Dupilumab, Dupilumab Coformulated With Berahyaluronidase Alfa, Sar231893, Dupixent
Healthy Volunteers
Phase I
Active Not Recruiting
Pharmacokinetics and Tolerability of Subcutaneous Dupilumab Coformulated With Berahyaluronidase Alfa and Dupilumab Without Berahyaluronidase Alfa in Healthy Participants
Jun 08, 2026
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Regn15505, Regn15505+Cemiplimab, Regn15505+Regn4336, Regn2810, Libtayo
Metastatic Castration-Resistant Prostate Cancer (Mcrpc), Clear Cell Renal Cell Carcinoma (Ccrcc)
Phase I/II
Recruiting
REGN15505 (PSMAx4-1BB) Alone or in Combination With Cemiplimab or REGN4336 (PSMAxCD3) in Adult Patients With Metastatic Castration-Resistant Prostate Cancer and Clear Cell Renal Cell Carcinoma
May 11, 2026
Itepekimab, Regn3500
Chronic Rhinosinusitis With Nasal Polyps
Phase III
Withdrawn
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
Mar 16, 2026
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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: Olatorepatide, Regn-2Cat, Freneslerbart, Mevonlerbart, Regn1908, Regn1909, Dupilumab, Dupilumab Coformulated With Berahyaluronidase Alfa, Sar231893, Dupixent. These drug candidates are in various stages of clinical development as the company works toward FDA approval.