This press release is issued in order to provide information to the media, shareholders, and investors; the information contained herein does not constitute product promotion or medical advice.
Asahi Kasei Therapeutics Corp., the Japanese-based pharmaceutical subsidiary of diversified global company Asahi Kasei, has initiated a Phase II clinical trial1 in Japan of isavuconazonium sulfate (brand name: Cresemba™, development code: AK1820) in pediatric patients (at least 1 year old and under 18 years old).
Primarily occurring in immunocompromised patients, invasive fungal infections can lead to severe clinical outcomes, necessitating prompt and appropriate treatment. In pediatric patients in particular, treatment options remain limited, making this an area of significant unmet medical need. While isavuconazonium sulfate has been approved for pediatric indications in several countries around the world, it is currently not approved for use in pediatric patients in Japan. Having the rights to isavuconazonium sulfate in Japan, Asahi Kasei Therapeutics Corp. initiated the Phase II trial for pediatric indications following consultation with the Japanese regulatory authorities. The trial is assessing the safety and pharmacokinetics in children at risk from deep mycoses.
Isavuconazonium sulfate was created as a new antifungal agent by the Swiss pharmaceutical company Basilea Pharmaceutica International Ltd, Allschwil. In September 2016, Asahi Kasei Therapeutics Corp. obtained exclusive rights to develop and commercialize isavuconazonium sulfate in Japan. In December 2022, it was approved in Japan as Cresemba™ Capsule 100 mg and Cresemba™ Intravenous Infusion 200 mg for the treatment of aspergillosis, mucormycosis, and cryptococcosis in adult patients. In September 2024, Cresemba™ Capsule 40 mg was approved as an additional formulation in Japan.
Daisuke Okajima, President of Asahi Kasei Therapeutics Corp., commented, “Cresemba™ is an important product in our focus area of severe infectious diseases. Fungal infections can lead to serious clinical outcomes, and treatment options for pediatric patients in Japan remain limited. By further developing Cresemba™, we look forward to addressing additional unmet medical needs and delivering new treatment options to more patients.”
Pharmaceuticals is positioned as a First Priority business in Asahi Kasei’s medium-term management plan, reflecting its strategic importance as a future growth driver. The advancement of Cresemba™ for pediatric patients aligns with this strategy by supporting the company’s commitment to patient-centered innovation and its objective of generating long-term business value through differentiated pharmaceutical products and pipeline assets.