDAL® CONSTA® [(risperidone) Long-Acting Injection] for the treatment of schizophrenia within specific patient populations, including those with renal and hepatic impairment. |
| 2007-04-03 | Eli Lilly and Company | Results New Data Show Early Non-Response to Antipsychotic Treatment May Be Strong Predictor of Subsequent Non-Response for People with Schizophrenia lilly.com ↗
New data presented at the 2007 International Congress on Schizophrenia Research (ICOSR) suggest that antipsychotic drug response be assessed earlier than is presently thought, and challenge the current schizophrenia treatment paradigm for when to evaluate if an antipsychotic medication is working effectively. |
| 2007-03-19 | ACADIA Pharmaceuticals Inc. | Results ACADIA Announces Positive Results From ACP-103 Phase II Schizophrenia Co-Therapy Trial acadia.com ↗
In addition, the co-therapy arm combining ACP-103 with low-dose risperidone demonstrated a statistically significant improvement in antipsychotic efficacy as compared to low-dose risperidone plus placebo, and comparable efficacy to high-dose risperidone plus placebo. |
| 2006-12-20 | Alkermes, Inc. | Regulatory Alkermes Announces Submission of New Drug Application for RISPERDAL(R) CONSTA(R) in Japan alkermes.com ↗ |
| 2006-12-01 | Eli Lilly and Company | Results Lilly Responds to the Cost-Effectiveness Analysis of the CATIE Schizophrenia Trial lilly.com ↗
Zyprexa was less costly by about $2,700 per year than quetiapine, $1,212 per year less than risperidone, and $3,564 per year less than ziprasidone. |
| 2006-10-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval for Generic Risperdal® Oral Solution tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Janssen's Risperdal® (Risperidone) Oral Solution, 1 mg/mL. |
| 2006-10-05 | Alkermes, Inc. | Results Fewer Hospitalizations and Lower Medical Costs Seen Among Patients with Schizophrenia Taking Risperidone Long-Acting Injection alkermes.com ↗ |
| 2006-04-01 | Eli Lilly and Company | Results CATIE Phase 2 Data Confirm Patients Stay on Treatment Longer Because of Symptom Improvement More So Than Tolerability lilly.com ↗
In the tolerability arm, risperidone and Zyprexa performed best in terms of all-cause discontinuation, which was contrary to the study's hypothesis that ziprasidone would be the most effective atypical because it caused little or no weight gain(ii). |
| 2005-12-20 | Eli Lilly and Company | Results New Study Showed No Difference in Total Treatment Costs When Comparing Those Starting Treatment with Older Conventional Antipsychotics and Those Starting Treatment with Zyprexa(R), an Atypical Antipsychotic, in the Treatment of Schizophrenia lilly.com ↗
The data showed that despite higher medication costs of Zyprexa, the difference in one-year direct total costs between Zyprexa, as initial (first-line) treatment, and conventional antipsychotics as first line treatment, was small and not statistically significant. |
| 2005-09-19 | Eli Lilly and Company | Results According to CATIE, Zyprexa(R) More Effective on Discontinuation Rate than Other Antipsychotics Studied lilly.com ↗
CATIE found that for Zyprexa the average time to discontinuation was 9.2 months as compared with 4.6 months for quetiapine, 4.8 months for risperidone, 3.5 months for ziprasidone and 5.6 months for perphenazine. |
| 2005-09-15 | Alkermes, Inc. | Regulatory Alkermes Announces RISPERDAL(R) CONSTA(R) Approved in Italy alkermes.com ↗
Alkermes, Inc. (Nasdaq: ALKS) today announced that its partner, Janssen-Cilag S.p.A., received approval from the Italian Regulatory Authorities to market RISPERDAL(R) CONSTA(R) ((risperidone) long-acting injection), an atypical antipsychotic medication for the treatment of schizophrenia. |
| 2005-05-23 | Eli Lilly and Company | Results New Study Showed Efficacy was Most Important Factor in Decision to Stay on Antipsychotic Treatment for Schizophrenia lilly.com ↗
