Radiprodil (RGH-896) Clinical Trials

Size	Price	Qty
5mg	USD 127

Clinical Trials

Several clinical trials sponsored by industry entities have evaluated the therapeutic potential, safety, and pharmacokinetics of Radiprodil across Phase 1, Phase 2, and Phase 1/2 protocols. Previous research includes a completed Phase 1 study in healthy volunteers and a terminated Phase 2 trial for infantile spasms. Currently, active recruitment is underway for Phase 1 and Phase 1/2 studies focusing on pediatric neurodevelopmental conditions, specifically GRIN-related disorders, tuberous sclerosis complex, and focal cortical dysplasia.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06392009	Recruiting	Tuberous Sclerosis Complex\|Focal Cortical Dysplasia	GRIN Therapeutics Inc.	2024-05	Phase 1\|Phase 2
NCT05818943	Recruiting	GRIN-related Disorders	GRIN Therapeutics Inc.	2023-03-07	Phase 1
NCT02829827	Terminated	Infantile Spasms (IS)	UCB Biopharma S.P.R.L.\|UCB Pharma	2017-12-04	Phase 2
NCT02647697	Completed	Healthy Volunteers	UCB Biopharma S.P.R.L.\|PRA Health Sciences\|UCB Pharma	2016-01	Phase 1

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

Check the Radiprodil (RGH-896) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Radiprodil selectively binds to the NR2B subunit of the N-methyl-D-aspartate (NMDA) receptor, blocking excessive glutamate-stimulated intracellular calcium influx and downstream excitotoxic signaling pathways. By dampening synaptic hyperexcitability and neuronal cytotoxicity, this selective antagonist mitigates pathological seizure activity, providing therapeutic rationale for its investigation in neurodevelopmental disorders such as GRIN-related conditions and tuberous sclerosis complex.

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>).