Education
About Us
Working with TipRanks
Follow Us
Ipsen (FR:IPN)
:IPN
Elafibranor
Primary Biliary Cholangitis
Phase III
Active Not Recruiting
A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid.
Apr 22, 2024
―
Tazverik (Tazemetostat)
Follicular Lymphoma, Refractory Follicular Lymphoma
Phase II
Not Yet Recruiting
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation
Sep 29, 2023
―
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 Ipsen (IPN) have in its pipeline
IPN is currently developing the following drugs: Ipn10200, Palovarotene, Ipn01195. These drug candidates are in various stages of clinical development as the company works toward FDA approval.