Lumateperone Clinical Trials

Size	Price	Qty
50mg	USD 79
250mg	USD 237

Clinical Trials

The clinical trial landscape for lumateperone includes a clinical trial focused on neuropsychiatric indications. Sponsored by Intra-Cellular Therapies Inc., this completed Phase I study evaluated the safety, tolerability, and single ascending dose pharmacokinetics of a subcutaneous injection of lumateperone in patients diagnosed with schizophrenia. Overall, this early-phase clinical effort establishes essential pharmacokinetic parameters to support alternative, injectable therapeutic delivery.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04709224	Completed	Schizophrenia	Intra-Cellular Therapies Inc.	2020-12-30	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lumateperone acts as a potent antagonist of the 5-HT2A receptor with a Ki of 0.54 nM, selectively inhibiting serotonin-mediated downstream signaling cascades and modulating neurotransmitter signaling within central neural pathways. This targeted receptor antagonism regulates monoaminergic pathway activity and neuronal excitability, providing clinical relevance for attenuated psychosis and symptom control in schizophrenia.

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>).