MIMRYLO (Rusfertide)

MIMRYLO (rusfertide), from Takeda, is the first hepcidin mimetic approved by the FDA. It treats erythrocytosis (too many red blood cells) in adults with polycythemia vera (PV), helping control haematocrit and cutting down the need for repeated phlebotomies (blood removal).

Rusfertide mimics hepcidin, the body’s natural iron-regulating hormone. It limits the iron available to the bone marrow, which slows excess red cell production. In the Phase 3 VERIFY trial, 76.9% of patients on rusfertide responded (no phlebotomy eligibility) versus 32.9% on placebo, and 62.6% kept haematocrit below 45% versus 14.4%. It is self-injected under the skin once a week, starting at 19 mg and adjusted up to a maximum of 108 mg weekly.

• Platelet counts may rise; a complete blood count should be checked every 2 to 4 weeks after starting and during dose changes.
• Injection site reactions are the most common side effect (56%), followed by anaemia (16%).
• Based on animal data, MIMRYLO can harm an unborn baby; effective contraception is advised, and breastfeeding is not recommended.

What documents are required to import MIMRYLO to India?

MIMRYLO may be imported in the patient’s name only, by patients or government hospitals. The following documentation is required:

• A valid prescription from a registered haematologist
• Haematology report confirming polycythemia vera (CBC, JAK2 status) and phlebotomy history
• Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription.

Is MIMRYLO available in India?

MIMRYLO was FDA-approved in August 2026 and is not marketed in India. It can be legally accessed through the Named Patient Program (NPP), subject to applicable regulations.

Indian Pharma Network (IPN) can source MIMRYLO from its authorized distribution network and facilitate supply to patients, doctors, and hospitals under applicable legal provisions.

For MIMRYLO cost in India and availability, contact IPN at Phone: +91-9310090915 or email info@indianpharmanetwork.in.

Global Approval Status:

• United States: FDA-approved — 28 August 2026 (Priority Review).
• European Union / Japan: Not approved as of October 2026.

What is MIMRYLO used for?

MIMRYLO (rusfertide) is a first-in-class hepcidin mimetic used for erythrocytosis in adults with polycythemia vera.

Who manufactures MIMRYLO?

MIMRYLO is from Takeda (discovered by Protagonist Therapeutics).

How does MIMRYLO work?

Rusfertide mimics hepcidin, the body’s natural iron-regulating hormone, limiting the iron available to the bone marrow and slowing excess red blood cell production.

Does MIMRYLO replace phlebotomy?

It is designed to keep haematocrit controlled so that far fewer phlebotomies are needed; in VERIFY most responders needed none during the assessment period.

Is MIMRYLO approved by the US FDA?

Yes. The FDA approved MIMRYLO in August 2026.