TK216 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials evaluate the therapeutic potential of TK216 across oncological indications, focusing primarily on Ewing sarcoma and relapsed or refractory acute myeloid leukemia. Spanning Phase 1, Phase 2, and combined Phase 1/2 protocols, these studies are supported by academic institutions such as M.D. Anderson Cancer Center and industry sponsors including Oncternal Therapeutics and Shanghai Pharmaceuticals. Trial statuses reflect varied outcomes, including a terminated Phase 1/2 trial, a withdrawn Phase 1 leukemia study, and a completed Phase 2 evaluation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05046314	COMPLETED	Sarcoma, Ewing	Shanghai Pharmaceuticals Holding Co., Ltd	2024-03-12	PHASE2
NCT02657005	TERMINATED	Sarcoma, Ewing	Oncternal Therapeutics, Inc	2016-08	PHASE1; PHASE2
NCT03752138	WITHDRAWN	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2019-03-31	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-19)

Check the TK216 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TK216 functions as a potent inhibitor of E26 transformation-specific transcription factors by directly disrupting their protein-protein interactions with RNA helicases, thereby impairing downstream oncogenic gene transcription and transcript processing. This molecular disruption halts malignant cell proliferation and promotes programmed cell death, providing a rationale for its therapeutic investigation in ETS-driven cancers such as Ewing sarcoma and acute myeloid leukemia.

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>).