Mimrylo

(Rusfertide)

Phase 3Peptide

Takeda

Mimrylo is one of 10 small molecule programs targeting Polycythemia Vera. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Polycythemia VeraActive, not recruiting

Polycythemia VeraPhase 3

Active, not recruiting

Competition

Competitive Landscape

10 competitors in Polycythemia Vera

#DrugCompanyPhaseTrials

Droxia

TTheravia

Approved

5 2

BESREMI

PPharmaEssentia

Approved

4 3

Jakafi

Incyte

Phase 3

11 4

Ojjaara

GGlaxo Dba Glaxosmithkline

Approved

—5

Zolinza

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Trisenox

Duvyzat

3 8

Bomedemstat

Merck & Co.

Phase 2

2 9

Mimrylo

Takeda

Phase 3

3 10

SLN124

SSilence Therapeutics plc

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Polycythemia Vera

NCT05210790

Q3 2028

Phase 2Not yet recruiting

Polycythemia Vera

NCT07765602

Q2 2030

Phase 2Recruiting

Polycythemia Vera

NCT07648030

Clinical

Trials by Indication[1]

Polycythemia Vera3 trials

A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera

Active, not recruiting· Protagonist Therapeutics logo

Protagonist Therapeutics·Phase 3·NCT05210790·293 enrolled

A Phase 2 Open-label Trial to Evaluate the Efficacy and Safety of Rusfertide in Japanese Patients With Polycythemia Vera

Recruiting· Takeda logo

Takeda·Phase 2·NCT07648030·9 enrolled

A Phase 2 Open-Label Trial to Evaluate the Efficacy and Safety of the Hepcidin Mimetic Rusfertide (TAK-121) in Chinese Patients With Polycythemia Vera

Not yet recruiting· Takeda logo

Takeda·Phase 2·NCT07765602·24 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 28, 2026

MIMRYLO

NDA NDA220605

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Rusfertide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rusfertide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rusfertide. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA220605). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Phase 3[1]
Company: Takeda

Mimrylo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2028

Q2 2030

Trials by Indication[1]

Polycythemia Vera3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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