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A prospective, double-blind, randomized efficacy and safety of IBI311 in thyroid associated ophthalmopathy patients

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Trial Profile

A prospective, double-blind, randomized efficacy and safety of IBI311 in thyroid associated ophthalmopathy patients

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs IBI-311 (Primary)
  • Indications Graves ophthalmopathy
  • Focus Registrational; Therapeutic Use
  • Acronyms RESTORE; RESTORE-1

Most Recent Events

  • 14 Mar 2025 According to a Innovent Biologics media release, data from the study were presented at World Ophthalmology Congress (WOC), Annual Meeting of Chinese Society of Endocrinology (CSE), and Congress of Chinese Ophthalmological Society (CCOS).
  • 14 Mar 2025 According to a Innovent Biologics media release, company announced that Chinas National Medical Products Administration (NMPA) has approved SYCUME (teprotumumab N01) for the treatment of thyroid eye disease (TED).
  • 21 May 2024 According to a Innovent Biologics media release, the New Drug Application (NDA) for IBI311 has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA) for the treatment of Thyroid Eye Disease (TED).

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