Calliditas’ lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO and conditional marketing authorization by the European Commission under the trade name KINPEYGO as of February 2023.
KINPEYGO is being commercialized in the European Union Member States and will be commercialized in the UK by Calliditas’ partner, STADA Arzneimittel AG. Additionally, Calliditas is conducting a Phase IIb/III clinical trial in primary biliary cholangitis and a Phase II proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.
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