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Sanofi

Total Trials
15
Recruiting
15
Phases
Phase 1, Phase 2, Phase 3, Phase 1, Phase 2

Sanofi is a French multinational pharmaceutical company and one of the world's five largest by revenue, with a global clinical development operation spanning immunology, oncology, rare diseases and blood disorders, vaccines, and consumer healthcare. Sanofi has a long legacy in diabetes (insulin glargine/Lantus was the world's best-selling insulin for over a decade), cardiovascular disease (alirocumab/Praluent for LDL reduction), and multiple sclerosis (teriflunomide/Aubagio, alemtuzumab/Lemtrada).

Sanofi's research transformation in recent years has concentrated investment heavily on immunology and inflammation — particularly the dupilumab program co-developed with Regeneron — and on rare blood disorders and oncology. In oncology, cemiplimab (Libtayo), a PD-1 inhibitor, is a key asset with multiple active indications. Sanofi acquired Translate Bio (mRNA technology) and Kadmon (itepekimab for COPD and pediatric asthma) and has early programs in mRNA therapeutics for cancer and infectious disease. The Rare Diseases unit — historically Genzyme — is a global leader in enzyme replacement therapy for lysosomal storage disorders.

Sanofi Pasteur, the company's vaccine division, is one of the world's largest vaccine producers, with approved vaccines for influenza, dengue, meningococcal disease, typhoid, rabies, and others, and active clinical trials in RSV, mRNA influenza, and pandemic preparedness. Sanofi conducts clinical research through partnerships with NIH, BARDA, CEPI, and academic institutions globally, and runs one of the most active Phase 3 trial programs in the rare disease space.

Frequently Asked Questions — Sanofi

What rare disease trials does Sanofi's Genzyme division sponsor?
Sanofi Genzyme, acquired in 2011, is the rare disease and specialty care unit. Genzyme pioneered enzyme replacement therapy (ERT) for lysosomal storage disorders and continues to run active trials in Gaucher disease (eliglustat, new formulations), Fabry disease (migalastat, pegunigalsidase alfa), Pompe disease (avalglucosidase alfa and next-generation ERTs), and mucopolysaccharidoses. Beyond enzyme replacement, Genzyme has programs in multiple sclerosis, PKD (polycystic kidney disease), and rare neurological conditions. The Genzyme rare disease research network spans centers across North America, Europe, and Latin America, with many trials enrolling patients in pediatric hospitals and metabolic disease centers.
What immunology conditions does Sanofi study in clinical trials?
Sanofi's immunology pipeline is anchored by the dupilumab program (co-developed with Regeneron), covering atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, COPD, and ongoing trials in additional type 2 inflammatory conditions. Beyond dupilumab, Sanofi has itepekimab (Dupixent anti-IL-33 sibling molecule) in late-stage trials for COPD and pediatric asthma, amlitelimab (anti-OX40L) in Phase 3 trials for atopic dermatitis and other inflammatory diseases, and frexalimab (anti-CD40L) in Phase 2 for multiple sclerosis. The breadth of Sanofi's immunology trial activity reflects a strategic decision to become a leading company in type 2 and B-cell-mediated inflammatory diseases.
What COVID-19 and respiratory virus trials does Sanofi run?
Sanofi partnered with GlaxoSmithKline to develop a COVID-19 recombinant protein subunit vaccine (VAT00002/Vidprevtyn Beta) that received EMA authorization. Sanofi Pasteur conducts active trials on quadrivalent influenza vaccines (including high-dose and adjuvanted formulations for older adults), RSV (respiratory syncytial virus) vaccine candidates in older adults and maternal programs, and mRNA-based influenza vaccine candidates leveraging the Translate Bio platform. The company also has active trials in dengue — Dengvaxia outcomes and safety surveillance studies — and investigational vaccines for other flaviviruses.

Clinical Trials by Sanofi

NCT07215234 Phase 1, Phase 2
Recruiting

A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Geographic Atrophy
NCT07190196 Phase 3
Recruiting

A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease

Immunoglobulin G4 Related Disease
NCT05584670 Phase 1, Phase 2
Recruiting

A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

Solid Tumor
NCT07380711
Recruiting

Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes

Chronic Obstructive Pulmonary Disease COPD
NCT06630806 Phase 1
Recruiting

A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma

Plasma Cell Myeloma Refractory
NCT06191315 Phase 3
Recruiting

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Wheezing
NCT07200206
Recruiting

A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea

Respiratory Syncytial Virus
NCT06684314
Recruiting

A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan

Hemophilia A
NCT06891417 Phase 1, Phase 2
Recruiting

Phase 1/2 Study of Chlamydia Trachomatis mRNA Vaccine in Adults Aged 18 to 29 Years

Chlamydia Trachomatis Immunization
NCT06958536 Phase 2
Recruiting

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Crohn's Disease
NCT07516418 Phase 1
Recruiting

Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age

Respiratory Syncytial Virus (RSV)
NCT07170917 Phase 2
Recruiting

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa
NCT07190209 Phase 3
Recruiting

Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype

Chronic Obstructive Pulmonary Disease
NCT07547436 Phase 2
Recruiting

A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age With Non-Cystic Fibrosis Bronchiectasis

Non-cystic Fibrosis Bronchiectasis
NCT06791291 Phase 2
Recruiting

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes

Type 1 Diabetes Mellitus
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