U-104 (SLC-0111) Clinical Trials

Size	Price	Qty
10mg	USD 247
1g	USD 1,990

Clinical Trials

Multiple clinical trials are evaluating the therapeutic potential of U-104 (SLC-0111) in oncology. A completed Phase I trial, sponsored by Welichem Biotech Inc. and Ozmosis Research Inc., assessed the safety, tolerability, and pharmacokinetics of U-104 in patients with advanced solid tumors. Additionally, an active Phase I/II trial supported by the British Columbia Cancer Agency, Canadian Cancer Society, and SignalChem Lifesciences Corporation is currently recruiting patients to evaluate U-104 in combination with gemcitabine for metastatic pancreatic ductal adenocarcinoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03450018	Recruiting	Metastatic Pancreatic Ductal Adenocarcinoma	British Columbia Cancer Agency\|Canadian Cancer Society (CCS)\|SignalChem Lifesciences Corporation	2019-01-10	Phase 1\|Phase 2
NCT02215850	Completed	Solid Tumours	Welichem Biotech Inc.\|Ozmosis Research Inc.	2014-10	Phase 1

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

Check the U-104 (SLC-0111) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

U-104 selectively binds to carbonic anhydrase IX (CA IX) and CA XII, inhibiting enzymatic hydration of carbon dioxide and disrupting extracellular acidification alongside intracellular pH homeostasis. This inhibition impairs hypoxic cancer cell survival and invasive potential, demonstrating clinical relevance in targeting advanced solid tumors and metastatic pancreatic ductal adenocarcinoma.

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>).