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 January 30, 2025) global submission timeline for each product and indication.

Expected Global Submission Timeline (as of January 30, 2025)

H1 2025

Sarclisa
SC formulation

Dupixenta
CSU

Cerezyme
GD3

fitusiran
Hemophilia A/B

MenQuadfi®
Meningitis (6 weeks+)

H2 2025

itepekimabaa
COPD

Dupixentaa
BP

SP0087
Rabies vaccine

rilzabrutinib
ITP

tolebrutinib
SPMS

2026

SAR447537    
AATD

riliprubart    
CIDP

venglustat
GD3
Fabry

tolebrutinib    
PPMS
 

Nexviazyme    
IOPD

Fluzone HD    
Flu

SP0218
Yellow Fever

Immuno-inflammation
Oncology
Neurology

Rare diseases
Rare blood disorders
Vaccines

Regulatory submission (solid)
Regulatory decision (texture)

aDeveloped in collaboration with Regeneron.
1 AATD, Alpha-1-antitrypsine deficiency; BP, Bullous pemphigoid; CIDP, Chronic inflammatory demyelinating polyneuropathy; COPD, chronic obstructive pulmonary disease; CSU, chronic spontaneous urticaria; GD3, Gaucher disease type 3; H1, First half; H2, second half; IOPD, infante-onset Pompe disease, ITP, immune thrombocytopenia; MM, Multiple myeloma; PPMS, primary progressive multiple sclerosis; SPMS, secondary progressive multiple sclerosis; R/R, Relapsed/refractory; SC, subcutaneous; US, United States
1. Sanofi. https://www.sanofi.com/en/investors/financial-results-and-events/financial-results/q4-results-2024. Accessed January 30, 2025.