Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials evaluate zegocractin (CM-4620) across hyperinflammatory and acute critical conditions, such as acute pancreatitis, pneumonia, and systemic inflammatory response syndrome. Sponsored by CalciMedica Inc. alongside academic collaborators including St. Jude Children's Research Hospital and Northwestern University, these studies assess the compound's safety, pharmacodynamics, and therapeutic potential across active, completed, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04195347 RECRUITING
Acute Pancreatitis
St. Jude Children's Research Hospital
 2020-09-04 PHASE1; PHASE2
NCT04681066 COMPLETED
Acute Pancreatitis; Systemic Inflammatory Response Syndrome
CalciMedica, Inc.
 2021-03-24 PHASE2
NCT04661540 TERMINATED
Pneumonia
CalciMedica, Inc.
 2021-03-02 PHASE2
NCT04345614 COMPLETED
Pneumonia
CalciMedica, Inc.
 2020-04-08 PHASE2
NCT04661540 Completed
Pneumonia
CalciMedica Inc.|Northwestern University
 2021-03-02 Phase 2
NCT04195347 Recruiting
Acute Pancreatitis
St. Jude Children''s Research Hospital|CalciMedica Inc.
 2020-09-04 Phase 1|Phase 2
NCT04345614 Completed
Pneumonia
CalciMedica Inc.
 2020-04-08 Phase 2
NCT03709342 COMPLETED
Acute Pancreatitis
CalciMedica, Inc.
 2019-01-06 PHASE2
NCT03401190 COMPLETED
Acute Pancreatitis; Systemic Inflammatory Response Syndrome
CalciMedica, Inc.
 2018-03-12 PHASE2
NCT03709342 Completed
Acute Pancreatitis
CalciMedica Inc.
 2019-01-06 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Zegocractin (CM-4620) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zegocractin (CM-4620) selectively inhibits calcium-release activated calcium channels, suppressing Orai1/STIM1- and Orai2/STIM1-mediated calcium influx to attenuate intracellular calcium signaling in immune cells. By blocking downstream calcium-dependent pro-inflammatory mediator release, this compound reduces inflammatory cell activation and tissue injury, offering therapeutic utility for conditions studied in clinical trials such as acute pancreatitis and pneumonia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.