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 in haemoglobin)

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: N/A
• MHRA: N/A