Trial Profile

A pediatric study of Terbinafine for the treatment of Onychomycosis

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 27 Oct 2021

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At a glance

Drugs Terbinafine (Primary)
Indications Onychomycosis
Focus Registrational; Therapeutic Use
Sponsors Moberg Pharma

Most Recent Events

27 Oct 2021 New trial record
22 Oct 2021 According to a Moberg Pharma media release, company has received approval of the pediatric plan for MOB-015 from EMA's paediatric committee (PDCO).This approval enables the company to pursue a full marketing authorization application providing up to ten years of exclusivity in Europe following approval. The company's timeline remains, with planned submission for MOB-015 in Europe this year and expected market approval in 2023.
22 Sep 2021 According to a Moberg Pharma media release, this study will be initiated in the second half of 2022.

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