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An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

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Trial Profile

An Open-Label Multiple-Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 30 Jan 2024

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At a glance

  • Drugs RZ 358 (Primary)
  • Indications Congenital hyperinsulinism; Hypoglycaemia
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms RIZE
  • Sponsors Rezolute; XOMA

    • Most Recent Events

    • 23 Jan 2024 According to a Rezolute media release, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI). The Innovation Passport designation was granted based on the substantial unmet medical need in this condition and the potential for RZ358 to benefit patients as evidenced by the Phase 2 RIZE study.
    • 17 Oct 2023 According to a Rezolute media release, company announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to RZ358 for the treatment of congenital hyperinsulinism based on the data from the RIZE study.
    • 07 Sep 2022 Status changed from active, no longer recruiting to completed.
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