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**Deflexifol** is a novel, proprietary formulation combining the chemotherapeutic agent **5-fluorouracil (5-FU)** and its biomodulator **leucovorin (LV)** in a single intravenous infusion at physiological pH 7, using cyclodextrin (HP-β-CD) for stability. This co-formulation addresses limitations of standard 5-FU/LV regimens by improving safety, tolerability, and potential efficacy through enhanced delivery, reduced toxicity, and higher achievable doses, particularly for solid tumors. Developed by **FivepHusion**, it is primarily investigated in pediatric relapsed/refractory brain tumors like ependymoma and in adults for metastatic colorectal cancer (mCRC), with ongoing Phase 1/2 trials demonstrating a maximum tolerated dose in children equivalent to 88% of the adult dose.[1][2][3][6]
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