Trial Profile

A phase III registrational trial of LUM-201 in Children With Growth Hormone Deficiency

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 25 Oct 2024

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At a glance

Drugs Ibutamoren (Primary)
Indications Somatotropin deficiency
Focus Registrational; Therapeutic Use
Sponsors Lumos Pharma

Most Recent Events

23 Oct 2024 According to a Lumos Pharma media release, company announced that the FDA are aligned on the Company's final Phase 3 trial design and This trial will be conducted at approximately 80 global sites.
01 Aug 2024 According to a Lumos Pharma media release, company expects to be in a position to initiate this trial in the second quarter of 2025
14 May 2024 According to a Lumos Pharma media release, End of Phase 2 Meeting Held with FDA, FDA indicated that a placebo-controlled trial design is an appropriate option for a Phase 3 trial for LUM-201.

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