Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring 
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  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Trial completion, Trial completion date:  Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus (clinicaltrials.gov) -  Mar 17, 2025   
    P3,  N=184, Completed, 
    In combination with controlled trials, these data suggest that difelikefalin is an effective and well-tolerated treatment for the management of CKD-aP in adult patients receiving hemodialysis. Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Sep 2024
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Insights into the Treatment Experience and Unmet Needs of Patients with Hemodialysis-Associated Pruritus: A Social Media Listening Study () -  Mar 13, 2025 - Abstract #NKFSCM2025NKF_SCM_762;    
    Treatments discussed included off-label medications such as phosphate binders, topical emollients, antihistamines, and corticosteroids, and on-label use of difelikefalin.Conclusion Our analysis shows that despite the high prevalence, patients report unmet needs for improved education and understanding of hemodialysis-associated pruritus and access to effective treatments. Social media listening is a novel tool to gather patient treatment experiences and unmet needs and may support disease management optimization.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Journal:  NIR Diradical-Featured Croconaine Nanoagent for Cancer Photoacoustic Imaging and Photothermal Therapy. (Pubmed Central) -  Jan 17, 2025   
    When assembled into nanoparticles, CR845 NPs showed good photostability, good biocompatibility, favorable NIR photoacoustic potential, effective cancer cell killing and complete tumor elimination upon 850 nm laser irradiation. The work demonstrates a diradical-featured CR PTA with favorable PAI/PTT effects, which can help to provide new ideas for the development of NIR PTAs, and further promote the application of organic radical materials in the field of biomedicine.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Efficacy and Safety of Difelikefalin in Patients Receiving Concomitant Opioid Medication () -  Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_500;    
    This exploratory analysis did not find any influence of concomitant opioid medications on the effectiveness of difelikefalin. The higher rate of TEAEs in patients receiving difelikefalin in combination with opioids makes careful assessment of continued use of opioid medications advisable.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Journal, Adverse events:  Conorphin-66 produces peripherally restricted antinociception via the kappa-opioid receptor with limited side effects. (Pubmed Central) -  Oct 17, 2024   
    In this study, Conorphin-66, an analog of the selective KOR peptide agonist Conorphin T, was pharmacologically characterized in a series of experiments, with CR845 serving as the reference compound...Further study showed that Conorphin-66 does not have apparent antipruritic effects in an acute itch model. Overall, Conorphin-66 emerges as a novel peripherally restricted KOR agonist that produced potent antinociception with reduced side effects.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Retrospective data, Journal:  Pruritus Severity and Serum Phosphate in CKD: A Post Hoc Analysis of Difelikefalin Studies. (Pubmed Central) -  Sep 26, 2024   
    No correlation was observed between pruritus severity and sP, or response to placebo or difelikefalin in patients with CKD-aP undergoing HD. Difelikefalin improved itch versus placebo irrespective of baseline sP.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Combination Treatment of Difelikefalin and Tolvaptan for Late-Stage Polycystic Kidney Disease (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1492;    
    Together, these results suggest that combination treatment of difelikefalin and tolvaptan preserves kidney filtration function, reduces side effects, and decreases necessity of dose escalation of tolvaptan in late stages of PKD. (Funding DoD W81XWH-22-1-0046)
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Validity of a Single Worst Itch Numeric Rating Scale (WI-NRS) Measurement to Identify Patients with Moderate or Severe CKD-Associated Pruritus (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1346;    
    A one-off measurement of the WI-NRS can reliably assess itch intensity and identify patients suffering from bothersome itch. Patients reporting a value of ?4 on a single WI-NRS can be considered to suffer from moderate or severe CKD-aP, and those with a reduction of ?3 points between two WI-NRS measurements to have a clinically meaningful improvement of their itch.These findings confirm that the WI-NRS is an easy-to-use and consistent tool that can be implemented in daily dialysis care without relevant disruptions to routine tasks.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Influence of Concomitant Opioid Medications on Antipruritic Effect and Safety of Difelikefalin in Patients on Hemodialysis (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1345;    
    Concomitant use of opioid medications did not influence the efficacy of DFK to relieve CKD-aP in HD patients. The increase in TEAEs in patients prescribed concomitant opioids in either the DFK or PBO arms indicates the importance of carefully evaluating polypharmacy, especially continuation of opioid treatments in HD patients treated with DFK for CKD-aP.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Single-Center Experience from Quebec with Intravenous Difelikefalin to Treat CKD-Associated Pruritus (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1344;    
    Our protocol has helped us identify patients with CKD-aP in our hemodialysis center and has allowed to improve patient quality of life. Our experience represents well the feasibility to incorporate framework for screening and diagnosis as well as a treatment algorithm of CKD-aP published in a recent Canadian narrative review.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Efficacy and Safety of Difelikefalin Compared with Placebo in Patients Receiving Concomitant Opioid Medication (Exhibit Hall, Convention Center) -  Sep 23, 2024 - Abstract #KIDNEYWEEK2024KIDNEY_WEEK_1342;    
