Drugs / paliperidone palmitate
paliperidone palmitate
also known as
PP3M · PP1M · INVEGA SUSTENNA · Invega · INVEGA TRINZA · LY03010 · paliperidone palmitate(sustenna) · Paliperidone palmitate: Xeplion or Invega Sustenna · +2 more
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | INVEGA HAFYERA | — | 2021-08-30 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | INVEGA SUSTENNA | — | 2012-08-29 – 2017-12-20 | fda.gov ↗ |
| Approved | EU (EMA) | Xeplion | — | 2011-03-04 | europa.eu ↗ |
| Approved | US (FDA) | INVEGA SUSTENNA | — | 2009-07-31 | fda.gov ↗ |
Trials 41 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04922593 | Jan 2021 → Mar 2022 | mood disorder, schizophrenia | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04572685 | Jan → Jun 2020 | schizophrenia | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01942382 | Apr 2009 → Mar 2010 | schizophrenia | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT01150448 | Sep 2007 → Jun 2009 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01110317 | Jul 2005 → Mar 2006 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01606254 | Jan 2007 → Apr 2008 | schizophrenia | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT00074477 | Oct 2003 → Jul 2004 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 319 trials | ||||||
| Phase 3 | NCT03345342 | Nov 2017 → May 2020 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02713282 | Apr 2016 → Mar 2018 | schizophrenia | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02431702 | Jul 2015 → Nov 2019 | schizophrenia | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01529515 | May 2012 → Apr 2014 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01515423 | May 2012 → Feb 2015 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01448720 | Sep 2011 → Dec 2013 | schizophrenia | Janssen-Cilag Farmaceutica Ltda. | Completed | No outcome recorded |
| Phase 3 | NCT01281527 | Nov 2010 → Nov 2012 | schizophrenia | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 3 | NCT01258920 | Oct 2010 → Nov 2012 | schizophrenia | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT01299389 | Oct 2010 → May 2012 | schizophrenia | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT01051531 | Apr 2010 → May 2013 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01081769 | Feb 2010 → Feb 2013 | schizophrenia | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 3 | NCT00604279 | Jan 2008 → Jan 2009 | schizophrenia | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00590577 | Mar 2007 → Mar 2008 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00119756 | Jun 2005 → Nov 2006 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00210548 | Apr 2005 → Jun 2006 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00210717 | Feb 2005 → Apr 2007 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00111189 | Feb 2005 → Feb 2007 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00101634 | Dec 2004 → Mar 2006 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 3 | NCT00073320 | Aug 2003 → May 2004 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07075237 | Oct 2025 → Oct 2026 expected | schizophrenia | Jiangsu Province Nanjing Brain Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04940039 | Jul 2021 → Apr 2024 | schizophrenia | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 4 | NCT03713658 | Oct 2018 → Dec 2019 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03080194 | Apr 2017 → Apr 2018 | schizophrenia | Maosheng Fang | Unknown | No outcome recorded |
| Phase 4 | NCT01947803 | Sep 2013 → Mar 2015 | schizophrenia | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01685931 | Nov 2012 → Dec 2014 | schizophrenia | Xian-Janssen Pharmaceutical Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01527305 | Jun 2012 → Dec 2013 | schizophrenia | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT01682161 | Jan 2012 → Sep 2013 | schizophrenia | Janssen Korea, Ltd., Korea | Completed | No outcome recorded |
| Phase 4 | NCT01451736 | Oct 2011 → Dec 2021 | schizophrenia | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT01860781 | Aug 2011 → Dec 2015 | schizophrenia | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01136772 | Mar 2011 → Jul 2013 | schizoaffective disorder, schizophrenia | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 4 | NCT01211704 | Oct 2010 → Dec 2011 | bipolar disorder | University of Miami | Withdrawn | No outcome recorded |
