Nilotinib hydrochloride monohydrate Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Nilotinib hydrochloride monohydrate is currently being evaluated across multiple clinical trials—primarily Phase 2 studies—spanning oncology and neurodegenerative disorders. These trials target conditions including chronic phase chronic myeloid leukemia, peritoneal carcinomatosis associated with gynecologic and gastrointestinal cancers, and dementia with Lewy bodies. Supported by diverse sponsors such as the National Cancer Institute, Georgetown University, Assiut University, and GIMEMA, the current trial portfolio encompasses recruiting, not yet recruiting, and unknown recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06409936	Not yet recruiting	CML Chronic Phase\|Chronic Myeloid Leukemia Chronic Phase\|Chronic Myeloid Leukemia BCR/ABL-Positive\|Chronic Myeloid Leukemia	Gruppo Italiano Malattie EMatologiche dell''Adulto\|Fundacion Espanola para la Curacion de la Leucemia Mieloide Cronica	2024-09	Phase 2
NCT05185947	Recruiting	Gynecologic Cancer\|Gynecologic Neoplasms\|Peritoneal Carcinomatosis\|Peritoneal Neoplasms\|Ovarian Cancer\|Ovarian Neoplasms\|Colorectal Cancer\|Colorectal Neoplasms\|Appendiceal Cancer\|Appendiceal Neoplasms	National Cancer Institute (NCI)\|National Institutes of Health Clinical Center (CC)	2022-10-13	Phase 2
NCT04326933	Unknown status	Patients Diagnosed as Chronic Meyloid Leukemia	Assiut University	2020-01-01	--
NCT04002674	Recruiting	Dementia With Lewy Bodies	Georgetown University\|National Institutes of Health (NIH)	2019-07-01	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nilotinib hydrochloride monohydrate selectively binds to and inhibits the BCR-ABL tyrosine kinase, suppressing downstream autophosphorylation and oncogenic signaling cascades required for malignant cell survival. This targeted pathway blockade suppresses pathological cell proliferation, establishing the therapeutic rationale for its clinical investigation in BCR-ABL-positive chronic myeloid leukemia and solid malignancies.

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>).