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RedHill Biopharma (RDHL)
NASDAQ:RDHL
Rhb-204
Lung Diseases, Bronchiectasis, Pulmonary Mycobacterium Avium Complex Infection
Phase III
Terminated
RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease
Oct 19, 2020
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Opaganib
Covid-19, Lung Infection
Phase II/III
Completed
Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
Jul 09, 2020
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Abc294640, Hydroxychloroquine Sulfate 200 Mg
Cholangiocarcinoma, Cholangiocarcinoma Non-Resectable, Cholangiocarcinoma, Intrahepatic, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Perihilar
Phase II
Completed
A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma
Dec 01, 2017
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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 RedHill Biopharma (RDHL) have in its pipeline
RDHL is currently developing the following drugs: Rhb-204, Opaganib, Abc294640, Hydroxychloroquine Sulfate 200 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.