(R)-Serine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate (R)-Serine for indications such as schizophrenia, Tourette syndrome, related psychotic disorders, and healthy volunteer cohorts. Spanning Phase 1, Phase 2, Phase 4, and unspecified phase protocols, these studies are sponsored by industry, academic, and governmental organizations, including Neurocrine Biosciences, Takeda, Johns Hopkins University, the National Institute of Mental Health, and Shalvata Mental Health Center. Recruitment statuses range from completed investigations to studies with an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03359785	Completed	Schizophrenia	Neurocrine Biosciences\|Takeda	2018-01-10	Phase 2
NCT02716987	Completed	Healthy	Neurocrine Biosciences\|Takeda	2016-03-21	Phase 1
NCT01018056	Completed	Tourette Syndrome	Johns Hopkins University\|National Institute of Mental Health (NIMH)	2009-11	Phase 4
NCT00789022	Unknown status	Schizophrenia\|Schizophreniform\|Schizoaffective Disorder\|Brief Psychotic Episode	Shalvata Mental Health Center	2009-01	--

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

Check the (R)-Serine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(R)-Serine acts as an obligatory coagonist by binding directly to the glycine site of the N-methyl-D-aspartate subtype of glutamate receptors. Receptor engagement facilitates ion channel activation and enhances downstream calcium-dependent signaling pathways essential for synaptic plasticity and neurodevelopment. This potentiation of central glutamatergic neurotransmission provides the therapeutic rationale for investigating (R)-Serine in clinical trials for psychiatric and neurological disorders such as schizophrenia and Tourette syndrome.

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>).