(S)-Sunvozertinib ((S)-DZD9008) Clinical Trials

Size	Price	Qty
5mg	USD 199
25mg	USD 597

Clinical Trials

Multiple clinical trials sponsored by Dizal Pharmaceuticals are evaluating the compound DZD9008 (Sunvozertinib) across Phase I and Phase II protocols. These studies investigate non-small cell lung cancer, non-Hodgkin's B-cell lymphoma, and pharmacokinetic profiles in healthy volunteers. Recruitment status across these evaluations varies, featuring completed early-phase studies, an actively recruiting safety and anti-tumor efficacy trial in lung cancer, and a suspended study in B-cell lymphoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06276283	Recruiting	Non-small Cell Lung Cancer	Dizal Pharmaceuticals	2023-02-15	Phase 2
NCT05159895	Completed	Healthy Volunteers	Dizal Pharmaceuticals	2021-09-24	Phase 1
NCT04148742	Suspended	Non-Hodgkin''s B-cell Lymphoma	Dizal Pharmaceuticals	2021-08	Phase 1\|Phase 2
NCT04909242	Completed	Healthy Volunteers	Dizal Pharmaceuticals	2021-04-21	Phase 1

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

Check the (S)-Sunvozertinib ((S)-DZD9008) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

(S)-Sunvozertinib covalently binds to mutant epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) Exon 20 insertion targets, blocking downstream oncogenic signal transduction to halt tumor cell proliferation. This irreversible inhibition triggers apoptotic cell death, leading to potent anti-tumor efficacy against mutant-driven non-small cell lung cancer as investigated in clinical studies.

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>).