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 23, 2026) 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
Nexviazyme – IOPD
H1 2026
venglustat - GD3
(US, EU, JP)
Tzield – T1D, S3 (US)
Dupixent – CSU children (US)
tolebrutinib – SPMS (EU)
Sarclisa – SC (EU)
amlitelimab – AD
(remaining data)
Dupixent – LSC
H2 2026
Dupixent – LSC (US)
Dupixent – BP (EU)
amlitelimab – AD
Dupixent – CSU children (JP)
Nexviazyme – IOPD (US)
Wayrilz – ITP (JP)
efdoralprin alfa – AATD (US)
Sarclisa – SC (US, JP)
SP0087 – rabies (US)
SP0087 – rabies (EU)
frexalimab – RMS
brivekimig – HS
riliprubart – CIDP
itepekimab – CRSwNP
SP0202 – PCV
fitusiran – haemophilia A/B
SP0218 – yellow fever
2027
fitusiran – haemophilia A/B
(EU, JP)
riliprubart – CIDP (US, EU)
frexalimab – RMS (US, EU)
SP0218 – yellow fever (EU)
Fluzone HD – flu 50y+ (US, EU)
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.