| Phase 4 | NCT01193166 | Aug 2010 → Sep 2012 | schizophrenia | Ortho-McNeil Janssen Scientific Affairs, LLC | Withdrawn | No outcome recorded |
| Phase 4 | NCT01157351 | May 2010 → Dec 2013 | schizophrenia | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 4 | NCT00946985 | Jun 2009 → Mar 2010 | schizophrenia | Ortho-McNeil Janssen Scientific Affairs, LLC | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 4 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03751488 Comparator | Dec 2018 → Jul 2019 | schizoaffective disorder, schizophrenia | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04754750 Comparator | Jan 2015 → Jun 2017 | schizophrenia | Calo Psychiatric Center | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT03345979 Comparator | Nov 2017 → Mar 2019 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01795547 Comparator | Feb 2013 → Sep 2014 | schizophrenia | H. Lundbeck A/S | 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 12 cited values
Every value below carries the sentence it was read from. 50 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Paliperidone palmitate | “Patients received paliperidone palmitate 1-monthly (PP1M, 100/150 mg eq.) or paliperidone palmitate 3-monthly (PP3M, 350/525 mg eq.) during the maintenance phase and entered a...” PMID 37653768 ↗ Aug 202344“Paliperidone palmitate 6-month (PP6M) demonstrated noninferiority to paliperidone palmitate 3-month in preventing relapse in patients with schizophrenia in a phase 3...” PMID 37480362 ↗ Aug 2023 “We evaluated the efficacy and safety of the investigational long-acting injectable antipsychotic agent paliperidone palmitate (PP) in the treatment of schizophrenia.” PMID 19941696 ↗ Nov 2009 “OBJECTIVE: To evaluate the efficacy and safety of the 3-month formulation of paliperidone palmitate vs placebo in delaying time to relapse of schizophrenia symptoms.” PMID 25820612 ↗ Aug 2015 “Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia” NCT01515423 ↗ “INVEGA® SUSTENNA™ (PALIPERIDONE PALMITATE) Extended-Release Injectable Suspension” NCT01211704 ↗ |
| Known as | Invega | “Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]” NCT04754750 ↗ |
| Known as | INVEGA SUSTENNA | “LY03010 (paliperidone palmitate) is a pharmaceutical equivalent drug product to the listed drug (LD) product INVEGA SUSTENNA.” NCT04922593 ↗2“INVEGA® SUSTENNA™ (PALIPERIDONE PALMITATE) Extended-Release Injectable Suspension” NCT01211704 ↗ |
| Known as | INVEGA TRINZA | “Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]” NCT04754750 ↗ |
| Known as | LY03010 | “LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.” NCT04922593 ↗ |
| Known as | paliperidone palmitate(sustenna) | “paliperidone palmitate(sustenna)” NCT01860781 ↗ |
| Known as | Paliperidone palmitate: Xeplion or Invega Sustenna | “Paliperidone palmitate: Xeplion® or Invega® Sustenna®” NCT01795547 ↗ |
| Known as | PP1M | “OBJECTIVE: To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world)...” PMID 32606705 ↗ Jun 20203“A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have...” NCT01515423 ↗ “All participants were also randomly assigned to either oral risperidone or paliperidone palmitate (PP1M) in a concurrent antipsychotic medication study.” PMID 40928164 ↗ Sep 2025 “Paliperidone Palmitate Injection (PP1M)” NCT07075237 ↗ |
| Known as | PP3M | “A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have...” NCT01515423 ↗4“Paliperidone palmitate 3-monthly (PP3M) is a second-generation, long-acting injectable antipsychotic formulation indicated for the maintenance treatment of adults with...” PMID 35186258 ↗ Dec 2020 “Patients received paliperidone palmitate 1-monthly (PP1M, 100/150 mg eq.) or paliperidone palmitate 3-monthly (PP3M, 350/525 mg eq.) during the maintenance phase and entered a...” PMID 37653768 ↗ Aug 2023 “OBJECTIVE: To analyze the efficacy and safety of paliperidone palmitate 3-monthly (PP3M) in Latin American patients with schizophrenia vs. rest-of-world (ROW).” PMID 30994855 ↗ Nov 2019 “Paliperidone Palmitate injection (PP3M) will be administered once every 12 weeks intramuscularly.” NCT02431702 ↗ |
| Known as | PP6M | “Paliperidone palmitate 6-month (PP6M) demonstrated noninferiority to paliperidone palmitate 3-month in preventing relapse in patients with schizophrenia in a phase 3...” PMID 37480362 ↗ Aug 2023 |
| Known as | R092670 | “Paliperidone palmitate (R092670)” NCT00604279 ↗ |
| Route | Intramuscular | “after repeated intramuscular injection of paliperidone palmitate in the arm or the buttock of subjects with schizophrenia” NCT00073320 ↗ |