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Etavopivat

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  • Product Information

    Product Information

    Scientific name: Etavopivat (FT-4202)
    Brand name: Ν/Α
    RESPONSIBLE: Novo Nordisk

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Trial Name: GLADIOLUS
    Code: NCT04987489
    Phase: 2
    Eligible patient diagnosis: Thalassaemia and SCD (12 – 65 years)
    No. of Patients enrolled: 53 [anticipated](Last update: 26/03/2026)
    Study Sites: 32 Sites per country

    Anticipated completion date: September 2025
    Scope of the Study / Aim: Safety and efficacy (reduction of RBC transfusions and increase in haemoglobin)

     

    Trial Name: FLORAL
    Code:     NCT06609226
    Phase:     3
    Eligible patient diagnosis:     Thalassaemia or SCD (any)
    No. of Patients enrolled:     480 [anticipated](Last update: 26/03/2026)

    Study Sites: 103 Sites per country

    Anticipated completion date: December 2030
    Scope of the Study / Aim: Safety and efficacy of long-term treatment with etavopivat (eligible: those who have completed a treatment period in a previous study)

  • Regulatory Information

    Regulatory Information

    Status: Not Authorised

    Additional notable points:

    • EMA: N/A
    • FDA: N/A
    • MHRA: N/A

Update: 30 June 2026

Data presented at the EHA Annual Congress (11 – 14 June 2026) announced resultsof the GLADIOLUS study, showing:

1. Improvement in haemoglobin levels:
• 50% of patients enrolled in cohort C (patients with α- or β-thalassaemia NOT receiving regular transfusions i.e. NTDT) achieved a haemoglobin response (defined as ≥1g/dL) at week 12.
• 39% of patients achieved a haemoglobin response at week 24
• 38% of patients achieved a haemoglobin response at week 48

2. Reduction of transfusion requirements:
• 89% of patients enrolled in cohort B (patients with α- or β-thalassaemia receiving regular transfusions i.e. TDT) achieved a ≥20% reduction over any continuous 12-week period
• 79% achieved a ≥33% reduction

Sources: Etavopivat Improves Hemoglobin Levels in Adults and Adolescents with Non-Transfusion-Dependent Alpha- Or Βeta-thalassemia: Results from the Open-Label Phase 2 Gladiolus Study
Etavopivat Reduces Transfusion Requirements in Adults and Adolescents With Transfusion-Dependent Alpha- Or Beta-thalassemia: Results from the Open-Label Phase 2 Gladiolus Study

 

Update: 31 March 2025

No update available.

 

Update: 22 December 2025

No update available.

 

Update: 30 September 2025

No update available.

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