Drugs / Auxora
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05171920 | Jan → Jul 2022 | pneumonia | CalciMedica, Inc. | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04345614 | Apr 2020 → Jun 2021 | pneumonia | CalciMedica, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03401190 | Mar 2018 → Feb 2019 | acute pancreatitis | CalciMedica, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2026-06-24 | CalciMedica, Inc. | Regulatory CalciMedica Announces Clinical Development of Auxora May Proceed Following FDA Review of KOURAGE Trial Interim Safety Data calcimedica.com ↗
Following the applicable review period, the Company has received no comments from the FDA on the submission, meaning that CalciMedica may continue to dose patients with Auxora™ in the study. |
| 2026-03-03 | CalciMedica, Inc. | Results CalciMedica Reports 2025 Financial Results and Provides Clinical Updates calcimedica.com ↗ |
| 2026-01-28 | CalciMedica, Inc. | Results CalciMedica Announces Discontinuation of Phase 2 KOURAGE Trial in AKI Following Independent Data Monitoring Committee Recommendation calcimedica.com ↗
Based on the IDMC's recommendation, the Company has discontinued the trial and plans to perform a comprehensive review of the unblinded clinical data. |
| 2025-11-10 | CalciMedica, Inc. | Results CalciMedica Presents Data from Preclinical Study of Auxora™ in an Animal Model of AKI at ASN Kidney Week 2025 calcimedica.com ↗
Treatment with Auxora significantly reduced IL-17–related inflammation in both kidney and lung, significantly increased glomerular filtration rate (GFR), and decreased renal injury in a rat model of AKI |
| 2025-03-04 | CalciMedica, Inc. | Results CalciMedica Presents AKI Data from a Post-Hoc Analysis of the Phase 2 CARDEA trial of Auxora™ in Severe COVID-19 Pneumonia at the 30th International AKI & CRRT Conference calcimedica.com ↗
Patients treated with Auxora showed a 62.7% relative reduction versus placebo in mortality at day 30 which persisted through day 60. |
| 2024-11-13 | CalciMedica, Inc. | Results CalciMedica Reports Third Quarter 2024 Financial Results and Provides Clinical & Corporate Updates calcimedica.com ↗
Additional positive data, including a win ratio analysis, announced from CARPO Phase 2b trial of Auxora™ in acute pancreatitis (AP); |
| 2024-10-30 | CalciMedica, Inc. | Results CalciMedica to Present Late-Breaking Positive Data, Including a Win Ratio Analysis, from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis (AP) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting calcimedica.com ↗
Statistically significant 100% reduction (p = 0.0027) in new-onset severe respiratory failure and 64.2% reduction (p = 0.0476) in new-onset persistent respiratory failure in combined high and medium dose Auxora patients versus combined low dose Auxora and placebo patients |
| 2024-06-27 | CalciMedica, Inc. | Results CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis (AP) calcimedica.com ↗ |
| 2024-03-13 | CalciMedica, Inc. | Results CalciMedica Presents Data from Preclinical Studies of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference calcimedica.com ↗
Preclinical results are consistent with clinical observations made with Auxora, supporting the KOURAGE trial in patients with severe AKI that will start enrolling in 2Q 2024 |
| 2024-02-28 | CalciMedica, Inc. | Results CalciMedica Announces Presentation of Data from a Preclinical Study of Auxora in Acute Kidney Injury at the 29th International AKI & CRRT Conference calcimedica.com ↗
Preclinical data show that therapeutic treatment with Auxora in a rat model of AKI improves kidney function as measured by glomerular filtration rate |
| 2024-02-13 | CalciMedica, Inc. | Regulatory CalciMedica Announces FDA Clearance of IND Application for Phase 2 Trial of Auxora™ for the Treatment of Severe Acute Kidney Injury calcimedica.com ↗
today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, Auxora™ |
| 2023-12-11 | CalciMedica, Inc. | Results CalciMedica Collaborator St. Jude Children's Research Hospital Presents Data from Initial Cohort of CRSPA Study at 65th Annual ASH Meeting & Exposition calcimedica.com ↗
None of the Auxora-treated patients had significant necrosis compared to 27% of historical control patients at 30 days |
| 2023-11-02 | CalciMedica, Inc. | Results CalciMedica Announces Presentation of Initial Data from the CRSPA Study of Auxora at the 65th Annual ASH Meeting & Exposition calcimedica.com ↗
Auxora ™ showed a 53% reduction in days in hospital, a 40% reduction in intensive care unit (ICU) days and eliminated the need for total parenteral nutrition (TPN) |
