TAK-659 Hydrochloride Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 247

Clinical Trials

Multiple Phase I and Phase II clinical trials have evaluated TAK-659 in monotherapy and combination regimens for advanced solid neoplasms and hematologic malignancies, including non-Hodgkin, diffuse large B-cell, and follicular lymphomas. Sponsored by industry entities such as Calithera Biosciences Inc and Nektar Therapeutics, these studies assessed pharmacokinetics, food-effect profiles, metabolic mass balance, and therapeutic efficacy. Recruitment statuses across the portfolio include completed, withdrawn, and terminated protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03772288	Withdrawn	Lymphoma Non-Hodgkin	Calithera Biosciences Inc\|Nektar Therapeutics	2019-04-03	Phase 1
NCT03338881	Withdrawn	Advanced Solid Neoplasms\|Lymphoma Neoplasms	Calithera Biosciences Inc	2018-05-10	Phase 1
NCT03359733	Withdrawn	Lymphoma Malignant\|Advanced Solid Neoplasms	Calithera Biosciences Inc	2018-02-28	Phase 1
NCT03357627	Completed	Lymphoma Non-Hodgkin\|Lymphoma Large B-cell Diffuse\|Lymphoma Follicular	Calithera Biosciences Inc	2018-02-16	Phase 1
NCT03123393	Terminated	Diffuse Large B-cell Lymphoma	Calithera Biosciences Inc	2017-10-10	Phase 2

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

Check the TAK-659 Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TAK-659 Hydrochloride is a potent, selective inhibitor of spleen tyrosine kinase (SYK) and FLT3 that blocks downstream kinase-mediated signaling cascades, thereby disrupting oncogenic pro-survival pathways and inducing apoptosis in malignant cells. By suppressing SYK- and FLT3-driven signaling networks, this targeted enzymatic inhibition provides the therapeutic rationale for investigating TAK-659 in clinical trials for non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and advanced solid neoplasms.

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>).