CALT Profile
Calliditas Therapeutics AB (publ), a clinical-stage biopharmaceutical company headquartered in Stockholm, Sweden, specializes in the development and commercialization of pharmaceutical products aimed at treating orphan diseases, with an emphasis on renal and hepatic conditions. Founded in 2004, Calliditas is dedicated to advancing innovative treatments for rare and complex diseases with significant unmet medical needs.
The company's flagship product, Nefecon, is an oral formulation of budesonide, a potent immunosuppressant specifically developed for treating immunoglobulin A nephropathy (IgAN), a challenging autoimmune renal disease. Nefecon represents a targeted approach to managing this condition, offering a novel option for patients who currently have limited treatment choices.
Calliditas is also advancing Setanaxib, its lead product candidate, which is a selective NOX inhibitor. Setanaxib is undergoing extensive clinical trials, with Phase 2b/3 studies focusing on primary biliary cholangitis (PBC), a chronic liver disease. Additionally, Setanaxib is being evaluated in Phase 2 trials for multiple other indications, including squamous cell carcinoma of the head and neck, idiopathic pulmonary fibrosis, and type 1 diabetic kidney disease. This broad clinical development program underscores the drug's potential across a range of serious conditions.
In addition to Nefecon and Setanaxib, Calliditas is developing Budenofalk, an oral budesonide formulation intended for the treatment of autoimmune hepatitis. This product aims to address the needs of patients with this severe liver condition, further expanding the company's portfolio in the realm of rare and complex diseases. Through its innovative pipeline and commitment to rare disease research, Calliditas Therapeutics continues to make strides in addressing significant medical challenges and improving patient outcomes.
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