Last reviewed 2026-04-20 · How we verify

Musredo (MOLIDUSTAT)

Molidustat (Musredo), marketed by Bayer Yakuhin, Ltd., is a renal anemia treatment that has secured a position in the competitive landscape of anemia management. Its key strength lies in its mechanism of action, which involves inhibiting the Egl nine homolog 1 enzyme to regulate erythropoiesis, offering a novel approach to treating renal anemia. The primary risk is the competition from daprodustat, which was FDA-approved on February 1, 2023, and is patent-protected until March 13, 2038.

At a glance

Approved indications

• Renal anemia

Common side effects

• Vomiting
• Increased systolic blood pressure
• Mild transient increases in serum potassium

Serious adverse events

• Thromboembolism (suspected)
• Seizures
• Severe hypertension
• Worsening CKD
• Declining quality of life
• Abdominal mass

Key clinical trials

• A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia
• Maintenance Treatment of Renal Anemia in Dialysis Subjects (PHASE3)
• A Study of Molidustat for Treatment of Renal Anemia in Peritoneal Dialysis Subjects (PHASE3)
• A Study of Molidustat for Correction of Renal Anemia in Dialysis Subjects (PHASE3)
• A Study of Molidustat for Correction of Renal Anemia in Non-dialysis Subjects (PHASE3)
• A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects (PHASE3)
• Single Dose Group Stratified Study in Renal Impaired and Healthy Aged and Gender Matched Subjects (PHASE1)
• To Investigate Pharmacokinetics (Absorption, Distribution, Elimination), Safety and Tolerability of a Single Oral Dose of 75 mg Molidustat Tablet in Male and Female Subjects Requiring Hemo- or Peritoneal Dialysis Compared to Healthy Subjects (PHASE1)

Primary sources

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