Sanofi Pipeline

Sanofi aims to raise the standards of disease treatment and prevention by focusing on drugs and vaccines with the greatest potential to improve the lives of patients. As of 30 June 2021, the drugs and vaccines in Sanofi's R&D pipeline include 83 projects, 35 of which are in phase 3 or have been submitted to regulatory authorities for approval. These projects represent new molecular entities as well as existing therapeutics being investigated for additional indications, or different formulations.

The table below provides an overview of selected projects in clinical development. The most recent pipeline update was communicated at the Q2 2021 Results Meeting, dated 29 July 2021. Brand names are trademarks either owned by or licensed to Sanofi or associated companies. The safety and efficacy of the investigational agents listed here have not been established.

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Legend

ADC: Antibody-Drug Conjugate; AML: Acute Myeloid Leukemia; ASMD: Acid Sphingomyelinase Deficiency, also known as Niemann Pick type B; BTK: Bruton’s Tyrosine Kinase; COPD: Chronic Obstructive Pulmonary Disease; CIDP: Chronic inflammatory demyelinating polyneuropathy; ERT, Enzyme Replacement Therapy; FGFR3: Fibroblast Growth Factor Receptor 3; GCS: Glucosylceramide Synthase; mAb: Monoclonal Antibody; Te: Transplant eligible; Ti: Transplant ineligible

