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Home » Left holding the bag: Diamedica’s phase II/III halted by FDA after adverse events
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Left holding the bag: Diamedica’s phase II/III halted by FDA after adverse events

July 7, 2022
By Lee Landenberger
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
BioWorld Clinical Regulatory Neurology/psychiatric FDA

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