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Pioneering New Approaches to Rare Diseases

We are dedicated to identifying and developing novel treatments for diseases that affect fewer than 200,000 individuals in the United States. In addition to our lead products, TARPEYO® (budesonide) delayed release capsules and Kinpeygo®, Calliditas also has a pipeline to address a variety of diseases, including primary biliary cholangitis and squamous cell carcinoma of the head and neck.

OUR PIPELINE

Preclinical
Phase 1
Phase 2
Phase 3
Approved
Status
Notes
NEFECON*
Immunoglobulin A Nephropathy (IgAN)
Commercial
US(TARPEYO)
Europe(KINPEYGO)
China(NEFECON)
Immunoglobulin A Nephropathy (IgAN)
Pre-Commercial
Japan
Setanaxib
Primary Biliary Cholangitis (PBC)
Ongoing
Phase 2b Trial
Idiopathic Pulmonary Fibrosis (IPF)
Ongoing
Investigator Led Phase 2 Trial
Alport Syndrome
Ongoing
Phase 2 Proof-of-Concept Trial
Solid Tumors (SCCHN)
Ongoing
Phase 2 Head and Neck Cancer Trial

*This asset received full approval in the United States as TARPEYO with an indication to reduce the loss of kidney function in adults with IgA nephropathy.

SETANAXIB: TARGETING PRIMARY BILIARY CHOLANGITIS WITH NOX ENZYME INHIBITION

In a Phase 2a trial, patients with primary biliary cholangitis (PBC) experienced statistically significant improvements in fatigue and liver stiffness.

At this time, Calliditas Therapeutics does not provide access to investigational products outside of clinical trials. You and your health care provider can learn more about our clinical trials by visiting www.clinicaltrials.gov and searching for “Calliditas Therapeutics”.