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Regeneron (REGN)
NASDAQ:REGN
Dupilumab
Chronic Obstructive Pulmonary Disease
Phase IV
Not Yet Recruiting
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Jun 27, 2025
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Vonsetamig
Lupus Nephritis (Ln)
Phase I
Not Yet Recruiting
Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis
May 08, 2025
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Garetosmab
Obesity
Phase I
Not Yet Recruiting
Study of Safety and Effects of Garetosmab in Healthy Obese Men and Post-Menopausal Women
May 06, 2025
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Aln-Cideb
Metabolic Dysfunction-associated Steatohepatitis, Metabolic Dysfunction-associated Steatotic Liver Disease
Phase I
Recruiting
A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
Feb 14, 2025
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Itepekimab (Sar440340), Mometasone Furoate Nasal Spray (Mfns)
Chronic Rhinosinusitis With Nasal Polyps
Phase III
Recruiting
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Feb 14, 2025
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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 Regeneron (REGN) have in its pipeline
REGN is currently developing the following drugs: Ubamatamab, Sarilumab, Regn7075, Pozelimab, Pozelimab, Cemdisiran. These drug candidates are in various stages of clinical development as the company works toward FDA approval.