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# FDA Orphan Drug Designation for Silmitasertib
- URL: https://www.fdaweb.com/fda-orphan-drug-designation-for-silmitasertib/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150836

FDA has granted orphan drug designation to Senhwa Biosciences’ silmiasertib, a casein kinase 2 inhibitor, to treat patients with medulloblastoma. The company [says](https://www.targetedonc.com/view/fda-grants-orphan-drug-designation-to-silmitasertib-to-treat-medulloblastoma?ref=fdaweb.com) silmitasertib is a small molecule drug that targets the CK2 pathway. In addition to medulloblastoma, it is being investigated for tolerability and efficacy in Covid-19, along with adult and pediatric patients with recurrent/advanced or metastatic cancer. The agent was designated an orphan drug in 2016 for treating cholangiocarcinoma; a rare pediatric disease designation in 2020 for treating medulloblastoma; and a fast track designation in August for treating recurrent sonic hedgehog-driven medulloblastoma.