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 · 12 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)” 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. FDA for Treatment of Schizophrenia in Adults” 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 | “Complete Response letter regarding the supplemental new drug application (sNDA) for once-monthly long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate).” jnj.com ↗ |
| Filed | US (FDA) | — | schizophrenia | 2014-11-19 | “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 4 milestones | |||||
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| Phase 319 trials · 8 met primary · 2 missed | ||||||
| Phase 3 | NCT03345342 | Nov 2017 → May 2020 | schizophrenia | Janssen Research & Development, LLC | Completed | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT01515423 | May 2012 → Feb 2015 | schizophrenia | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT01529515 | May 2012 → Apr 2014 | schizophrenia | Janssen Research & Development, LLC | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00111189 | Feb 2005 → Feb 2007 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Met primary |
| Phase 3 | NCT00210717 | Feb 2005 → Apr 2007 | schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Missed primary |
| 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 · 2 met primary · 1 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| Phase 4 | NCT01211704 | Oct 2010 → Dec 2011 | bipolar disorder | University of Miami | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01193166 | Aug 2010 → Sep 2012 | schizophrenia | Ortho-McNeil Janssen Scientific Affairs, LLC | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01157351 | May 2010 → Dec 2013 | schizophrenia | Janssen Scientific Affairs, LLC | Completed | Met primary |
| Phase 4 | NCT00946985 | Jun 2009 → Mar 2010 | schizophrenia | Ortho-McNeil Janssen Scientific Affairs, LLC | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT03751488 Comparator | Dec 2018 → Jul 2019 | schizoaffective disorder, schizophrenia | Luye Pharma Group Ltd. | Completed | Met primary |
| Phase 1/2 | NCT04754750 Comparator | Jan 2015 → Jun 2017 | schizophrenia | Calo Psychiatric Center | Completed | No outcome recorded |
| Phase 3 | NCT03345979 Comparator | Nov 2017 → Mar 2019 | schizophrenia | Alkermes, Inc. | Completed | Met primary |
| Phase 3 | NCT01795547 Comparator | Feb 2013 → Sep 2014 | schizophrenia | H. Lundbeck A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 29
| 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 |
| 2024-07-30 | Luye Pharma Group Ltd. | Regulatory 绿叶制药每月一针精神分裂症新药ERZOFRI® 获得美国FDA上市批准 luye.com ↗
2024年7月28日，上 海——绿 叶 制 药 集 团 宣 布，其 自 主 研 发 的ERZOFRI®（棕 榈 酸 帕 利 哌 酮 缓 释 混 悬 注 射 液）已 根 据 联 邦 食 品、药 品 和 化 妆 品 法 案 第505（b）（2）条 款 获 得 美 国 食 品 药 品 监 督 管 理 局（FDA）的 上 市 批 准. |
| 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 |
| 2023-10-09 | Luye Pharma Group Ltd. | Regulatory 绿叶制药在美提交棕榈酸帕利哌酮缓释混悬注射液新药上市申请 luye.com ↗
绿 叶 制 药 集 团 宣 布，其 已 通 过505(b)(2)的 途 径 向 美 国 食 品 药 品 监 督 管 理 局(FDA)提 交 棕 榈 酸 帕 利 哌 酮 缓 释 混 悬 注 射 液（LY03010）的 新 药 上 市 申 请（NDA），用 于 治 疗 精 神 分 裂 症 和 分 裂 情 感 性 障 碍. |
| 2023-02-24 | Luye Pharma Group Ltd. | Regulatory 绿叶制药创新制剂帕利哌酮长效注射剂LY03010在欧洲获准开展临床试验 luye.com ↗
2023年2月23日，上 海 —— 绿 叶 制 药 集 团 宣 布，其 自 主 研 发 的 棕 榈 酸 帕 利 哌 酮 缓 释 混 悬 注 射 液（LY03010）已 获 得 监 管 部 门 批 准 在 欧 洲 开 展 临 床 试 验. |
| 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 ↗ |
| 2020-12-04 | Janssen Research & Development, LLC | Regulatory 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 ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson submitted a Marketing Authorisation Extension Application to the European Medicines Agency (EMA) to register paliperidone palmitate 6-monthly (PP6M) for the maintenance treatment of schizophrenia in adult patients who are clinically stable on paliperidone palmitate 1-monthly (PP1M)1 or 3-monthly (PP3M)2 injectable products. |
| 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 |
| 2019-04-09 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Innovative Study of ARISTADA® and INVEGA SUSTENNA® for the Treatment of Schizophrenia alkermes.com ↗
