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Biogen (BIIB)
NASDAQ:BIIB
Felzartamab
Microvascular Inflammation
Phase II
Not Yet Recruiting
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Oct 17, 2025
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Omeprazole, Omaveloxolone
Healthy Volunteer
Phase I
Completed
A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
Aug 28, 2025
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Biib142
Healthy Volunteer
Phase I
Recruiting
A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old
Aug 14, 2025
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Omaveloxolone
Healthy Volunteer
Phase I
Completed
A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55
Jun 05, 2025
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Tacrolimus, Felzartamab, Standard Of Care Ist
Primary Membranous Nephropathy
Phase III
Recruiting
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
Apr 30, 2025
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Felzartamab
Immunoglobulin A Nephropathy (Igan)
Phase III
Recruiting
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)
Apr 17, 2025
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Omaveloxolone
Friedreich Ataxia
Phase III
Recruiting
A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old
Apr 11, 2025
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Litifilimab, Ai, Obi, Pfs
Healthy Volunteer
Phase I
Recruiting
A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways
Dec 15, 2024
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Felzartamab
Antibody-Mediated Rejection
Phase III
Recruiting
A Trial of Felzartamab in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Nov 11, 2024
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Biib091
Healthy Volunteer
Phase I
Completed
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
Oct 10, 2024
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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 Biogen (BIIB) have in its pipeline
BIIB is currently developing the following drugs: Felzartamab, Omeprazole, Omaveloxolone, Biib142. These drug candidates are in various stages of clinical development as the company works toward FDA approval.