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  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  KOURAGE: A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" (clinicaltrials.gov) -  Apr 24, 2025   
    P2,  N=150, Recruiting, 
    In conclusion, the current investigation revealed that edaravone attenuates MCs degranulation and neuroinflammation, at least partially, via ROS/STIM1 pathway after HI injury. Trial completion date: Aug 2025 --> Mar 2026 | Trial primary completion date: Aug 2025 --> Mar 2026
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    PANCREATIC CELL-SPECIFIC ORAI1 MEDIATES CHRONIC PANCREATITIS AND ITS ASSOCIATED PAIN IN EXPERIMENTAL CHRONIC PANCREATITIS (Halls C-E, Lower Level - SDCC) -  Mar 8, 2025 - Abstract #DDW2025DDW_6930;    
    Pancreatic cell-specific deletion or inhibition of Orai1 mitigates PSC activation, pancreatic fibrosis, and CP-associated pain in two experimental chronic pancreatitis via pancreatic epithelial-stromal crosstalk. Our findings provide invaluable preclinical evidence for using Orai1 inhibitor to relieve the progression of CP and CP-associated pain in man.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    PATIENTS WITH ACUTE PANCREATITIS (AP) AND ACCOMPANYING SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (SIRS) HAVE A LARGER VOLUME OF DISTRIBUTION COMPARED TO HEALTHY VOLUNTEERS (Halls C-E, Lower Level - SDCC) -  Mar 8, 2025 - Abstract #DDW2025DDW_560;    
    P2
    CARPO (NCT04681066) was a global blinded RCT that assessed the dose response and efficacy of zegocractin, a calcium release-activated calcium channel inhibitor, in 214 patients with AP and SIRS...An elevated hematocrit (?44% in men and ?40% in women) was associated with lower plasma concentrations at the 24 hour time point, consistent with the increase in volume of distribution. Conclusion AP and SIRS is characterized by an increased volume of distribution and higher doses of therapeutic agents may be required in treating this disease.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    NEUTROPHIL ORAI1 CALCIUM CHANNEL PROTECTS AGAINST ACUTE PANCREATITIS-ASSOCIATED ACUTE LUNG INJURY VIA NFATC2-CD166 AXIS AND LIPOSOME TARGETED THERAPY (Halls C-E, Lower Level - SDCC) -  Mar 8, 2025 - Abstract #DDW2025DDW_559;    
    Anti-Ly6G-modified liposomes loaded with the Orai1 inhibitor (CM4620) were designed to target neutrophils and downregulate Orai1 in vivo...Liposomes targeting neutrophil Orai1 showed promising targeting efficiency with both intranasal and systemic administration, significantly reducing pulmonary neutrophil infiltration and ameliorating AP-ALI. Conclusion Neutrophil-specific Orai1 deletion ameliorates AP-ALI via the NFATC2-CD166 axis, highlighting liposomes targeting neutrophil Orai1 as a promising therapeutic strategy.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Review, Journal:  Contemporary Approach to Acute Pancreatitis in Emergency Medicine. (Pubmed Central) -  Mar 7, 2025   
    We discussed diagnostic, intervention, and disposition considerations relevant to emergency clinicians and considered risk assessment using available clinical decision tools. We also discussed changes to traditional treatments and ongoing investigational therapies, including steroids, monoclonal antibodies, and calcium release-activated calcium channel inhibitors.
