Sebetralstat Pregnancy and Breastfeeding Warnings
Brand names: Ekterly
Medically reviewed by Drugs.com. Last updated on Aug 12, 2025.
Sebetralstat Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned
Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.
Animal studies have revealed evidence of embryofetal losses and fetal malformations at doses causing maternal toxicity. No fetal harm was observed in rats and rabbits with oral dose exposures up to approximately 15 and 11 times, respectively, the human exposure at the maximum recommended human dose (MRHD). However, embryofetal losses (early and late fetal deaths, mean number of live fetuses, postimplantation loss) and fetal malformations, including cleft palates and ventricular septal defects, were seen in rats at an exposure that was 60 times the MRHD. Maternal toxicity, evidenced by a decrease in body weight gain, was observed in pregnant rabbits at an oral dose 11 times the MRHD. There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Sebetralstat Breastfeeding Warnings
Safety has not been established.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
See also
References for pregnancy information
- (2025) "Product Information. Ekterly (sebetralstat)." Kalvista Pharmaceuticals, Inc.
References for breastfeeding information
- (2025) "Product Information. Ekterly (sebetralstat)." Kalvista Pharmaceuticals, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.