Therapeutic area Phase Name Description Indication Notes
ONCOLOGY Phase 1 SAR441000 Cytokine mRNA Solid tumors Developed in collaboration with BioNTech
ONCOLOGY Phase 1 SAR442085 Anti CD38 mAb Fc engineered Multiple myeloma  
ONCOLOGY Phase 1 SAR442257 Anti-CD38xCD28xCD3 trispecific mAb Multiple myeloma / Non-Hodgkin lymphoma  
ONCOLOGY Phase 1 SAR442720 SHP2 inhibitor Solid tumors Developed in collaboration with Revolution Medicines
ONCOLOGY Phase 1 SAR439459 Anti-TGFb mAb Advanced solid tumors  
ONCOLOGY Phase 1 SAR444245 Non-alpha IL-2 mono, combo (PD-1, EGFR) Solid tumors Formerly known as THOR707
ONCOLOGY Phase 1 SAR444881 Anti-ILT2 Solid tumors Developed in collaboration with Biond
ONCOLOGY Phase 1 SAR445419 NK-cell-based immunotherapy Acute Myeloid Leukemia Formerly known as KDS1001
IMMUNO-INFLAMMATION Phase 1 SAR444727 BTK inhibitor (topical) Immune-mediated diseases  
IMMUNO-INFLAMMATION Phase 1 SAR441566 Oral TNF inhibitor Inflammatory indications  
IMMUNO-INFLAMMATION Phase 1 SAR444656 IRAK4 degrader Atopic dermatitis Developed in collaboration with Kymera (KT474)
NEUROLOGY Phase 1 SAR443820 RIPK1 inhibitor Amyotrophic Lateral Sclerosis Developed in collaboration with Denali. Also known as DNL788. Receptor-Interacting serine/threonine-Protein Kinase 1
RARE BLOOD DISORDERS Phase 1 ST400 Ex vivo ZFN gene-edited cell therapy Beta thalassemia Developed in collaboration with Sangamo
RARE BLOOD DISORDERS Phase 1 SAR445136 Ex vivo ZFN gene-edited cell therapy Sickle cell disease Formerly known as BIVV003. Developed in collaboration with Sangamo.
RARE BLOOD DISORDERS Phase 1 SAR445088 Complement C1s inhibitor Cold Agglutinin Disease Formerly known as BIVV020
VACCINES Phase 1 SP0273 mRNA vaccine Influenza  
VACCINES Phase 1 SP0148 Therapeutic vaccine Herpes simplex virus type 2 Developed in collaboration with Immune Design/Merck
RARE DISEASES Phase 1 SAR442501 FGFR3 antibody Achondroplasia  
ONCOLOGY Phase 2 amcenestrant SERD Metastatic breast cancer 2/3L Formerly known as SAR439859. Registrational study (other than Phase 3)
ONCOLOGY Phase 2 amcenestrant SERD Early breast cancer Formerly known as SAR439859
ONCOLOGY Phase 2 tusamitamab ravtansine Anti-CEACAM5 ADC + pembrolizumab Non-small-cell lung cancer 1L Formerly known as SAR408701
ONCOLOGY Phase 2 tusamitamab ravtansine Anti-CEACAM5 ADC + ramucirumab Non-small-cell lung cancer 2/3L Formerly known as SAR408701
ONCOLOGY Phase 2 tusamitamab ravtansine Anti-CEACAM5 ADC Exploratory Solid tumors Formerly known as SAR408701
ONCOLOGY Phase 2 Sarclisa® Anti-CD38 mAb + atezolizumab Metastatic colorectal cancer 1L  
ONCOLOGY Phase 2 Sarclisa® Anti-CD38 mAb+ combinations Relapsed, Refractory Multiple Myeloma Registrational study (other than Phase 3)
ONCOLOGY Phase 2 Sarclisa® Anti-CD38 mAb 1-2L AML / acute lymphoblastic leukemia pediatrics Registrational study (other than Phase 3)
ONCOLOGY Phase 2 Sarclisa® Anti-CD38 mAb Patients awaiting kidney transplantation Registrational study (other than Phase 3)
ONCOLOGY Phase 2 SAR445256 Anti-ICOS Solid tumors Formerly known as KY1044
IMMUNO-INFLAMMATION Phase 2 dupilumab Anti-IL4/IL13 mAb Peanut allergy Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 2 SAR445229 Anti-Ox40L Atopic Dermatitis Formerly known as KY1005
IMMUNO-INFLAMMATION Phase 2 SAR443122 RIPK1 inhibitor Cutaneous Lupus Erythematosus Developed in collaboration with Denali. Also known as DNL758. *Receptor-Interacting serine/threonine-Protein Kinase 1
IMMUNO-INFLAMMATION Phase 2 Kevzara® Anti-IL6 mAb Polyarticular juvenile idiopathic arthritis Developed in collaboration with Regeneron. Registrational study (other than Phase 3).
IMMUNO-INFLAMMATION Phase 2 Kevzara® Anti-IL6 mAb Systemic juvenile arthritis Developed in collaboration with Regeneron. Registrational study (other than Phase 3).
IMMUNO-INFLAMMATION Phase 2 rilzabrutinib BTK inhibitor IgG4-related disease  
IMMUNO-INFLAMMATION Phase 2 SAR441344 Anti-CD40L mAb Sjögren‘s Syndrome Developed in collaboration with Immunext
NEUROLOGY Phase 2 SAR441344 Anti-CD40L mAb Multiple Sclerosis Developed in collaboration with Immunext
NEUROLOGY Phase 2 SAR445088 Complement C1s inhibitor CIDP Formerly known as BIVV020
RARE BLOOD DISORDERS Phase 2 SAR445088 Complement C1s inhibitor Immune Thrombocytopenia Formerly known as BIVV020. Registrational Study (other than Phase 3).
