Drugs / Rusfertide
Rusfertide
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04516382 | Sep 2020 → Jan 2021 | — | Protagonist Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT07648030 | Jun 2026 → Oct 2027 expected | acquired polycythemia vera | Takeda | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04767802 | Feb 2021 → Mar 2023 | acquired polycythemia vera | Protagonist Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04202965 | Mar 2020 → Oct 2021 | hereditary hemochromatosis | Protagonist Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04057040 | Oct 2019 → Feb 2023 | acquired polycythemia vera | Protagonist Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT04054921 | May 2019 → Jul 2020 | beta thalassemia | Protagonist Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03802201 | Dec 2018 → Jul 2020 | beta thalassemia | Protagonist Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06033586 | Jan 2024 → Apr 2026 overdue | acquired polycythemia vera | Protagonist Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05210790 | Apr 2022 → Feb 2025 overdue | acquired polycythemia vera | Protagonist Therapeutics, Inc. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-08-28 | Takeda | Regulatory Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. |
| 2025-12-06 | Takeda | Results Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera takeda.com ↗ |
| 2025-06-01 | Takeda | Results Protagonist and Takeda Announce ASCO Plenary Presentation Highlighting Full 32-Week Results from Phase 3 VERIFY Study of Rusfertide, Showing Reductions in Phlebotomy, Improved Hematocrit Control in Polycythemia Vera takeda.com ↗
Protagonist Therapeutics, Inc. (“Protagonist”) ( NASDAQ:PTGX ) and Takeda ( TSE:4502/NYSE:TAK ) announced detailed results from the Phase 3, randomized, placebo-controlled VERIFY study evaluating rusfertide in patients with polycythemia vera (PV), which met the primary and all key secondary endpoints. |
| 2025-03-03 | Takeda | Results Protagonist and Takeda Announce Positive Topline Results from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera takeda.com ↗
The primary endpoint of the study was met, with a significantly higher proportion of clinical responders 1 among rusfertide-treated patients with PV (77%) compared to those who received placebo (33%) during weeks 20-32; p<0.0001. |
All press releases naming this drug 6 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rusfertide | “Rusfertide, an injectable peptide mimetic of the master iron regulatory hormone hepcidin, restricts the availability of iron for erythropoiesis.” PMID 38381675 ↗ Feb 2024 |
| Known as | PTG-300 | “Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera” NCT06033586 ↗7“A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera” NCT05210790 ↗ |
| Known as | PTG-300FB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650507 ↗ |
| Known as | TAK-121 | “Participants will receive rusfertide (TAK-121) injections, subcutaneously once a week for 52 weeks (Part 1) followed by 182 weeks long-term extension (Part 2)” NCT07648030 ↗ |
| Modality | Peptide | “an injectable peptide mimetic of the master iron regulatory hormone hepcidin” PMID 38381675 ↗ Feb 2024 |
| Route | Subcutaneous | “Subcutaneous (SC)” NCT03802201 ↗ |