Clinical Trials

Several clinical trials investigate paliperidone palmitate for psychiatric conditions, primarily schizophrenia and bipolar disorder. Encompassing Phase 3 and Phase 4 trials alongside observational studies, these protocols reflect recruitment statuses ranging from completed to withdrawn. Sponsorship is distributed across major pharmaceutical companies—including Janssen and Johnson & Johnson—and academic centers such as the University of Maryland, Baltimore and the University of Miami.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02532842 Completed
Schizophrenia
Janssen Pharmaceutica N.V. Belgium
 2015-07 --
NCT01584466 Withdrawn
Schizophrenia
University of Maryland Baltimore
 2014-01 Not Applicable
NCT01926912 Completed
Schizophrenia
Janssen-Cilag International NV
 2013-05 --
NCT01211704 Withdrawn
Bipolar Disorder
University of Miami|Ortho-McNeil Inc.
 2010-10 Phase 4
NCT01051531 Completed
Schizophrenia
Johnson & Johnson Pte Ltd
 2010-04 Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Paliperidone Palmitate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paliperidone palmitate is a prodrug ester that binds antagonistically to dopamine D2 and serotonin 5-HT2A receptors, thereby suppressing downstream G-protein-coupled signal transduction pathways in central neurons. This targeted receptor blockade reduces aberrant hyperdopaminergic and serotonergic neurotransmission, which restores neurochemical balance relevant to treating clinical conditions such as schizophrenia and bipolar disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.