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 June 30, 2025) global submission timeline for each product and indication.
As of June 30, 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
amlitelimab
AD (first data)
Fluzone HD
flu (50y +)
tolebrutinib
PPMS
H2 2025
itepekimaba
COPD
rilzabrutinib
ITP
SP0087
Rabies vaccine
tolebrutinib
nrSPMS
Sarclisa
SC formulation
venglustat
Fabry disease
venglustat
GD3
Nexviazyme
IOPD
SP0125
RSV toddlers
amlitelimab
AD (full data)
H1 2026
venglustat
GD3
Cerezyme
GD3
venglustat
Fabry disease
Fluzone HD
Flu (50 years+)
tolebrutinib
PPMS
riliprubart
CIDP
SP0218
Yellow fever
H2 2026
Nexviazyme
IOPD
efdoralprin alfa
AATD
Immuno-inflammation
Oncology
Neurology
Rare diseases
Rare blood disorders
Vaccines
%20(1)%20(1).png)
Phase 3 read out
.png)
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.