Specialty Care Pipeline
The agents and uses mentioned below are investigational and have not been approved by the US Food and Drug Administration (FDA) for the uses under investigation. No conclusions regarding safety and efficacy should be drawn for such agents and uses.
The Sanofi pipeline includes new molecular entities as well as potential new indications for existing products. The graphic below summarizes the expected (as of April 25, 2025) global submission timeline for each product and indication.
As of April 25, 2025
Phase 3 Readout and Expected US Regulatory Submission and Decision Timeline1
These agents and uses are not yet approved by the US Food and Drug Administration and thus have not been determined to be safe and effective
SP0087
Rabies vaccine
H1 2025
Sarclisa
SC formulation
Dupixenta
BP
Cerezyme
GD3
MenQuadfi®
Meningitis (6 weeks+)
itepekimabaa
COPD
Fluzone HD
Flu (50 years+)
tolebrutinib
PPMS
H2 2025
itepekimaba
COPD
rilzabrutinib
ITP
SP0087
Rabies vaccine
tolebrutinib
nrSPMS
amlitelimab
AD
Nexviazyme
IOPD
riliprubart
CIDP
venglustat
Fabry disease
SP0218
Yellow fever
venglustat
GD3
SP0125
RSV (toddlers)
2026
SAR447537
AATD
Nexviazyme
IOPD
venglustat
GD3
riliprubart
CIDP
venglustat
Fabry disease
tolebrutinib
PPMS
Fluzone HD
Flu (50 years+)
Immuno-inflammation
Oncology
Neurology
Rare diseases
Rare blood disorders
Vaccines
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Phase 3 read out
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Regulatory decision (solid)
Regulatory decision (texture)
aDeveloped in collaboration with Regeneron.1
AD, atopic dermatitis; AATD, alpha-1 antitrypsine deficiency; BP, Bullous pemphigoid; CIDP, Chronic inflammatory demyelinating polyneuropathy; COPD, chronic obstructive pulmonary disease; GD3, Gaucher disease type 3; H1, First half; H2, second half; IOPD, infante-onset Pompe disease; ITP, immune thrombocytopenia; PPMS, primary progressive multiple sclerosis; nrSPMS, non-relapsing secondary progressive multiple sclerosis; RSV, respiratory syncytial virus; SC, subcutaneous; US, United States.