Paliperidone
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed schizoaffective disorder 1 milestone | |||||
| Filed | US (FDA) | INVEGA SUSTENNA | schizoaffective disorder | 2014-05-13 | “Additional sNDA's were also submitted to the FDA for once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) for approval to treat...” jnj.com ↗ “Supplemental New Drug Applications for Once -Monthly Long-Acting Therapy INVEGA ® SUSTENNA® (paliperidone palmitate) Submitted to the U.S. FDA for the Treatment of” jnj.com ↗ |
| Filed schizophrenia 5 milestones | |||||
| Filed | EU (EMA) | — | schizophrenia | 2020-12-04 | “Janssen Submits Marketing Authorisation Extension to the European Medicines Agency to Register Paliperidone Palmitate 6-Monthly (PP6M) for Treatment of Schizophrenia in Adults” jnj.com ↗ |
| Filed | US (FDA) | — | schizophrenia | 2020-11-02 | “Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S.” jnj.com ↗ |
| Filed | EU (EMA) | — | schizophrenia | 2015-08-21 | “submission of an Extension Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation for...” jnj.com ↗ “Marketing Authorization Applications were submitted to the European Medicines Agency for paliperidone palmitate once-every-three-months formulation for the treatment of schizophrenia” jnj.com ↗ |
| Rejected (CRL) | US (FDA) | INVEGA SUSTENNA | schizophrenia | 2015-05-11 | “and Drug Administration (FDA) issued a Complete Response letter regarding the supplemental new drug application (sNDA) for once-monthly long-acting antipsychotic INVEGA...” jnj.com ↗ |
| Filed | US (FDA) | — | schizophrenia | 2014-11-19 | “today announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to the U.S. Food and Drug Administration (FDA).” jnj.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | INVEGA | — | 2007-12-21 – 2011-04-06 | fda.gov ↗ |
| Approved | EU (EMA) | Invega | — | 2007-06-24 | europa.eu ↗ |
| Approved | US (FDA) | INVEGA | — | 2006-12-19 | fda.gov ↗ |
Trials 105 · started per year
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
Additional new data comparing initiation of UZEDY® (risperidone) versus Invega Sustenna® (paliperidone palmitate) in hospitalized patients found that UZEDY was associated with shorter length of stay |
| 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 ↗
Switching to UZEDY at four weeks after the last dose of once-monthly paliperidone palmitate provided the most comparable pharmacokinetic (PK) profile based on the relevant PK modeling data |
| 2021-11-23 | Janssen Research & Development, LLC | Regulatory European Commission Approves BYANNLI® (6-monthly Paliperidone Palmitate; PP6M) for the Maintenance Treatment of Schizophrenia in Adults jnj.com ↗ |
| 2021-09-17 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for BYANNLI® (6-monthly Paliperidone Palmitate) for the Maintenance Treatment of Schizophrenia in Adults jnj.com ↗
Janssen Receives Positive CHMP Opinion for BYANNLI® (6-monthly Paliperidone Palmitate) for the Maintenance Treatment of Schizophrenia in Adults |
| 2021-09-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™(6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults. |
| 2021-09-01 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of INVEGA HAFYERA™ (6-month paliperidone palmitate), First and Only Twice-Yearly Treatment for Adults with Schizophrenia jnj.com ↗ |
| 2020-11-02 | Janssen Research & Development, LLC | Regulatory Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults jnj.com ↗
Janssen Submits Paliperidone Palmitate 6-Month (PP6M) Supplemental New Drug Application to U.S. FDA for Treatment of Schizophrenia in Adults |
| 2016-05-31 | Janssen Research & Development, LLC | Regulatory European Commission Approves TREVICTA® (paliperidone palmitate a 3-monthly injection), for Maintenance Treatment of Schizophrenia jnj.com ↗
Janssen-Cilag International NV announced today that the European Commission (EC) has approved the use of TREVICTA(paliperidone palmitate a 3-monthly injection) for the maintenance treatment of schizophrenia in adult patients. |
| 2016-04-01 | Janssen Research & Development, LLC | Regulatory Janssen Receives CHMP Positive Opinion for TREVICTA® (paliperidone palmitate a 3-monthly injection) Recommending Approval in the European Union for the Maintenance Treatment of Schizophrenia jnj.com ↗
Janssen Receives CHMP Positive Opinion for TREVICTA® (paliperidone palmitate a 3-monthly injection) Recommending Approval in the European Union for the Maintenance Treatment of Schizophrenia |
