LA JOLLA, Calif., July 29, 2026
CalciMedica, Inc. has announced a significant regulatory milestone after reaching alignment with the U.S. Food and Drug Administration (FDA) on the Phase 2b clinical trial design for Auxora™ (zegocractin) in acute pancreatitis (AP). The agreement follows a Type C Focused Meeting with the FDA and establishes new-onset severe respiratory failure as the primary endpoint for the planned Phase 2b study, alongside multi-organ failure and time to medically indicated discharge as key secondary endpoints. In addition, both parties aligned on evaluating elevated lactate dehydrogenase (LDH) as a potential biomarker to identify patients at greater risk of severe disease, creating what could become the first registrational clinical endpoint framework for acute pancreatitis. The regulatory agreement represents a major advancement for Auxora, a novel calcium release-activated calcium (CRAC) channel inhibitor, and supports the development of what may become the first FDA-approved therapy specifically targeting acute pancreatitis, an inflammatory condition that currently has no approved treatments in the United States.
FDA Alignment Establishes New Clinical Development Pathway
The FDA’s agreement on the Phase 2b trial design provides CalciMedica with a clearer regulatory roadmap for advancing Auxora toward late-stage clinical development. The company will evaluate new-onset severe respiratory failure as the primary endpoint because respiratory complications remain one of the leading causes of mortality and prolonged hospitalization in patients with acute pancreatitis. The FDA also endorsed the inclusion of multi-organ failure and time to medically indicated discharge as key secondary endpoints while agreeing that the Phase 2b study should help refine patient selection and inform the design of a future Phase 3 registrational program. Importantly, the agency supported the evaluation of LDH as a potential enrichment biomarker to identify patients at increased risk of severe disease progression, potentially enabling more targeted enrollment and improving the efficiency of future clinical trials.
Auxora Demonstrates Encouraging Clinical Potential
Auxora™ is CalciMedica’s proprietary intravenous CRAC channel inhibitor, designed to reduce inflammation and tissue injury by regulating abnormal calcium signaling in immune and endothelial cells. The investigational therapy has already demonstrated encouraging results in the completed Phase 2b CARPO trial, where medium and high doses achieved a 100% reduction in new-onset severe respiratory failure among treated patients compared with placebo. Additional exploratory analyses showed that patients with elevated LDH levels experienced a greater incidence of severe respiratory complications, supporting the biomarker’s potential role in identifying high-risk patients. Beyond acute pancreatitis, Auxora has been evaluated in multiple clinical studies involving more than 350 patients, including trials in COVID-19 pneumonia and acute kidney injury, demonstrating the broader therapeutic potential of CRAC channel inhibition across inflammatory and cardiopulmonary diseases.
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Advancing the First Potential Therapy for Acute Pancreatitis
Acute pancreatitis remains a serious inflammatory disease responsible for approximately 300,000 hospitalizations annually in the United States, yet no FDA-approved therapy currently exists to directly treat the condition. CalciMedica’s regulatory progress represents an important step toward establishing the first standardized clinical development framework for acute pancreatitis while advancing a novel therapeutic approach that targets the underlying inflammatory mechanisms driving disease severity. The company is actively preparing for the Phase 2b clinical trial, including collaboration with contract research organizations and clinical sites to begin patient enrollment. If successful, Auxora could become the first therapy specifically approved for acute pancreatitis, offering physicians a much-needed treatment option capable of reducing respiratory complications, shortening hospital stays, and improving patient outcomes. The FDA alignment also reinforces the growing importance of biomarker-driven clinical trial design in accelerating the development of innovative therapies for serious inflammatory diseases.
Source: CalciMedica press release
