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Clinical Trial Updates (SCD)

Tebapivat

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  • Product Information

    Product Information

    Scientific name: Tebapivat
    Brand name: Ν/Α
    RESPONSIBLE: Agios Pharmaceuticals Inc

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Trial Name: A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
    Code: NCT06924970
    Phase: 2
    Eligible patient diagnosis: : SCD (over 16 years)
    No. of Patients enrolled: 56 [anticipated] (Last update: 23/07/2025)
    Study Sites: 2 Sites per country

    Completion date: May 2027
    Scope of the Study / Aim: Hb response

  • Regulatory Information

    Regulatory Information

    Status: Not Authorised

     

    Additional notable points:

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

Update: 30 September 2025

  • 1st patient dosed in clinical trial
  • The trial is enrolling across three dose cohorts (2.5mg, 5mg, 7.5mg) and placebo.
  • Primary endpoint will measure hemoglobin response, defined as a ≥1g/dL increase in hemoglobin concentration from week 10 to week 12, compared to baseline.

Sources: Agios Reports Second Quarter 2025 Financial Results and Provides Business Update – Agios Pharmaceuticals, Inc.

 

Update: 30 June 2025

Improved RBC function and reduction of sickling tendency observed in 6 patients.

Source: EX VIVO ACTIVATION OF PYRUVATE KINASE BY TEBAPIVAT REDUCES SICKLING… – Rab M – EHA-4147 – Jun 14 2025

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