Early U.S. Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients With Hypoparathyroidism.

Graham T, Shoback DM, Abbott L, Lubitz S, Edelson G, Haider A, Ing SW, Rothman MS, Cusano NE, Zhao C, Ukena J, Schneider M, Sibley CT, Rubin MR

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists20 Aug 2025Cited by 1 (Europe PMC)

PMID40846304DOI10.1016/j.eprac.2025.08.008PepBankPUB-40846304

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Summary

ObjectiveTo examine the impact of palopegteriparatide (YORVIPATH; TransCon PTH) on real-world clinical outcomes in adult patients with hypoparathyroidism.MethodsAdult patients with hypoparathyroidism who enrolled in the U.S. expanded access program as of October 2024 and provided consent were included in the analysis. Palopegteriparatide was administered at a recommended starting dose of 18 μg/day and titrated alongside conventional therapy (calcitriol and calcium). Conventional therapy requirements, palopegteriparatide dosing, serum calcium levels, and adverse events were assessed up to 12 months of treatment.ResultsAmong 135 patients enrolled in the expanded access program who received at least 1 dose of palopegteriparatide, 123 provided consent for data use and were included in analysis. Nearly all patients (95.1%, 117/123) were previously treated with short-lived parathyroid hormone (PTH) therapy (primarily teriparatide or recombinant human PTH [1-84]), and 50.4% (62/123) switched directly from short-lived PTH or PTH-related protein therapy to palopegteriparatide. There was no clinically meaningful difference (>3 μg) in palopegteriparatide dose between direct switch and nondirect switch patients, with a similar trend over time. With palopegteriparatide treatment, the proportion of patients achieving independence from conventional therapy (defined as taking no calcitriol and ≤600 mg/day of elemental calcium) increased over 12 months. Mean serum calcium levels remained within the reference range (8.3-10.6 mg/dL) with palopegteriparatide, and no new safety signals were identified with up to 12 months of treatment.ConclusionThis real-world analysis of palopegteriparatide treatment of hypoparathyroidism outside of a clinical trial setting reaffirms its efficacy and safety profile and provides insights into outcomes associated with different treatment transition practices.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanObservational studyOther
In adults receiving palopegteriparatide, direct versus nondirect switch groups showed no clinically meaningful dose difference (>3 μg), with similar trends over time.
In plain wordsIn adults receiving palopegteriparatide, direct and nondirect switch groups showed no clinically meaningful dose difference, with similar trends over time.
Peptide
Palopegteriparatide
Outcome
Not applicableDose by treatment transition pattern
Study
n: not reported in source
Comparator
nondirect switch patients
Outcome group
Dose requirements · Endocrine and hormones
Studied dose
recommended starting dose 18 μg/day, titratedAs given in this study (human).
Measurements
Clinically meaningful dose difference threshold
> 3 μg
direct versus nondirect switch; difference did not exceed threshold
Source sentences
Summary
There was no clinically meaningful difference (>3 μg) in palopegteriparatide dose between direct switch and nondirect switch patients, with a similar trend over time.
4 context sentences(design, population, supporting numbers)
Summary · context
Adult patients with hypoparathyroidism who enrolled in the U.S. expanded access program as of October 2024 and provided consent were included in the analysis.
Summary · context
Palopegteriparatide was administered at a recommended starting dose of 18 μg/day and titrated alongside conventional therapy (calcitriol and calcium).
Summary · context
Conventional therapy requirements, palopegteriparatide dosing, serum calcium levels, and adverse events were assessed up to 12 months of treatment.
Summary · context
Among 135 patients enrolled in the expanded access program who received at least 1 dose of palopegteriparatide, 123 provided consent for data use and were included in analysis.
Show in the study text Report a problemFND-4084630401
02HumanObservational studyEfficacy outcome
In adults with hypoparathyroidism, independence from conventional therapy increased over 12 months during palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, independence from conventional therapy increased over 12 months during palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
IncreaseIndependence from conventional therapy
Study
n: not reported in source
Outcome group
Conventional therapy requirements · Endocrine and hormones
Studied dose
recommended starting dose 18 μg/day, titrated · up to 12 months of treatmentAs given in this study (human).
Source sentences
