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hepcidin
hepcidin is a Biologic drug developed by University Hospital, Montpellier. It is currently in Phase 1 development.
Hepcidin is a protein that regulates the entry of iron into the circulation in mammals. It is being studied in clinical trials for various conditions, including Chronic Renal Disease, Iron-Deficiency Anemia, and Anemia of Chronic Kidney Disease, often in conjunction with oral iron supplementation.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | hepcidin |
|---|---|
| Sponsor | University Hospital, Montpellier |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
- EFFECTS of MORINGA OLEIFERA LEAF POWDERS on HEMATOLOGICAL PROFILES IN PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA (NA)
- Diet, Hepcidin, and Chemotherapy RDI
- Association Between Vitamin D and Perioperative Hemoglobin Levels in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery: Role of Hepcidin
- Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment (PHASE1, PHASE2)
- Elastography vs Iron Regulators in the Diagnosis of Hepatic Fibrosis- Iron Overload in Children With Beta- Thalassemia
- Modulation of hepcidIN With Co-supplementation of Iron and FORMulated Curcumin in Recreational Athletes (NA)
- Ischemic Preconditioning - Perspectives of Use Vivio/in Vitro Studies (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- hepcidin CI brief — competitive landscape report
- hepcidin updates RSS · CI watch RSS
- University Hospital, Montpellier portfolio CI
Frequently asked questions about hepcidin
What is hepcidin?
Who makes hepcidin?
What development phase is hepcidin in?
Related
- Manufacturer: University Hospital, Montpellier — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing