Clinical Trials

Multiple clinical trials have evaluated iloperidone, primarily encompassing Phase 1 and Phase 2 studies sponsored by pharmaceutical organizations such as Vanda Pharmaceuticals and Novartis Pharmaceuticals. These investigations focused on bioequivalence, pharmacokinetic profiles, and long-acting injectable formulations across conditions including schizophrenia, Parkinson disease psychosis, hepatic impairment, and overall safety and tolerability in patient populations and healthy subjects. Although the majority of these studies are completed, a clinical trial evaluating Parkinson disease psychosis was withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05344365 Withdrawn
Parkinson Disease Psychosis
Vanda Pharmaceuticals
 2022-06 Phase 2
NCT04969211 Completed
Healthy
Vanda Pharmaceuticals
 2021-06-30 Phase 1
NCT04712734 Completed
Schizophrenia
Vanda Pharmaceuticals
 2021-01-13 Phase 1
NCT01495169 Completed
Safety and Tolerability of Iloperidone
Vanda Pharmaceuticals
 2011-10 Phase 1
NCT01529294 Completed
Hepatic Impairment
Novartis Pharmaceuticals|Novartis
 2010-08 Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Iloperidone acts as an atypical antipsychotic agent that selectively binds to and antagonizes dopamine D2 and serotonin 5-HT2 receptor subtypes, thereby inhibiting hyperactive monoaminergic neurotransmission and downstream signaling cascades within the central nervous system. This receptor blockade modulates neurotransmitter imbalance to suppress abnormal cellular excitation, which ultimately mitigates positive and negative symptoms associated with schizophrenia and related psychotic disorders evaluated in clinical trials.

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.