    This exploratory analysis confirms that DFK can effectively relieve CKD-aP in HD patients despite the use of concomitant opioid medications. The higher rate of TEAEs in patients receiving either DFK or PBO in combination with opioids makes careful assessment of continued use of opioid medications advisable.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Review, Journal:  Difelikefalin for pruritus associated with chronic kidney disease. (Pubmed Central) -  Sep 4, 2024   
    The higher rate of TEAEs in patients receiving either DFK or PBO in combination with opioids makes careful assessment of continued use of opioid medications advisable. No abstract available
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring, Remitch (nalfurafine) / Toray, Mitsubishi Tanabe
    Review, Journal:  Clinical Research Progress on Using ?-Opioid Receptor Agonists to Treat Uremic Pruritus (Pubmed Central) -  Aug 22, 2024   
    Recently, there is growing evidence showing that ?-opioid receptor agonists, including nalfurafine, difelikefalin, and nalbuphine, can effectively and safely reduce itching symptoms in patients with refractory uremic pruritus. Herein, we reviewed the epidemiology, pathogenesis, clinical symptoms, and treatment strategies of uremic pruritus, and summarized in detail the progress in clinical research on the use of ?-opioid receptor agonists, including nalfurafine, difelikefalin, and nalbuphine, in the management of patients with uremic pruritus.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Journal:  Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis. (Pubmed Central) -  Jun 27, 2024   
    P3
    In patients undergoing HD with moderate-to-severe CKD-aP, itch reduction with intravenous difelikefalin was associated with improved sleep quality. As disturbed sleep may contribute to mortality and morbidity in CKD-aP, difelikefalin may help to address a major clinical burden by improving sleep quality, secondary to itch relief.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring, Veltassa (patiromer) / CSL Behring
    New, new and new! So many new drugs in kidneyland. What they are and how to use them? (Plaza Auditorium) -  Jun 12, 2024 - Abstract #RSA2024RSA_189;    
    These results show that difelikefalin, prescribed according to its therapeutic indication, is effective in the treatment of CKD-aP under real-life conditions, outside the controlled conditions of a clinical trial. Cationion exchange resins (patiromer), MRAs (finerorone) , KappaORA (difelikefalin)
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, CSL Behring
    Trial completion, Trial completion date, Trial primary completion date:  Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis (clinicaltrials.gov) -  Jun 4, 2024   
    P1,  N=30, Completed, 
    Cationion exchange resins (patiromer), MRAs (finerorone) , KappaORA (difelikefalin) Recruiting --> Completed | Trial completion date: Jun 2024 --> Oct 2023 | Trial primary completion date: Jun 2024 --> Oct 2023
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma
    Review, Journal:  Intravenous difelikefalin for the treatment of hemodialysis pruritus. (Pubmed Central) -  Jan 9, 2024   
    Clinical data on intravenous difelikefalin is promising regarding its ability to reduce itch in CKD patients on hemodialysis and improve patient quality of life, with few, mild adverse side effects. As intravenous difelikefalin becomes more widely used in the clinical setting, further studies assessing long-term efficacy and safety will be needed.
  • ||||||||||  Review, Journal, Metastases:  Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs. (Pubmed Central) -  Jan 8, 2024   
    in 2017), tralokinumab (anti-IL-13 in 2021), lebrikizumab (anti-IL-13 in 2023), and the oral janus kinase (JAK) inhibitors (JAKi) targeting JAK1/2 (baricitinib in 2020 in the EU) or JAK1 (upadacitinib in 2021 and abrocitinib in 2022)...Among the topical therapies, tapinarof (aryl hydrocarbon receptor), ruxolitinib (JAK1/2i), delgocitinib (pan-JAKi), asivatrep (anti-transient receptor potential vanilloid), and phosphodiesterase-4-inhibitors (roflumilast, difamilast) are discussed. Among systemic therapies, current data on cord-blood-derived mesenchymal stem cells, CM310 (anti IL-4R?), nemolizumab (anti-IL-31RA), anti-OX40/OX40L-antibodies, neurokinin-receptor-1-antagonists, and difelikefalin (?-opioid-R) are reported.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, libvatrep oral (SAF312) / Novartis, Lodonal (naltrexone low dose oral) / Immune Therap, Statera BioPharma
    Journal:  Ocular surface itch and pain: key differences and similarities between the two sensations. (Pubmed Central) -  Aug 31, 2023   
    Identifying contributors to abnormal ocular sensations is vital for precise medical care. Novel therapeutics for these conditions aim to improve patient outcomes and quality of life.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, Korsuva oral (difelikefalin oral) / Cara Therap, Maruishi Pharma
    P2 data, Journal:  A Phase 2 Study of Oral Difelikefalin in Subjects With Chronic Kidney Disease and Moderate-to-Severe Pruritus. (Pubmed Central) -  Jul 18, 2023   
    Novel therapeutics for these conditions aim to improve patient outcomes and quality of life. Oral difelikefalin significantly reduced itch intensity in stage 3?5 CKD subjects with moderate-to-severe pruritus, supporting continued development for this condition.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, hexasodium phytate (SNF472) / Sanifit
    Journal:  Hemodialysis complications: focus on pruritus and vascular calcifications (Pubmed Central) -  Jul 3, 2023   
    Although recommended, this screening is rarely performed in dialysis centers. Prevention and treatment against the development of cardiovascular calcifications are the control of risk factors associated with atherosclerosis, control of phosphatemia, and new therapeutic strategies such as sodium thiosulfate, rheopheresis, vitamin K, magnesium supplementation or SNF-472, a calcium chelator currently in clinical development.
  • ||||||||||  Korsuva IV (difelikefalin IV) / Cara Therap, Maruishi Pharma, hexasodium phytate (SNF472) / Sanifit
    Journal:  Hemodialysis complications: focus on pruritus and vascular calcifications (Pubmed Central) -  Jun 13, 2023   
    Although recommended, this screening is rarely performed in dialysis centers. Prevention and treatment against the development of cardiovascular calcifications are the control of risk factors associated with atherosclerosis, control of phosphatemia, and new therapeutic strategies such as sodium thiosulfate, rheopheresis, vitamin