A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

Study identification

• EU PAS number:
  EUPAS1000000921
• Study ID:
  1000000921
• Official title and acronym:
  A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this registry study is to collect both prospective and; retrospective data in women exposed to palopegteriparatide during pregnancy; to assess risk of pregnancy and maternal complications, and adverse effects; on the developing fetus, neonate, and infant and to assess infant outcomes; through at least the first year of life.
• Study status:
  Planned

Research institutions and networks

Institutions

Ascendis Pharma

Study timelines

Date when funding contract was signed

Actual:18/09/2025

Study start date

Planned:13/02/2026

Date of final study report

Planned:15/08/2036

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ascendis Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only