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A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis

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Trial Profile

A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2022

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At a glance

  • Drugs Isavuconazonium (Primary) ; Isavuconazonium (Primary) ; Voriconazole; Voriconazole
  • Indications Aspergillosis; Cryptococcosis; Invasive bronchopulmonary aspergillosis; Zygomycosis
  • Focus Adverse reactions; Registrational
  • Sponsors Asahi Kasei Pharma Corp

Most Recent Events

  • 23 Dec 2022 According to a Basilea Pharmaceutica media release, the company's license partner Asahi Kasei Pharma has received the marketing authorization from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Cresemba (isavuconazole) for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis.
  • 15 Feb 2022 According to a Basilea Pharmaceutica media release, at the end of September 2021, Asahi Kasei Pharma, filed a New Drug Application (NDA) for the marketing authorization of isavuconazole in Japan for the treatment of the fungal infections: aspergillosis, mucormycosis and cryptococcosis. A regulatory decision on the NDA is expected in the second half of 2022.
  • 26 Jul 2021 According to a Basilea Pharmaceutica media release, company plans to publish topline results of the study at a later point in time.

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