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# Vivace Mesothelioma Drug Gets Orphan Status
- URL: https://www.fdaweb.com/vivace-mesothelioma-drug-gets-orphan-status/
- Published: 2025-07-30T12:00:00.000Z
- Updated: 2026-09-14T15:17:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159593

FDA has granted Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma. The company describes the drug as a first-in-class inhibitor targeting the Hippo signaling pathway, a key regulator of cell growth and organ size. Specifically, the drug is designed to block autopalmitoylation of TEAD proteins, a mechanism believed to be central to certain cancers, it says.

To date, VT3989 has been tested in more than 200 patients in an ongoing open-label Phase 1 trial evaluating the drug’s safety, pharmacokinetics, and biological activity in patients with advanced solid tumors, including pleural and non-pleural mesothelioma. According to Vivace, the drug has shown early signs of clinical efficacy and a favorable safety profile — particularly in patients whose disease progressed after chemotherapy and immunotherapy, the current standard treatments.

Full trial results are expected to be presented at a major medical conference later this year. The company says it plans to begin a Phase 3 study by the end of the year.