NDASUBCUTANEOUSSOLUTIONPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 2d ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
YORVIPATH (palopegteriparatide) is a subcutaneous solution approved in August 2024 by the FDA as an NDA from Ascend Therapeutics. The mechanism of action and specific indications are not publicly detailed in available data, but the pegylated teriparatide backbone suggests PTH1R agonism for bone metabolism disorders. This is a biologic in early commercial launch phase with substantial patent protection through 2042.
Growth16.4 years to LOE
Early-stage post-launch biologic with zero reported Part D claims; commercial team is building market infrastructure and establishing reimbursement frameworks with modest initial headcount.
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 (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.