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Ersodetug - Rezolute

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Drug Profile

Ersodetug - Rezolute

Alternative Names: RZ-358; X 358; XOMA 247; XOMA 358; XPA.15.247

Latest Information Update: 06 Jun 2025

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At a glance

  • Originator XOMA
  • Developer Rezolute; XOMA
  • Class Antihypoglycaemics; Monoclonal antibodies
  • Mechanism of Action Insulin receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Congenital hyperinsulinism; Hypoglycaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Congenital hyperinsulinism; Hypoglycaemia

Most Recent Events

  • 28 May 2025 Rezolute plans to file Biologics license application (BLA) for Congenital hyperinsulinism in USA in 2026
  • 28 May 2025 Rezolute completes enrolment in the phase III sunRIZE clinical trials in Congenital-hyperinsulinism (In adults, In adolescents, In infants, In children) in Georgia, Spain, Israel, France, Vietnam, United Kingdom, United Arab Emirates, Saudi Arabia, Qatar, Oman, Greece, Germany, Denmark, Canada, Bulgaria, Turkey and USA (IV) (NCT06208215)
  • 05 May 2025 Rezolute plans a phase III trial for Hypoglycemia (Treatment-resistant) in mid 2025 (NCT06881992)

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