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A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency

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Trial Profile

A Phase 3, Open-Label, Randomized, Multicenter, 12-month, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin Therapy in Japanese Pre-pubertal Children With Growth Hormone Deficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2022

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At a glance

  • Drugs Somatrogon (Primary) ; Somatropin
  • Indications Somatotropin deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors OPKO Health

    • Most Recent Events

    • 20 Jan 2022 According to Pfizer Japan media release, NGENLA (somatrogon) Inj. 24 mg Pens and 60 mg Pens, has been approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan. NGENLA is a once-weekly long-acting recombinant human growth hormone, for the indication of short statue due to growth hormone deficiency without closed epiphyses.
    • 23 Mar 2021 Results comparing the efficacy and safety of somatrogon administered once weekly with Genotropin administered once daily in Japanese in Pediatric Growth Hormone Deficiency , presented at the 103rd Annual Meeting of the Endocrine Society
    • 28 Jan 2021 According to an OPKO Health media release, its partner, Pfizer Japan Inc., submitted a New Drug Application (NDA) to the Ministry of Health, Labour, and Welfare in Japan.This submission is based on the results of the Japan Phase 3 and global Phase 3 clinical studies, conducted in subjects with pediatric GHD
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