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Budesonide controlled release - Calliditas Therapeutics

Drug Profile

Budesonide controlled release - Calliditas Therapeutics

Alternative Names: Nefecon; PL-56

Latest Information Update: 27 Jan 2020

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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

  • 22 Jan 2020 Calliditas Therapeutics receives a positive opinion on Paediatric Investigation Plan (PIP) from the European Medicine Agency for IgA nephropathy
  • 26 Dec 2019 Calliditas Therapeutics completes enrolment in the part A of the phase III NefIgArd trial
  • 17 Dec 2019 National Medical Products Administration (NMPA) approves IND application for Budesonide controlled release in IgA nephropathy
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