| 2015-06-25 | Janssen Research & Development, LLC | Regulatory INVEGA TRINZA™, First and Only Four-Times-A-Year Treatment for Schizophrenia, Now Commercially Available jnj.com ↗
Janssen Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) recently approved INVEGA TRINZA™ under Priority Review. |
| 2014-11-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Aripiprazole Once-Monthly Injectable Shows Superior Effectiveness to Paliperidone Palmitate Once-Monthly Injectable on Quality of Life Scale in Patients with Schizophrenia otsuka-us.com ↗
Patients treated with aripiprazole once-monthly demonstrated a statistically significant improvement on the primary endpoint, quality-of-life measures, compared to those treated with paliperidone palmitate |
| 2014-06-04 | Janssen Research & Development, LLC | Regulatory INVEGA® receives European Commission approval to extend its adult indication for treatment of schizophrenia to include adolescents aged 15 years and older jnj.com ↗
Janssen-Cilag International NV announced today that the European Commission has approved an extension of the oral atypical antipsychotic INVEGA® (paliperidone ER) schizophrenia indication, to include adolescents aged 15 years and older. |
| 2014-03-20 | Janssen Research & Development, LLC | Results Janssen Investigational Treatment for Schizophrenia Shows Positive Efficacy, Delays Relapse jnj.com ↗
Independent Data Monitoring Committee Recommends Halting Trial and Unblinding Data Based on Treatment Efficacy |
All press releases naming this drug 28 releases
Evidence & citations 20 cited values
Every value below carries the sentence it was read from. 136 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Paliperidone | “Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol...” NCT01323205 ↗124“Drugs: Aripiprazole, Olanzapine, Zuclopenthixol, Clotiapine, Flupentixol, Risperidone, Sulpiride, Trifluoperazine, Haloperidol, Quetiapine, Paliperidone, Chlorpromazine,...” NCT01765829 ↗ “A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied...” NCT01592201 ↗ “For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone,...” NCT02181803 ↗ “Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\])” NCT01556763 ↗ “Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.” NCT03319953 ↗ “Including Olanzapine, Risperidone, Paliperidone, Quetiapine, Aripiprazole, Ziprasidone, Lurasidone, Cariprazine, and all Typical antipsychotics” NCT05741502 ↗ “Paliperidone, the primary active metabolite of risperidone, is a long-acting atypical neuroleptic (antipsychotic) medication.” NCT02541513 ↗ “AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone” NCT03565068 ↗ |
| Known as | 9-hydroxy-risperidone | “Paliperidone (9-hydroxy-risperidone) is an active metabolite of the second-generation antipsychotics risperidone.” NCT02433717 ↗ |
| Known as | 9-OH-risperidone | “Paliperidone (9-OH-risperidone, metabolite of risperidone), when used with OROS technology has a unique pharmacokinetic profile undergoing limited hepatic metabolism.” PMID 17466492 ↗ Apr 2007 |
| Known as | ER OROS paliperidone | “ER OROS paliperidone (12 mg, oral) on Days 2 to 6, ER OROS paliperidone (12 mg, oral) on Days 1 to 6, or IR risperidone (oral) 2 mg on Day 1 and 4 mg on Days 2 to 6” NCT00791232 ↗3“All volunteers will receive single doses of 3 mg ER OROS paliperidone with and without a standard Japanese breakfast.” NCT00892320 ↗ “A Dose-proportionality Study of Five Tablet Strengths of ER OROS Paliperidone” NCT00796835 ↗ “ER OROS paliperidone, paliperidone ER” NCT00796081 ↗ |
| Known as | extended-release paliperidone | “The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in...” NCT00488319 ↗ |
| Known as | Immediate release (IR) Paliperidone | “Immediate release (IR) Paliperidone” NCT00791349 ↗ |
| Known as | Invega Sustenna | “Patients without previous exposure to paliperidone ER (Invega), paliperidone palmitate (Invega Sustenna), risperidone, or RISPERDAL CONSTA will be given 4 to 6 days of...” NCT01193153 ↗ |
| Known as | JNS007ER | “Paliperidone extended-release (JNS007ER)” NCT01561898 ↗ |
| Known as | Oral Paliperidone ER | “Drug: Oral Paliperidone ER” NCT02431702 ↗ |
| Known as | PALI | “Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)” NCT01742390 ↗ |
