Rusfertide
Also known as: PTG-300, Rusfertide injection
Key Facts: Rusfertide
- Category
- Hormonal
- FDA Status
- Not FDA Approved
- Clinical Status
- Phase 3 - FDA Breakthrough Therapy Designation
- Administration
- Subcutaneous injection, once weekly
- Typical Dose
- 40-80 mg weekly
- Frequency
- Once weekly
- Duration
- Ongoing — designed for chronic use
Mechanism of Action
Rusfertide mimics the action of hepcidin, the master regulator of iron metabolism. It binds to ferroportin (the only known cellular iron exporter) and triggers its internalization and degradation. This reduces iron absorption from the gut and iron release from macrophages and hepatocytes, limiting iron availability for erythropoiesis (red blood cell production). The result is a controlled reduction in hematocrit and hemoglobin levels.
Research Summary
Phase 2 REVIVE trial (2023): 70 PV patients showed significant hematocrit control. 69% achieved composite response (hematocrit <45% + elimination of phlebotomy). Median number of phlebotomies dropped from 4 to 0 over 28 weeks. Phase 3 VERIFY trial (NCT05210790) is ongoing with 300+ patients across multiple sites. FDA granted Breakthrough Therapy designation in June 2022. Most promising peptide therapeutic for managing erythrocytosis from any cause, including TRT-induced polycythemia.
Dosing Information
Typical Dosingⓘ
Community experience
40-80 mg weekly
10-120 mg weekly (trial range)
Once weekly
Dose titrated based on hematocrit response. In REVIVE trial, most patients stabilized at 40-80 mg weekly. Designed as chronic therapy. Being studied primarily for polycythemia vera but has potential application for TRT-induced erythrocytosis (elevated hematocrit from testosterone therapy).
Research Dosingⓘ
Scientific studies
Doses from clinical trials only
Doses from Studies
40-80 mg weekly maintenance
Duration
Ongoing — designed for chronic use
Administration
Subcutaneous injection, once weekly
Timing & Administration
Best Time to Take
Once weekly, consistent day
Once weekly
Food Recommendation
With or without food
Why This Timing?
Long-acting hepcidin mimetic with weekly dosing schedule. Designed for once-weekly subcutaneous injection for convenience and compliance.
Possible Side Effects
Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.
- ●Injection site reactions (most common, mild)
- ●Iron deficiency (expected mechanism of action)
- ●Fatigue
- ●Dizziness
- ●Headache
- ●Nausea
- ●Generally well-tolerated in Phase 2 trials
- ●Long-term safety data still being collected in Phase 3
References
- https://pubmed.ncbi.nlm.nih.gov/37285542/
- https://clinicaltrials.gov/ct2/show/NCT05210790
- https://clinicaltrials.gov/ct2/show/NCT04057040
- https://pubmed.ncbi.nlm.nih.gov/35045228/
Research This Peptide Further
Frequently Asked Questions
What does Rusfertide do?
A synthetic hepcidin mimetic peptide developed by Protagonist Therapeutics for managing polycythemia vera (PV). Rusfertide reduces iron availability for red blood cell production, effectively lowering hematocrit levels without phlebotomy. Granted FDA Breakthrough Therapy designation in 2022 and currently in Phase 3 clinical trials.
How does Rusfertide work?
Rusfertide mimics the action of hepcidin, the master regulator of iron metabolism. It binds to ferroportin (the only known cellular iron exporter) and triggers its internalization and degradation. This reduces iron absorption from the gut and iron release from macrophages and hepatocytes, limiting iron availability for erythropoiesis (red blood cell production). The result is a controlled reduction in hematocrit and hemoglobin levels.
Is Rusfertide FDA approved?
No, Rusfertide is not currently FDA approved. Current status: Phase 3 - FDA Breakthrough Therapy Designation
What are the side effects of Rusfertide?
Reported side effects include: Injection site reactions (most common, mild), Iron deficiency (expected mechanism of action), Fatigue, Dizziness, Headache. Individual responses vary based on dosage, duration, and personal health factors.
What is the typical dose of Rusfertide?
Community-reported common dose: 40-80 mg weekly (Once weekly). Range: 10-120 mg weekly (trial range). Administration: Subcutaneous injection, once weekly. Currently investigational. Not yet FDA approved. Only available through clinical trials. All dosing from published trial data. Not medical advice.
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