Bones & muscles Long-acting PTH prodrug
Palopegteriparatide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- Yorvipath
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Palopegteriparatide (sold as Yorvipath) is a long-acting form of parathyroid hormone designed to release the hormone steadily over 24 hours, used to treat hypoparathyroidism in adults. Its sustained delivery aims to mimic the body's natural, around-the-clock parathyroid hormone levels more closely than earlier products. It has been FDA-approved in the U.S. since 2024 and is given as a once-daily injection.
At a glance
- What it is
- A long-acting prodrug of parathyroid hormone, PTH(1-34)
- Approved for
- Hypoparathyroidism in adults
- Key fact
- In the PaTHway trial, most patients reached normal calcium and independence from conventional therapy at six months
- Route
- Subcutaneous injection, once daily
- Evidence strength
- FDA approved
Summary
Palopegteriparatide (Yorvipath) is an FDA-approved, long-acting parathyroid hormone for adults with hypoparathyroidism. Learn how it works and what trials show.
What is palopegteriparatide?
Palopegteriparatide, sold under the brand Yorvipath, is a long-acting form of parathyroid hormone built using a sustained-release (TransCon) design: the active PTH(1-34) is attached to an inert carrier through a linker that slowly releases the hormone over the day. The goal is to supply parathyroid hormone continuously, the way healthy glands do, in people whose own glands cannot. Palopegteriparatide, developed by Ascendis Pharma, was approved in the United States in 2024.
How does palopegteriparatide work?
Palopegteriparatide is an inactive prodrug that gradually releases active PTH(1-34) after injection, producing steady hormone levels across 24 hours rather than the sharp peak and rapid fall of standard teriparatide. The released hormone binds the PTH-1 receptor and restores calcium balance through the kidney, vitamin D activation, and bone, replacing the hormone that is deficient in hypoparathyroidism.
The continuous exposure is the point: in hypoparathyroidism, steady parathyroid hormone keeps blood calcium normal while reducing reliance on high-dose calcium and active vitamin D. In the phase 3 PaTHway trial, most patients on the drug met a composite goal of normal calcium with independence from conventional therapy at 26 weeks, and the large majority became independent of calcium and active vitamin D.
Is it FDA-approved?
Editor’s note
Status: Yes. Palopegteriparatide was approved by the FDA in 2024 as Yorvipath for hypoparathyroidism in adults, following earlier approval in Europe. Its label warns of a potential risk of osteosarcoma, based on rat studies of parathyroid hormone analogs, and it is not recommended for people at increased risk of that cancer. It is given as a once-daily subcutaneous injection.
Category: FDA-approved · Primary body area: Bones & muscles
Yes. Palopegteriparatide was approved by the FDA in 2024 as Yorvipath for hypoparathyroidism in adults, following earlier approval in Europe. Its label warns of a potential risk of osteosarcoma, based on rat studies of parathyroid hormone analogs, and it is not recommended for people at increased risk of that cancer. It is given as a once-daily subcutaneous injection.
What is palopegteriparatide prescribed for?
Palopegteriparatide is prescribed for the treatment of hypoparathyroidism in adults, to maintain blood calcium and reduce the need for calcium and active vitamin D supplementation. It offers a steady-exposure alternative within the parathyroid hormone replacement class.
What are the side effects?
According to the prescribing information, common side effects include:
- Injection-site reactions
- Flushing, lightheadedness, or a drop in blood pressure on standing
- Headache
- Back pain
- Diarrhea
- High blood calcium
- Sore throat
More serious considerations include:
- A potential risk of osteosarcoma, based on rat studies of parathyroid hormone analogs
- High or low blood calcium, particularly when doses are adjusted
- Hypersensitivity reactions
Sources: FDA prescribing information for Yorvipath; the PaTHway trial (Khan et al., Journal of Bone and Mineral Research, 2023, DOI: 10.1002/jbmr.4726), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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