Name: Atebrioz (zilurgisertib) in Fibrodysplasia ossificans progressiva: Special populations
Published: 2026-09-27T12:28:00-04:00

Pregnancy

“There are no available data on the use of ATEBRIOZ during pregnancy to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.” (opens the prescribing information at this quote)
“In animal reproduction studies, oral administration of zilurgisertib to pregnant rats during the period of organogenesis resulted in adverse outcomes, including embryofetal lethality, decreased fetal body weight, lower viability, and skeletal malformations (one or more fused sacral centra) at exposures ≥ 3-times the clinical exposure” (opens the prescribing information at this quote)

Effects on offspring bone development in rats

“Adverse developmental effects included low pup viability and malformations (bilateral retinal folds, small eye bulge, ventricular septal defect), reflex deficits (no pupillary light reflex on post-natal day 21), and lower femur width and length, abnormal tail morphology, kidney pelvic dilatation, and decreased mating index in the offspring at doses ≥ 20 mg/kg/day (at exposures equivalent to clinical exposures by AUC).” (opens the prescribing information at this quote)

Lactation

“There are no data on the presence of zilurgisertib in human milk, the effects on the breastfed infant, or the effects on milk production. During the lactation period of the pre- and post-natal development study in rats, zilurgisertib was detected in rat pup plasma. Because of the potential for serious adverse reactions, including effects on bone development, in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with ATEBRIOZ and for at least one week after the final dose.” (opens the prescribing information at this quote)

Females of reproductive potential

“Verify that the patient is not pregnant prior to initiating ATEBRIOZ” (opens the prescribing information at this quote)
“Advise females of reproductive potential to use effective contraception during treatment with ATEBRIOZ and for one week after the final dose.” (opens the prescribing information at this quote)

Pediatric patients aged 12 to 16 years

“The safety and effectiveness of ATEBRIOZ to reduce the volume of total new HO have been established in pediatric patients aged 12 years and older with FOP. Use of ATEBRIOZ for this indication is supported by evidence from an adequate and well-controlled study in 35 pediatric patients aged 12 to 16 years with FOP” (opens the prescribing information at this quote)
“In pediatric patients with FOP (12 to 16 years of age), the estimated steady-state AUC and Cmax for zilurgisertib was 11478 nM·h and 883 nM, respectively. Zilurgisertib accumulated with a median ratio of 1.6 following once daily dosing.” (opens the prescribing information at this quote)

Pediatric patients younger than 12 years

“The safety and effectiveness of ATEBRIOZ have not been established in pediatric patients younger than 12 years of age.” (opens the prescribing information at this quote)

Geriatric patients

“Clinical studies of ATEBRIOZ did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.” (opens the prescribing information at this quote)

Renal impairment

“No significant difference in the exposure of zilurgisertib was observed in patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m2, MDRD) compared to healthy subjects with normal renal function. Zilurgisertib exposure (AUC0-∞) was approximately 64% higher in patients with moderate renal impairment (eGFR 30 to 59 mL/min/1.73 m2)” (opens the prescribing information at this quote)

“Compared with matched controls, GMRs (90% CIs) for Cmax and AUC0‐∞ were as follows: mild renal impairment, 0.92 (0.64–1.34) and 0.98 (0.77–1.24); moderate, 1.22 (0.92–1.63) and 1.64 (1.28–2.10); severe, 1.00 (0.74–1.35) and 1.70 (1.33–2.16), respectively. Among participants with ESRD, values were the following: before haemodialysis, 1.17 (0.91–1.49) and 1.47 (1.15–1.88); after, 1.32 (1.00–1.75) and 1.68 (1.29–2.19), respectively.” (opens the source at this quote in a new tab)
“Our results indicate zilurgisertib dose adjustment is not required in patients with mild renal impairment or mild to moderate hepatic impairment. However, dose adjustment may be needed in those with moderate to severe renal impairment, ESRD undergoing haemodialysis, or severe hepatic impairment.” (opens the source at this quote in a new tab)

Hepatic impairment

“The zilurgisertib Cmax and AUC in patients with moderate hepatic impairment was comparable to healthy subjects with normal hepatic function. In patients with severe hepatic impairment, zilurgisertib AUC was 25% higher and Cmax was similar to that in subjects with normal hepatic function.” (opens the prescribing information at this quote)

“Among participants with hepatic impairment, values were as follows: moderate, 1.06 (0.80–1.42) and 1.13 (0.93–1.38); severe: 1.36 (1.05–1.76) and 1.25 (1.06–1.48), respectively.” (opens the source at this quote in a new tab)
“Zilurgisertib exposure was unchanged with mild renal or moderate hepatic impairment, but increased by 30%–70% with moderate or more severe renal impairment and by 25% with severe hepatic impairment.” (opens the source at this quote in a new tab)