An Open-label, Multi-centre, Rollover Study to Characterise Long-term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children Who Have Sickle Cell Disease or Thalassaemia and Have Completed a Treatment Period in an Etavopivat Study
Latest Information Update: 14 Dec 2025
At a glance
- Drugs Etavopivat (Primary)
- Indications Sickle cell anaemia; Thalassaemia
- Focus Adverse reactions; Registrational
- Acronyms FLORAL
- Sponsors Novo Nordisk
Most Recent Events
- 08 Oct 2025 Timeframe for primary endpoints increased to 316 week. Minimum age updated to 2 year.
- 08 Oct 2025 Planned number of patients changed from 325 to 480.
- 08 Oct 2025 Planned End Date changed from 30 Nov 2029 to 30 Dec 2030.