Paliperidone
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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
Also used as a comparator or background therapy in 20 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03565068 Background | Jun 2018 → Apr 2020 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT02634463 Background | Nov 2015 → Nov 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02181803 Background | Aug 2014 → Apr 2015 | schizophrenia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01556763 Background | Apr → Aug 2008 | schizoaffective disorder, schizophrenia | FORUM Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT03730857 Comparator | Jan → Dec 2008 | schizophrenia | Calo Psychiatric Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03425552 Comparator | Mar 2018 → May 2019 | schizophrenia | Pharmathen S.A. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT03557931 Background | Jul 2018 → Oct 2019 | schizophrenia | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03319953 Background | Dec 2017 → Sep 2019 | schizophrenia | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 2 | NCT01323205 Background | May 2011 → Nov 2012 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03485417 Comparator | Jun 2019 → May 2024 | schizophrenia, substance abuse, substance dependence, substance-induced psychosis | The University of Hong Kong | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02431702 Comparator | Jul 2015 → Nov 2019 | schizophrenia | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01795547 Comparator | Feb 2013 → Sep 2014 | schizophrenia | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT07047651 Background | Jun 2025 → Dec 2027 expected | treatment-refractory schizophrenia | Dr. Stavroula Rakitzi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05741502 Comparator | Aug 2023 → Jan 2026 | schizophrenia | Ohio State University | Terminated | No outcome recorded |
| Phase 4 | NCT02146547 Comparator | Feb 2015 → Aug 2020 | schizophrenia | UMC Utrecht | Completed | No outcome recorded |
| Phase 4 | NCT01742390 Comparator | Feb → Dec 2013 | hyperprolactinemia, sexual disorder | Si Tianmei | Unknown | No outcome recorded |
| Phase 4 | NCT00934635 Comparator | Sep → Dec 2009 | schizophrenia | Janssen-Cilag GmbH | Terminated | No outcome recorded |
| Phase 4 | NCT01279213 Comparator | Jan → Oct 2009 | schizophrenia | Universidad Nacional de Rosario | Completed | No outcome recorded |
| Phase 4 | NCT00806234 Comparator | Jan 2009 → Mar 2014 | psychotic disorder | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT00330863 Comparator | May 2006 → Jan 2011 | schizoaffective disorder, schizophrenia | Northwell Health | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-06-01 | Teva Branded Pharmaceutical Products R&D, Inc. | New Data Provide Schizophrenia Treatment Insights into Switching to UZEDY® (risperidone) Extended-Release Injectable Suspension from Invega Sustenna® (paliperidone palmitate) tevapharm.com ↗ |
| 2014-11-03 | Otsuka Pharmaceutical Development & Commercialization, Inc. | 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 ↗ |
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 ↗ “Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months.” NCT00915512 ↗ “Paliperidone extended-release tablet (paliperidone ER) is an oral psychotropic agent developed for schizophrenia treatment.” PMID 17466492 ↗ Apr 2007 “assessing the efficacy and safety of paliperidone ER in a real-world, multi-site setting” NCT07153835 ↗ “Subjects received higher-dose (12 mg/d) or lower-dose (6 mg/d) paliperidone ER.” PMID 20492853 ↗ May 2010 “Paliperidone ER, 3, 6, or 12 mg/day or placebo once daily for 3 weeks.” NCT00299715 ↗ “6-mg paliperidone ER once daily from Day 1 through Day 7, route oral” NCT00892125 ↗ “ER OROS paliperidone, paliperidone ER” NCT00796081 ↗ “Drug: Paliperidone ER” NCT01577186 ↗ “Drug: Paliperidone ER” NCT00488319 ↗ “Drug: Paliperidone ER” NCT00412373 ↗ |
| 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 ↗ |