Specialty Care R&D Pipeline

With many potential new therapies currently in clinical trials, our goal is to be the industry leader in specialty care. We remain focused on discovering scientific breakthroughs to address complex, debilitating diseases.

Explore highlights of our research and development pipeline across our five areas of focus.

Items marked with ^ are being developed in collaboration with Regeneron, ❅ are being developed in collaboration with Sangamo Therapeutics, ♕ are being developed in collaboration with Roche, ♢ are being developed in collaboration with SOBI, ✿ are being developed in collaboration with Revolution Medicines, ⚙ are being developed in collaboration with BioNtech, ⚜ are being developed in collaboration with Immunext, ✪ are being developed in collaboration with Denali, ➤ are being developed in collaboration with Lead Pharma and Items shown with a ✜ denote a Phase 1/2 trial. Items shown with a † denote a Phase 2/3 trial. Items shown with ▼ denote the INN in the US is cemiplimab-rwlc. Items shown with ♠ denote opt in rights product for which rights have not been exercised yet. Items shown with ❒ denote identification of out-licensing partner ongoing. Items shown with ♣ denotes Pfizer product.

Product Candidate	Technology	Phase I	Phase II	Phase III	Current Phase
Rare Diseases
Eliglustat Gaucher disease Type 1, ERT switch Pediatric	small molecule				PHASE III
Avalglucosidase alfa Pompe disease	protein-based therapy			$Isatuximab 3L Relapsed Refractory Multiple Myeloma (ICARIA)- Phase III - 100% of progress$	PHASE III
Venglustat GM2 Gangliosidosis	small molecule				PHASE III
Venglustat Autosomal Dominant Polycystic Kidney Disease (ADPKD)	small molecule				PHASE III
Olipudase Alfa† Acid Sphingomyelinase Deficiency (ASMD) - Adult+Pediatric	protein-based therapy				PHASE II
Venglustat Fabry disease	small molecule				PHASE II
Venglustat Gaucher disease Type 3	small molecule				PHASE II
SAR339375 Alport Syndrome	miRNA-21				PHASE II
SAR442501 Achondroplasia	FGFR3 antibody				PHASE I
Rare Blood Disorders
Sutimlimab Cold agglutinin disease	mAb to C1s			$Isatuximab 3L Relapsed Refractory Multiple Myeloma (ICARIA)- Phase III - 100% of progress$	PHASE III
Fitusiran Hemophilia A & B	RNAi				PHASE III
Fitusiran Hemophilia A & B - pediatric	RNAi				PHASE III
efanesoctocog alfa (BIVV001)♢ Hemophilia A	Extended Half Life Factor				PHASE III
ST400❅✜ Beta Thalassemia	ZFN gene editing				PHASE I/II
BIVV003❅✜ Sickle Cell Disease	ZFN gene editing				PHASE I/II
Sutimlimab Immune Thrombocytopenic Purpura	mAb to C1s				PHASE I
BIVV020 Cold agglutinin disease	mAb to C1s				PHASE I
Neurology
Teriflunomide Relapsing Multiple Sclerosis - Pediatric	small molecule			$Isatuximab 3L Relapsed Refractory Multiple Myeloma (ICARIA)- Phase III - 100% of progress$	PHASE III
Tolebrutinib Relapsing Multiple Sclerosis (RMS)	BTK inhibitor				PHASE III
Tolebrutinib Primary Progressive Multiple Sclerosis (PPMS)	BTK inhibitor				PHASE III
Tolebrutinib Secondary Progressive Multiple Sclerosis (SPMS)	BTK inhibitor				PHASE III
SAR441344⚜ Multiple Sclerosis	mAb				PHASE I
SAR43820 Amyotropic lateral sclerosis	RIPK1 inhibitor				PHASE I
Oncology
Isatuximab 2L Relapsed Refractory Multiple Myeloma (IKEMA)	mAb	$Isatuximab Relapsed Refractory Multiple Myeloma - Phase I - 100% of progress$	$Isatuximab Relapsed Refractory Multiple Myeloma - Phase II - 100% of progress$	$Isatuximab 3L Relapsed Refractory Multiple Myeloma (ICARIA)- Phase III - 100% of progress$	PHASE III
Isatuximab 1L Newly Diagnosed Multiple Myeloma Transplant Ineligible (IMROZ)	mAb				PHASE III
Isatuximab Newly Diagnosed Multiple Myeloma Transplant Eligible (GMMG)	mAb				PHASE III
Isatuximab Smoldering Multiple Myeloma (ITHICA)	mAb				PHASE III
Cemiplimab^▼ 2L Cervical Cancer	mAb				PHASE III
Cemiplimab^▼ Adjuvant in Cutaneous Squamous Cell Carcinoma (CSCC)	mAb				PHASE III
