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Regeneron Pharmaceuticals

Total Trials
9
Recruiting
9
Phases
Phase 2, Phase 1, Phase 2, Phase 3, Phase 1

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

NCT07154290 Phase 2
Recruiting

A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Advanced/Metastatic Non-Small Cell Lung Cancer
NCT05828511 Phase 1, Phase 2
Recruiting

A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

Multiple Myeloma
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)
NCT05363319
Recruiting

An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe

Non-small Cell Lung Cancer
NCT07222761 Phase 3
Recruiting

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Relapsed and/or Refractory Multiple Myeloma (RRMM)
NCT07318597 Phase 2
Recruiting

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

Pulmonary Arterial Hypertension (PAH)
NCT03761108 Phase 1, Phase 2
Recruiting

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma
NCT05685173 Phase 1
Recruiting

A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas

B-cell Non-Hodgkins Lymphoma (B-NHL)
NCT07271186 Phase 2
Recruiting

Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease

Diabetic Kidney Disease (DKD)
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