People taking atypical antipsychotics for schizophrenia were most likely to discontinue therapy due to continued presence of psychiatric symptoms, according to data presented today at the 158th annual meeting of the American Psychiatric Association (APA). |
| 2005-04-06 | Eli Lilly and Company | Results Studies Show Schizophrenia Patients Taking Atypicals Stayed on Treatment Longer Than Patients Taking Older, Typical Antipsychotics lilly.com ↗
One of the studies revealed that patients taking olanzapine or clozapine remained on treatment longer than other atypicals (risperidone, quetiapine, ziprasidone) or the typical perphenazine. |
| 2004-12-14 | Eli Lilly and Company | Results Study Demonstrated Long-Term Treatment with Zyprexa® Reduced Violent Behavior in People with Schizophrenia Compared to Risperidone lilly.com ↗
Long-term treatment with Zyprexa® (olanzapine) significantly lowered risk of violent behavior in people with schizophrenia versus risperidone (Risperdal®, Janssen), according to a study published in the December issue of the Journal of Clinical Psychiatry. |
| 2003-10-29 | Alkermes, Inc. | Regulatory FDA Approves Risperdal Consta for Treating Schizophrenia; First Long-Acting, Newer-Generation Antipsychotic Addresses Major Challenge of Schizophrenia Treatment alkermes.com ↗
Alkermes, Inc. (NASDAQ: ALKS) today announced the U.S. Food and Drug Administration (FDA) approved RISPERDAL(R) CONSTA(TM) ((risperidone) long-acting injection) for the treatment of schizophrenia. |
| 2003-10-09 | Alkermes, Inc. | Regulatory Alkermes Announces Risperdal Consta Approved in France alkermes.com ↗
Alkermes, Inc. (Nasdaq:ALKS) today announced that its partner, Janssen-Cilag S.A., has received approval from the French Regulatory Authorities to market Risperdal Consta(TM). |
| 2003-04-29 | Alkermes, Inc. | Regulatory Alkermes Announces Additional Data and Analyses Submitted to FDA for Risperdal Consta; Response Package Sets in Motion New FDA Action on NDA alkermes.com ↗
This submission represents an important step towards our goal of bringing the first long-acting atypical antipsychotic drug to patients with schizophrenia in the U.S. |
| 2003-02-26 | Alkermes, Inc. | Regulatory Alkermes Announces Risperdal Consta Approved in Spain alkermes.com ↗
Alkermes, Inc. (Nasdaq:ALKS) today announced that its partner, Janssen-Cilag S.A., has received approval from the Spanish Ministry of Health to market Risperdal Consta(TM). |
| 2002-08-09 | Alkermes, Inc. | Regulatory Alkermes Announces Approval in United Kingdom for Risperdal Consta alkermes.com ↗
Alkermes, Inc. (Nasdaq:ALKS) today announced that its partner, Johnson and Johnson Pharmaceutical Research & Development (J&JPRD), has received approval from The Medicines Control Agency to market Risperdal Consta(TM) (risperidone) in the United Kingdom. |
| 2002-08-01 | Alkermes, Inc. | Regulatory Alkermes Announces Approval in Germany for Risperdal Consta; First Atypical Antipsychotic to be Available as Long-Acting Injection alkermes.com ↗
Alkermes, Inc. (Nasdaq: ALKS) today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development (J&JPRD), has received approval to market Risperdal Consta(TM) (risperidone) in Germany. |
| 2002-02-26 | Alkermes, Inc. | Results Poster Titled 'Maintenance of Efficacy Without Compromising Safety When Switching From Oral Risperidone to Risperdal Consta', Posted On Alkermes' Website alkermes.com ↗
This poster demonstrates the maintenance of efficacy without compromising safety when switching from Risperdal(R) (risperidone) tablets to Risperdal Consta. |
All press releases naming this drug 100 releases
Evidence & citations 30 cited values
