Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap 
Welcome,         Profile    Billing    Logout  
 0 Diseases   3 Trials   3 Trials   36 News 


1234»
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Journal:  New Perspectives on Antimicrobial Agents: Rezafungin. (Pubmed Central) -  Dec 12, 2024   
    Herein, we review the most recent published data pertaining to rezafungin including anti-fungal activity, pharmacokinetics, and clinical data relating to the treatment of invasive candidiasis. Given its prolonged half-life allowing for once-weekly dosing, rezafungin has the potential as an anti-fungal prophylactic agent in high-risk patients, and studies to examine this potential role are ongoing.
  • ||||||||||  Review, Journal:  Proline Analogues in Drug Design: Current Trends and Future Prospects. (Pubmed Central) -  Nov 28, 2024   
    Additionally, we discuss several intriguing cases where nonproline residues were replaced with proline analogues as a strategy to eliminate unwanted hydrogen bond donor sites. In conclusion, we present some suggestions for the future exploration of this promising class of molecular entities in drug discovery.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    PK/PD data, Review, Journal:  Rezafungin acetate for the treatment of candidemia and invasive candidiasis: a pharmacokinetic evaluation. (Pubmed Central) -  Nov 18, 2024   
    The differentiated PK characteristics of rezafungin which enables once weekly dosing could reduce catheter overuse and provide a rapid transition to outpatient treatment for Candida infections in which azoles cannot be used, due to resistance or drug-drug interactions. Besides weekly dosing, other potential pharmacokinetic/pharmacodynamic advantages of rezafungin are its good penetration into anatomically challenging sites and a potentially reduced probability of local resistance promotion, making it an attractive option also for deep-seated infections that could warrant dedicated clinical investigation.
  • ||||||||||  40 Years of Preventing Fungal Infections in Hematological Malignancies - Lessons Learned from Clinical Trials with 20,753 Patients (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_6259;    
    In pts treated with gilteritinib, 2 studies reported 55 pts with an IFI rate of 27.2% (including possible IFI)...Despite numerous trials for prevention of IFI, only posaconazole and fluconazole proved reduction in OM rates. There is a need for prospective clinical trials addressing risk-adjusted prophylaxis in AL and MDS in particular due to high observed IFI rates during treatment with novel targeted therapies.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap, Eraxis (anidulafungin) / RaQualia, Mycamine (micafungin) / Astellas
    Comparative Effectiveness of Echinocandins in the Treatment of Invasive Candidiasis: A Systematic Review and Network Meta-Analysis () -  Nov 4, 2024 - Abstract #ISPOREU2024ISPOR_EU_2522;    
    There was no evidence of a difference in efficacy among the echinocandins evaluated. However, rezafungin is a differentiated echinocandin with a low clearance and long half-life, enabling a once weekly front-loaded dosing regimen which may confer additional benefits not recognized herein.
  • ||||||||||  Review, Journal:  Usage of Antifungal Agents in Pediatric Patients Versus Adults: Knowledge and Gaps. (Pubmed Central) -  Sep 26, 2024   
    Despite the promising potential of novel antifungal drugs, their performance in heavily immunosuppressed patients remains unstudied. Until then, dedicated antifungal stewardship programs for high-risk patients are essential to optimize therapeutic outcomes, improve patient care, and limit the emergence of resistance.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Journal:  Regulatory Considerations in the Approval of Rezafungin (REZZAYO) for the Treatment of Candidemia and Invasive Candidiasis in Adults. (Pubmed Central) -  Aug 15, 2024   
    P2, P3
    Nonclinical studies of rezafungin in non-human primates identified a neurotoxicity safety signal; however, rezafungin's safety profile in the completed clinical studies was similar to other FDA-approved echinocandins. Here we describe the rationale for this approval and important considerations during the review process for a flexible development program intended to expedite the availability of antimicrobial therapies to treat serious infections in patients with limited treatment options.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Enrollment open, Trial initiation date:  Rezafungin Pharmacokinetics in Patients on ECMO (clinicaltrials.gov) -  Aug 1, 2024   
    P1,  N=8, Recruiting, 
