Product information and disease description Place of product in therapy Approaches to treatment

Place in treatment, anticipated use, and care setting

5 evidence topics · 5 sources

Summary: anticipated position of an oral ALK2 inhibitor

Zilurgisertib is the second oral product and the third product overall approved for fibrodysplasia ossificans progressiva. It is taken once daily at home, with or without food, and tablets may be crushed into water, juice, apple sauce, or yogurt for patients who cannot swallow them. Its labeled population (12 years and older) includes adolescents aged 12 to 17 years, for whom garetosmab-grts is not labeled, and growing adolescents, for whom the palovarotene label carries a boxed warning for premature epiphyseal closure. Garetosmab-grts, by contrast, is given by intravenous infusion over 60 minutes every 4 weeks using an infusion pump. The international clinical guideline has not been updated since the 2026 approvals and classifies zilurgisertib as an investigational Class III agent. Zilurgisertib is expected to be commercially available in October 2026 through the Mirum Access Plus patient support program. No source identified in this review defines the order in which the three approved products should be used.

Oral administration, including crushed tablets

“Administer ATEBRIOZ tablets whole or crushed. If crushed, mix 4 tablets (100 mg total) with four tablespoons (60 mL) of water, orange juice, apple sauce, or plain yogurt and administer immediately.” (opens the prescribing information at this quote)

Intravenous administration of the activin A antibody

“PASATRU should be administered using an infusion pump to control the rate of infusion.” (opens the source at this quote in a new tab)

Commercial availability and investigator statement on adolescents

“Atebrioz is expected to be commercially available in the U.S. in October, with eligible patients paying as little as $0 per month through MAP.” (opens the source at this quote in a new tab)
“Having another treatment option is meaningful in a progressive disease like FOP, particularly for adolescents who may be earlier in the course of their disease.” (opens the source at this quote in a new tab)

Guideline classification before approval

“Class III Agents are compounds under development, being tested in clinical trials, and are not yet available for general use.” (opens the source at this quote in a new tab)
“ACVR1/ALK2 Signal Transduction Inhibitor, STI (Zilurgisertib; INCB000928) [Incyte; PROGRESS]” (opens the source at this quote in a new tab)