Clinical Trials

Multiple clinical trials span research areas from oncology to behavioral health. An ongoing, actively recruiting Early Phase 1 trial sponsored by CHU de Quebec-Universite Laval, the Canadian Institutes of Health Research, and Biovalorem evaluates metabolic interventions in pancreatic ductal adenocarcinoma and advanced metastatic cancer. Additionally, a completed trial with a non-applicable phase status, supported by San Diego State University and the National Institute on Minority Health and Health Disparities, investigated group-based prevention strategies for eating disorders and body image concerns.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04862260 Recruiting
Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer|Pancreas Cancer|Metastatic Cancer
CHU de Quebec-Universite Laval|Canadian Institutes of Health Research (CIHR)|Biovalorem
 2021-10-04 Early Phase 1
NCT03451513 Completed
Eating Disorder|Body Image
San Diego State University|National Institute on Minority Health and Health Disparities (NIMHD)
 2018-01-24 Not Applicable

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

Check the Sulforhodamine B sodium salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sulforhodamine B sodium salt electrostatically binds to basic amino acid residues of cellular proteins under mild acidic conditions, forming a stable dye-protein complex that enables accurate stoichiometric quantification of cellular protein mass. By directly linking dye absorbance to total cellular biomass, this mechanism provides a robust readout of cell proliferation and cytotoxicity, serving as an essential analytical tool in evaluating therapeutic responses against targets in pancreatic ductal adenocarcinoma and metastatic cancers.

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>).

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Note: Technical data last updated: Sep 1, 2026.