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Study · Randomized controlled trial · 2024

14 results

Pharmacokinetics and Pharmacodynamics of Rusfertide, a Hepcidin Mimetic, Following Subcutaneous Administration of a Lyophilized Powder Formulation in Healthy Volunteers.

Modi NB, Khanna S, Rudraraju S, Valone F

Drugs in R&D15 Nov 2024Cited by 5 (Europe PMC)

PMID39546273 (opens in a new tab)PMCIDPMC11652423 (opens in a new tab)DOI10.1007/s40268-024-00497-z (opens in a new tab)PepBankPUB-39546273
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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. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy adults, rusfertide showed rapid initial absorption.

    In plain wordsIn healthy adults, rusfertide entered the blood rapidly at first.

    Peptide
    Rusfertide
    Outcome
    Not applicableInitial absorption
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Rusfertide showed a rapid initial absorption.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy adults, median time to peak lyophilized rusfertide concentration was 24 h at 10-30 mg.

    In plain wordsIn healthy adults, lyophilized rusfertide blood concentration peaked after 24 h at 10-30 mg.

    Peptide
    Rusfertide
    Outcome
    Not applicableTime to peak concentration at lower doses
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10-30 mg lyophilized formulation · subcutaneousAs given in this study (human).

    Measurements

    Median time to peak plasma concentration
    24 h
    lyophilized formulation, 10-30 mg

    Source sentences

    Summary
    Median time to peak plasma concentrations for the lyophilized formulation was 24 h for doses of 10-30 mg and 2-4 h for doses of 45 and 60 mg.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy adults, median time to peak lyophilized rusfertide concentration was 2-4 h at 45 and 60 mg.

    In plain wordsIn healthy adults, lyophilized rusfertide blood concentration peaked after 2-4 h at 45 and 60 mg.

    Peptide
    Rusfertide
    Outcome
    Not applicableTime to peak concentration at higher doses
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    45 and 60 mg lyophilized formulation · subcutaneousAs given in this study (human).

    Measurements

    Median time to peak plasma concentration
    2 to 4 h
    lyophilized formulation, 45 and 60 mg

    Source sentences

    Summary
    Median time to peak plasma concentrations for the lyophilized formulation was 24 h for doses of 10-30 mg and 2-4 h for doses of 45 and 60 mg.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy adults, mean terminal rusfertide half-life ranged from 19.6 to 57.1 h.

    In plain wordsIn healthy adults, average terminal rusfertide half-life ranged from 19.6 to 57.1 h.

    Peptide
    Rusfertide
    Outcome
    Not applicableTerminal half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Mean terminal half-life
    19.6 to 57.1 h
    rusfertide, across doses

    Source sentences

    Summary
    Mean terminal half-life ranged from 19.6 to 57.1 h.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy adults, rusfertide peak concentration increased less than proportionally with dose.

    In plain wordsIn healthy adults, rusfertide peak blood concentration increased less than proportionally with dose.

    Peptide
    Rusfertide
    Outcome
    IncreaseDose dependence of peak concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Rusfertide peak concentration and area under the concentration-time curve increased with an increasing dose, but in a less than dose-proportional manner.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  6. 06HumanRandomized controlled trialPharmacokinetics

    In healthy adults, rusfertide area under the concentration-time curve increased less than proportionally with dose.

    In plain wordsIn healthy adults, total rusfertide exposure increased less than proportionally with dose.

    Peptide
    Rusfertide
    Outcome
    IncreaseDose dependence of exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Rusfertide peak concentration and area under the concentration-time curve increased with an increasing dose, but in a less than dose-proportional manner.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  7. 07HumanRandomized controlled trialPharmacokinetics

    In healthy adults, M4 and M9 were identified as major rusfertide metabolites.

    In plain wordsIn healthy adults, M4 and M9 were major rusfertide breakdown products.

    Peptide
    Rusfertide
    Outcome
    Not applicableMajor metabolites
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Metabolites M4 and M9 were identified as major metabolites.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  8. 08HumanRandomized controlled trialPharmacokinetics

    In healthy adults, lyophilized rusfertide exposure was approximately 1.5-fold higher than aqueous rusfertide exposure at 20 mg.

