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Open-label rusfertide
Open-label rusfertide is a Erythropoietin receptor agonist Small molecule drug developed by Protagonist Therapeutics, Inc.. It is currently in Phase 3 development for Chronic kidney disease-associated anemia.
Rusfertide is a human erythropoietin receptor agonist.
Rusfertide is a human erythropoietin receptor agonist. Used for Chronic kidney disease-associated anemia.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Open-label rusfertide |
|---|---|
| Sponsor | Protagonist Therapeutics, Inc. |
| Drug class | Erythropoietin receptor agonist |
| Target | Erythropoietin receptor |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 3 |
Mechanism of action
Rusfertide works by binding to the erythropoietin receptor, stimulating erythropoiesis and increasing red blood cell production. This can help alleviate anemia in patients with chronic kidney disease. By increasing red blood cell mass, rusfertide may also improve exercise capacity and quality of life in these patients.
Approved indications
- Chronic kidney disease-associated anemia
Common side effects
- Injection site reaction
- Headache
- Nausea
Key clinical trials
- PTG-300 in Subjects With Hereditary Hemochromatosis (PHASE2)
- A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera (PHASE3)
- Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (PHASE3)
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:
- Open-label rusfertide CI brief — competitive landscape report
- Open-label rusfertide updates RSS · CI watch RSS
- Protagonist Therapeutics, Inc. portfolio CI
Frequently asked questions about Open-label rusfertide
What is Open-label rusfertide?
How does Open-label rusfertide work?
What is Open-label rusfertide used for?
Who makes Open-label rusfertide?
What drug class is Open-label rusfertide in?
What development phase is Open-label rusfertide in?
What are the side effects of Open-label rusfertide?
What does Open-label rusfertide target?
Related
- Drug class: All Erythropoietin receptor agonist drugs
- Target: All drugs targeting Erythropoietin receptor
- Manufacturer: Protagonist Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Chronic kidney disease-associated anemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing