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Study · Non-randomized trial · n = 13 · 2026

4 results

Palopegteriparatide in Japanese adults with hypoparathyroidism: 52-week results from the phase 3 PaTHway Japan trial.

Ashida K, Nomura M, Makita N, Imanishi Y, Kanamoto N, Zhao C, Schneider M, Ukena J, Lai B, Shu AD, Takeuchi Y

Endocrine journal18 Nov 2025Cited by 1 (Europe PMC)

PMID41260697 (opens in a new tab)PMCIDPMC12895123 (opens in a new tab)DOI10.1507/endocrj.ej25-0376 (opens in a new tab)PepBankPUB-41260697
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study4

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

  1. 01HumanNon-randomized trialEfficacy outcome

    After 26 weeks of palopegteriparatide, 92% (12/13) of Japanese adults with hypoparathyroidism achieved the primary multicomponent endpoint.

    In plain wordsAfter 26 weeks of palopegteriparatide, 92% of Japanese participants achieved the combined calcium and supplement-independence endpoint.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicablePrimary multicomponent endpoint at week 26
    Study

    n = 13

    Analysis
    Primary
    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    Responders
    92%
    week 26
    Responders
    12 participants
    of 13

    Source sentences

    Summary
    After 26 weeks of treatment with palopegteriparatide, 92% (12/13) of participants achieved the primary multi-component endpoint.
    4 context sentences
    Summary · context
    The main outcomes measures included the proportion of participants at week 26 who achieved albumin-adjusted serum calcium in the normal reference range, independence from active vitamin D, and independence from therapeutic doses of elemental calcium.
    Summary · context
    PaTHway Japan is an ongoing, phase 3, multicenter, single-arm, open-label trial comprised of a 26-week efficacy period with an extension period through week 182 designed to demonstrate the efficacy, safety, and tolerability of palopegteriparatide in Japanese individuals with hypoparathyroidism.
    Summary · context
    Japanese men and women (≥18 years of age) with hypoparathyroidism of any etiology (≥26 weeks) taking stable doses of active vitamin D were enrolled across five sites in Japan.
    Summary · context
    Once-daily palopegteriparatide was self-administered subcutaneously via a pre-filled pen injector.
  2. 02HumanNon-randomized trialEfficacy outcome

    At week 52, 92% (11/12) of extension participants with hypoparathyroidism met the multicomponent endpoint during palopegteriparatide treatment.

    In plain wordsAt week 52, 92% of extension participants met the combined endpoint during palopegteriparatide treatment.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableMulticomponent endpoint at week 52
    Study

    n = 12

    Outcome group
    Electrolyte balance · Endocrine and hormones
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Responders
    92%
    week 52
    Responders
    11 participants
    of 12

    Source sentences

    Summary
    Of the participants who entered the extension period, 92% (11/12) met the multi-component endpoint at week 52.
    4 context sentences
    Summary · context
    The main outcomes measures included the proportion of participants at week 26 who achieved albumin-adjusted serum calcium in the normal reference range, independence from active vitamin D, and independence from therapeutic doses of elemental calcium.
    Summary · context
    PaTHway Japan is an ongoing, phase 3, multicenter, single-arm, open-label trial comprised of a 26-week efficacy period with an extension period through week 182 designed to demonstrate the efficacy, safety, and tolerability of palopegteriparatide in Japanese individuals with hypoparathyroidism.
    Summary · context
    Japanese men and women (≥18 years of age) with hypoparathyroidism of any etiology (≥26 weeks) taking stable doses of active vitamin D were enrolled across five sites in Japan.
    Summary · context
    Once-daily palopegteriparatide was self-administered subcutaneously via a pre-filled pen injector.
  3. 03HumanNon-randomized trialSafety outcome

    Adverse events during palopegteriparatide treatment in Japanese adults with hypoparathyroidism were mild to moderate.

    In plain wordsAdverse events during palopegteriparatide treatment were mild to moderate in Japanese adults with hypoparathyroidism.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Adverse events were mild to moderate in severity; none led to discontinuation of palopegteriparatide treatment.
    3 context sentences
    Summary · context
    PaTHway Japan is an ongoing, phase 3, multicenter, single-arm, open-label trial comprised of a 26-week efficacy period with an extension period through week 182 designed to demonstrate the efficacy, safety, and tolerability of palopegteriparatide in Japanese individuals with hypoparathyroidism.
    Summary · context
    Japanese men and women (≥18 years of age) with hypoparathyroidism of any etiology (≥26 weeks) taking stable doses of active vitamin D were enrolled across five sites in Japan.
    Summary · context
    Once-daily palopegteriparatide was self-administered subcutaneously via a pre-filled pen injector.
  4. 04HumanNon-randomized trialSafety outcome

    No adverse event led to palopegteriparatide discontinuation in Japanese adults with hypoparathyroidism.

    In plain wordsNo adverse event caused participants to stop palopegteriparatide treatment.

    Peptide
    Palopegteriparatide
    Outcome
    Not applicableDiscontinuation due to adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Adverse events were mild to moderate in severity; none led to discontinuation of palopegteriparatide treatment.
    3 context sentences
    Summary · context
    PaTHway Japan is an ongoing, phase 3, multicenter, single-arm, open-label trial comprised of a 26-week efficacy period with an extension period through week 182 designed to demonstrate the efficacy, safety, and tolerability of palopegteriparatide in Japanese individuals with hypoparathyroidism.
    Summary · context
    Japanese men and women (≥18 years of age) with hypoparathyroidism of any etiology (≥26 weeks) taking stable doses of active vitamin D were enrolled across five sites in Japan.
    Summary · context
    Once-daily palopegteriparatide was self-administered subcutaneously via a pre-filled pen injector.

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

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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