zipalertinib (TAS6417) Clinical Trials

Size	Price	Qty
2mg	USD 197
5mg	USD 387

Clinical Trials

Multiple clinical trials are currently evaluating zipalertinib across various stages of non-small cell lung cancer, specifically targeting tumors with EGFR exon 20 insertion and uncommon mutations. Ranging from Phase 2 and Phase 3 studies to expanded access programs, these protocols encompass active not recruiting, recruiting, available, and not yet recruiting recruitment statuses. Clinical development is sponsored by industry partner Taiho Oncology, Inc., alongside academic institutions including Jonsson Comprehensive Cancer Center and Stanford University.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07128199	ACTIVE_NOT_RECRUITING	Lung Cancer; Adjuvant; Post-surgical; EGFR; Exon 20; Early Stage Lung Cancer; Uncommon EGFR Mutations; NSCLC, Early Stage	Taiho Oncology, Inc.	2025-12-22	PHASE3
NCT07229339	NOT_YET_RECRUITING	Lung Non-Squamous Non-Small Cell Carcinoma	Jonsson Comprehensive Cancer Center	2027-06-01	PHASE2
NCT07802834	NOT_YET_RECRUITING	EGFR; Lung Cancer (NSCLC); Non Small Cell Lung Cancer	Stanford University	2026-11	PHASE2
NCT05967689	RECRUITING	Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations	Taiho Oncology, Inc.	2023-07-31	PHASE2
NCT05973773	ACTIVE_NOT_RECRUITING	Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation	Taiho Oncology, Inc.	2023-12-18	PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the zipalertinib (TAS6417) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zipalertinib selectively binds to and inhibits epidermal growth factor receptor mutants harboring exon 20 insertions while sparing wild-type receptor signaling, thereby blocking downstream oncogenic pathways and suppressing cell proliferation. This targeted inhibition suppresses tumor progression, demonstrating therapeutic relevance for patients with advanced or early-stage non-small cell lung cancer harboring EGFR exon 20 insertion mutations.

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>).