FDA approves Incyte's Atebrioz (zilurgisertib) as new molecular entity
The FDA record shows approval of NDA 221198 for Atebrioz, an oral tablet containing zilurgisertib, sponsored by Incyte Corp.
The FDA's drug approval database lists NDA221198 for Atebrioz as approved, with a submission status date of 2026-09-25. The application is classified as submission class "Type 1 - New Molecular Entity" and carries a priority review designation.1
Atebrioz is formulated as an oral tablet containing the active ingredient zilurgisertib at a strength of 25MG.1 Incyte Corp is listed as the sponsor of the application.1
The FDA's approval letter for the original submission (ORIG 1) is dated September 29, 2026, and is available in the agency's application documents listing.
No further details on indication, dosing regimen, or clinical trial results are included in this FDA database record.
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