Every value below carries the sentence it was read from. 451 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Risperidone | “Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗436“Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with...” NCT00094926 ↗ “In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied...” NCT00159133 ↗ “If the patient is within the primary medication arm and reports a 20-50% improvement in GAD symptoms compared to baseline after six weeks on the new medication, the medication...” NCT04478526 ↗ “Subjects (N = 44) who failed to respond to SSRIs were randomly assigned to 1 of 3 atypical antipsychotics -- olanzapine, quetiapine, or risperidone -- and were consecutively...” PMID 19422759 ↗ May 2009 “Patients randomized to oral comparator arm will receive oral antipsychotics (haloperidol, paliperidone ER, risperidone, olanzapine, quetiapine or aripiprazole) as per...” NCT01081769 ↗ “The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test...” NCT00179244 ↗ “For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗ “RYKINDO® (Rykindo) is a novel, long-acting injectable risperidone formulation administered biweekly (Q2W) through intramuscular gluteal injection for the treatment of...” PMID 38244179 ↗ Jan 2024 “This study was developed in order to assess the effects of risperidone (Risperdal) as compared with placebo on cognitive-motor performance (attention, memory, and hand...” NCT00399698 ↗ |
| Known as | (Risperdal M-TAB) tablets of Janssen Pharmaceutica Products | “(Risperdal M-TAB) tablets of Janssen Pharmaceutica Products” NCT01155921 ↗ |
| Known as | Consta | “Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks” NCT00177164 ↗1“Depot Risperidone Microsphere (Consta)” NCT00215579 ↗ |
| Known as | EN3342 | “EN3342 (risperidone) subcutaneous implant” NCT01774435 ↗ |
| Known as | LYN-005 | “LYN-005 (risperidone)” NCT06878833 ↗ |
| Known as | Oral Ris | “Risperidone, administered orally (Oral Ris)” NCT00333177 ↗ |
| Known as | Oral Risperidone | “Drug: Oral Risperidone” NCT02431702 ↗ |
| Known as | QUAR | “quarterly Risperidone (QUAR)” NCT06276361 ↗ |
| Known as | R064766 | “A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder” NCT01624675 ↗ |
| Known as | RBP-7000 | “RBP-7000, a recently marketed long-acting subcutaneous injectable risperidone formulation, were examined to determine if dose-response relationships existed for different items...” PMID 34551218 ↗ Sep 20211“A single subcutaneous injection of RBP-7000 containing 120 mg risperidone in the ATRIGEL® Delivery System formulated with 21 kDa PLGH polymer.” NCT02687984 ↗ |
| Known as | RCN3028 | “A Study to Evaluate the Effects of RCN3028 on Moderate to Severe Vasomotor Symptoms in Women” NCT02100540 ↗ |
| Known as | RIS | “OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with...” NCT00004393 ↗2“Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)” NCT01742390 ↗ “4. 320 begin double-blind treatment with risperidone (RIS)” NCT00014001 ↗ |
| Known as | RIS-LAI | “injectable atypical antipsychotic paliperidone palmitate (PP) versus risperidone long-acting injectable (RIS-LAI)” PMID 21092748 ↗ Nov 2010 |
| Known as | RISP | “This study compared the efficacy in reducing aggressive behavior of risperidone (RISP), divalproex sodium (DVPX), and placebo (PBO) added to stimulant medication among...” PMID 32007604 ↗ Jan 2020 |
| Known as | Risperdal | “The purpose of this study is to evaluate the comparative effectiveness of Risperdal (risperidone) or bupropion ER (extended release) combined with a SSRI medication and to test...” NCT00179244 ↗20“This study was developed in order to assess the effects of risperidone (Risperdal) as compared with placebo on cognitive-motor performance (attention, memory, and hand...” NCT00399698 ↗ “An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres (RISPERDAL CONSTA) Administered Once Monthly in Adults With Schizophrenia or...” NCT00236353 ↗ “A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children” NCT00254930 ↗ “This 3-year study will determine if the antipsychotic medications olanzapine (Zyprexa®) and risperidone (Risperdal®) can help patients with first-episode schizophrenia.” NCT00000374 ↗ “The Safety And Efficacy Of Risperdal� (Risperidone) Versus Placebo As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder” NCT00250367 ↗ “The changes in brain chemicals that occur when an SSRI type antidepressant is supplemented with risperidone (Risperdal®) will be studied.” NCT00178854 ↗ “Switched From RISPERDAL® Tablets (Risperidone) to an Equivalent Dose of a rapidly-dissolving Tablet Formulation of Risperdone” NCT00246272 ↗ “This study will compare the safety and effectiveness two medications, citalopram (Celexa®) and risperidone (Risperdal®).” NCT00073658 ↗ “Long actiing risperidone injection (Consta), oral risperidone (risperdal).” NCT00177164 ↗ “olanzapine (Zyprexa), risperidone (Risperdal) or quetiapine (Seroquel)” NCT00048802 ↗ |
