Hematology · In Clinical Trials
Hepcidin
No lawful US pathway
01 · Overview
Hepcidin is a 25-amino-acid peptide hormone secreted mainly by the liver in response to iron loading and inflammation, and it is the central regulator of systemic iron homeostasis. It binds ferroportin, the cellular iron exporter on enterocytes, macrophages, hepatocytes and placental cells, and causes its internalization and degradation, reducing iron export into plasma (PMID 15514116).
Hepcidin mimetics and hepcidin-lowering agents are being developed respectively for disorders of iron overload or excessive erythropoiesis and for anemia associated with high hepcidin levels. Hepcidin itself is not an approved drug product.
02 · Research summary & key findings
The hepcidin-ferroportin mechanism was established in 2004 in cell-based work showing that hepcidin binding triggers ferroportin internalization and degradation (PMID 15514116). Peptide hepcidin mimetics have now reached late-stage development: in the phase 2 REVIVE trial, rusfertide controlled hematocrit and reduced phlebotomy need in patients with polycythemia vera (PMID 38381675), and a rusfertide product was approved by the FDA in August 2026 under NDA 220605 according to the FDA drug approval database. The earlier statement that no hepcidin-pathway agent had achieved regulatory approval is therefore out of date, although the native hepcidin peptide itself has no approved product. Other approaches, including an siRNA that raises endogenous hepcidin by targeting TMPRSS6, have been tested in healthy volunteers (PMID 37497888).
03 · Regulatory status
Hepcidin is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.
No lawful pathway today
Hepcidin is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding.
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04 · Administration routes
- Subcutaneous injection
References
- [1]Hepcidin regulates cellular iron efflux by binding to ferroportin and inducing its internalization Science, 2004. PMID 15514116
- [2]SLN124, a GalNAc conjugated 19-mer siRNA targeting tmprss6, reduces plasma iron and increases hepcidin levels of healthy volunteers Am J Hematol, 2023. PMID 37497888
- [3]Rusfertide, a Hepcidin Mimetic, for Control of Erythrocytosis in Polycythemia Vera N Engl J Med, 2024. PMID 38381675
Primary literature
- PubMed: "Hepcidin"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Hepcidin"
Registered interventional and observational studies, including status and phase.
- PubChem: "Hepcidin"
Chemical structure, molecular properties, and bioactivity data.
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