UPDATE: Due to the high circulation of the SARS-CoV-2 Omicron variant, our antibody combination is not currently authorized for use in any U.S. Region. Please refer to the authorized Fact Sheet and FDA statement for additional details.
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INVESTIGATIONAL PIPELINE A POWERFUL RESEARCH AND DEVELOPMENT ENGINE

Our pipeline is powered by end-to-end research and development capabilities. The Research team discovers promising new drug compounds. From there, Global Development brings these investigational candidates through the full clinical development process, from trial design to study execution and lifecycle management. Our product portfolio reflects the true collaborative spirit of Regeneron. This page is intended for U.S. residents only.

Explore the Regeneron clinical pipeline

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Phase 1

  • ALN-APP1
    RNAi therapeutic targeting APP Early-onset Alzheimer’s disease
    Neurology General Medicine
  • ALN-HSD
    RNAi therapeutic targeting HSD17B13 Nonalcoholic steatohepatitis ("NASH")
    Immunology & Inflammation General Medicine
  • ALN-PNP1
    RNAi therapeutic targeting PNPLA3 NASH
    Immunology & Inflammation General Medicine
  • DB-OTO
    AAV-based gene therapy Hearing loss in pediatrics (Phase 1/2)
    Rare Diseases
  • FIANLIMAB
    Antibody to LAG-3 Solid tumors and advanced hematologic malignancies
    Solid Organ Oncology Hematology
  • LINVOSELTAMAB
    Bispecific antibody targeting BCMA and CD3 Multiple myeloma
    Hematology
  • "NEXT GENERATION" COVID ANTIBODY
    Antibody to SARS-CoV-2 Variants Healthy volunteers
    Infectious Diseases General Medicine
  • NTLA-20013
    TTR gene knockout using CRISPR/Cas9 Transthyretin ("ATTR") amyloidosis
    Rare Diseases Hematology
  • ODRONEXTAMAB6
    Bispecific antibody targeting CD20 and CD3 Certain B-cell malignancies
    Solid Organ Oncology Hematology
  • REGN4336
    Bispecific antibody targeting PSMA and CD3 Prostate cancer
    Solid Organ Oncology
  • REGN5093
    Bispecific antibody targeting two distinct MET epitopes MET-altered advanced NSCLC
    Solid Organ Oncology
  • REGN5093-M114
    Bispecific antibody-drug conjugate targeting two distinct MET epitopes MET overexpressing advanced cancer
    Solid Organ Oncology
  • REGN5381/REGN9035
    Agonist Antibody to NPR1/Reversal Agent to REGN5381 Reversal agent in healthy volunteers
    Cardiovascular & Metabolic Diseases General Medicine
  • REGN5459
    Bispecific antibody targeting BCMA and CD3 Transplant desensitization in patients with chronic kidney disease
    Solid Organ Oncology Hematology
  • REGN5668
    Bispecific antibody targeting MUC16 and CD28 Platinum-resistant ovarian cancer
    Solid Organ Oncology
  • REGN5678
    Bispecific antibody targeting PSMA and CD28 Prostate cancer
    Solid Organ Oncology
  • REGN5837
    Bispecific antibody targeting CD22 and CD28 B-NHL
    Hematology
  • REGN6569
    Antibody to GITR Solid tumors
    Solid Organ Oncology
  • REGN7075
    Bispecific antibody targeting EGFR and CD28 Solid tumors
    Solid Organ Oncology
  • REGN7257
    Antibody to IL2Rg Aplastic anemia
    Hematology
  • REGN7508
    Antibody to Factor XI Thrombosis
    Hematology
  • REGN7999
    Antibody to TMPRSS6 Transfusion dependent iron overload
    Hematology