Cemiplimab^▼ + Chemotherapy 1L Non-small Cell Lung Cancer	mAb				PHASE III
Tusamitamab ravtansine 2-3L Non-Small Cell Lung Cancer	ADC				PHASE III
Amcenestrant + palbociclib♣ Metastatic Breast Cancer	small molecule				PHASE III
Tusamitamab ravtansine + ramucirumab 2-3L Non-Small Cell Lung Cancer	mAb	$isatuximab + Cemiplimab^ Relapsed Refractory Multiple Myeloma - Phase I - 100% of progress$	$isatuximab + Cemiplimab^ Relapsed Refractory Multiple Myeloma - Phase II - 50% of progress$	$isatuximab + Cemiplimab^ Relapsed Refractory Multiple Myeloma - Phase III - 0% of progress$	PHASE II
Isatuximab + atezolizumab♕ Metastatic Colorectal Cancer	mAb				PHASE II
Isatuximab▼ Patients Awaiting Kidney Transplant	mAb				PHASE II
Isatuximab 1-2L Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) - Pediatrics	mAb				PHASE II
Amcenestrant Early Breast Cancer	small molecule				PHASE II
Amcenestrant 2-3L Metastatic Breast Cancer	small molecule				PHASE I
REGN5458^♠ Relapsed Refractory Multiple Myeloma	bi-specific mAb	$REGN5458 Relapsed Refractory Multiple Myeloma - Phase I - 50% of progress$	$REGN5458 Relapsed Refractory Multiple Myeloma - Phase II - 0% of progress$	$REGN5458 Relapsed Refractory Multiple Myeloma - Phase III - 0% of progress$	PHASE I
REGN4018^♠ Ovarian Cancer	bi-specific mAb				PHASE I
SAR442720✿ Solid Tumors	small molecule				PHASE I
SAR440234 Leukemia	multi-specific mAb				PHASE I
SAR441000⚙ Solid Tumors	cytokine mRNA				PHASE I
SAR439459^ Advanced Solid Tumors	mAb				PHASE I
cemiplimab +REGN4018^♠ Ovarian Cancer	mAb				PHASE I
SAR442085 Multiple Myeloma	mAb				PHASE I
SAR442257 Multiple Myeloma / Non-Hodgkin's Lymphoma	tri-specific mAb				PHASE I
REGN5459♠ Relapsed Refractory Multiple Myeloma	bi-specific mAb	$REGN5459 Relapsed Refractory Multiple Myeloma - Phase I - 25% of progress$	$REGN5459 Relapsed Refractory Multiple Myeloma - Phase II - 0% of progress$	$REGN5459 Relapsed Refractory Multiple Myeloma - Phase III - 0% of progress$	PHASE I
SAR444245 (THOR-707) Solid Tumors	non-alpha IL-2				PHASE I
Immunology
Dupilumab^ Atopic Dermatitis (6 mo - 5 years old)	mAb				PHASE III
Dupilumab^ Asthma (6-11 years old)	mAb				PHASE III
Dupilumab^ Eosinophilic Esophagitis	mAb				PHASE III
Dupilumab^ Bullous pemphigoid	mAb				PHASE III
Dupilumab^ Prurigo nodularis	mAb				PHASE III
Dupilumab^ Chronic spontaneous urticaria	mAb				PHASE III
Rilzabrutinib Pemphigus	BTK inhibitor				PHASE III
Dupilumab^ COPD	mAb				PHASE III
Dupilumab^ Cold Urticaria (CindU-Cold)	mAb				PHASE III
Dupilumab^ Chronic Sinusitis without Nasal Polyps	mAb				PHASE III
Dupilumab^ Allergic Fungal Rhinosinusitis	mAb				PHASE III
Rilzabrutinib Immune Thrombocytopenia	BTK inhibitor				PHASE III
Itepekimab^ COPD	mAb				PHASE III
Dupilumab^ Grass Pollen Allergy	mAb				PHASE II
Dupilumab^ Peanut Allergy	mAb				PHASE II
Rilzabrutinib IgG4-related disease	BTK inhibitor				PHASE II
Sarilumab^ Polyarticular Juvenile Idiopathic Arthritis	mAb				PHASE II
Sarilumab^ Systemic Juvenile Arthritis	mAb				PHASE II
SAR441169➤ Psoriasis	small molecule				PHASE I
SAR441236 HIV	mAb				PHASE I
SAR443122✪ Inflammatory Indications	RIPK1 inhibitor				PHASE I
SAR444727 Immune mediated diseases	BTK inhibitor				PHASE I

The agents mentioned here are investigational and have not been approved by the US Food and Drug Administration (FDA) or any other regulatory agency worldwide for the uses under investigation.

As of February 5, 2021.

Sanofi’s R&D portfolio

The full Sanofi research pipeline focuses on finding innovative solutions to a variety of major public health challenges.

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Specialty Care R&D Pipeline

Specialty Care R&D Pipeline

Rare Diseases

Rare Blood Disorders

Neurology

Oncology

Immunology

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