| Known as | Risperdal (risperidone) Consta | “Risperdal (risperidone) Consta” NCT00571688 ↗ |
| Known as | Risperdal Consta | “A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2...” NCT00297388 ↗7“The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with...” NCT00094926 ↗ “The specific aim of this study is to determine whether the new, long-acting, form of risperidone, Risperdal Consta, improves the ability of schizophrenia patients to benefit...” NCT00148083 ↗ “An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres (RISPERDAL CONSTA) Administered Once Monthly in Adults With Schizophrenia or...” NCT00236353 ↗ “A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)” NCT00216528 ↗ “long-acting injectable risperidone (RISPERDAL® CONSTA™) compared with the previous treatment with oral olanzapine” NCT00216632 ↗ “The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta).” NCT00539071 ↗ “RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection)” NCT00589914 ↗ |
| Known as | Risperidone ISM | “The primary objective of this study was to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once-daily 4 mg...” NCT05179525 ↗ |
| Known as | risperidone LAI | “a long-acting injectable formulation of risperidone (risperidone LAI)” NCT00236587 ↗1“Risperidone LAI 37.5 mg” NCT01888107 ↗ |
| Known as | Risperidone Long-Acting Injection (RLAI) | “Risperidone Long-Acting Injection (RLAI) (Period 1)” NCT00378092 ↗ |
| Known as | Risperidone Long-Acting Intramuscular Injection | “RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection)” NCT00589914 ↗ |
| Known as | Risperidone, H20010309 | “Risperidone, H20010309” NCT04071639 ↗ |
| Known as | Risperidone-SABER | “ZX003 (Risperidone-SABER®)” NCT02411526 ↗ |
| Known as | RLAI | “Participants were randomly assigned at a 2:1 ratio to a recommendation of changing to LAI risperidone microspheres (RLAI) (n = 26) or continuing oral antipsychotic treatment (n...” PMID 22938760 ↗ Aug 20127“Long-term treatment with risperidone long-acting injectable (RLAI), the first available long-acting atypical antipsychotic, versus oral atypical antipsychotics showed better...” PMID 22339430 ↗ Apr 2012 “This study was designed to investigate long-term clinical outcomes of risperidone long-acting injectable (RLAI) in patients with schizophrenia or schizoaffective disorder.” PMID 24583566 ↗ Sep 2014 “Treatment With Risperidone Long Acting Injectable (RLAI) in an Early Phase of Psychosis” NCT00369239 ↗ “Risperidone Long-Acting Injection (RLAI) (Period 1)” NCT00378092 ↗ “Risperidone, administered via injection (RLAI)” NCT00333177 ↗ “risperidone long-acting injectable (RLAI)” NCT01888107 ↗ “Risperidone Long-Acting Injectable (RLAI)” NCT00269919 ↗ |
| Known as | RLAT | “This study assessed whether adjunctive maintenance treatment with risperidone long-acting therapy (RLAT), added to treatment-as-usual (TAU) medications for bipolar disorder,...” PMID 19922552 ↗ Dec 2009 |
| Known as | Rykindo | “RYKINDO® (Rykindo) is a novel, long-acting injectable risperidone formulation administered biweekly (Q2W) through intramuscular gluteal injection for the treatment of...” PMID 38244179 ↗ Jan 2024 |
| Known as | ZX003 | “ZX003 (Risperidone-SABER®)” NCT02411526 ↗ |
| Action | Inhibit | “risperidone's relatively potent dopamine D2 receptor blockade” PMID 26302441 ↗ Oct 2015 |
| Modality | Other / unclassified | “an antipsychotic medication” NCT00266552 ↗ |
| Route | Oral | “as an oral solution each day” NCT00034749 ↗ |