A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)

Study identification

• EU PAS number:
  EUPAS1000000922
• Study ID:
  1000000922
• Official title and acronym:
  A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational, opportunistic lactation study to be conducted in lactating female participants who are currently receiving therapeutic doses of YORVIPATH® as part of their usual care and who have chosen to breastfeed; their infant(s). The potential transfer of palopegteriparatide (YORVIPATH®) into breast milk will be assessed.
• 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:01/11/2028

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