Data edition of
Residue An evidence-graded reference for peptide science

Afamelanotide dosage in clinical trials

What dose levels researchers actually tested, quoted from the trial registry and the published reports — so the numbers circulating online can be checked against their source.

Doses in published trials

Table 1. Dose arms of the principal published Afamelanotide trials, as reported in the cited paper.
TrialPopulationDose armsScheduleRef.
US phase 3 RCTEPP; 94 randomized16 mg implantSC every 60 days, 3 implants over 180 days1
EU phase 3EPP; 74 randomized16 mg implantSC every 60 days, 5 implants over 270 days1
Early volunteer studiesHealthy volunteers0.08–0.21 mg/kgSC in saline, 10 daily doses2
Figure 1. Dose levels named in ClinicalTrials.gov arm descriptions that mention Afamelanotide, counted once per study (4 interventional studies). Includes titration steps and single-dose pharmacology studies; a level appearing often is not evidence that it is effective or safe.

Arms as registered

Verbatim arm text from ClinicalTrials.gov. Only arms naming Afamelanotide and a dose are shown.

  1. NCT01605136 · Phase 3 · Completed · n=93

    Phase III Confirmatory Study in Erythropoietic Protoporphyria

    • Afamelanotide — One 16mg subcutaneous implant every 2 months for 6 months.

  2. NCT06388642 · Phase 1/Phase 2 · Completed · n=28

    Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

    • Afamelanotide 16 mg implant

  3. NCT01097044 · Phase 2 · Completed · n=77

    Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP)

    • Afamelanotide — Dose: 16 mg implant; release of 16 mg over 7 to 10 days Mode of administration: Subcutaneous implantation Frequency: Every 60 days (on Days 0, 60 and 120)

  4. NCT03634137 · Phase 1 · Completed · n=24

    Implant Pharmacokinetic and Pharmacodynamic Study

    • Afamelanotide Group 1 — A 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process.
    • Afamelanotide Group 2 — A 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process.

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

  1. 1 PubMed Langendonk JG, Balwani M, Anderson KE, et al. Afamelanotide for Erythropoietic Protoporphyria. N Engl J Med 2015. PMID 26132941; doi:10.1056/NEJMoa1411481.
  2. 2 PubMed Minder EI, Barman-Aksoezen J, Schneider-Yin X. Pharmacokinetics and Pharmacodynamics of Afamelanotide and its Clinical Use in Treating Dermatologic Disorders. Clin Pharmacokinet 2017. PMID 28063031; doi:10.1007/s40262-016-0501-5.

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