LA JOLLA, Calif., June 24, 2026
CalciMedica, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of a protocol amendment and interim safety data from the company’s Phase 2 KOURAGE trial, which is evaluating Auxora™ (zegocractin) in patients suffering from Stage 2 or Stage 3 Acute Kidney Injury (AKI) associated with Acute Hypoxemic Respiratory Failure (AHRF). Following the review period, the company reported that it received no comments, questions, or clinical hold notifications from the FDA, allowing patient dosing and clinical development activities to continue. The outcome represents a significant regulatory milestone for CalciMedica as it advances its lead investigational therapy for serious inflammatory and critical care conditions.
Protocol Updates Address Previous Safety Concerns
Earlier this year, CalciMedica voluntarily paused enrollment in the KOURAGE study after recommendations from the trial’s Independent Data Monitoring Committee (IDMC), which identified a mortality imbalance requiring further investigation. Importantly, neither the IDMC nor the company’s independent experts found evidence suggesting drug-related toxicity associated with Auxora. A comprehensive review of data from 107 treated patients revealed that differences in baseline disease severity among participants likely contributed to the observed outcomes. To address these factors, CalciMedica submitted a protocol amendment in March 2026 that included refined patient eligibility criteria and updated stratification methods designed to improve study balance and data interpretation. The submission also included a detailed safety review covering all serious adverse events and causes of death reported during the trial.
FDA Feedback Supports Continued Auxora Development
The FDA’s Clinical Pharmacology team within the Division of Cardiology and Nephrology reviewed the submission and raised no concerns regarding the proposed modifications or safety findings. Because the KOURAGE trial was never placed under an official clinical hold, the FDA was not required to issue a formal response. However, after more than 60 days of review, the absence of regulatory objections provides important validation for CalciMedica’s assessment that the serious adverse events observed were consistent with previous clinical experience and did not appear to be related to Auxora treatment. This outcome strengthens confidence in the ongoing development of Auxora and supports the company’s strategy of targeting inflammatory pathways through Calcium Release-Activated Calcium (CRAC) channel inhibition.
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Expanding the Auxora Pipeline Across Multiple Indications
CalciMedica continues to position Auxora as a potential treatment for multiple serious inflammatory, immunologic, and cardiopulmonary disorders. The intravenous CRAC channel inhibitor has already been evaluated in more than 350 patients across completed and ongoing clinical studies. Beyond the KOURAGE trial, the company plans to evaluate Auxora in a Phase 1b proof-of-concept study for Pulmonary Arterial Hypertension (PAH) and is awaiting FDA feedback on a potential pivotal development program for acute pancreatitis, expected during the third quarter of 2026. In parallel, CalciMedica is advancing CM5480, its proprietary oral CRAC channel inhibitor candidate, which is being developed as a potential chronic therapy for inflammatory diseases and pulmonary hypertension. Together, these programs aim to establish CRAC channel inhibition as a differentiated therapeutic approach capable of addressing both inflammation and organ dysfunction across a broad range of serious diseases.
Source: CalciMedica press release
