A clinical study of linaprazan glurate in pediatric patients with Gastroesophageal reflux disease (GERD)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 27 Nov 2024

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27 Nov 2024 New trial record
22 Nov 2024 According to a Cinclus Pharma media release, an agreement includes a deferral under which the pediatric efficacy and safety trial is anticipated to be undertaken after a Marketing Authorization Application has been submitted.
22 Nov 2024 According to a Cinclus Pharma media release, company made an agreement with the US Food and Drug Administration (FDA) on initial Pediatric Study Plan (iPSP) which is a prerequisite for market approval of a new medicine for adult patients, such as linaprazan glurate. It also provides an opportunity for an expanded approval for use in children.

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