NCT06612268 (Hibiscus 2) is a Phase 3 clinical trial of Etavopivat in Sickle Cell Disease, sponsored by Novo Nordisk A/S.

Who is sponsoring NCT06612268?

NCT06612268 is sponsored by Novo Nordisk A/S.

What drugs are being tested in NCT06612268?

Interventions in NCT06612268: Etavopivat, Placebo.

What condition does NCT06612268 study?

NCT06612268 studies Sickle Cell Disease.

Is NCT06612268 still recruiting?

NCT06612268 is currently recruiting now. Last updated 24 March 2026.

Last reviewed 2026-03-24 · How we verify

NCT06612268: Hibiscus 2

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

A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

Recruiting now Phase 3 Last updated 24 March 2026

What this trial tests

Phase 3 trial testing Etavopivat in Sickle Cell Disease in 408 participants. Currently enrolling.

Timeline

17 February 2025

Primary endpoint
27 August 2027

12 March 2029

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	408
Start date	17 February 2025
Primary completion	27 August 2027
Estimated completion	12 March 2029
Sites	172 locations across Italy, Colombia, Ghana, Lebanon, Kenya, Netherlands, Belgium, United States

Drugs / interventions tested

Etavopivat — full drug profile →
Placebo

Conditions studied

Sickle Cell Disease — all drugs for Sickle Cell Disease →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

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

Sponsor's own description

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.

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 trials of Etavopivat

Trials testing the same drug.

NCT07023029 — A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants · Phase 1 · completed
NCT06813924 — A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants · Phase 1 · completed
NCT06581627 — A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants · Phase 1 · completed
NCT06433661 — A Research Study of the Effect of Food on Etavopivat in Healthy Participants · Phase 1 · completed
NCT06336018 — A Research Study on Etavopivat in Participants With and Without Liver Disease · Phase 1 · completed

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 NCT06612268 (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/NCT06612268.

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