NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
YORVIPATH (palopegteriparatide) by Ascend Therapeutics. Approved for hypoparathyroidism. First approved in 2024.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YORVIPATH (palopegteriparatide) is a subcutaneous parathyroid hormone analog approved in August 2024 for hypoparathyroidism and parathyroid diseases. It works by raising serum calcium through increased renal tubular calcium reabsorption, intestinal calcium absorption, and bone turnover. This represents a new mechanism-of-action approach to an endocrine disorder previously managed by existing PTH analogs.
Growth16.5 years to LOE
Recently approved asset in growth phase with emerging commercial infrastructure; brand team expanding field specialist roles across multiple geographies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (1)
Clinical Trials (4)
A Phase 3 Randomized Clinical Trial to Investigate the Safety and Efficacy of Palopegteriparatide at Doses Greater Than 30 μg/Day in Adult Participants With Hypoparathyroidism
Started Apr 2026
36 enrolled
HypoparathyroidismEndocrine System DiseasesParathyroid Diseases
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
Started Mar 2026
10 enrolled
Hypoparathyroidism
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
Started Feb 2026
50 enrolled
Hypoparathyroidism
Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
Hypoparathyroidism
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.