The ALPINE study showed that both ARISTADA, given every two months, and INVEGA SUSTENNA, given every month, demonstrated statistically significant improvements from baseline in schizophrenia symptoms, and that the efficacy was similar for both medicines throughout the six-month study. |
| 2018-09-26 | Luye Pharma Group Ltd. | Regulatory 绿叶制药LY03010在美获批进入临床，中枢神经全球产品组合进一步强化 luye.com ↗
绿 叶 制 药 集 团 宣 布：由 其 自 主 研 发 的、用 于 治 疗 精 神 分 裂 症 和 分 裂 情 感 性 障 碍 的 新 药——帕 利 哌 酮 缓 释 混 悬 肌 肉 注 射 剂（LY03010）已 获 得 美 国 食 品 药 品 管 理 局（FDA）批 准，可 在 美 进 入 临 床 研 究. |
| 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 |
| 2015-08-21 | Janssen Research & Development, LLC | Regulatory Janssen Submits European Extension Marketing Authorisation Application for Paliperidone Palmitate Once-Every-Three-Months Formulation jnj.com ↗
Janssen-Cilag International NV (Janssen) today announced the submission of an Extension Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for paliperidone palmitate once-every-three-months formulation for the 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. |
| 2015-05-19 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves INVEGA TRINZA™, First and Only Four-Times-A-Year Treatment for Schizophrenia jnj.com ↗
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved under priority review the New Drug Application (NDA) for the three-month long-acting atypical antipsychotic INVEGA TRINZA™. |
| 2015-05-11 | Janssen Research & Development, LLC | Regulatory U.S. FDA Issues Complete Response Letter to sNDA Seeking to Expand the Label for INVEGA SUSTENNA® jnj.com ↗
Janssen Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter regarding the supplemental new drug application (sNDA) for once-monthly long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate). |
| 2015-04-15 | Janssen Research & Development, LLC | Results Study Published in The Journal of Clinical Psychiatry Shows INVEGA SUSTENNA® Effective Six Months Longer Than Common Oral Antipsychotics in Treatment of Schizophrenia jnj.com ↗ |
| 2015-03-29 | Janssen Research & Development, LLC | Results New Study Published in JAMA Psychiatry Found Three-Month Paliperidone Palmitate Significantly Delayed Time to Relapse in Patients with Schizophrenia jnj.com ↗ |
| 2015-01-19 | Janssen Research & Development, LLC | Regulatory FDA Grants Priority Review for Three-Month Paliperidone Palmitate for the Treatment of Schizophrenia jnj.com ↗
Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to treat schizophrenia in adults. |
| 2014-11-19 | Janssen Research & Development, LLC | Regulatory Janssen Submits New Drug Application to U.S. FDA for Three-Month Paliperidone Palmitate jnj.com ↗
Janssen Research & Development, LLC (Janssen) 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). |
| 2014-11-13 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (paliperidone palmitate) for the Treatment of Schizoaffective Disorder jnj.com ↗
Janssen Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA® SUSTENNA® (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. |
| 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 |
| 2014-07-14 | Janssen Research & Development, LLC | Regulatory Janssen Pharmaceuticals Seeks Expanded Label for Once-Monthly INVEGA® SUSTENNA® (paliperidone palmitate) to Show Delayed Time to Relapse Compared to Daily Oral Schizophrenia Therapies jnj.com ↗
Janssen Pharmaceuticals, Inc. today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking a label change |
| 2014-05-13 | Janssen Research & Development, LLC | Regulatory Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (paliperidone palmitate) Submitted to the U.S. FDA for the Treatment of Schizoaffective Disorder jnj.com ↗ |
| 2014-05-07 | Janssen Research & Development, LLC | Results Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir) for Once-Daily Use in Combination with Sofosbuvir for 12 Weeks for the Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C jnj.com ↗ |
| 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 34 releases
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 ↗ |