etavopivat (NN7535) / Novo Nordisk 
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  • ||||||||||  etavopivat (NN7535) / Novo Nordisk
    Trial completion date:  Hibiscus 2: A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease (clinicaltrials.gov) -  Oct 16, 2025   
    P3,  N=408, Recruiting, 
    This study establishes the chemically induced hypoxia OcclusionChip assay as a reliable and clinically useful tool for evaluating RBC deformability in SCD, with significant potential to improve personalized treatment strategies and thus patient outcomes. Trial completion date: Sep 2028 --> Apr 2029
  • ||||||||||  etavopivat (NN7535) / Novo Nordisk
    Trial completion:  A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants (clinicaltrials.gov) -  Sep 30, 2025   
    P1,  N=33, Completed, 
    N=325 --> 480 | Trial completion date: Nov 2029 --> Dec 2030 | Trial primary completion date: Nov 2029 --> Dec 2030 Not yet recruiting --> Completed
  • ||||||||||  etavopivat (NN7535) / Novo Nordisk
    Phase classification, Enrollment change, Trial primary completion date:  A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS) (clinicaltrials.gov) -  Jan 23, 2025   
    P3,  N=450, Recruiting, 
    Trial primary completion date: Mar 2025 --> Mar 2026 Phase classification: P2/3 --> P3 | N=344 --> 450 | Trial primary completion date: Mar 2026 --> Mar 2025
  • ||||||||||  etavopivat (NN7535) / Novo Nordisk, Pyrukynd (mitapivat) / Agios Pharma
    Pyruvate Kinase Activators in Sickle Cell Anemia: A Systematic Review and Single-Arm Meta-Analysis () -  Dec 7, 2024 - Abstract #ASH2024ASH_7383;    
    However, the small sample size, observed heterogeneity, and variations in concurrent hydroxyurea use highlight the need for larger, comparative trials to confirm these findings and assess PK activators relative to existing treatments. Future research should focus on more extensive and homogeneous cohorts to validate these results and investigate long-term outcomes.
  • ||||||||||  etavopivat (NN7535) / Novo Nordisk
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date:  FORTITUDE: A Study of Etavopivat for the Treatment of Anemia in Patients With Myelodysplastic Syndromes (MDS) (clinicaltrials.gov) -  Sep 19, 2024   
    P2,  N=17, Terminated, 
    Trial completion date: Feb 2026 --> Oct 2026 | Trial primary completion date: Jan 2025 --> Jul 2025 N=45 --> 17 | Trial completion date: Aug 2025 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Jul 2024; Futility assessment concluded low likelihood of the trial showing meaningful patient benefit.
  • ||||||||||  etavopivat (NN7535) / Novo Nordisk
    Trial completion date, Trial primary completion date:  A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS) (clinicaltrials.gov) -  Jul 17, 2024   
    P2/3,  N=344, Recruiting, 
    In this first study of etavopivat in SCD, 400 mg once daily for 12 weeks was well-tolerated, resulting in rapid and sustained increases in hemoglobin, improved RBC physiology, and decreased hemolysis. Trial completion date: Dec 2026 --> Apr 2027 | Trial primary completion date: Dec 2025 --> Mar 2026
  • ||||||||||  Review, Journal:  An update review of new therapies in sickle cell disease: the prospects for drug combinations. (Pubmed Central) -  Feb 12, 2024   
    Since 1998 Hydroxyurea remained the only disease modifying therapy until the FDA approved L-glutamine (2017), Crizanlizumab and Voxelotor (2019) and gene therapies (Exa-cel and Lovo-cel, 2023)...However, for pragmatic purposes we have approached this review in line with the different mechanisms of action, considering the possible options for search was performed in Pubmed Central using the search terms [sickle cell disease] or [sickle cell anemia] and the known treatments, i.e. Hydroxycarbamide/Hydroxyurea, L-Glutamine, Voxelotor, Crizanlizumab, Mitapivat, Etopivat, gene therapy, hematopoietic stem cell transplantation, and combination therapy...In our opinion section, we recommend the consideration for combination therapies for specific complications such as VOCs, pain and renal impairment as well as personalized medicine based on disease phenotype and patient patience characteristics. Following the wake of recent approval of gene therapy for SCD, more curative option is now a reality, the challenge is addressing how to address the issues such as for access, affordability and shared decision- making with families.
  • ||||||||||  Oxbryta (voxelotor) / Pfizer, etavopivat (NN7535) / Novo Nordisk
    Journal:  Quantitative Model-Based Assessment of Multiple Sickle Cell Disease Therapeutic Approaches Alone and in Combination. (Pubmed Central) -  Jan 17, 2024   
    The model also suggests combination therapy will have added benefit in the case of dose limitations, as is the case for voxelotor, which the model predicts could be combined with 20% HbF or 2,3-BPG reduction to 3.75?mM to reach equivalent protection as 30% HbF. The proposed model represents a unified framework that is useful in supporting decisions in preclinical and early clinical development and capable of evolving with clinical experience to gain new and increasingly confident insights into treatment strategies for SCD.