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Regeneron Pharmaceuticals

Total Trials
16
Recruiting
16
Phases
Phase 2, Phase 1, Phase 4, Phase 1, Phase 2, Phase 3

Regeneron Pharmaceuticals is a US biopharmaceutical company founded in 1988 and headquartered in Tarrytown, New York. Regeneron built its reputation on the VelociSuite technology platform — a suite of proprietary gene targeting and antibody discovery tools that generate fully human monoclonal antibodies with exceptional speed and precision. The company's approved medicines and clinical pipeline reflect deep expertise in ophthalmology, oncology, immunology, cardiovascular disease, and rare genetic diseases.

Regeneron's flagship marketed products include aflibercept (Eylea), which has become the standard of care for wet age-related macular degeneration and diabetic macular edema with multiple active extensions including Eylea HD and PHOTON trial data; dupilumab (Dupixent), a blockbuster IL-4/IL-13 inhibitor approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, COPD, prurigo nodularis, and additional conditions under active investigation; and cemiplimab (Libtayo), a PD-1 inhibitor co-developed with Sanofi with approvals in cutaneous squamous cell carcinoma, basal cell carcinoma, and NSCLC.

Regeneron's oncology strategy combines cemiplimab with bispecific antibodies — including costimulatory bispecifics (CD28 × tumor antigen) designed to amplify T-cell activation specifically within the tumor microenvironment — and with antibody-drug conjugates. The VelociSuite platform also enables rapid generation of antibodies against emerging pathogens (as demonstrated during Ebola and COVID-19), supporting BARDA and NIH-funded infectious disease programs.

Frequently Asked Questions — Regeneron Pharmaceuticals

What conditions is Regeneron studying dupilumab for beyond atopic dermatitis?
Dupilumab (Dupixent) blocks the shared receptor component for IL-4 and IL-13, cytokines central to type 2 (Th2) inflammation. After initial approval in atopic dermatitis, dupilumab has been approved across a remarkable breadth of type 2 inflammatory conditions: moderate-to-severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and COPD with eosinophilic phenotype. Regeneron and Sanofi continue to run Phase 3 trials investigating dupilumab in chronic spontaneous urticaria, alopecia areata, bullous pemphigoid, pediatric younger age groups, and several additional rare type 2 inflammatory diseases — making this one of the most broadly studied monoclonal antibodies in history.
What cancer clinical trials does Regeneron sponsor?
Regeneron's oncology trials center on cemiplimab (Libtayo), its PD-1 inhibitor developed with Sanofi. Cemiplimab is approved for advanced cutaneous squamous cell carcinoma, basal cell carcinoma, and NSCLC, with ongoing Phase 3 trials in cervical cancer, head and neck squamous cell carcinoma, prostate cancer, and other indications. Regeneron is also running Phase 1 and Phase 2 trials of novel bispecific antibodies that combine PD-1 blockade with CD28 costimulatory agonism to amplify T-cell killing specifically within tumors — a next-generation approach designed to improve response rates beyond standard checkpoint inhibition. Additionally, REGN5668, REGN5678, and REGN4461 represent other pipeline immuno-oncology candidates in early trials.
What is Regeneron's VelociSuite and why does it matter for clinical trial development?
VelociSuite is Regeneron's proprietary integrated platform for antibody discovery, optimization, and target validation. The core component — VelocImmune — comprises mice with humanized immunoglobulin loci, enabling direct generation of fully human antibodies against virtually any target without subsequent humanization steps. This reduces both the time from target identification to clinical candidate selection (typically 12–18 months) and the risk of immunogenicity in humans. VelociSuite also includes VelociGene (precise genome editing for target validation), VelociMab (antibody optimization), and VelociMAb (multi-specific antibody generation). The platform's speed was demonstrated during COVID-19, when Regeneron generated REGN-COV2 (casirivimab + imdevimab) and entered Phase 1 within months of viral sequence publication.

Clinical Trials by Regeneron Pharmaceuticals

NCT07175428 Phase 2
Recruiting

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Atrial Fibrillation (AF)
NCT07543055 Phase 1
Recruiting

A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has Spread

Prostate Cancer
NCT07142343 Phase 4
Recruiting

A Study to Test the Safety of Pozelimab in Pediatric Participants 1 to 5 Years of Age With a Rare Disease Called CHAPLE (Complement Hyperactivation, Angiopathic Thrombosis, Protein-losing Enteropathy) Disease

CHAPLE Disease
NCT06379789 Phase 1, Phase 2
Recruiting

A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B

Hemophilia B
NCT07759167 Phase 1
Recruiting

Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Participants With End-Stage Kidney Disease on Hemodialysis

End-Stage Kidney Disease (ESKD)
NCT06975787 Phase 1
Recruiting

Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis

Lupus Nephritis (LN)
NCT07527910 Phase 2
Recruiting

A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT05137054 Phase 1
Recruiting

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Multiple Myeloma
NCT04590326 Phase 1, Phase 2
Recruiting

A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab

Ovarian Cancer
NCT05648214 Phase 1, Phase 2
Recruiting

A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Healthy Volunteers
NCT07187401 Phase 1, Phase 2
Recruiting

A First-in-Human Safety and Efficacy Study of ALN-CFB, a Small Interfering RNA (siRNA) Targeting Complement Factor B, in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria With Persistent Anemia on a C5 Inhibitor

Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT06585410 Phase 3
Recruiting

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Cutaneous Squamous Cell Carcinoma (CSCC)
NCT05788536 Phase 1, Phase 2
Recruiting

A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations

Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
NCT07594106 Phase 1, Phase 2
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

Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT05744921 Phase 3
Recruiting

A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works

Paroxysmal Nocturnal Hemoglobinuria
NCT07230834 Phase 1
Recruiting

Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants

Geographic Atrophy (GA)
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