Clinical hold on studies of zelnecirnon (RPT193) in atopic ...
The FDA issued a clinical hold on zelnecirnon trials due to a patient's liver failure, potentially linked to the drug. Dosing and new enrollments are paused, except for RAPT's tivumecirnon oncology trial. No liver toxicity was found in other participants or nonclinical studies. RAPT investigates the case, emphasizing patient safety and FDA collaboration.
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Clinical hold on studies of zelnecirnon (RPT193) in atopic ...
The FDA issued a clinical hold on zelnecirnon trials due to a patient's liver failure, potentially linked to the drug. Dosing and new enrollments are paused, except for RAPT's tivumecirnon oncology trial. No liver toxicity was found in other participants or nonclinical studies. RAPT investigates the case, emphasizing patient safety and FDA collaboration.