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# Clinical Hold Lifted on Sickle Cell Drug
- URL: https://www.fdaweb.com/clinical-hold-lifted-on-sickle-cell-drug/
- Published: 2023-08-22T12:00:00.000Z
- Updated: 2026-09-14T18:52:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155149

FDA has lifted a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease (SCD). The hold was ordered 2/23 based on preclinical data previously submitted in 4/2022, 10/2022 and 12/2022, Fulcrum says, adding that non-clinical and clinical evidence of hematological malignancies observed with other inhibitors of polycomb repressive complex 2 was also an FDA concern.

“Based on the initial data from the Phase 1b trial, which showed increasing levels of HbF \[fetal hemoglobin\] with each dose escalation, we believe in the potential of FTX-6058 to not only shift the current standard of care but importantly, offer these patients a differentiated oral option,” the company says. Earlier data in SCD demonstrated that HbF increases were associated with potential overall patient benefit, it adds.

FDA has granted FTX-6058 a fast track designation and an orphan drug designation for treating SCD.