Drugs / CM4620
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04195347 | Sep 2020 → Jan 2027 expected | acute pancreatitis | St. Jude Children's Research Hospital | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06374797 | Jul 2024 → Jul 2026 overdue | acute kidney injury | CalciMedica, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04661540 | Mar → Dec 2021 | pneumonia | CalciMedica, Inc. | Terminated | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04681066 Comparator | Mar 2021 → May 2024 | acute pancreatitis | CalciMedica, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| 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 ↗ |
| 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 |
| 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. | Results CalciMedica to Present Results of PD/PK Study in Acute Pancreatitis Patients for Its CRAC Channel Inhibitor CM4620 at APA Annual Meeting calcimedica.com ↗
In addition, as blood levels of CM4620-IE dropped, as determined by the pharmacokinetic (PK) assay, inhibition in the PD assay declined and returned to baseline. |
| 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 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 Preclinical Data in EMBO Molecular Medicine Supporting the Development of CRAC Channel Inhibitors for Inflammatory Bowel Disease (IBD) calcimedica.com ↗
Moreover, inhibiting SOCE with CM4620 (zegocractin, the active agent in Auxora), CalciMedica’s selective ORAI1 CRAC channel inhibitor, resulted in reduced intestinal inflammation, colitogenic T cell function and weight loss, suggesting that inhibition of ORAI1 CRAC channels could be a viable treatment for IBD in humans. |
| 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 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CM4620 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04195347 ↗ |
| Known as | zegocractin | “We conducted a phase 2b trial of the calcium release-activated calcium channel inhibitor zegocractin, previously found to accelerate recovery of food intake in AP, to determine...” PMID 41938843 ↗ Feb 20261“1.25 mL/kg (2.0 mg/kg of zegocractin) intravenously (IV) over 4 hours at 0 hours, and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72 and 96 hours for a...” NCT06374797 ↗ |
| Action | Inhibit | “calcium release-activated calcium channel inhibitor zegocractin” PMID 41938843 ↗ Feb 2026 |
| Route | Intravenous | “as an IV infusion” NCT04195347 ↗ |