A Phase 3 interventional study of Etavopivat A and Etavopivat B in Sickle Cell Disease and Thalassemia, sponsored by Novo Nordisk A/S. Recruiting at 107 sites in 17 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 480 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive an oral dose of Etavopivat A or C.
Drug: Etavopivat A · Drug: Etavopivat C
Participants will receive an oral dose of Etavopivat A or C.
Drug: Etavopivat A · Drug: Etavopivat C
Participants will receive an oral dose of Etavopivat A or C.
Drug: Etavopivat A · Drug: Etavopivat C
Participants will receive an oral dose of Etavopivat A or C.
Drug: Etavopivat A · Drug: Etavopivat C
Participants ≥ 12 years of age will receive an oral dose of Etavopivat A or C and participants \< 12 years of age will receive an oral dose of Etavopivat B.
Drug: Etavopivat A · Drug: Etavopivat B · Drug: Etavopivat C
Participants will receive an oral dose of Etavopivat A.
Participants will receive an oral dose of Etavopivat B.
Participants will receive an oral dose of Etavopivat C.
Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately
Measured as number of events.
Time frame: Baseline (week 0 of FLORAL) up to end of study (up to week 316)
Number of adverse reactions, reported for each indication and age group separately
Measured as number of adverse reactions.
Time frame: Baseline (week 0 of FLORAL) up to end of study (up to week 316)
Annualised vaso-occlusive crisis (VOC) rates, reported for each age group separately
Measured as count.
Time frame: Baseline (week 0 of FLORAL) up to end of treatment (up to week 312)
Change in VOCs, reported for each age group separately
Measured as count.
Time frame: Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312)
Change in hemoglobin (Hb) concentration, reported for each age group separately
Measured as grams per deciliter (g/dL).
Time frame: Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312)
Annualised number of hospitalisations, reported for each age group separately
Measured as count.
Time frame: Baseline (week 0 of FLORAL) up to end of treatment (up to week 312)
Average length of stay of hospitalisations, reported for each age group separately
Measured as days.
Time frame: Baseline (week 0 of FLORAL) up to end of treatment (up to week 312)
Change in Hb concentration
Measured as g/dL.
Time frame: Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312)
Number of red blood cell (RBC) units transfused, reported for each indication separately
Measured as units.
Time frame: Baseline (week 0 of FLORAL) up to end of treatment (up to week 312)
Change in RBC units transfused, reported for each indication separately
Measured as units.
Time frame: Baseline (of parent study [i.e., the previous etavopivat study that a participant is rolling over from]) up to end of treatment (up to week 312)
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Showing the first 100 of 107 sites across 17 countries. Choose a country and city above to see the rest.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
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