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Cinclus Pharma announces positive FDA interaction

Cinclus Pharma today announces that the company has completed a successful so-called end-of-phase-II meeting, with the US Food and Drug Administration (FDA) for the indication erosive gastroesophageal reflux disease (eGERD). The FDA broadly accepted Cinclus Pharma's proposal for the phase III program, including study design and primary endpoint for the studies. The positive outcome allows Cinclus Pharma to proceed with its phase III program.

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Cinclus Pharma's phase II eGERD study in two presentations at UEG

Two abstracts from Cinclus Pharma's phase II study, LEED, on its leading drug candidate linaprazan glurate, developed for the treatment of moderate to severe erosive GERD ("eGERD"), are being presented at the leading gastro conference United European Gastroenterology ("UEG") 14 – 17 October 2023. One of the abstracts focuses on linaprazan glurate's effectiveness, the other one on its safety.

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