Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Palopegteriparatide (Yorvipath, TransCon PTH): what the evidence says
At a glance
What it is: a prodrug that slowly releases PTH(1-34), the active part of parathyroid hormone, from a large PEG carrier, giving steady hormone levels. Approved as Yorvipath (Aug 2024) for adults with hypoparathyroidism. R1, R2
What the evidence says: Human in PaTHway (84 adults), 79% met the main goal (normal calcium without conventional active vitamin D and high-dose calcium) vs 5% with placebo at 26 weeks; 81% kept this at 52 weeks. R3, R4
Biggest risks: label warnings: blood calcium too high or too low, possible osteosarcoma risk (seen in rats), dizziness on standing (orthostatic hypotension) and a digoxin interaction. R2
Rating
| Human Human evidence | Strong: phase 3 RCT with 52-week follow-up R3, R4 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R5, R6, R7 · not named by WADA R8 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: Adult hypoparathyroidism: Strong (phase 3 RCT) · Osteoporosis or bone building: No human data
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: one pivotal RCT of moderate size; long-term data are still limited.
What is it?
Related pages: parathyroid-hormone, teriparatide, abaloparatide.
Does it work?
- Human PaTHway (26 weeks): 79% vs 5% met the composite goal; 93% became independent of conventional therapy. R3, R9
- 🟨 52 weeks (open-label): 81% met the goal and 95% were independent of conventional therapy. R4
Is it safe?
- Label warnings: hypersensitivity, hypercalcemia, hypocalcemia, osteosarcoma risk, orthostatic hypotension, digoxin interaction. R2
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved, prescription (Yorvipath). R1
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R5, R6, R7
- Sport: not named on WADA's 2026 Prohibited List. R8
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| PaTHway 2023 | 84 adults with hypoparathyroidism | SC | Titrated, per label | 26 weeks | 79% vs 5% met goal | PMID 36271471 |
| PaTHway 52-week | 78 completers | SC | Titrated, per label | 52 weeks | 81% met goal | PMID 39376010 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Yorvipath (palopegteriparatide), application NDA216490 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA216490
- R2 Yorvipath prescribing information, label published Oct 26, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a1fa23fd-c434-443e-9a17-5750578c8602
- R3 Khan AA, et al. J Bone Miner Res. 2023. PMID 36271471
- R4 Clarke BL, et al. J Clin Endocrinol Metab. 2025. PMID 39376010
- R5 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R7 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R8 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- R9 ClinicalTrials.gov NCT04701203, PaTHway, phase 3 (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT04701203
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Palopegteriparatide (Yorvipath, TransCon PTH). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).