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# FDA OKs Amendment to Uproleselan Trial
- URL: https://www.fdaweb.com/fda-oks-amendment-to-uproleselan-trial/
- Published: 2023-06-15T12:00:00.000Z
- Updated: 2026-09-14T18:39:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154698

FDA has cleared the addition of a protocol amendment to the Phase 3 trial of GlycoMimetics’ uproleselan for relapsed/refractory acute myeloid leukemia. The company says the amendment will allow a time-based analysis of the overall survival primary endpoint to be conducted following a defined cutoff date if the 295 survival events originally planned for an event-driven analysis have not been observed. As part of the protocol amendment, GlycoMimetics says, FDA also cleared the addition of landmark event-free survival and overall survival analyses as secondary endpoints.

Uproleselan is described as an investigational first-in-class E-selectin antagonist. It is designed to block E-selectin binding and stimulation of myeloid cells. FDA has awarded it breakthrough therapy and fast-track designations.