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paliperidone palmitate

Generic: PALIPERIDONE PALMITATE·Brand: ERZOFRI, INVEGA HAFYERA, INVEGA SUSTENNA, INVEGA TRINZA

paliperidone palmitate: developed by 1 company · 1 clinical trial tracked · 1 FDA decision.

paliperidone palmitate evidence translation

What we can confirm

1 FDA record · 1 tracked trial

What it means

Source-backed records connect paliperidone palmitate to VTRS; that link alone does not prove the drug works.

What to watch

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

Prepared research question

How could paliperidone palmitate → VTRS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 1 study sponsors
Development Pipeline (1)
CompanyPhase
Viatris Inc (VTRS)Approved
Clinical Trials (1)

A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics

NCT02431702·Phase 3·BRSF
Completed

Primary endpoint: Part-2 (Disease Progression): Time to First Treatment Failure

InterventionalRandomizedopen337 enrolledStarted 2015-07Completion 2019-1138 sites · Brazil, Mexico, United StatesJanssen Scientific Affairs, LLC
FDA Decisions1 records
Tentative Approval1 INDICATIONS AND USAGE INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults [see Clinical Studies (14.1) ]. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2) ]. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers o(VTRS)FDA ↗
ANDA215682UNKNOWNStandardOtherInjection

Frequently asked questions

Who is developing paliperidone palmitate?

paliperidone palmitate is being developed by Viatris Inc.

How many clinical trials involve paliperidone palmitate?

BioSniper tracks 1 clinical trial involving paliperidone palmitate.

What is paliperidone palmitate's latest FDA decision?

The most recent tracked FDA decision for paliperidone palmitate is Tentative Approval for 1 INDICATIONS AND USAGE INVEGA SUSTENNA (paliperidone palmitate) is indicated for the treatment of: Schizophrenia in adults [see Clinical Studies (14.1) ]. Schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants [see Clinical Studies (14.2) ]. INVEGA SUSTENNA is an atypical antipsychotic indicated for Treatment of schizophrenia in adults. ( 1 ) Treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers o, dated December 3, 2024.