NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 21h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YORVIPATH (palopegteriparatide) is a subcutaneous solution approved by the FDA in August 2024 from Ascend Therapeutics. The specific indication and mechanism of action are not detailed in available data, but the drug represents a new therapeutic option in a growth phase lifecycle. Palopegteriparatide is a pegylated parathyroid hormone analog designed for enhanced pharmacokinetics.
Growth16.1 years to LOE
Early-stage commercial launch with no competitors currently positioned in the market creates significant opportunity for foundational brand-building and team expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
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 May 2026
36 enrolled
HypoparathyroidismEndocrine System DiseasesParathyroid Diseases
A Study to Test the Effects and Safety of Palopegteriparatide in Adolescents With Long-term Hypoparathyroidism
Started Apr 2026
12 enrolled
Hypoparathyroidism
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.