Date: 2016-12-22
Type of information: Granting of the orphan status in the US
Product name: CX-4945 - silmitasertib
Compound: silmitasertib
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: kinase inhibitor. CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, which plays an important role in the DNA damage repair mechanisms of cancer cells.
Company: Senhwa Biosciences (Taiwan)
Disease: cholangiocarcinoma
Latest news: * On December 22, 2016, the FDA has granted orphan drug designation for silmitasertib for the treatment of
cholangiocarcinoma.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2016-12-22
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
