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Atebrioz (zilurgisertib)

Fibrodysplasia ossificans progressiva

Also known as INCB000928
Regulatory submission
NDA submitted by May 2026
Last updated
96 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Ongoing post-approval monitoring

3 evidence topics · 5 sources

Open-label extension of the pivotal trial

“Patients who completed the 24-week double-blind period entered the 292-week open-label extension” (opens the prescribing information at this quote)

“The open-label period of PROGRESS for adolescents and adults is ongoing, and enrollment of younger age groups has begun” (opens the source at this quote in a new tab)

Iron parameters during long-term treatment

“Compared to placebo, ATEBRIOZ-treated patients experienced mean increases in serum iron, hemoglobin, and transferrin saturation levels; the mean values for all three measures remained within the normal range.” (opens the prescribing information at this quote)

“Based on the data through Week 100, the increases in serum iron and transferrin saturation with ATEBRIOZ were not associated with signs or symptoms of iron overload.” (opens the prescribing information at this quote)

Pregnancy exposure registry

No evidence found.

Post-marketing registry for the retinoic acid receptor gamma agonist

“Finally, the FOPal registry (NCT06089616) has been started and will collect long-term information about safety and efficacy in patients taking palovarotene.” (opens the source at this quote in a new tab)