Summary
With palopegteriparatide treatment, the proportion of patients achieving independence from conventional therapy (defined as taking no calcitriol and ≤600 mg/day of elemental calcium) increased over 12 months.
4 context sentences(design, population, supporting numbers)
Summary · context
Adult patients with hypoparathyroidism who enrolled in the U.S. expanded access program as of October 2024 and provided consent were included in the analysis.
Summary · context
Palopegteriparatide was administered at a recommended starting dose of 18 μg/day and titrated alongside conventional therapy (calcitriol and calcium).
Summary · context
Conventional therapy requirements, palopegteriparatide dosing, serum calcium levels, and adverse events were assessed up to 12 months of treatment.
Summary · context
Among 135 patients enrolled in the expanded access program who received at least 1 dose of palopegteriparatide, 123 provided consent for data use and were included in analysis.
Show in the study text Report a problemFND-4084630402
03HumanObservational studyEfficacy outcome
In adults with hypoparathyroidism, mean calcium remained within 8.3-10.6 mg/dL during palopegteriparatide treatment for up to 12 months.
In plain wordsIn adults with hypoparathyroidism, mean calcium remained within the reference range during palopegteriparatide treatment for up to 12 months.
Peptide
Palopegteriparatide
Outcome
Not applicableSerum calcium
Study
n: not reported in source
Outcome group
Electrolyte balance · Endocrine and hormones
Studied dose
recommended starting dose 18 μg/day, titrated · up to 12 months of treatmentAs given in this study (human).
Measurements
Reference range for mean serum calcium
8.3 to 10.6 mg/dL
range within which mean serum calcium remained
Source sentences
Summary
Mean serum calcium levels remained within the reference range (8.3-10.6 mg/dL) with palopegteriparatide, and no new safety signals were identified with up to 12 months of treatment.
4 context sentences(design, population, supporting numbers)
Summary · context
Adult patients with hypoparathyroidism who enrolled in the U.S. expanded access program as of October 2024 and provided consent were included in the analysis.
Summary · context
Palopegteriparatide was administered at a recommended starting dose of 18 μg/day and titrated alongside conventional therapy (calcitriol and calcium).
Summary · context
Conventional therapy requirements, palopegteriparatide dosing, serum calcium levels, and adverse events were assessed up to 12 months of treatment.
Summary · context
Among 135 patients enrolled in the expanded access program who received at least 1 dose of palopegteriparatide, 123 provided consent for data use and were included in analysis.
Show in the study text Report a problemFND-4084630403
04HumanObservational studySafety outcome
In adults with hypoparathyroidism, no new safety signals appeared with up to 12 months of palopegteriparatide treatment.
In plain wordsIn adults with hypoparathyroidism, no new safety signals appeared with up to 12 months of palopegteriparatide treatment.
Peptide
Palopegteriparatide
Outcome
Not applicableNew safety signals
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
recommended starting dose 18 μg/day, titrated · up to 12 months of treatmentAs given in this study (human).
Source sentences
Summary
Mean serum calcium levels remained within the reference range (8.3-10.6 mg/dL) with palopegteriparatide, and no new safety signals were identified with up to 12 months of treatment.
4 context sentences(design, population, supporting numbers)
Summary · context
Adult patients with hypoparathyroidism who enrolled in the U.S. expanded access program as of October 2024 and provided consent were included in the analysis.
Summary · context
Palopegteriparatide was administered at a recommended starting dose of 18 μg/day and titrated alongside conventional therapy (calcitriol and calcium).
Summary · context
Conventional therapy requirements, palopegteriparatide dosing, serum calcium levels, and adverse events were assessed up to 12 months of treatment.
Summary · context
Among 135 patients enrolled in the expanded access program who received at least 1 dose of palopegteriparatide, 123 provided consent for data use and were included in analysis.
Show in the study text Report a problemFND-4084630404

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase not statedNCT07299838

Palopegteriparatide in Chronic Hypoparathyroidism

National and Kapodistrian University of Athensn = 901 Jun 2024 to 23 Oct 2025

Hypoparathyroidism

Trial page ClinicalTrials.govUpdated 26 Jan 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:37 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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Journal Article

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