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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Foundayo™ (orforglipron) be used in pregnant women?
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus and discontinue orforglipron.
See important safety information, including boxed warning, in the attached prescribing information.
Orforglipron Use in Pregnancy
Risk Summary
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus and discontinue orforglipron.1
There are no adequate and well-controlled studies of orforglipron during pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to orforglipron during pregnancy.1
Imbalances in malformations have been reported in rats and rabbits at low multiples of clinical exposure with glucagon-like peptide-1 (GLP-1) receptor agonists active in those species. Orforglipron is not pharmacologically active in rats and rabbits.1
In animal reproduction studies, oral administration of orforglipron to pregnant monkeys during organogenesis at doses lower than the maximum recommended human dose (MRHD) did not result in embryofetal effects.1
Higher dose levels and exposures could not be evaluated in monkeys due to dose limiting effects on body weight.1
In a rabbit dose-range finding study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures 14 times the clinical exposure at the MRHD resulted in external malformations and decreases in fetal and placental weights in the absence of maternal toxicity.1
In the definitive rabbit study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures up to 6 times the clinical exposure at the MRHD did not result in embryofetal effects.1
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated background risk of major birth defects and miscarriage for the indicated population is increased when compared to the general population.1
Clinical Considerations: Disease-Associated Maternal and/or Embryo/Fetal Risk
Appropriate weight gain relative to pre-pregnancy weight is currently recommended for all pregnant patients, including those with obesity or overweight, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.1
Animal Data
Embryofetal development was evaluated in pregnant monkeys administered orforglipron orally during organogenesis (gestation days 20 to 50) at doses of 0.15 and 0.7 mg/kg/day resulting in systemic exposures lower than the human exposure at the MRHD of 17.2 mg orforglipron, based on area under the cureve (AUC). No effects on pregnancy outcome, placental weight, fetal viability, fetal body weight, fetal measurements or external, visceral or skeletal evaluations were observed.1
Exposure in monkeys was lower than exposure at the MRHD. Higher dose levels and exposures cannot be achieved in pregnant monkeys due to on-target body weight effects.1
Orforglipron is not pharmacologically active in rabbits.1
In a rabbit dose-range finding study, orforglipron was administered orally once daily during organogenesis (gestation days 7 to 19) at dose levels of 2, 20, and 200 mg/kg/day. These doses resulted in exposures that were approximately 0.03, 0.8 and 14 times, respectively, the clinical exposure at the MRHD, based on AUC. Statistically significant decreases in fetal and placental weights and external malformations in 2 fetuses from 2 dams were observed at 200 mg/kg/day.1
In the definitive rabbit study, orforglipron was given orally once daily during organogenesis (gestation days 7 to 19) at dose levels of 4, 40, and 200 mg/kg/day resulting in exposures approximately 0.06, 1.4, and 6.2 times the clinical exposure at the MRHD, respectively, based on AUC. No embryofetal effects were observed in the definitive rabbit study at any dose level.1
Orforglipron is not pharmacologically active in rats.1
In a pre- and post-natal study in rats, orforglipron was administered orally once daily from implantation through lactation at doses of 5, 30, and 200 mg/kg/day, which resulted in exposures that were approximately 2.9, 4.5, and 13 times the clinical exposure at the MRHD, respectively, based on AUC. No effects were noted at any dose level in the F0 maternal rats or the F1 pups in the pre- and post-natal development study in rats.1
In a tissue distribution study, [14C]orforglipron-derived radioactivity was not distributed to fetal tissues in pregnant rats.1
Patient Counseling Information
Advise a pregnant patient of the potential risk to a fetus. Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with orforglipron.1
Advise women of childbearing potential to use effective contraception during treatment with orforglipron.1
Advise patients that there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to orforglipron during pregnancy.1
Pregnancy Registry
There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Foundayo (orforglipron) during pregnancy. Pregnant patients exposed to Foundayo and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).1
Enclosed Prescribing Information
Reference
1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Date of Last Review: September 16, 2026