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Cumberland Pharmaceuticals Inc (CPIX)
NASDAQ:CPIX
Ifetroban Sodium
Idiopathic Pulmonary Fibrosis
Phase II
Recruiting
Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Sep 27, 2022
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Ifetroban
Duchenne Muscular Dystrophy Cardiomyopathy, Cardiomyopathy, Dilated
Phase II
Active Not Recruiting
Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy
Nov 03, 2017
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Oral Ifetroban
Autoimmune Diseases, Scleroderma, Diffuse, Skin Diseases, Connective Tissue Diseases, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic, Pathologic Processes
Phase II
Active Not Recruiting
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
Feb 08, 2016
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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 Cumberland Pharmaceuticals Inc (CPIX) have in its pipeline
CPIX is currently developing the following drugs: Ifetroban Sodium, Ifetroban, Oral Ifetroban. These drug candidates are in various stages of clinical development as the company works toward FDA approval.