Trial Profile
A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 11 Mar 2024
Price :
$35
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At a glance
- Drugs Rezafungin (Primary) ; Caspofungin; Fluconazole
- Indications Candidaemia; Invasive candidiasis
- Focus Registrational; Therapeutic Use
- Acronyms ReSTORE
- Sponsors Cidara Therapeutics
- 02 Feb 2024 According to a Napp Pharmaceuticals media release, company announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain. The authorisation was based on positive results from the pivotal ReSTORE Phase III clinical trial. The findings are supported by the STRIVE Phase II clinical trial and an extensive nonclinical development program.
- 29 Jan 2024 According to a Cidara Therapeutics media release, the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults. This approval comes after positive results from the ReSTORE Phase III clinical trial.
- 22 Dec 2023 According to Mundipharma media release, company today announced rezafungin (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasisin adults. The approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from the pivotal ReSTORE Phase III clinical trial.