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Study · Randomized controlled trial · 2021

4 results

Comparison of Steroidogenic Exposure Following the Administration of Repository Corticotropin Injection With a Synthetic ACTH1-24 Depot and Methylprednisolone in Healthy Subjects.

Wang X, Pham L, Poola N, Brooks LR, Due B

Clinical pharmacology in drug development23 Dec 2020Cited by 18 (Europe PMC)

PMID33369276 (opens in a new tab)PMCIDPMC8359281 (opens in a new tab)DOI10.1002/cpdd.894 (opens in a new tab)PepBankPUB-33369276
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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. 01HumanRandomized controlled trialMechanism

    In healthy adults, Acthar 40 IU twice weekly produced steroidogenic exposure equivalent to approximately 5 mg daily prednisone.

    In plain wordsIn healthy adults, the lowest Acthar regimen produced exposure equivalent to approximately 5 mg daily prednisone.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicablePrednisone-equivalent steroidogenic exposure, low regimen
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    40 IU twice weekly · subcutaneous · 15 daysAs given in this study (human).

    Measurements

    Prednisone equivalent
    ≈ 5 mg daily
    40 IU twice weekly

    Source sentences

    Summary
    The 3 repository corticotropin injection regimens were equivalent to approximately 5, 8, and 16 mg of daily prednisone, respectively.
    2 context sentences
    Summary · context
    We compared the steroidogenic exposure of repository corticotropin injection and synthetic ACTH1-24 depot in healthy adults at therapeutic doses using data from 2 separate phase 1 studies.
    Summary · context
    Subjects were randomly assigned to repository corticotropin injection 40 or 80 IU subcutaneously twice weekly or 80 IU subcutaneously 3 times weekly for 15 days or to daily synthetic ACTH1-24 depot doses of 0.5 mg subcutaneously, 0.75 mg subcutaneously, 1 mg subcutaneously, or 1 mg intram…
  2. 02HumanRandomized controlled trialMechanism

    In healthy adults, Acthar 80 IU twice weekly produced steroidogenic exposure equivalent to approximately 8 mg daily prednisone.

    In plain wordsIn healthy adults, the middle Acthar regimen produced exposure equivalent to approximately 8 mg daily prednisone.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicablePrednisone-equivalent steroidogenic exposure, middle regimen
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    80 IU twice weekly · subcutaneous · 15 daysAs given in this study (human).

    Measurements

    Prednisone equivalent
    ≈ 8 mg daily
    80 IU twice weekly

    Source sentences

    Summary
    The 3 repository corticotropin injection regimens were equivalent to approximately 5, 8, and 16 mg of daily prednisone, respectively.
    2 context sentences
    Summary · context
    We compared the steroidogenic exposure of repository corticotropin injection and synthetic ACTH1-24 depot in healthy adults at therapeutic doses using data from 2 separate phase 1 studies.
    Summary · context
    Subjects were randomly assigned to repository corticotropin injection 40 or 80 IU subcutaneously twice weekly or 80 IU subcutaneously 3 times weekly for 15 days or to daily synthetic ACTH1-24 depot doses of 0.5 mg subcutaneously, 0.75 mg subcutaneously, 1 mg subcutaneously, or 1 mg intram…
  3. 03HumanRandomized controlled trialMechanism

    In healthy adults, Acthar 80 IU 3 times weekly produced steroidogenic exposure equivalent to approximately 16 mg daily prednisone.

    In plain wordsIn healthy adults, the highest Acthar regimen produced exposure equivalent to approximately 16 mg daily prednisone.

    Peptide
    ACTH (corticotropin)
    Outcome
    Not applicablePrednisone-equivalent steroidogenic exposure, high regimen
    Study

    n: not reported in source

    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    80 IU 3 times weekly · subcutaneous · 15 daysAs given in this study (human).

    Measurements

    Prednisone equivalent
    ≈ 16 mg daily
    80 IU 3 times weekly

    Source sentences

    Summary
    The 3 repository corticotropin injection regimens were equivalent to approximately 5, 8, and 16 mg of daily prednisone, respectively.
    2 context sentences
    Summary · context
    We compared the steroidogenic exposure of repository corticotropin injection and synthetic ACTH1-24 depot in healthy adults at therapeutic doses using data from 2 separate phase 1 studies.
    Summary · context
    Subjects were randomly assigned to repository corticotropin injection 40 or 80 IU subcutaneously twice weekly or 80 IU subcutaneously 3 times weekly for 15 days or to daily synthetic ACTH1-24 depot doses of 0.5 mg subcutaneously, 0.75 mg subcutaneously, 1 mg subcutaneously, or 1 mg intram…
  4. 04HumanNon-randomized trialMechanism

    In healthy-adult data analyses, Acthar steroidogenic exposure was substantially lower than synthetic ACTH1-24 depot exposure, with its clinically relevant comparator dose simulated.

    In plain wordsIn healthy-adult data analyses, Acthar had lower steroidogenic exposure than synthetic ACTH1-24 depot, whose clinically relevant dose exposure was simulated.

    Peptide
    ACTH (corticotropin)
    Outcome
    DecreaseComparative steroidogenic exposure
    Study

    n: not reported in source

    Comparator
    Synthetic ACTH1-24 depot, including simulated clinically relevant dose exposure
    Outcome group
    Receptor activity and mechanism · Endocrine and hormones
    Studied dose
    Dose not stated · subcutaneous · 15 daysAs given in this study (human).

    Source sentences

    Summary
    These analyses revealed that the steroidogenic exposure of repository corticotropin injection at clinically relevant doses was substantially lower than that for synthetic ACTH1-24 depot.
    2 context sentences
    Summary · context
    We compared the steroidogenic exposure of repository corticotropin injection and synthetic ACTH1-24 depot in healthy adults at therapeutic doses using data from 2 separate phase 1 studies.
    Summary · context
    A population PK/PD model was developed to simulate the free cortisol exposure of a clinically relevant dose of synthetic ACTH1-24 depot (1 mg subcutaneously twice weekly).

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, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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