SC-1 Clinical Trials

Size	Price	Qty
5mg	USD 427

Clinical Trials

Multiple clinical trials are currently evaluating interventions across neurodegenerative and hematologic indications. An academic study sponsored by Northwestern University is enrolling by invitation for Alzheimer disease with a phase classification of Not Applicable. Additionally, an industry-sponsored Phase 1/Phase 2 trial conducted by Amgen is actively recruiting participants for B cell precursor acute lymphoblastic leukemia, demonstrating ongoing research efforts across academic and pharmaceutical sectors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05477862	Enrolling by invitation	Alzheimer Disease	Northwestern University	2023-10-15	Not Applicable
NCT04521231	Recruiting	B Cell Precursor Acute Lymphoblastic Leukemia	Amgen	2021-01-04	Phase 1\|Phase 2

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

Check the SC-1 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SC-1 functions as a sorafenib analogue that potently inhibits STAT3 phosphorylation via SHP-1-dependent STAT3 inactivation, thereby suppressing downstream pro-survival biochemistry and inducing cell apoptosis. This targeted disruption of oncogenic STAT3 signaling provides a mechanistic foundation for evaluating therapeutic responses in conditions such as B cell precursor acute lymphoblastic leukemia.

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>).