Clinical Trials
31
19 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2007
Active, not recruiting
13
41.9%
Completed
5
16.1%
Not yet recruiting
6
19.4%
Recruiting
5
16.1%
Terminated
2
6.5%
No approval data available
- Etavopivat demonstrated a 27% reduction in vaso-occlusive crisis events and delayed first crisis by approximately 4 months compared to placebo in the HIBISCUS phase 3 trial. - The oral pyruvate kinase-R activator achieved superior hemoglobin response, with 48.7% of patients showing >1g/dL increase versus 7.2% on placebo after 24 weeks. - Novo Nordisk plans to submit for regulatory approval in the second half of 2026, potentially offering the first therapy in a new drug class for sickle cell disease patients. - The trial enrolled 385 participants aged 12 years and older with sickle cell disease, successfully meeting both co-primary endpoints in the 52-week study.
• Novo Nordisk is initiating a Phase 3 trial for etavopivat in December, following promising Phase 2 results in sickle cell disease patients. • The Phase 2 HIBISCUS trial demonstrated that etavopivat, at both 200mg and 400mg doses, reduced the rate of vaso-occlusive crises by approximately 46% compared to placebo. • Etavopivat, a once-daily pyruvate kinase activator, aims to improve red blood cell function by enhancing oxygen binding and preventing sickling. • The Phase 2 trial reported mostly mild-to-moderate adverse events, supporting the continued development of etavopivat for sickle cell disease.