    In plain wordsIn healthy adults, lyophilized rusfertide exposure was approximately 1.5-fold higher than aqueous rusfertide exposure at 20 mg.

    Peptide
    Rusfertide
    Outcome
    IncreaseFormulation exposure comparison
    Study

    n: not reported in source

    Comparator
    Aqueous rusfertide formulation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    20 mg · subcutaneousAs given in this study (human).

    Measurements

    AUC from time zero to infinity, lyophilized versus aqueous
    ≈ 1.5 fold
    20 mg dose

    Source sentences

    Summary
    At the rusfertide 20-mg dose, the lyophilized formulation had an area under the concentration-time curve from time zero to infinity approximately 1.5-fold higher than the aqueous formulation.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  9. 09HumanRandomized controlled trialPharmacokinetics

    In healthy adults, rusfertide elimination half-life was comparable between lyophilized and aqueous formulations.

    In plain wordsIn healthy adults, rusfertide elimination half-life was similar for lyophilized and aqueous formulations.

    Peptide
    Rusfertide
    Outcome
    No significant changeFormulation half-life comparison
    Study

    n: not reported in source

    Comparator
    Aqueous rusfertide formulation
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    The elimination half-life was comparable for the two formulations.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  10. 10HumanRandomized controlled trialEfficacy outcome

    In healthy adults, serum iron decreased in a dose-related manner after rusfertide.

    In plain wordsIn healthy adults, blood iron decreased in a dose-related manner after rusfertide.

    Peptide
    Rusfertide
    Outcome
    DecreaseSerum iron
    Study

    n: not reported in source

    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Dose-related decreases in serum iron and transferrin-iron saturation were seen following rusfertide treatment.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  11. 11HumanRandomized controlled trialEfficacy outcome

    In healthy adults, transferrin-iron saturation decreased in a dose-related manner after rusfertide.

    In plain wordsIn healthy adults, transferrin iron saturation decreased in a dose-related manner after rusfertide.

    Peptide
    Rusfertide
    Outcome
    DecreaseTransferrin-iron saturation
    Study

    n: not reported in source

    Outcome group
    Blood biochemical markers · Whole body
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Dose-related decreases in serum iron and transferrin-iron saturation were seen following rusfertide treatment.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  12. 12HumanRandomized controlled trialSafety outcome

    In healthy adults, most treatment-emergent adverse events in the rusfertide study were mild.

    In plain wordsIn healthy adults, most adverse events during the rusfertide study were mild.

    Peptide
    Rusfertide
    Outcome
    Not applicableTreatment-emergent adverse 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
    The majority of treatment-emergent adverse events were mild; treatment-related treatment-emergent adverse events seen in ≥10% of subjects were injection-site erythema and injection-site pruritus.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  13. 13HumanRandomized controlled trialSafety outcome

    In healthy adults, treatment-related injection-site erythema occurred in at least 10% of subjects in the rusfertide study.

    In plain wordsIn healthy adults, treatment-related injection-site redness occurred in at least 10% of subjects in the rusfertide study.

    Peptide
    Rusfertide
    Outcome
    Not applicableInjection-site erythema
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Subjects with treatment-related injection-site erythema
    ≥ 10%
    treatment-related TEAE seen in >=10% of subjects

    Source sentences

    Summary
    The majority of treatment-emergent adverse events were mild; treatment-related treatment-emergent adverse events seen in ≥10% of subjects were injection-site erythema and injection-site pruritus.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects
  14. 14HumanRandomized controlled trialSafety outcome

    In healthy adults, treatment-related injection-site pruritus occurred in at least 10% of subjects in the rusfertide study.

    In plain wordsIn healthy adults, treatment-related injection-site itching occurred in at least 10% of subjects in the rusfertide study.

    Peptide
    Rusfertide
    Outcome
    Not applicableInjection-site pruritus
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Measurements

    Subjects with treatment-related injection-site pruritus
    ≥ 10%
    treatment-related TEAE seen in >=10% of subjects

    Source sentences

    Summary
    The majority of treatment-emergent adverse events were mild; treatment-related treatment-emergent adverse events seen in ≥10% of subjects were injection-site erythema and injection-site pruritus.
    1 context sentence
    Summary · context
    A randomized open-label crossover study was conducted in two groups of healthy adult subjects

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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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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