Palopegteriparatide

(Yorvipath®)

Yorvipath®

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 6 mcg, 9 mcg, 12 mcg, 15 mcg, 18 mcg, 21 mcg, 24 mcg, 27 mcg, 30 mcg)
Drug ClassParathyroid hormone analogs
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of hypoparathyroidism in adults.

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Summary
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  • Yorvipath (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults.
  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Composite Primary Efficacy Endpoint: At week 26, 79% (48/61) of participants treated with TransCon PTH achieved normal albumin-adjusted serum calcium levels, independence from conventional therapy, and no increase in study drug, compared to 5% (1/21) in the placebo group (p < 0.0001).
  • Health-Related Quality of Life (SF-36) and Hypoparathyroidism-Related Symptoms (HPES): TransCon PTH resulted in significant improvements in the SF-36 Physical Functioning subscale (p = 0.0347) and in all key secondary endpoint HPES domain scores (all p < 0.01), indicating enhanced well-being and reduced hypoparathyroidism-related symptoms.
  • Independence from Conventional Therapy: 93% (57/61) of participants on TransCon PTH achieved independence from conventional therapy, with no comparative data provided for the placebo group.
  • Adverse Events: 82% (50/61) of participants on TransCon PTH experienced adverse events, with most being mild (46%) or moderate (46%) in severity. In the placebo group, 100% (21/21) experienced adverse events, though severity details were not provided.
  • Withdrawals: There were no study drug-related withdrawals in the TransCon PTH group. No comparative data were provided for the placebo group.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
YORVIPATH (palopegteriparatide) Prescribing Information2024Ascendis Pharma Endocrinology Inc., Princeton, NJ

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Efficacy and safety of parathyroid hormone replacement with TransCon PTH in hypoparathyroidism: 26-week results from the phase 3 PaTHway Trial.
82Subjects
F: 78%
M: 22%
2023Journal of Bone and Mineral Research

Sex Distribution:

F:78%
M:22%
82Subjects

Year:

2023

Source:Journal of Bone and Mineral Research