Trial Profile
A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of Remdesivir and Metabolites in Participants with Normal Renal Function and Renal Impairment
Status:
Recruiting
Phase of Trial:
Phase I
Latest Information Update: 18 Jul 2023
Price :
$35
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At a glance
- Drugs Remdesivir (Primary)
- Indications COVID 2019 infections
- Focus Pharmacokinetics; Registrational
- Sponsors Gilead Sciences
- 14 Jul 2023 According to a Gilead Sciences media release, based on results from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as results from the Phase 3 REDPINE trial, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.
- 26 May 2023 According to a Gilead Sciences media release, based on results from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as results from the Phase 3 REDPINE trial, he Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission (EC) will review the CHMP recommendation.
- 22 Oct 2021 Planned End Date changed from 28 May 2021 to 16 Mar 2022.