Lurasidone HCl Clinical Trials

Size	Price	Qty
5mg	USD 170
25mg	USD 497

Clinical Trials

Multiple clinical trials evaluate lurasidone for psychiatric disorders, including schizophrenia, bipolar disorder, and bipolar I disorder. Sponsored by commercial entities such as Sumitomo Pharma and academic institutions like the University of British Columbia, these Phase 1 and Phase 3 studies encompass both recruiting and completed recruitment statuses. Completed Phase 1 trials investigated safety, tolerability, and pharmacokinetics, whereas several clinical trials in Phase 3 evaluate therapeutic efficacy and cognitive outcomes in bipolar disorder populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03627195	Completed	Schizophrenia	Sumitomo Pharma America Inc.	2018-06-07	Phase 1
NCT02731612	Recruiting	Bipolar Disorder	Nazlin Walji\|University of British Columbia	2017-05-08	Phase 3
NCT02147379	Completed	Bipolar I Disorder	University of British Columbia	2014-05	Phase 3
NCT02174523	Completed	Schizophrenia	Sumitomo Pharma (Suzhou) Co. Ltd.\|Xuhui Central Hospital Shanghai	2014-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lurasidone acts as a potent antagonist at dopamine D2 receptors, serotonin 5-HT2A, 5-HT7, and alpha-2C adrenergic receptors, as well as a partial agonist at 5-HT1A receptors, thereby inhibiting monoaminergic neurotransmitter binding and downstream G-protein-mediated signaling cascades. This receptor modulation normalizes aberrant dopaminergic and serotonergic neurotransmission in central neural circuits, which underlies its therapeutic relevance in managing 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>).