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Budesonide controlled release - Calliditas Therapeutics

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Drug Profile

Budesonide controlled release - Calliditas Therapeutics

Alternative Names: Nefecon; PL-56

Latest Information Update: 20 Aug 2019

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At a glance

  • Originator Uppsala University
  • Developer Calliditas Therapeutics
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Corticosteroids; Glucocorticoids; Pregnenediones; Small molecules
  • Mechanism of Action Glucocorticoid receptor agonists
  • 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
  • Available For Licensing Yes

Highest Development Phases

  • Phase III IgA nephropathy

Most Recent Events

  • 10 Jun 2019 Budesonide controlled release licensed to Everest Medicines in China, Hong Kong, Macau, Taiwan and Singapore for IgA nephropathy (option for other potential indications)
  • 09 Jun 2019 Calliditas Therapeutics intends to make accelerated and conditional regulatory submissions respectively, to the US FDA and EMA, for IgA nephropathy in the second half of 2020
  • 03 Apr 2019 Calliditas Therapeutics announces intention to launch Nefecon for IgA nephropathy in the US
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