Trial Profile

A phase 3 study of PAX-101

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 15 Apr 2024

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At a glance

11 Apr 2024 According to a PaxMedica media release, the company has completed execution of its three pivotal registration/validation batches of PAX-101, an IV formulation of suramin. This achievement is an important milestone to enabling a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which is currently planned for Q4 2024.
17 Nov 2023 According to a PaxMedica media release, the company has been featured in a broadcast via NetworkNewsAudio The audio news release covers PaxMedicas recent announcement of the completion of a type-B meeting with the FDA. During the live meeting, the company discussed the positive results of the recent data from its PAX-HAT-301 study
14 Nov 2023 According to a PaxMedica media release, the company successfully concluded a crucial FDA Type-B meeting, gathering vital guidance for the NDA submission of PAX-101.

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