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Ardelyx (ARDX)
NASDAQ:ARDX
tenapanor
Irritable Bowel Syndrome With Constipation (Ibs-C)
Phase II
Recruiting
4-Week, Multi-center Dose-Ranging Study for the IBS-C in Pts. 6 to <12 Yrs
Aug 12, 2024
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tenapanor
Irritable Bowel Syndrome With Constipation (Ibs-C)
Phase III
Enrolling By Invitation
Safety Study of Tenapanor for the Treatment of Pediatric Patients (6 to Less Than 18 Years Old) With IBS-C
Mar 07, 2023
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Tenapanor 50 Mg, Tenapanor 25 Mg Bid
Irritable Bowel Syndrome With Constipation (Ibs-C)
Phase III
Recruiting
Study to Assess Safety and Efficacy of Tenapanor for Treatment of IBS-C in Pediatric Patients 12 to Less Than 18 Years
Nov 30, 2022
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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 Ardelyx (ARDX) have in its pipeline
ARDX is currently developing the following drugs: tenapanor, tenapanor, Tenapanor 50 Mg, Tenapanor 25 Mg Bid. These drug candidates are in various stages of clinical development as the company works toward FDA approval.