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# Actuate Gets Orphan Status for Pancreatic Cancer
- URL: https://www.fdaweb.com/actuate-gets-orphan-status-for-pancreatic-cancer/
- Published: 2023-08-01T12:00:00.000Z
- Updated: 2026-09-14T18:47:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155003

FDA has granted Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer. Elraglusib is described as a glycogen synthase kinase-3 beta (GSK-3β) inhibitor that targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy. Actuate says elraglusib is also “emerging as a mediator of anti-tumor immunity through the inhibition of multiple immune checkpoints and the regulation of immune cell function.”

The therapy is currently being studied in an open label, randomized Phase 2 study in combination with gemcitabine/nab-paclitaxel for the frontline treatment of patients with metastatic pancreatic cancer. It is also being assessed in Phase 2 studies for the front-line treatment of patients with advanced pancreatic cancer in combination with a checkpoint inhibitor, and in patients with metastatic pancreatic cancer in combination with Folfirinox, a chemotherapy regimen.