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Calcimedica, Inc. (CALC)
NASDAQ:CALC
Auxora
Acute Kidney Injury
Phase II
Recruiting
A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"
Apr 16, 2024
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Cm-4620 Injectable Emulsion Or Cm-4620-Ie
Acute Pancreatitis, Systemic Inflammatory Response Syndrome
Phase II
Completed
A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
Dec 15, 2020
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Auxora (Part 1), Standard Of Care (Part 1), Auxora (Part 2)
Pneumonia
Phase II
Completed
A Study of Auxora in Patients With Severe COVID-19 Pneumonia
Apr 07, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Calcimedica, Inc. (CALC) have in its pipeline
CALC is currently developing the following drugs: Auxora, Cm-4620 Injectable Emulsion Or Cm-4620-Ie, Auxora (Part 1), Standard Of Care (Part 1), Auxora (Part 2). These drug candidates are in various stages of clinical development as the company works toward FDA approval.