  • ||||||||||  aspirin / Generic mfg., Auxora (zegocractin) / CalciMedica
    Journal:  Enhanced STIM1 expression drives platelet hyperactivity in diabetes. (Pubmed Central) -  Mar 2, 2025   
    Furthermore, the store-operated calcium entry channel inhibitor CM4620 demonstrated superior antiplatelet and antithrombotic efficacy compared to aspirin in both db/db mice and patients with T2DM. Our results suggest that elevated STIM1 expression contributes to enhanced platelet reactivity in diabetes, and targeting STIM1 may offer a promising novel therapeutic approach for thrombosis prevention in this patient population.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion, Trial completion date, Trial primary completion date:  CARPO: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (clinicaltrials.gov) -  Jul 22, 2024   
    P2,  N=216, Completed, 
    Auxora decreases the time solid food tolerance, as well as the rates of respiratory failure and necrotizing pancreatitis in patients with AP presenting with > 2 SIRS criteria. Active, not recruiting --> Completed | Trial completion date: Sep 2024 --> May 2024 | Trial primary completion date: Sep 2024 --> May 2024
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date:  CRSPA: Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase (clinicaltrials.gov) -  Jul 10, 2024   
    P1/2,  N=42, Recruiting, 
    The novel combination of CM4620 with galactose synergistically targets complementary pathological mechanisms of AP. Trial completion date: Dec 2025 --> Dec 2027
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Journal:  Vulnerability of Store-Operated Calcium Entry to Inhibitors and Microenvironment in Cells of Different Breast Cancer Subtypes. (Pubmed Central) -  Mar 28, 2024   
    We have observed that the SOCE inhibitors Leflunomide and Teriflunomide suppress SOCE in the triple-negative BC cell line MDA-MB-231, but not in the luminal A BC cell line MCF-7...In addition, the oxygen scavenger sodium dithionide also affects SOCE, stimulating it in MDA-MB-231 cells but inhibiting in MCF-7 cells. Overall, our data highlight the importance of considering the different sensitivities of various BC cell types to inhibitors and to microenvironmental factors such as hypoxia and acidification when developing targeted drugs.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    SERUM PROTEOMICS REVEALS THAT THE ORAI1 INHIBITOR AUXORA MAY PROVIDE BENEFITS IN SEVERE ACUTE PANCREATITIS SIMILAR TO THOSE SEEN IN COVID-19 PNEUMONIA (Hall A, Poster Hall - Walter E. Washington Convention Center) -  Mar 14, 2024 - Abstract #DDW2024DDW_1043;    
    P2
    In COVID-19 pneumonia patients, Auxora significantly increased proteins reflecting improved liver function and lipid metabolism, and decreased proteins that mediate coagulopathy, which were previously found increased in cohorts of patients with severe AP and systemic inflammation. The results suggest that treatment with Auxora in patients with AP may offer beneficial clinical outcomes like those seen in patients with severe COVID-19 pneumonia.
  • ||||||||||  Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Auxora (zegocractin) / CalciMedica
    Review, Journal:  Trends and recent developments in pharmacotherapy of acute pancreatitis. (Pubmed Central) -  Apr 18, 2023   
    However, challenges for exploring targeted treatment approaches include disease complexity, timing of therapeutic intervention, and establishing appropriate clinical endpoints. Understanding the role of specific biomarkers may help in identifying appropriate targets for drug discovery and facilitate determining relevant clinical study endpoints to monitor disease severity and progression, thereby aiding in design of more precise therapies with improved clinical outcomes.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  CRSPA: Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase (clinicaltrials.gov) -  Mar 24, 2023   
    P1/2,  N=42, Recruiting, 
    Understanding the role of specific biomarkers may help in identifying appropriate targets for drug discovery and facilitate determining relevant clinical study endpoints to monitor disease severity and progression, thereby aiding in design of more precise therapies with improved clinical outcomes. Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Jun 2025
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Journal:  Regulation of neuropathic pain by microglial Orai1 channels. (Pubmed Central) -  Jan 28, 2023   
    Unexpectedly, these protective effects were not seen in female mice, revealing sexual dimorphism in Orai1 regulation of microglial reactivity and hyperalgesia. Together, these findings indicate that Orai1 channels are key regulators of the sexually dimorphic role of microglia for the neuroinflammation that underlies neuropathic pain.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  CARPO: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (clinicaltrials.gov) -  Sep 19, 2022   
    P2,  N=216, Recruiting, 
    More large-scale RCTs are still needed to confirm the results of this study. Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion, Enrollment change, Trial completion date:  A Study of Auxora in Patients With Critical COVID-19 Pneumonia (clinicaltrials.gov) -  Aug 18, 2022   
    P2,  N=9, Completed, 
    Trial completion date: Sep 2023 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Sep 2024 Active, not recruiting --> Completed | N=36 --> 9 | Trial completion date: Jun 2022 --> Nov 2021