Phase 2

  • ALN-HSD
    RNAi therapeutic targeting HSD17B13 Nonalcoholic steatohepatitis ("NASH")
    Immunology & Inflammation General Medicine
  • CEMIPLIMAB
    Antibody to PD-1 Neoadjuvant CSCC; Second-line cervical cancer, ISA101b combination; First-line NSCLC, BNT116 combination
    Solid Organ Oncology
  • DUPILUMAB5
    Antibody to IL-4R alpha subunit Ulcerative colitis; Eosinophilic gastroenteritis (Phase 2/3)
    Immunology & Inflammation
  • FIANLIMAB
    Antibody to LAG-3 First-line advanced NSCLC (Phase 2/3) (pivotal study)
    Solid Organ Oncology
  • LINVOSELTAMAB
    Bispecific antibody targeting BCMA and CD3 Multiple myeloma (pivotal study)
    Solid Organ Oncology Hematology
  • MIBAVADEMAB
    Agonist antibody to leptin receptor ("LEPR") Generalized lipodystrophy; Partial lipodystrophy
    Cardiovascular & Metabolic Diseases Rare Diseases General Medicine
  • ODRONEXTAMAB6
    Bispecific antibody targeting CD20 and CD3 B-cell non-Hodgkin lymphoma ("B-NHL") (pivotal study)
    Cardiovascular & Metabolic Diseases Solid Organ Oncology Hematology
  • POZELIMAB
    Antibody to C5; studied as monotherapy and in combination with cemdisiran CD55-deficient protein-losing enteropathy ("CHAPLE"), monotherapy (potentially pivotal study)
    Rare Diseases Hematology
  • REGN5381/REGN9035
    Agonist Antibody to NPR1/Reversal Agent to REGN5381 Heart failure
    Cardiovascular & Metabolic Diseases General Medicine
  • REGN9933
    Antibody to Factor XI Thrombosis
    Hematology
  • SARILUMAB5
    Antibody to IL-6R Polyarticular-course juvenile idiopathic arthritis ("pcJIA") (pivotal study); systemic juvenile idiopathic arthritis ("sJIA") (pivotal study)
    Immunology & Inflammation
  • UBAMATAMAB
    Bispecific antibody targeting MUC16 and CD3 Platinum-resistant ovarian cancer
    Solid Organ Oncology
  • VIDUTOLIMOD
    Immune activator targeting TLR9 Solid tumors
    Solid Organ Oncology

Phase 3

  • AFLIBERCEPT 8MG2
    VEGF-Trap Wet AMD, DME, RVO
    Ophthalmology
  • ALIROCUMAB
    Antibody to PCSK9 HeFH in pediatrics and adolescents
    Cardiovascular & Metabolic Diseases General Medicine
  • CEMIPLIMAB
    Antibody to PD-1 Adjuvant CSCC
    Solid Organ Oncology
  • DUPILUMAB5
    Antibody to IL-4R alpha subunit EoE in pediatrics; chronic obstructive pulmonary disease ("COPD"); bullous pemphigoid; chronic spontaneous urticaria ("CSU"); chronic pruritis of unknown origin
    Immunology & Inflammation
  • FIANLIMAB
    Antibody to LAG-3 First-line metastatic melanoma; First-line adjuvant melanoma
    Solid Organ Oncology
  • GARETOSMAB
    Antibody to Activin A Fibrodysplasia ossificans progressiva ("FOP")
    Rare Diseases General Medicine
  • ITEPEKIMAB5
    Antibody to IL-33 COPD
    Immunology & Inflammation
  • POZELIMAB
    Antibody to C5; studied as monotherapy and in combination with cemdisiran Myasthenia gravis, cemdisiran combination; paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination
    Cardiovascular & Metabolic Diseases Rare Diseases Hematology
  • REGN5713-5714-5715
    Multi-antibody therapy to Bet v 1 Birch allergy
    Immunology & Inflammation

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1In collaboration with Alnylam

2In collaboration with Bayer outside of the U.S.

3In collaboration with Intellia

4In collaboration with Roche outside of the U.S.

5In collaboration with Sanofi

6In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan and Macau

This graphic displays pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been fully evaluated by any regulatory authorities for the indications described in this section.

Pipeline last updated:

Scientific trailblazers

Following the science leads to unexpected breakthroughs and diverse areas of study —from ophthalmology to cancer to inflammation to pain to cardiovascular disease.

Our Current Research

Explore our clinical trials

The discoveries never stop as we work to help people with serious diseases. Clinical trials allow us to carefully test and collect data about investigational products before they can be approved for use. Learn more about our clinical trials or find a relevant one near you.

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