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Phase III trial of BioChaperone Lispro in patients with type 1 diabetes mellitus

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Phase III trial of BioChaperone Lispro in patients with type 1 diabetes mellitus

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 04 Mar 2025

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At a glance

  • Drugs Insulin lispro (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Adocia

    • Most Recent Events

    • 25 Feb 2025 According to an Adocia media release, topline results from this study are expected in mid-2025 and assuming successful Phase 3 results, Tonghua Dongbao plans on submitting Ultra-Rapid Insulin BioChaperone Lispro for Chinese regulatory review in 2025.
    • 14 Oct 2021 According to an Adocia media release, the application of phase 3 clinical trial application was based on positive Phase 1 clinical trial results in Europe. The Phase 3 clinical program is expected to enroll over 1,300 people with diabetes
    • 14 Oct 2021 According to an Adocia media release, the Tonghua Dongbao Pharmaceutical received clearance from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to conduct the Phase 3 clinical trial of BioChaperone Lispro, an Ultra-Rapid Insulin for the treatment of Type 1 and Type 2 diabetes. The first patient enrolled in the phase 3 program will trigger a milestone payment to Adocia.

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