| 2023-03-15 | CalciMedica, Inc. | Regulatory FDA Grants CalciMedica Permission to Begin Dosing CM4620-IE in Patients with Severe COVID-19 Pneumonia under a Newly Opened IND calcimedica.com ↗ |
| 2023-03-15 | CalciMedica, Inc. | Regulatory CalciMedica Announces that FDA Has Strongly Recommended Moving to a Blinded Placebo-controlled Trial with Auxora™ in Patients with Severe COVID-19 Pneumonia calcimedica.com ↗
The FDA has strongly recommended that CalciMedica transition from the current randomized open-label study to a blinded placebo-controlled trial as soon as possible. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Reports Topline Data from the AuxoraTM CARDEA Phase 2 COVID-19 Pneumonia Clinical Trial calcimedica.com ↗
Initial efficacy signals for both time to recovery and mortality in CARDEA suggest that Auxora may rapidly reduce inflammation and reduce damage to vital organ tissue—both key in the fight against disease progression. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Publishes Positive Data from Phase 2a Study of Auxora in Patients with Acute Pancreatitis and Announces First Patients Dosed in Phase 2b Study calcimedica.com ↗
Data from Phase 2a Study Demonstrated Patients Treated with Auxora Experienced Reduced Severity of Acute Pancreatitis, Less Persistent Systemic Inflammatory Response Syndrome (SIRS) and More Rapid Restoration of Gut Function with Favorable Safety Profile |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Presents New Clinical Data Demonstrating Improved D-Dimer Biomarker Levels with Auxora™ in Severe COVID-19 Pneumonia at the 50th Critical Care Congress calcimedica.com ↗
The data showed that levels of D-dimer, a key marker of clotting and inflammation, decreased in patients receiving Auxora combined with standard of care therapy but increased in patients receiving standard of care alone. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Announces Publication of Results from CARDEA COVID-19 Study in Critical Care calcimedica.com ↗
The article, titled “ Auxora vs. placebo for the treatment of patients with severe COVID-19 pneumonia: a randomized-controlled clinical trial ,” details the trial findings on Auxora, CalciMedica’s lead CRAC channel inhibitor product candidate. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Announces Publication of Peer-Reviewed Paper in The Journal of Physiology calcimedica.com ↗ |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Announces Positive Topline Data from Interim Analysis of Trial Evaluating Auxora™ in Patients with Severe COVID-19 Pneumonia calcimedica.com ↗
The interim analysis showed Auxora plus standard of care reduced ventilator use and improved time to recovery in treated patients compared to standard of care alone. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Announces Peer-Reviewed Publication of Positive COVID-19 Data and Initiation of Blinded, Placebo-Controlled Trial of Auxora™ in Patients with Severe COVID-19 Pneumonia calcimedica.com ↗
Auxora, a potent and selective small molecule CRAC channel inhibitor, combined with standard of care therapy showed faster recovery and reduced by over half the use of invasive mechanical ventilation and death in patients with severe COVID-19 pneumonia as compared to standard of care alone. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Announces IDMC Recommendation to Continue with Trial Evaluating Auxora™ in Patients with Severe COVID-19 Pneumonia calcimedica.com ↗
The IDMC recommendation that the trial continue is based on an unblinded analysis of safety data from over 50 patients. |
| 2023-03-14 | CalciMedica, Inc. | Results CalciMedica Announces Data Showing Auxora™ Substantially Improved Outcomes in Patients with Severe COVID-19 Pneumonia calcimedica.com ↗
today announced data from a randomized, controlled, open-label clinical study showing substantially improved outcomes with Auxora™ (formerly called CM4620-IE) as a treatment for severe COVID-19 pneumonia. |
All press releases naming this drug 36 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Auxora | “Auxora for the Treatment of Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome: Clinical Development of a Calcium Release-Activated...” PMID 33939666 ↗ Apr 2021 |
| Known as | CM4620 | “Part 1 of this trial enrolled 30 patients to receive Auxora (formerly CM4620) in a 2:1 randomized, open label trial of patients with severe and critical COVID-19 pneumonia.” NCT04345614 ↗ |
| Route | Intravenous | “All doses of Auxora will be administered intravenously (IV) over 4 hours.” NCT04345614 ↗ |