Last reviewed · How we verify
Yorvipath (PALOPEGTERIPARATIDE)
Palopegteriparatide releases PTH(1-34) to maintain calcium and phosphate homeostasis through PTH1R.
At a glance
| Generic name | PALOPEGTERIPARATIDE |
|---|---|
| Sponsor | Ascendis Pharma Bone |
| Target | parathyroid hormone 1 receptor (PTH1R) |
| Modality | Recombinant protein |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Palopegteriparatide works by releasing PTH(1-34), which mimics the actions of natural parathyroid hormone. This helps maintain proper levels of calcium and phosphate in the body by stimulating bone turnover, enhancing calcium reabsorption in the kidneys, and promoting vitamin D synthesis.
Approved indications
- hypoparathyroidism
- acute post-surgical hypoparathyroidism
Common side effects
- Injection site reactions
- Vasodilatory signs and symptoms
- Headache
- Diarrhea
- Back pain
- Hypercalcemia
- Oropharyngeal pain
Drug interactions
- Digoxin
- YORVIPATH
Key clinical trials
- 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 (PHASE3)
- A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
- A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism (PHASE3)
- Palopegteriparatide in Chronic Hypoparathyroidism
- A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
- Translation and Validation of the Hypoparathyroidism Patient Experience Scales (HPES) Questionnaire in Greek
- Expanded Access Program of Palopegteriparatide in Patients With Hypoparathyroidism
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Yorvipath CI brief — competitive landscape report
- Yorvipath updates RSS · CI watch RSS
- Ascendis Pharma Bone portfolio CI