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A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

Study acronym: FLORAL
StatusRecruiting
PhasePhase 3
Started2025-01-10
View on ClinicalTrials.gov ↗
Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.

Amendment record

Amended 13 times since 2024-09-20; most recent filed 2026-08-12. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-08-12
Amendment Study Status, Contacts/Locations v13
2026-06-08
Amendment Study Status, Contacts/Locations v12
2026-03-23
Amendment Study Status, Contacts/Locations v11
2026-02-10
Amendment Study Status, Contacts/Locations v10
2025-12-29
Amendment Study Status, Contacts/Locations v9
2025-12-05
Amendment Study Status, Contacts/Locations v8
2025-10-29
Amendment Study Status, Contacts/Locations v7
2025-10-03
Amendment Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
2025-07-14
Amendment Study Status, Contacts/Locations v5
2025-06-19
Amendment Study Status, Contacts/Locations v4
2025-05-19
Amendment Study Status, Contacts/Locations v3
2025-04-09
Amendment Not Yet RecruitingRecruiting Study Status, Contacts/Locations v2
2024-10-08
Amendment Study Status, Contacts/Locations v1
2024-09-20
Original filing
Trial Details
NCT Number NCT06609226
Lead Sponsor Novo Nordisk A/S
Conditions Sickle Cell Disease, Thalassemia
Enrollment 480 participants
Start Date 2025-01-10
Primary Completion 2030-12-30 (estimated)
Study Completion 2030-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13