SC-43 Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 897

Clinical Trials

Several clinical trials are investigating the therapeutic potential of SC-43 in advanced non-small-cell lung cancer, advanced biliary tract cancer, and refractory solid tumors. These early-phase (Phase 1 and Phase 1/2) studies, sponsored by industry entities including RaND Biosciences and SupremeCure Pharma Inc., aim to establish the compound's safety, tolerability, pharmacokinetics, and initial efficacy. While specific protocols evaluating an oral solution or cisplatin combination therapy currently reflect withdrawn or unknown recruitment statuses, the broader clinical evaluation continues to assess SC-43 across advanced solid tumor indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04733521	UNKNOWN	Advanced Non-small-cell Lung Cancer; Advanced Biliary Tract Cancer	RaND Biosciences	2021-05-01	PHASE1; PHASE2
NCT03443622	WITHDRAWN	Refractory Solid Tumor	SupremeCure Pharma Inc.	2021-05	PHASE1
NCT04733521	Unknown status	Advanced Non-small-cell Lung Cancer\|Advanced Biliary Tract Cancer	RaND Biosciences	2021-05-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2021-02-02)

Check the SC-43 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SC-43 functions as a small-molecule agonist of Src-homology protein tyrosine phosphatase-1 (SHP-1), which promotes the dephosphorylation of signal transducer and activator of transcription 3 (STAT3) to disrupt downstream oncogenic pathways and trigger apoptotic cell death. By suppressing STAT3-mediated survival signaling and inhibiting tumor growth, this mechanism provides the biological rationale for investigating SC-43 in advanced solid malignancies, including non-small-cell lung cancer and 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>).