RARE DISEASES Phase 2 olipudase alfa rhASM ASMD adult and pediatric  
RARE DISEASES Phase 2 SAR339375 miRNA-21 Alport syndrome  
RARE DISEASES Phase 2 venglustat Oral GCS inhibitor Fabry disease  
RARE DISEASES Phase 2 venglustat Oral GCS inhibitor Gaucher type 3  
VACCINES Phase 2 SP0202 Next-gen conjugate vaccine Pneumococcal Developed in collaboration with SK
VACCINES Phase 2 SP0218 Vaccine (Vero cell) Yellow Fever  
VACCINES Phase 2 Fluzone® HD Inactivated influenza vaccine (IIV) Pediatric flu  
VACCINES Phase 2 SP0125 Vaccine Respiratory syncytial virus (infants)  
VACCINES Phase 2 SP0254 mRNA vaccine COVID-19 Developed in collaboration with Translate Bio
VACCINES Phase 2 SP0230 Multicomponent vaccine Meningitis B  
ONCOLOGY Phase 3 amcenestrant SERD + palbociclib 1L metastatic breast cancer Formerly known as SAR439859
ONCOLOGY Phase 3 Libtayo® Anti-PD-1 mAb + chemotherapy 1L Non-small cell lung cancer Developed in collaboration with Regeneron
ONCOLOGY Phase 3 Libtayo® Anti-PD-1 mAb 2L cervical cancer Developed in collaboration with Regeneron
ONCOLOGY Phase 3 Libtayo® Anti-PD-1 mAb Adjuvant CSCC Developed in collaboration with Regeneron
ONCOLOGY Phase 3 Sarclisa® Anti-CD38 mAb 1L newly diagnosed multiple myeloma Ti  
ONCOLOGY Phase 3 Sarclisa® Anti-CD38 mAb 1L newly diagnosed multiple myeloma Te  
ONCOLOGY Phase 3 Sarclisa® Anti-CD38 mAb Smoldering multiple myeloma  
ONCOLOGY Phase 3 tusamitamab ravtansine Anti-CEACAM5 ADC Non-small cell lung cancer 2/3L Formerly known as SAR408701
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Atopic dermatitis 6 months–5 years old Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Prurigo nodularis Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Eosinophilic esophagitis Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Bullous pemphigoid Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Chronic spontaneous urticaria Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Chronic obstructive pulmonary disease Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Chronic inducible cold urticaria Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Chronic rhinosinusitis without nasal polyps Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Allergic fungal rhinosinusitis Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 rilzabrutinib BTK inhibitor Pemphigus vulgaris  
IMMUNO-INFLAMMATION Phase 3 itepekimab Anti-IL33 mAb Chronic obstructive pulmonary disease Developed in collaboration with Regeneron
RARE DISEASES Phase 3 venglustat Oral GCS inhibitor GM2 Gangliosidosis  
RARE DISEASES Phase 3 Cerdelga® Oral GCS inhibitor Gaucher type 1, ERT switch, pediatric  
NEUROLOGY Phase 3 tolebrutinib BTK inhibitor Relapsing Multiple Sclerosis (RMS) Proposed international nonproprietary name for SAR442168
NEUROLOGY Phase 3 tolebrutinib BTK inhibitor Primary Progressive MS (PPMS) Proposed international nonproprietary name for SAR442168
NEUROLOGY Phase 3 tolebrutinib BTK inhibitor Secondary Progressive MS (SPMS) Proposed international nonproprietary name for SAR442168
RARE BLOOD DISORDERS Phase 3 fitusiran RNAi targeting anti-thrombin Hemophilia A and B  
RARE BLOOD DISORDERS Phase 3 fitusiran RNAi targeting anti-thrombin Hemophilia A and B pediatric  
RARE BLOOD DISORDERS Phase 3 rilzabrutinib BTK inhibitor Immune Thrombocytopenia  
RARE BLOOD DISORDERS Phase 3 efanesoctocog alfa (BIVV001) Recombinant Coagulation Factor VIII Fc – von Willebrand Factor – XTEN Fusion protein Hemophilia A Developed in collaboration with Sobi.
VACCINES Phase 3 SP0253 Recombinant baculovirus vaccine COVID-19 Developed in collaboration with GSK and with funding from the Biomedical Advanced Research and Development Authority (BARDA)
VACCINES Phase 3 nirsevimab Monoclonal antibody Respiratory Syncytial Virus (RSV) Developed in collaboration with AstraZeneca
VACCINES Phase 3 MenQuadfi™ Meningococcal (A,C,Y,W) conjugate vaccine Meningitis 6 weeks+ (US / EU)  
VACCINES Phase 3 VerorabVax® (VRVg) Purified Vero rabies vaccine Rabies  
IMMUNO-INFLAMMATION Registration Dupixent® Anti-IL4/IL13 mAb Asthma 6–11 years old Developed in collaboration with Regeneron
RARE BLOOD DISORDERS Registration sutimlimab Anti-complement C1s mAb Cold Agglutinin Disease  
RARE DISEASES Registration avalglucosidase alfa Enzyme replacement therapy Pompe Disease