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CTRI Number  CTRI/2025/08/093581 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 20/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A research study looking at long-term treatment with etavopivat in people with sickle cell disease or thalassaemia 
Scientific Title of Study   An open-label, multi-centre, rollover study to characterise long-term safety and efficacy of etavopivat in adults, adolescents and children who have sickle cell disease or thalassaemia and have completed a treatment period in an etavopivat study 
Trial Acronym  FLORAL 
Secondary IDs if Any  
Secondary ID  Identifier 
2024-510805-27  EudraCT 
NCT06609226  ClinicalTrials.gov 
NN7535-7822 Version 1.0 Dated 03 May 2024  Protocol Number 
U1111-1301-8130  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
Affiliation  Novo Nordisk India Private Limited, 
Address  Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park,Nagavara Village, Kasaba Hobli, Bangalore,KARNATAKA 560045,India

Bangalore
KARNATAKA
560045
India 
Phone  8030713355  
Fax    
Email  VJYP@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Vijay Parthasarathy 
Designation  Director, CDC India 
Affiliation  Novo Nordisk India Private Limited, 
Address  Nxt Tower - 2, Floor 1 & 2 Embassy Manyata Business Park,Nagavara Village, Kasaba Hobli, Bangalore, KARNATAKA 560045 India

Bangalore
KARNATAKA
560045
India 
Phone  8030713355  
Fax    
Email  VJYP@novonordisk.com  
 
Source of Monetary or Material Support  
Novo Nordisk A S Novo Alle, 2880 Bagsvaerd, Denmark 
 
Primary Sponsor  
Name  Novo Nordisk India Private Limited 
Address  Nxt Tower - 2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore –560045, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
Germany
India
Spain
United Kingdom
United States of America
Egypt
France
Ghana
Greece
Italy
Kenya
Lebanon
Nigeria
Oman
Saudi Arabia
Turkey  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tulika Seth  All India Institute Medical Sciences  Room 202, Dept of Hematology, Second Floor, New Private Ward- Delhi -110029
New Delhi
DELHI 		 9811262092

drtulikaseth@gmail.com 
Dr Pankaj Kumar Kannauje  All India Institute of Medical Sciences,  Great Eastern Road, AIIMS Campus, Tatibandh Raipur - 492099, Chhattisgarh, India.
Raipur
CHHATTISGARH 		 9572696488

drpankajkannauje@aiimsraipur.edu.in 
Dr Shrinath Manikrao Kshirsagar  K. J. Somaiya Hospital and Research Centre  Somaiya ayurvihar complex everard nagar, near Eastern Express Highway, Mumbai, Maharashtra-400022, India
Mumbai
MAHARASHTRA 		 9821556030

shrinathk2000@gmail.com 
Dr Dharmesh Vaghasiya   NIRMAL HOSPITAL PVT. LTD  RING ROAD , SURAT-395002 , GUJARAT , INDIA
Surat
GUJARAT 		 7767054520

drdharmeshrvaghasiya@gmail.com  
Dr Mustfa Fakhruddin Ali   Suretech Hospital and Research Centre Ltd  13-A Banerjee Marg Dhantoli Nagpur, Maharashtra-440012.India
Nagpur
MAHARASHTRA 		 9881293805

drmustafafali@gmail.com 
Dr Meera Varadarajan  Victoria hospital   Department of Clinical Hematology,5th Floor,New OPD block,Mysore road,Near City market,New Tharagupet,Bangalore,Karnataka-560002
Bangalore
KARNATAKA 		 9845134167

meerachakra@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College and research Institute(BMCRI)  Approved 
Institute Ethics Committee AIIMS,Delhi  Approved 
Institute Ethics Committee, AIIMS, Raipur   Approved 
Institutional Ethics Committee - Suretech Hospital and Research Centre Ltd.   Approved 
Institutional Ethics Committee – Clinical Trials K. J. Somaiya Medical College  Approved 
NIRMAL HOSPITAL ETHICS COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D574||Sickle-cell thalassemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Etavopivat A  Pharmaceutical form: Tablet Route of administration: Oral Trial product strength :200 mg per tablet Dose and dose frequency:400 mg QD 
Intervention  Etavopivat B  Pharmaceutical form:Granules for oral suspension Route of administration:Oral Trial product strength:20 mg and 100 mg per stick pack Dose and dose frequency:Age- and weight-based dose QD 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  11.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Participant must have ongoing participation in an etavopivat parent study for treatment of sickle cell disease (SCD) or thalassaemia and have completed at least a treatment period of the parent study.
2. Participant must have derived clinical benefit from treatment with etavopivat, as determined by the investigator.
3. Any participant with dose reduction or temporary discontinuation will need to be rechallenged before transferring.
4.Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®) treatment at the time of consent may be eligible if they:
5.Have been on a stable dose during participation in the parent study (i.e., no changes to the dose except for changes to weight or age reasons).
6. Have been compliant with the treatment regimen at the discretion of the investigator during participation of the parent study. 
 
ExclusionCriteria 
Details  1.Any disorder, except for conditions associated with SCD or thalassaemia, which in the investigators opinion might jeopardise participants safety or compliance with the protocol.
2. Participant withdrew or had permanent treatment discontinuation from an etavopivat clinical study.
3. Participants on permanent dose reduction or temporary treatment discontinuation.
4. Use of any of the following within the timeframes prior to the transfer visit as stated:
5. Use of voxelotor within participation of the parent study or anticipated need for this agent during this study.
6. Use of an experimental selectin antagonist (e.g., monoclonal antibody or small molecule) within the parent study or anticipated need for such agents during this study.
7. Use of erythropoietin or other haematopoietic growth factor treatment within the parent study or anticipated need for such agents during this study.
8. Receiving or use of concomitant medications that are strong inducers of cytochrome P450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for such agents during the study.
9. Current participation in a study that is not a designated parent study, or planned participation in any other clinical trial, for the duration of FLORAL. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately.

2.Number of adverse reactions, reported for each indication and age group separately 		 Baseline (week 0 of
FLORAL) to end of study
(week 264, or earlier)  
 
Secondary Outcome  
Outcome  TimePoints 
Annualised vaso-occlusive crisis (VOC) rates, reported for each age group separately  Baseline (week 0 of FLORAL) to end of treatment at week 260, or earlier 
Change in VOCs, reported for each age group separately  Baseline (of parent study) to end of treatment at week 260, or earlier 
Change in hemoglobin (Hb) concentration, reported for each age group separately  Baseline (of parent study) to end of treatment at week 260, or earlier 
Annualised number of hospitalisations, reported for each age group separately  Baseline (week 0 of FLORAL) to end of treatment at week 260, or earlier 
Average length of stay of hospitalisations, reported for each age group separately  Baseline (week 0 of FLORAL) to end of treatment at week 260, or earlier 
Change in Hb concentration  Baseline (of parent study) to end of treatment at week 260, or earlier 
Number of red blood cell (RBC) units transfused, reported for each indication separately  Baseline (week 0 of FLORAL) to end of treatment at week 260, or earlier 
Change in RBC units transfused, reported for each indication separately  Baseline (of parent study) to end of treatment at week 260, or earlier 
 
Target Sample Size   Total Sample Size="325"
Sample Size from India="54" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 19/01/2027 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/01/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
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