Dewpoint receives FDA orphan drug designation for DPTX3186

Dewpoint Receives FDA Orphan Drug Designation for DPTX3186

Dewpoint Therapeutics has received the US FDA's Orphan Drug Designation (ODD) for DPTX3186, a small-molecule condensate modulator for treating gastric cancer.

The ODD program incentivizes the development of medicines for conditions affecting fewer than 200,000 individuals in the US.

Dewpoint Therapeutics recently opened its Investigational New Drug application for the oral therapy, marking its entry as a clinical-stage biotech and the beginning of the first human trial involving a condensate-modulating therapeutic.

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Author's summary: Dewpoint receives FDA orphan drug designation.

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Pharmaceutical Technology Pharmaceutical Technology — 2025-10-30

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