SSR128129E Clinical Trials

Size	Price	Qty
5mg	USD 147
20mg	USD 370

Clinical Trials

Several clinical trials, all currently classified as not yet recruiting, are evaluating therapeutic interventions across Phase II, Phase IV, and non-applicable phase protocols. These studies address psychiatric, metabolic, and neurodegenerative indications, including suicidal ideation, self-injurious behavior, depression, Parkinson's disease, and schizophrenia combined with prediabetes. The trial landscape is supported by a combination of academic institutions, government bodies such as the National Institute of Mental Health and the VA Pittsburgh Healthcare System, and industrial sponsors including Mthera Pharma Co. Ltd.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06194331	Not yet recruiting	Suicidal Ideation\|Suicidal and Self-injurious Behavior\|Depression	University of Pittsburgh\|Pediatric Research in Office Settings\|National Institute of Mental Health (NIMH)	2024-12-01	Not Applicable
NCT06175767	Not yet recruiting	Parkinson''s Disease	Mthera Pharma Co. Ltd.	2024-07	Phase 2
NCT03575000	Not yet recruiting	Schizophrenia\|PreDiabetes	VA Pittsburgh Healthcare System	2024-07-01	Phase 4

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

Check the SSR128129E product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SSR128129E functions as an orally active allosteric inhibitor of fibroblast growth factor receptor 1 (FGFR1) with an IC50 of 1.9 μM, selectively binding the receptor to block downstream biochemical signaling without altering related receptor tyrosine kinases. This target blockade modulates intracellular cascades and cellular dynamics, providing potential therapeutic relevance for managing central nervous system and metabolic disorders evaluated in clinical trials such as Parkinson's disease, depression, and prediabetes.

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>).