U.S. FDA

organization

Last mentioned: Mar 5, 2026

Timeline

  1. Data Readout

    Anticipated preliminary safety and pharmacokinetic results from Phase I.

  2. Trial Initiation

    Expected commencement of patient recruitment and site activation.

  3. FDA IND Approval

    GNTbm receives official clearance to begin Phase I trials for GNTbm-38.

Stories mentioning U.S. FDA 1

fda-approval Bullish

GNTbm Secures FDA IND Clearance for Novel Anti-Cancer Candidate GNTbm-38

GNTbm has received Investigational New Drug (IND) approval from the U.S. FDA to initiate Phase I clinical trials for its self-developed anti-cancer therapy, GNTbm-38. This milestone marks the company's formal entry into the U.S. clinical landscape, targeting advanced malignancies with its proprietary therapeutic candidate.

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