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risperidone

Generic: RISPERIDONE·Brand: PERSERIS KIT, Perseris, RISPERDAL, RISPERDAL CONSTA, RISPERIDONE, RISVAN, RYKINDO, Risperdal, Rykindo, UZEDY, Uzedy

risperidone: sourced relationships with 4 companies · 5 clinical trials tracked · 4 FDA decisions.

risperidone evidence translation

What we can confirm

4 FDA records · 5 tracked trials

What it means

More than one company relationship is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about risperidone, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 2 study sponsors

Related indications

Schizophrenia
Dated Pipeline Records (4)
CompanyDated record stage
Amneal Pharmaceuticals, Inc. (AMRX)
Reported 2011-05-25 · Current development: unknownSource
Approved
LANNETT CO INC (LCI)
Reported 2010-12-03 · Current development: unknownSource
Approved
DR REDDYS LABORATORIES LTD (RDY)
Reported 2008-10-24 · Current development: unknownSource
Approved
Teva Pharmaceutical Industries Limited (TEVA)
Reported 2023-04-28 · Current development: unknownSource
Approved
Clinical Trial Registry Records (5)

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Study to Evaluate Efficacy of Roluperidone on Negative Symptoms in Adult Subjects With Schizophrenia, Followed by a 52-Week, Randomized, Double-Dummy Phase to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications

NCT07565428Registry updated 2026-07-28·Phase 3·NERV
Recruiting

Primary endpoint: Change from Baseline to Week 12 in Marder Negative Symptoms Factor Score (NSFS)

InterventionalRandomizedquadruple380 targetStarted 2026-04Completion 2028-1213 sites · United StatesMinerva Neurosciences

A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia

NCT02469155Registry updated 2025-10-02·Phase 3·ITCI
Completed

Primary endpoint: Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score

InterventionalRandomizedquadruple696 enrolledStarted 2015-06Completion 2016-0811 sites · United StatesIntra-Cellular Therapies, Inc.

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

NCT01499563Registry updated 2025-10-03·Phase 2·ITCI
Completed

Primary endpoint: Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score

InterventionalRandomizedquadruple335 enrolledStarted 2011-12Completion 2013-118 sites · United StatesIntra-Cellular Therapies, Inc.

Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Schizoaffective Disorders, Who is Receiving Psychiatric Home-care Treatment, When Switching From Typical Depot or Oral Antipsychotics to Long-acting Risperidone Microspheres

NCT00526877Registry updated 2026-06-03·Phase 4
Completed

Primary endpoint: Change From Baseline in Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24

Interventionalopen31 enrolledStarted 2007-07Completion 2009-011 site · TaiwanJohnson & Johnson Taiwan Ltd

The Effectiveness of Supplementing Supported Employment With Behavioral Skills Training

NCT00183625Registry updated 2026-02-09·Phase 4
Completed

Primary endpoint: Total Weeks Worked

InterventionalRandomizedquadruple107 enrolledStarted 2000-06Completion 2006-092 sites · United StatesUniversity of California, Los Angeles
FDA Decisions4 records
Approval(TEVA)FDA ↗
NDA213586Type 5 - New Formulation or New ManufacturerStandardSubcutaneousSuspension, Extended Release
Approval1 INDICATIONS AND USAGE Risperidone oral solution is an atypical antipsychotic indicated for: Treatment of schizophrenia. (1.1) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. (1.2) Treatment of irritability associated with autistic disorder. (1.3) 1.1 Schizophrenia Risperidone oral solution is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adul(AMRX)FDA ↗
ANDA091384OralSolution
Approval1 INDICATIONS AND USAGE Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia Risperidone tablets are indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 s(LCI)FDA ↗
ANDA079158OralSolution
Approval(RDY)FDA ↗
ANDA076879OralTablet

Frequently asked questions

Which companies have sourced relationships with risperidone?

risperidone has dated SEC/FDA relationship records for Amneal Pharmaceuticals, Inc., LANNETT CO INC, DR REDDYS LABORATORIES LTD and 1 other.

How many clinical trials involve risperidone?

BioSniper tracks 5 clinical trials involving risperidone.

What is risperidone's latest FDA decision?

The most recent tracked FDA decision for risperidone is Approval, dated April 28, 2023.