TAS4464 Clinical Trials

Size	Price	Qty
5mg	USD 337
25mg	USD 970

Clinical Trials

Several Phase 1, open-label clinical trials sponsored by Taiho Oncology, Inc. were designed to evaluate the safety, pharmacokinetic properties, and preliminary efficacy of TAS4464 in patients with hematologic malignancies, specifically multiple myeloma and non-Hodgkin lymphoma. However, clinical records indicate that recruitment for these early-stage studies has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02978235	TERMINATED	Multiple Myeloma; NonHodgkin Lymphoma	Taiho Oncology, Inc.	2017-03-01	PHASE1
NCT02978235	Terminated	Multiple Myeloma\|NonHodgkin Lymphoma	Taiho Oncology Inc.	2017-03-01	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-09-05)

Check the TAS4464 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAS4464 is a highly potent and selective NEDD8 activating enzyme inhibitor with an IC50 of 0.955 nM that binds NAE to suppress NEDD8 conjugation, thereby preventing the neddylation of cullin-RING ligases and disrupting downstream ubiquitin-proteasome protein degradation pathways to induce tumor cell death. By provoking prolonged target inhibition and destabilizing oncogenic protein turnover, TAS4464 demonstrates robust antitumor activity, providing a mechanistic rationale for its clinical investigation in multiple myeloma and non-Hodgkin 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>).