| Known as | Paliperidone ER | “Paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to...” NCT00460512 ↗20“Patients previously treated with any oral antipsychotic, except those treated with paliperidone ER, olanzapine or clozapine during the last 6 months, can be enrolled and will...” NCT00645099 ↗ “Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the...” NCT00757705 ↗ “The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and...” NCT00334126 ↗ “The purpose of this study is to evaluate the effects of a CYP2D6 inhibitor, paroxetine, on the pharmacokinetics of a single dose of orally administered paliperidone ER and to...” NCT00791713 ↗ “Paliperidone ER has been shown to be effective in treating schizophrenia, and has an improved delivery system (with delivery at a relatively controlled rate over 24 hours) and...” NCT00309686 ↗ “This study will investigate the effect of paliperidone ER (in combination with or without benzodiazepines) in patients presenting with symptoms of agitation and/or aggression...” NCT01050478 ↗ “The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.” NCT00086320 ↗ “This study is designed to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (6, 9, and 12 mg/day) compared with placebo in patients with schizophrenia.” NCT00078039 ↗ “In this uncontrolled population of patients with schizophrenia who were treated with paliperidone ER, the percentage of patients who were employed increased over time.” PMID 21155708 ↗ Dec 2010 “Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults.” NCT00518323 ↗ |
| Known as | paliperidone extended-release | “We evaluated the efficacy of paliperidone extended-release (ER), an investigational psychotropic agent, in delaying symptom recurrence in adult patients with schizophrenia and...” PMID 17224706 ↗ Feb 20075“Participants with suboptimal response to oral risperidone were randomized to paliperidone extended release (ER) immediate or delayed (week 2) initiation.” PMID 20216424 ↗ May 2010 “Paliperidone extended release (ER) might be considered as a treatment option for patients presenting with agitation and/or aggression” NCT01050478 ↗ “This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design.” PMID 24491033 ↗ Feb 2014 “randomly assigned to treatment with paliperidone extended-release, quetiapine, or placebo.” PMID 19411369 ↗ May 2009 “paliperidone extended-release (ER) tablets were assessed in patients with acute mania.” PMID 20624657 ↗ Jul 2010 |
| Known as | paliperidone extended-release (ER) | “The purpose of this study is to measure the effectiveness and assess the safety of two dosages of the antipsychotic paliperidone extended-release (ER) in patients who are...” NCT00397033 ↗4“This study assessed potentially prolactin-related treatment-emergent adverse events (PPRL-TEAEs) and sexual maturation during long-term treatment of adolescents with...” PMID 28660406 ↗ Sep 2017 “Data were from three 52-week open-label extensions of the double-blind pivotal trials of paliperidone extended-release (ER) (trial numbers NCT00650793, NCT00210769 and NCT00668837).” PMID 21155708 ↗ Dec 2010 “Paliperidone extended-release (ER) tablets will be administered orally once daily at flexible doses ranging from 6 mg to 12 mg” NCT07153835 ↗ “This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design.” PMID 24491033 ↗ Feb 2014 |
| Known as | Paliperidone Extended-Release Tablets | “F. Trial medications Paliperidone Extended-Release Tablets (Invega): 9 mg/tab, 3 mg/tab” NCT02433717 ↗ |
| Known as | paliperidone palmitate | “Two formulations of paliperidone have been studied for these indications: an extended-release oral formulation (NCT00397033, NCT00412373) and long-acting injectable...” PMID 26934062 ↗ Mar 20162“injectable atypical antipsychotic paliperidone palmitate (PP) versus risperidone long-acting injectable (RIS-LAI)” PMID 21092748 ↗ Nov 2010 “Drug: Paliperidone palmitate” NCT02146547 ↗ |
| Known as | Paliperidone: Invega | “Paliperidone: Invega®” NCT01795547 ↗ |
| Known as | R078543 (+) | “Treatment D, 1 mg (+)-paliperidone (R078543) oral solution” NCT00796276 ↗ |
| Known as | R078544 (-) | “Treatment E, 1 mg (-)-paliperidone (R078544) oral solution” NCT00796276 ↗ |
| Action | Inhibit | “Antipsychotic medications like risperidone and paliperidone ER are used to treat psychosis by blocking the dopamine receptors.” NCT00934635 ↗ |
| Route | Oral | “Patients will be randomized into 1 of 4 treatment groups to receive oral dosages of paliperidone ER 6 mg or 12 mg, olanzapine 10 mg, or placebo once daily for a 6-week period.” NCT00077714 ↗ |