Rusfertide is named as an intervention in 2 current clinical trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Portugal, Turkey, Canada, Mexico, Australia, Israel and Japan registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Protagonist Therapeutics, Inc (1). The most-studied condition is Polycythemia Vera.
Rusfertide was first approved in the US on 28 Aug 2026.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
A Study of Rusfertide in Japanese Adults With Polycythemia Vera
NCT07648030 · ClinicalTrials.gov ↗ · Polycythemia Vera
|
Phase 2 | Recruiting | Takeda | Japan |
|
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
NCT05210790 · Polycythemia Vera
|
Phase 3 | Active, closed | Protagonist Therapeutics, Inc | UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Portugal, Turkey, Canada, Mexico, Australia, Israel |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
| Lead sponsor | Trials |
|---|---|
| Protagonist Therapeutics, Inc | 1 |
| Takeda | 1 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our UK, USA, Germany, France, Spain, Italy, Netherlands, Belgium, Poland, Austria, Czechia, Portugal, Turkey, Canada, Mexico, Australia, Israel and Japan registers name Rusfertide (also registered as TAK-121) as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.
Yes. 1 of the 2 trials is recruiting: 1 with sites in Japan. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Protagonist Therapeutics, Inc (1) and Takeda (1). The number in brackets is how many trials each organisation leads.
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Rusfertide works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records โ it is not written from memory, and nothing here describes how Rusfertide works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Rusfertide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.