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A Multi-centre, Randomized, Two-armed, Parallel Group and Evaluator-blinded Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

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Trial Profile

A Multi-centre, Randomized, Two-armed, Parallel Group and Evaluator-blinded Study of Efficacy and Safety of Topical MOB015B in the Treatment of Mild to Moderate Distal Subungual Onychomycosis (DSO)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2023

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At a glance

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

    • Most Recent Events

    • 28 Jun 2023 According to a Moberg Pharma media release, topline results are expected in the first quarter of 2025.
    • 28 Jun 2023 According to a Moberg Pharma media release, The Decentralized Procedure includes the following EU countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Hungary, Ireland, Italy, Netherlands, Norway, Spain and Sweden. Next steps include national implementation in each country and granting of marketing authorizations including OTC-approvals when applicable.
    • 28 Jun 2023 According to a Moberg Pharma media release, the Decentralized Procedure has ended with a positive outcome and that MOB-015 is recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults. Approval is supported by two Phase 3 trials. National approvals are expected to follow during upcoming months and timelines may vary between countries.

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