Varlitinib Clinical Trials

Size	Price	Qty
5mg	USD 270

Clinical Trials

ASLAN Pharmaceuticals has sponsored multiple clinical trials evaluating Varlitinib across Phase 1, Phase 1/2, and Phase 2, with recruitment statuses designated as completed or terminated. These studies primarily targeted advanced biliary tract cancer, investigating Varlitinib in combination with capecitabine or with gemcitabine and cisplatin. Additionally, clinical pharmacology assessments were conducted, including a Phase 1 study in healthy volunteers that completed pharmacokinetic and metabolic profiling.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03231176	Completed	Biliary Tract Cancer	ASLAN Pharmaceuticals	2017-12-19	Phase 2
NCT03368846	Completed	Healthy Volunteers	ASLAN Pharmaceuticals	2017-11-23	Phase 1
NCT02992340	Terminated	Biliary Tract Cancer	ASLAN Pharmaceuticals	2016-12-13	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Varlitinib functions as a potent, reversible ATP-competitive inhibitor targeting ErbB1 (EGFR) and ErbB2 (HER2) receptor tyrosine kinases, effectively blocking receptor phosphorylation and downregulating downstream signaling through the AKT pathway. This molecular blockade suppresses tumor cell proliferation and induces cell growth inhibition, providing a therapeutic rationale for limiting tumor growth in clinical conditions such as biliary tract cancer.

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>).