Asahi Kasei launches Phase II pediatric trial of Cresemba in Japan
- Asahi Kasei has started a Phase II trial in Japan of isavuconazonium sulfate (Cresemba) in patients aged ≥1 and <18 years.
- The trial will assess safety and pharmacokinetics in children at risk of deep mycoses after consultation with Japanese regulators.
- Isavuconazonium (Cresemba) was approved for adults in Japan in December 2022; a 40 mg capsule formulation was approved in September 2024.
- Asahi Kasei obtained exclusive development and commercialization rights in Japan from Basilea in September 2016; the drug has pediatric approvals in other countries but not yet in Japan.
Trial launch
Asahi Kasei Therapeutics Corp. has initiated a Phase II clinical trial in Japan of isavuconazonium sulfate (Cresemba, development code AK1820) in pediatric patients aged at least 1 year and under 18 years. The study follows consultation with Japanese regulatory authorities and is designed to assess safety and pharmacokinetics in children at risk from deep mycoses.
Regulatory status in Japan
Isavuconazonium sulfate is approved in Japan for adult indications: Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg were approved in December 2022, and a Cresemba Capsule 40 mg formulation received approval in September 2024. The drug is not yet approved for pediatric use in Japan, though it has pediatric approvals in other countries.
Origin and rights
The antifungal was created by Basilea Pharmaceutica International Ltd. In September 2016 Asahi Kasei Therapeutics obtained exclusive rights to develop and commercialize isavuconazonium sulfate in Japan and is now advancing a pediatric indication through the current Phase II trial.
Source: Asahi Kasei
