Itanapraced (CHF 5074) Clinical Trials

Size	Price	Qty
5mg	USD 127
25mg	USD 390

Clinical Trials

The clinical research landscape for Itanapraced (CHF 5074) comprises numerous clinical trials targeting Alzheimer's disease across Phase I and Phase II development, primarily sponsored by Chiesi Farmaceutici S.p.A., Chiesi USA Inc., and CERESPIR. Early-phase studies evaluated the pharmacokinetics, pharmacodynamics, safety, and food-effect parameters of single and multiple ascending doses, while Phase II trials focused on the safety and tolerability of multiple dosing regimens. The majority of these clinical trials are completed, alongside recorded study withdrawals within the registry.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01723670	WITHDRAWN	Alzheimer's Disease	CERESPIR	2012-12	PHASE2
NCT01602393	COMPLETED	Alzheimer's Disease	Chiesi Farmaceutici S.p.A.	2012-05	PHASE2
NCT01421056	COMPLETED	Alzheimer's Disease	Chiesi Farmaceutici S.p.A.	2011-07	PHASE2
NCT01602393	Completed	Alzheimer''s Disease	Chiesi Farmaceutici S.p.A.\|Chiesi USA Inc.	2012-05	Phase 2
NCT01303744	COMPLETED	Alzheimer's Disease	CERESPIR	2011-03	PHASE2
NCT01421056	Completed	Alzheimer''s Disease	Chiesi Farmaceutici S.p.A.\|Chiesi USA Inc.	2011-07	Phase 2
NCT01258452	COMPLETED	Alzheimer's Disease	CERESPIR	2011-02	PHASE1
NCT01258452	Completed	Alzheimer''s Disease	CERESPIR	2011-02	Phase 1
NCT01203384	COMPLETED	Alzheimer's Disease	CERESPIR	2010-09	PHASE1
NCT00954252	COMPLETED	Alzheimer's Disease	CERESPIR	2009-10	PHASE1
NCT00954252	Completed	Alzheimer''s Disease	CERESPIR	2009-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2015-02-10)

Check the Itanapraced (CHF 5074) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Itanapraced functions as a gamma-secretase modulator that selectively targets gamma-secretase to decrease the cleavage and secretion of neurotoxic amyloid-beta 42 (Aβ42) and amyloid-beta 40 (Aβ40) peptides while displaying minimal activity against cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) with IC50 values exceeding 100 μmol/L. By decreasing pathogenic amyloid-beta accumulation and preventing oligomeric aggregate toxicity, this biochemical modulation aims to slow neurodegenerative progression in patients evaluated for 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>).