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Tenofovir disoproxil fumarate - Gilead Sciences

Drug Profile

Tenofovir disoproxil fumarate - Gilead Sciences

Alternative Names: Bis-POC-PMPA; GSK548470; PMPA-prodrug; Tenofovir DF; Tenozet; Viread

Latest Information Update: 07 Mar 2019

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At a glance

  • Originator Institute of Organic Chemistry and Biochemistry (Prague); Rega Institute for Medical Research
  • Developer Gilead Sciences; GlaxoSmithKline
  • Class Antiretrovirals; Phosphonic acids; Purines; Small molecules
  • Mechanism of Action Nucleotide reverse transcriptase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Hepatitis B; HIV infections

Most Recent Events

  • 07 Mar 2019 The CHMP of EMA adopts a positive opinion recommending a change to the terms of the marketing authorization of tenofovir disoproxil fumarate (tablet) to include paediatric patients (6-12 years) who weigh from 28 kg to less than 35 kg, with compensated liver disease and evidence of immune active disease, and persistently elevated serum ALT levels or histological evidence of moderate to severe inflammation and/or fibrosis, in treatment of Hepatitis B
  • 28 Feb 2019 The CHMP of EMA adopts a positive opinion recommending a change to the terms of the marketing authorization of tenofovir disoproxil fumarate (granules) to include paediatric patients (2-18 years) for whom a solid dosage form is not appropriate with compensated liver disease and evidence of immune active disease, persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis, in treatment of Hepatitis B
  • 10 Dec 2018 Adverse events and efficacy data from a phase III trial in Hepatitis B presented at the 69th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2018)
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