NCT06609226 (FLORAL) is a Phase 3 clinical trial of Etavopivat A in Sickle Cell Disease, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT06609226?

NCT06609226 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT06609226?

Interventions in NCT06609226: Etavopivat A, Etavopivat B, Etavopivat C.

What condition does NCT06609226 study?

NCT06609226 studies Sickle Cell Disease, Thalassemia.

Is NCT06609226 still recruiting?

NCT06609226 is currently recruiting now. Last updated 24 March 2026.

Last reviewed 2026-03-24 · How we verify

NCT06609226: FLORAL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 3 Last updated 24 March 2026

What this trial tests

Phase 3 trial testing Etavopivat A in Sickle Cell Disease in 480 participants. Currently enrolling.

Timeline

10 January 2025

Primary endpoint
30 December 2030

30 December 2030

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	480
Start date	10 January 2025
Primary completion	30 December 2030
Estimated completion	30 December 2030
Sites	103 locations across France, Italy, Greece, Ghana, Turkey (Türkiye), Saudi Arabia, United Kingdom, Germany

Drugs / interventions tested

Etavopivat A — full drug profile →
Etavopivat B — full drug profile →
Etavopivat C — full drug profile →

Conditions studied

Sickle Cell Disease — all drugs for Sickle Cell Disease →
Thalassemia — all drugs for Thalassemia →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

2 and older, any sex, with Sickle Cell Disease or Thalassemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

From old to new: Repurposed drugs in the battle towards curing sickle cell disease.
El Hoss S, Bazoum H. · · 2025 · cited 1× · PMID 39568202 · DOI 10.1111/bjh.19912

Verify or expand the search:

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

NCT07369024 — Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults · Phase 2 · recruiting
NCT06016634 — Alendronate for Osteonecrosis in Adults With Sickle Cell Disease · Phase 2 · recruiting
NCT06260891 — Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial · Phase 2 · recruiting
NCT07222475 — Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease · NA · recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting

Other Novo Nordisk A/S trials

Trials by the same sponsor.

NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06609226 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 24 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06609226.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing