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Budesonide controlled release - Calliditas Therapeutics

Drug Profile

Budesonide controlled release - Calliditas Therapeutics

Alternative Names: Nefecon; PL-56

Latest Information Update: 09 Sep 2020

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At a glance

  • Originator Uppsala University
  • Developer Calliditas Therapeutics
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antivirals; Corticosteroids; Glucocorticoids; Pregnenediones; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists; Immunosuppressants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - IgA nephropathy; Primary biliary cirrhosis; Autoimmune hepatitis
  • New Molecular Entity No

Highest Development Phases

  • Phase III IgA nephropathy

Most Recent Events

  • 10 Sep 2020 Calliditas Therapeutics plans a phase IIIb Nefigard-OLE trial for IgA nephropathy (PO) in November 2020 (NCT04541043) (EudraCT2020-003308-14)
  • 07 Sep 2020 Phase-III clinical trials in IgA nephropathy in China (PO) (NCT03643965)
  • 25 Jun 2020 Calliditas Therapeutics announces intention to launch nefecon in USA for IgA nephropathy
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