    Here we describe the rationale for this approval and important considerations during the review process for a flexible development program intended to expedite the availability of antimicrobial therapies to treat serious infections in patients with limited treatment options. Not yet recruiting --> Recruiting | Initiation date: Apr 2024 --> Jul 2024
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Journal:  Case Commentary: Extending our therapeutic range against multidrug-resistant Candida. (Pubmed Central) -  Jul 22, 2024   
    While excellent clinical evidence supports the short-term safety of rezafungin, these cases demonstrate that rezafungin may additionally have a role in long-term suppressive therapy for antifungal-resistant Candida spp. infections.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Review, Journal:  Twenty Years in EUCAST Anti-Fungal Susceptibility Testing: Progress & Remaining Challenges. (Pubmed Central) -  Jul 11, 2024   
    Variability in rezafungin MIC testing due to laboratory conditions, which has been solved by the addition of Tween 20 to the growth medium in E.Def 7.4...In summary, EUCAST AFST continues to play a pivotal role in standardizing AFST and facilitating accurate interpretation of susceptibility data for clinical decision-making. Adoption of EUCAST breakpoints for commercial test methods, however, requires thorough validation to ensure concordance with EUCAST reference testing species-specific MIC distributions.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Journal:  Rezafungin (Rezzayo) for invasive Candida infections. (Pubmed Central) -  Jun 21, 2024   
    Trial completion date: Aug 2024 --> Dec 2025 | Trial primary completion date: Aug 2024 --> Dec 2025 No abstract available
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap, Brexafemme (ibrexafungerp) / SCYNEXIS, GSK, fosmanogepix (APX001) / Basilea
    Review, Journal:  Management of invasive candidiasis: A focus on rezafungin, ibrexafungerp, and fosmanogepix. (Pubmed Central) -  May 9, 2024   
    Lastly, fosmanogepix, a mechanistically novel, investigational antifungal agent, may be a potential future option in the management of IC and candidemia. Future research is needed to evaluate the potential use of these agents among diverse patient populations.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    P3 data, Journal:  Outcomes by Candida spp. in the ReSTORE Phase 3 trial of rezafungin versus caspofungin for candidemia and/or invasive candidiasis. (Pubmed Central) -  May 2, 2024   
    Two patients had baseline isolates with non-susceptible MIC values (both in the rezafungin group: one non-susceptible to rezafungin and one to caspofungin, classified as intermediate); both were candidemia-only patients in whom rezafungin treatment was successful based on the day 30 all-cause mortality endpoint. This analysis of ReSTORE demonstrated the efficacy of rezafungin for candidemia and IC in patients infected with a variety of Candida species.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Review, Journal:  An evaluation of Rezafungin: the latest treatment option for adults with candidemia and invasive candidiasis. (Pubmed Central) -  Apr 28, 2024   
    Rezafungin offers a promising option for the outpatient management of difficult to treat fungal infections. It has become a valuable addition to the antifungal arsenal, with the potential to reduce hospital length of stay and hospitalization costs and combat drug resistant Candida species.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Enrollment open, Trial completion date, Monotherapy:  Rezafungin for Treatment of Pneumocystis Pneumonia in HIV Adults (clinicaltrials.gov) -  Mar 29, 2024   
    P2,  N=50, Recruiting, 
    It has become a valuable addition to the antifungal arsenal, with the potential to reduce hospital length of stay and hospitalization costs and combat drug resistant Candida species. Not yet recruiting --> Recruiting | Trial completion date: Sep 2024 --> Dec 2024
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    New P1 trial:  Rezafungin Pharmacokinetics in Patients on ECMO (clinicaltrials.gov) -  Mar 26, 2024   
    P1,  N=8, Not yet recruiting, 
  • ||||||||||  Journal:  Pipeline of Novel Antifungals for Invasive Fungal Disease in Transplant Recipients: A Pediatric Perspective. (Pubmed Central) -  Feb 28, 2024   
    The overarching goal of this review is to discuss the mechanisms of action, spectrum of activity, stage of development, and pediatric-specific data for the following agents: encochleated amphotericin B deoxycholate, fosmanogepix, ibrexafungerp, isavuconazole, olorofim, opelconazole, oteseconazole, and rezafungin. Additionally, key drug attributes of these novel agents and their potential future therapeutic roles in pediatric transplant recipients are discussed.
