Peptide Graded

Palopegteriparatide

Does Palopegteriparatide work?

Yes, in a controlled trial of 84 adults.

AStrong human evidenceFDA approvedas of 2026-10-26

Approval rests on the PaTHway phase 3 trial, a randomized, double-blind, placebo-controlled study in 84 adults with hypoparathyroidism, in which the composite endpoint of normal calcium without conventional therapy was met by a large majority on drug and almost none on placebo. The randomized period was short at 26 weeks; the open-label extension, published out to 3.5 years in 2026, carries the long-term story. 123

PaTHway randomized 84 adults with long-term hypoparathyroidism, about three to one. They got palopegteriparatide or placebo for 26 weeks. Both groups kept their usual therapy, which was then tapered. The main measure combined several goals. Blood calcium had to be normal. Patients had to stop active vitamin D and therapeutic calcium doses. They could not need more study drug in the final weeks. About 79 percent of patients on palopegteriparatide met it. About 5 percent on placebo did. Urinary calcium is chronically high on usual therapy and damages kidneys. On the drug, it fell into the normal range. Patient-reported symptom and quality of life scores also improved. 1

The label sums up the open-label extension of PaTHway. Among patients first randomized to the drug, 64% kept normal calcium at week 52. They also stayed free of active vitamin D and therapeutic calcium. At week 78, 66% did, when dose increases were allowed. 2

Evidence checklist

  • Randomised controlled trial PaTHway, double-blind placebo-controlled
  • Human study over 100 people PaTHway enrolled 84 adults
  • More than one research group Sponsor trial and its extension
  • Clinical outcomes, not surrogate markers Calcium and supplement independence measures
  • Human safety data beyond case reports Calcium swings; rat osteosarcoma warning; 3.5-year follow-up published

Read the full Palopegteriparatide page

More on Palopegteriparatide

Citations

  1. Khan 2023, J Bone Miner Res: efficacy and safety of palopegteriparatide (TransCon PTH) in adults with hypoparathyroidism, PaTHway phase 3 trial pubmed.ncbi.nlm.nih.gov
  2. Ascendis Pharma: Yorvipath (palopegteriparatide) prescribing information ascendispharma.us
  3. Khan 2026, J Clin Endocrinol Metab: palopegteriparatide in adults with hypoparathyroidism, 3.5-year results from the phase 3 PaTHway trial pubmed.ncbi.nlm.nih.gov

Reference information only, not medical advice. Drawn from the Palopegteriparatide article, fact-checked against the cited sources. No dosing anywhere on this site.