NGP 555 Clinical Trials

Size	Price	Qty
2mg	USD 147

Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by NeuroGenetic Pharmaceuticals Inc. have investigated orally administered NGP 555 for therapeutic use in Alzheimer's Disease. These studies utilized single and multiple ascending dose protocols to systematically evaluate the candidate drug's safety, tolerability, and pharmacokinetics. Consequently, the clinical profile for NGP 555 remains focused on early-phase safety and pharmacokinetic characterization for neurodegenerative therapeutics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02537938	COMPLETED	Alzheimer's Disease	NeuroGenetic Pharmaceuticals Inc	2016-01	PHASE1
NCT02534480	COMPLETED	Alzheimer's Disease	NeuroGenetic Pharmaceuticals Inc	2015-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2017-03-29)

Check the NGP 555 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

NGP 555 functions as a small-molecule modulator of γ-secretase, selectively altering enzyme cleavage of amyloid precursor protein to decrease the production of neurotoxic amyloid-beta peptides. By preventing the accumulation of toxic amyloid-beta aggregates in the central nervous system, this targeted modulation mitigates neurodegenerative processes associated with Alzheimer's Disease.

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>).