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  CARPO: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (clinicaltrials.gov) -  May 23, 2022   
    P2,  N=216, Recruiting, 
    Active, not recruiting --> Completed | N=36 --> 9 | Trial completion date: Jun 2022 --> Nov 2021 Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Enrollment closed:  A Study of Auxora in Patients With Critical COVID-19 Pneumonia (clinicaltrials.gov) -  May 12, 2022   
    P2,  N=36, Active, not recruiting, 
    Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Jun 2023 --> Sep 2023 Recruiting --> Active, not recruiting
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  CARPO: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (clinicaltrials.gov) -  Mar 24, 2022   
    P2,  N=216, Recruiting, 
    N=240 --> 0 | Not yet recruiting --> Withdrawn Trial completion date: Oct 2022 --> Jun 2023 | Trial primary completion date: Oct 2022 --> Jun 2023
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  A Study of Auxora in Patients With Critical COVID-19 Pneumonia (clinicaltrials.gov) -  Mar 10, 2022   
    P2,  N=36, Recruiting, 
    The S1-elicited Ca signals we have observed in the pancreatic stellate cells and endogenous macrophages may play an important part in the development of the inflammatory process. Trial completion date: Oct 2021 --> Jun 2022 | Trial primary completion date: Sep 2021 --> May 2022
  • ||||||||||  Auxora (CM4620) / CalciMedica
    Clinical, Journal:  Orai1-STIM1 Regulates Increased Ca Mobilization, Leading to Contractile Duchenne Muscular Dystrophy Phenotypes in Patient-Derived Induced Pluripotent Stem Cells. (Pubmed Central) -  Nov 29, 2021   
    In this study, we utilized DMD patient-derived induced pluripotent stem cells (iPSCs) to differentiate myotubes using doxycycline-inducible MyoD overexpression, and searched for a target molecule that mediates dystrophin deficiency-dependent Ca overload using commercially available chemicals and siRNAs...These findings were further confirmed by demonstrating that STIM1-Orai1 inhibitors, CM4620, AnCoA4, and GSK797A, prevented Ca overload in dystrophic myotubes...In conclusion, SOCs are major contributors to dystrophin deficiency-dependent Ca overload through STIM1-Orai1 as molecular mediators. Modulating STIM1-Orai1 activity was effective in ameliorating the decline in contractile performance in DMD.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion date, Trial primary completion date:  A Study of Auxora in Patients With Critical COVID-19 Pneumonia (clinicaltrials.gov) -  Aug 18, 2021   
    P2,  N=36, Recruiting, 
    Modulating STIM1-Orai1 activity was effective in ameliorating the decline in contractile performance in DMD. Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: May 2021 --> Sep 2021
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial completion:  CARDEA: A Study of Auxora in Patients With Severe COVID-19 Pneumonia (clinicaltrials.gov) -  Aug 3, 2021   
    P2,  N=284, Completed, 
    Trial completion date: Jun 2021 --> Oct 2021 | Trial primary completion date: May 2021 --> Sep 2021 Recruiting --> Completed
  • ||||||||||  CM3457 / CalciMedica
    Journal:  Biochemical Profiling for Antioxidant and Therapeutic Potential of Pakistani Chickpea (Cicer arietinum L.) Genetic Resource. (Pubmed Central) -  May 1, 2021   
    In other biochemical parameters, the highest seed total oxidant status (TOS) (356 ± 17.50 μM/g s. wt.) was detected in CM3457/91 (desi); malondialdehyde (MDA) content (295.74 ± 3.097 uM/g s. wt.) was observed in CM-2008 (kabuli), and total antioxidant capacity (TAC) (8.36 ± 0.082 μM/g s. wt.) was found in CM-72 (desi)...For seed therapeutic potential, the highest seed α-amylase inhibition (82.33 ± 8.06%) was observed in CM-88 (desi), while WH-1, WH-6, and ICCV-96030 (desi) depicted the highest value for seed anti-inflammatory potential (78.88 ± 0.55%). Genotypes with the highest antioxidant and therapeutic potential can be utilized as a natural antioxidant source and in breeding programs aimed at improving these traits in new breeding lines.
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Trial primary completion date:  CARDEA: A Study of Auxora in Patients With Severe COVID-19 Pneumonia (clinicaltrials.gov) -  Apr 22, 2021   
    P2,  N=346, Recruiting, 
    Genotypes with the highest antioxidant and therapeutic potential can be utilized as a natural antioxidant source and in breeding programs aimed at improving these traits in new breeding lines. Trial primary completion date: Apr 2021 --> Jul 2021
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Enrollment open, Trial completion date, Trial primary completion date:  CARPO: A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (clinicaltrials.gov) -  Mar 26, 2021   
    P2,  N=216, Recruiting, 
    Trial primary completion date: Apr 2021 --> Jul 2021 Not yet recruiting --> Recruiting | Trial completion date: May 2022 --> Aug 2022 | Trial primary completion date: May 2022 --> Aug 2022
  • ||||||||||  Auxora (zegocractin) / CalciMedica
    Enrollment open:  A Study of Auxora in Patients With Critical COVID-19 Pneumonia (clinicaltrials.gov) -  Mar 12, 2021   
    P2,  N=36, Recruiting, 
    Not yet recruiting --> Recruiting | Trial completion date: May 2022 --> Aug 2022 | Trial primary completion date: May 2022 --> Aug 2022 Not yet recruiting --> Recruiting