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# Qualigen Therapeutics Gains Orphan Drug Designation
- URL: https://www.fdaweb.com/qualigen-therapeutics-gains-orphan-drug-designation/
- Published: 2023-01-12T12:00:00.000Z
- Updated: 2026-09-14T18:11:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153527

FDA has granted Qualigen Therapeutics an orphan drug designation for QN-302 and its use in treating pancreatic cancer. QN-302 is described as a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells. “Pre-clinical in-vitro and in-vivo studies of QN-302 have shown that G-quadruplex (G4) stabilization may result in inhibition of target gene expression and cessation of cell growth in a variety of cancers, including pancreatic ductal adenocarcinoma (PDAC), which represents 98% of pancreatic cancers,” the company says.