KW-2478 Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

Multiple completed clinical trials sponsored by Kyowa Kirin Co., Ltd. have evaluated KW-2478 in early clinical phases for hematological malignancies, including multiple myeloma, chronic lymphocytic leukemia, and B-cell non-Hodgkin's lymphoma. These studies assessed intravenously administered KW-2478 both as a single agent in patients with advanced B-cell neoplasms and in combination with bortezomib for relapsed or refractory multiple myeloma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01063907	COMPLETED	Multiple Myeloma	Kyowa Kirin Co., Ltd.	2010-03	PHASE1; PHASE2
NCT00457782	COMPLETED	Multiple Myeloma; Chronic Lymphocytic Leukaemia; B-cell Non-Hodgkin's Lymphoma	Kyowa Kirin Co., Ltd.	2007-04	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-04-25)

Check the KW-2478 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

KW-2478 selectively binds to heat shock protein 90 (Hsp90), depleting key client proteins such as Cdk9 and phosphorylated 4E-BP1 to disrupt downstream transcriptional and translational signaling pathways. This downregulation of oncogenic drivers suppresses tumor cell proliferation, providing therapeutic relevance in the treatment of hematological malignancies such as multiple myeloma, chronic lymphocytic leukemia, and non-Hodgkin's lymphoma.

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>).