Etavopivat

Product Information

Scientific name: Etavopivat (FT-4202)
Brand name: Ν/Α
RESPONSIBLE: Novo Nordisk

Clinical Trial/Study Information

Trial Name: GLADIOLUS
Code: NCT04987489
Phase: 2
Eligible patient diagnosis: Thalassaemia and SCD (12 – 65 years)
No. of Patients enrolled: 60 [anticipated](Last update: 23/07/2025)
Study Sites: 16 Sites per country

Anticipated completion date: September 2025
Scope of the Study / Aim: Safety and efficacy (reduction of RBC transfusions and increase haemoglobin)

Trial Name: HIBISCUS
Code: NCT04624659
Phase: 2/3
Eligible patient diagnosis: : SCD (adolescent & adults) (age 12-65)
No. of Patients enrolled: : 344 [anticipated] (Last update: 15/2/2023)
Study Sites: 87 Sites per country

Anticipated completion date: December 2026
Scope of the Study / Aim: Increase haemoglobin; decrease annual VOCs

Trial Name: HIBISCUS KIDS
Code: NCT06198712
Phase: 1/2
Eligible patient diagnosis: SCD (age 12-18)
No. of Patients enrolled: 50 [anticipated] (Last update: 23/07/2025)
Study Sites: 13 Sites per country

Anticipated completion date: August 2029
Scope of the Study / Aim: Safety, efficacy and learn how long etavopivat stays in the bloodstream

Trial Name: HIBISCUS 2
Code: NCT06612268
Phase: 3
Eligible patient diagnosis: SCD (12 years and older)
No.  of Patients enrolled: 408 [anticipated](Last update: 23/07/2025)

Study Sites: 156 Sites per country

Anticipated completion date: September 2028
Scope of the Study / Aim: Reduction of VOCs

Trial Name: FLORAL
Code: NCT06609226
Phase: 3
Eligible patient diagnosis: Thalassaemia or SCD (any)
No. of Patients enrolled: 325 [anticipated](Last update: 23/07/2025)

Study Sites: 94 Sites per country

Anticipated completion date: November 2029
Scope of the Study / Aim: Safety and efficacy of long-term treatment with etavopivat (eligible: those who have completed a treatment period in a previous study)

Regulatory Information

Status: Not Authorised

Additional notable points:

• EMA: N/A
• FDA: Orphan drug designation (2020)
• MHRA: N/A