Zotatifin (eFT226) Clinical Trials

Size	Price	Qty
1mg	USD 1,590

Clinical Trials

Multiple early-phase clinical trials evaluate the therapeutic potential of zotatifin across oncology and infectious disease indications, including advanced solid tumors, coronavirus infection, hormone receptor-positive/HER2-negative breast cancer, and advanced triple-negative breast cancer. These Phase 1 and Phase 2 studies are sponsored by industry leader eFFECTOR Therapeutics, academic institutions such as M.D. Anderson Cancer Center, and individual investigators including Jennifer Lee Caswell-Jin. Across these recorded studies, recruitment statuses currently include completed, unknown, and not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07783659	NOT_YET_RECRUITING	Phase IB; Zotatifin; EIF4A; Advanced TNBC; Platinum Helix Inhibition	M.D. Anderson Cancer Center	2027-02-12	PHASE1
NCT04092673	UNKNOWN	Solid Tumor, Adult	Effector Therapeutics	2019-10-25	PHASE1; PHASE2
NCT05101564	COMPLETED	Breast Cancer; HER2-negative Breast Cancer; ER Positive Breast Cancer	Jennifer Lee Caswell-Jin	2023-03-20	PHASE2
NCT04632381	COMPLETED	Corona Virus Infection	Effector Therapeutics	2021-07-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-25)

Check the Zotatifin (eFT226) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zotatifin selectively binds the eukaryotic initiation factor 4A (eIF4A) RNA helicase, promoting its interaction with specific 5'-untranslated region recognition motifs to disrupt eIF4F complex assembly and block target mRNA translation. By repressing the translation of key oncogenic drivers, zotatifin suppresses cellular proliferation and tumor growth, underlying its clinical evaluation in patients with advanced solid tumors, breast cancer, and viral infections.

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>).