Name: Atebrioz (zilurgisertib) in Fibrodysplasia ossificans progressiva: Dosage forms and strengths
Published: 2026-09-27T12:28:00-04:00

Product information and disease description Product description Product information

Dosage forms and strengths

4 evidence topics · 2 sources

Tablet strength and appearance

“ATEBRIOZ Tablets: 25 mg of zilurgisertib, film-coated, white to off-white, round, debossed with "INCY" on one side and "25" on the other side.” (opens the prescribing information at this quote)

Tablet composition and excipients

“Each tablet contains 25 mg of zilurgisertib (equivalent to 32.55 mg of zilurgisertib fumarate dihydrate) and the following inactive ingredients, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, and microcrystalline cellulose. The tablet coating consists of polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.” (opens the prescribing information at this quote)

Package presentation and storage

“ATEBRIOZ contains 25 mg of zilurgisertib and is available as a round, white to off-white film-coated tablet debossed on one side with "INCY" and "25" on the other side in bottles of 120 tablets with child-resistant closure (NDC 79378-029-16). Dispense in a tight container (See USP).” (opens the prescribing information at this quote)
“Store ATEBRIOZ tablets at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted between 15ºC and 30ºC (59ºF and 86ºF) [see USP Controlled Room Temperature].” (opens the prescribing information at this quote)

Tablet strengths used in the phase 1 studies

“Both studies used a tablet formulation of the study drug, with doses comprising 5-mg or 25-mg tablets.” (opens the source at this quote in a new tab)