Sanofi R&D Pipeline

At the end of March 2021, the R&D pipeline contained 80 projects, including 36 new molecular entities in clinical development (or that have been submitted to the regulatory authorities). Thirty seven projects are in phase 3 or have been submitted to the regulatory authorities for approval.

Pipeline update communicated at Q1 2021 Results Meeting, dated 28 April 2021.

Download expected submission timelines     Download expected R&D milestones

Legend

ADC: Antibody-Drug Conjugate; ADPKD: Autosomal Dominant Polycystic Kidney Disease; ALL: Acute Lymphoblastic Leukemia; AML: Acute Myeloid Leukemia; BCC: Basal Cell Carcinoma; BTKi: Bruton’s Tyrosine Kinase inhibitor; COPD: Chronic Obstructive Pulmonary Disease; CSCC: Cutaneous Squamous Cell Carcinoma; FGFR3: Fibroblast Growth Factor Receptor 3; GCS: Glucosylceramide Synthase; Hib: Haemophilus influenzae type b; mAb: Monoclonal Antibody; mBC: metastaic Breast Cancer; MM: Multiple Myeloma; NSCLC: Non-Small Cell Lung Cancer; ped: pediatric; RRMM: Relapsed Refractory Multiple Myeloma; Te: Transplant eligible; Ti: Transplant ineligible

Therapeutic area Phase Name Description Indication Notes
ONCOLOGY Phase 1 SAR439459 Anti-TGFb mAb Advanced solid tumors  
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 / N-H lymphoma  
ONCOLOGY Phase 1 SAR442720 SHP2 inhibitor mono, combo Solid tumors Developed in collaboration with Revolution Medicines
ONCOLOGY Phase 1 SAR444245 Non-alpha IL-2 mono, combo (PD-1, EGFR) Solid tumors Formerly known as THOR707
IMMUNO-INFLAMMATION Phase 1 SAR441236 Tri-specific neutralizing mAb HIV  
IMMUNO-INFLAMMATION Phase 1 SAR443122 RIPK1 inhibitor Inflammatory indications Developed in collaboration with Denali. Also known as DNL758. *Receptor-Interacting serine/threonine-Protein Kinase 1
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 SAR441344 Anti-CD40L mAb Multiple Sclerosis Developed in collaboration with Immunext
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
RARE BLOOD DISORDERS Phase 1 sutimlimab Complement C1s inhibitor Immune Thrombocytopenic Purpura  
VACCINES Phase 1 SP0148 Therapeutic vaccine Herpes simplex virus type 2 Developed in collaboration with Immune Design/Merck
VACCINES Phase 1 SP0218 Vaccine (Vero cell) Yellow Fever  
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 Sarclisa® Anti-CD38 mAb + atezolizumab Metastatic colorectal cancer 1L  
ONCOLOGY Phase 2 Sarclisa® Anti-CD38 mAb 1-2L AML / acute lymphoblastic leukemia pediatrics Registrational study (other than Phase 3)
ONCOLOGY Phase 2 isatuximab Anti-CD38 mAb Patients awaiting kidney transplantation Registrational study (other than Phase 3)
IMMUNO-INFLAMMATION Phase 2 dupilumab Anti-IL4/IL13 mAb Peanut allergy Developed in collaboration with Regeneron
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
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 Acid Sphingomyelinase Deficiency also known as Niemann Pick type B 
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 Fluzone® HD Inactivated influenza vaccine (IIV) Pediatric flu  
VACCINES Phase 2 SP0125 Vaccine Respiratory syncytial virus (infants)  
VACCINES Phase 2 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 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 (IMROZ)  
ONCOLOGY Phase 3 Sarclisa® Anti-CD38 mAb 1L newly diagnosed multiple myeloma Te (GMMG)  
ONCOLOGY Phase 3 Sarclisa® Anti-CD38 mAb Smoldering multiple myeloma (ITHACA)  
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 (COPD) Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Cold urticaria (CIndU-Cold) Developed in collaboration with Regeneron
IMMUNO-INFLAMMATION Phase 3 Dupixent® Anti-IL4/IL13 mAb Chronic sinusitis 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  
IMMUNO-INFLAMMATION Phase 3 itepekimab Anti-IL33 mAb Chronic Obstructive Pulmonary Disease (COPD) Developed in collaboration with Regeneron
RARE DISEASES Phase 3 venglustat Oral GCS inhibitor ADPKD  
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 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-compliment C1s mAb Cold Agglutinin Disease  
RARE DISEASES Registration avalglucosidase alfa Enzyme replacement therapy Pompe Disease  
NEUROLOGY Registration Aubagio® Pyrimidine synthesis inhibitor Relapsing Multiple Sclerosis – pediatric  
VACCINES Registration Shan 6® Pediatric hexavalent vaccine DTP-HepB-Polio-Hib