Palopegteriparatide

The labelled product is Yorvipath (Ascendis). FDA approved it on 9 August 2024 (NDA 216490) for treatment of hypoparathyroidism in adults. It was not studied for acute post-surgical hypoparathyroidism. It is a TransCon PTH prodrug of PTH(1-34), distinct from teriparatide/Forteo, which is labelled for osteoporosis uses rather than hypoparathyroidism replacement. A research or compounded PTH listing is not Yorvipath.

A parathyroid hormone analog (PTH(1-34)) prodrug. Under physiological conditions it releases PTH(1-34), which acts at PTH1R to support extracellular calcium and phosphate homeostasis—renal calcium reabsorption and phosphate excretion, bone turnover effects, and facilitation of active vitamin D synthesis. Continuous systemic exposure to released PTH over the dosing interval is the labelled design intent. That is replacement physiology for labelled hypoparathyroidism, not an osteoporosis anabolic protocol.

PaTHway Phase 3 (NCT04701203): 26-week randomized, double-blind, placebo-controlled trial in 82 adults with hypoparathyroidism (Yorvipath n=61; placebo n=21), published as Khan et al., J Bone Miner Res 2023 (PMID 36271471). Per the Yorvipath label and FDA approval notice, the composite Week-26 efficacy endpoint (normal albumin-corrected serum calcium, independence from active vitamin D and therapeutic calcium, stable study-drug dose constraints) was met by 68.9% on Yorvipath versus 4.8% on placebo (treatment difference 64.2%). Clarke et al., J Clin Endocrinol Metab 2025 (PMID 39376010) report 52-week PaTHway results. That body of evidence supports the labelled adult hypoparathyroidism use. It does not establish acute post-surgical use, pediatric use, or osteoporosis anabolic use.

• FDA approval notice — Yorvipath for hypoparathyroidism · 2024

  FDA approves new drug for hypoparathyroidism, a rare disorder. Yorvipath (palopegteriparatide) for adults; not studied in acute post-surgical hypoparathyroidism. PaTHway 26-week RCT summary (69% vs 5% composite responders). Orphan designation and priority review. Dated with approval 9 Aug 2024.

• Yorvipath (palopegteriparatide) DailyMed label · 2026

  Prescribing information. PTH(1-34) analog for hypoparathyroidism in adults. NDA 216490. Setid a1fa23fd-c434-443e-9a17-5750578c8602. Limitations of use and PTH-class osteosarcoma warning on label.

• Khan et al., PaTHway 26-week · 2023 · J Bone Miner Res

  Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. J Bone Miner Res. 2023. PMID 36271471. DOI 10.1002/jbmr.4726. NCT04701203. PMID 36271471.

• Clarke et al., PaTHway 52-week · 2025 · J Clin Endocrinol Metab

  Efficacy and Safety of TransCon PTH in Adults With Hypoparathyroidism: 52-Week Results From the Phase 3 PaTHway Trial. J Clin Endocrinol Metab. 2025. PMID 39376010. DOI 10.1210/clinem/dgae693. PMID 39376010.

• PaTHway ClinicalTrials.gov · 2021

  NCT04701203. A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Daily in Adults With Hypoparathyroidism. Phase 3; completed.