  • ||||||||||  Review, Journal:  2023 FDA TIDES (Peptides and Oligonucleotides) Harvest. (Pubmed Central) -  Feb 24, 2024   
    Furthermore, Rett syndrome has found its first-ever core symptoms treatment, which is also peptide-based. Here, we analyze the TIDES approved in 2023 on the basis of their chemical structure, medical target, mode of action, administration route, and common adverse effects.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    THE CASE OF SUCCESSFUL USE OF REZAFUNGIN IN A PEDIATRIC PATIENT WITH MIXED INFECTION CAUSED BY YEAST IN THE REPUBLIC OF BELARUS (Hall C1M2) -  Feb 9, 2024 - Abstract #ESPID2024ESPID_129;    
    The primary endpoint of FFS at the Day 90 time point aims to assess efficacy during the acute phase of allogeneic HSCT and to minimise the potential for bias due to patient drop-out in this setting. Candida tropicalis has been isolated for sterility in the blood test, Rhodotorula mucilaginosa is isolated during the seeding of pericardial fluid (MIC voriconazole, postconazole, isovuconazole and micafungin
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap, Olorofim (orotomide) / F2G, Noxafil (posaconazole) / Merck (MSD)
    Review, Journal:  High-Risk Neutropenic Fever and Invasive Fungal Diseases in Patients with Hematological Malignancies. (Pubmed Central) -  Jan 23, 2024   
    The incidence rates (IRs) of b-IFDs (95% confidence interval (95% CI), per 100 person years follow-up (PYFU)) were 5.04 (0.47, 14.45) in induction (n = 2), 3.25 (0.0013, 12.76) in consolidation (n = 1) and 18.38 (3.46, 45.06) in salvage chemotherapy (n = 3). Finally, we highlight the current challenges in the field of b-IFDs; these include the improvement of diagnoses, the expanding treatment landscape of AML with molecular targeted drugs (and related drug-drug interactions with azoles), evolving transplantation techniques (and their related impacts on IFDs' risk stratification), and new antifungals and their features (rezafungin and olorofim).
  • ||||||||||  Review, Journal:  Update on therapeutic approaches for invasive fungal infections in adults. (Pubmed Central) -  Jan 22, 2024   
    We discuss management of complex infections with specific emerging fungi such as Scedosporium spp., Fusarium spp., Trichosporon asahii, and Candida auris. We briefly explore newer antifungal agents or formulations that are now being investigated to overcome therapeutic pitfalls, including but not limited to olorofim, rezafungin, fosmanogepix, and encochleated Amphotericin B. We discuss the role of surgical resection or debridement, duration of treatment, follow-up modalities, and need for secondary prophylaxis, all of which remain challenging, especially in patients chronically immunocompromised or awaiting more immunosuppressive therapies.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Enrollment open:  Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age (clinicaltrials.gov) -  Dec 14, 2023   
    P1,  N=32, Recruiting, 
    We briefly explore newer antifungal agents or formulations that are now being investigated to overcome therapeutic pitfalls, including but not limited to olorofim, rezafungin, fosmanogepix, and encochleated Amphotericin B. We discuss the role of surgical resection or debridement, duration of treatment, follow-up modalities, and need for secondary prophylaxis, all of which remain challenging, especially in patients chronically immunocompromised or awaiting more immunosuppressive therapies. Not yet recruiting --> Recruiting
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap, Brexafemme (ibrexafungerp) / SCYNEXIS, GSK, fosmanogepix (APX001) / Pfizer
    Review, Journal:  Review of treatment options for a multi-drug resistant fungus: Candida auris. (Pubmed Central) -  Dec 9, 2023   
    Among these antifungal agents, rezafungin was approved by the FDA for the treatment of candidemia and invasive candidiasis on March 22, 2023. Ibrexafungerp and fosmanogepix have entered phase III clinical trials.
  • ||||||||||  Review, Journal:  Antifungal resistance, combinations and pipeline: oh my! (Pubmed Central) -  Nov 29, 2023   
    Fosmanogepix, ibrexafungerp, olorofim and rezafungin may help fill some of these gaps in the antifungal armamentarium. This article is part of the Challenges and strategies in the management of invasive fungal infections Special Issue: https://www.drugsincontext.com/special_issues/challenges-and-strategies-in-the-management-of-invasive-fungal-infections.
  • ||||||||||  Rezzayo (rezafungin for injection) / Cidara Therap, Mundipharma, Melinta Therap
    Journal:  New antifungals development: rezafungin in candidiasis treatment. (Pubmed Central) -  Nov 26, 2023   
    These findings are of clinical importance in fighting active and aggressive infections and reducing the morbidity and mortality caused by candidaemia and invasive candidiasis. No abstract available
  • ||||||||||  Review, Journal:  Treatment of Invasive Aspergillosis: How It's Going, Where It's Heading. (Pubmed Central) -  Oct 23, 2023   
    Current investigations show encouraging results, so far mostly in preclinical settings. In this review we discuss current treatment strategies, give an outlook on possible new pharmaceutical therapeutic options, and, lastly, provide an overview of the ongoing research in immunotherapy for IA.