satralizumab

Phase 3

Roche Holding AG (RHHBY)

00%

What is LOA?

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

Q1 '27

RHHBYPhase 3$316.4B

Satralizumab Phase 3 Est. Readout

satralizumab• Neuromyelitis Optica Spectrum Disorder8

Q1 2027~QConfirmed

CT.gov

00%

4mo

RHHBYPDUFA$316.4B

Phase 3✅Approved

FDA PDUFA Date Enspryng (satralizumab) (priority review)

satralizumab• Neuromyelitis Optica Spectrum Disorder

Jan 10Confirmed

Source

Dec '26

RHHBYPhase 3$316.4B

Satralizumab Phase 3 Est. Readout

satralizumab• Neuromyelitis Optica Spectrum Disorder122

Dec 2026~Confirmed

CT.gov

00%

Development History

Aug '26

RHHBYPhase 2$316.4B

Satralizumab Phase 2 Est. Readout

satralizumab• Neuromyelitis Optica Spectrum Disorder30

Aug 2026~ConfirmedSTALE

CT.gov

00%

Competitive Landscape

0 competitors in Neuromyelitis Optica Spectrum Disorder

View Full Landscape

Drug Information

Target Indication

Neuromyelitis Optica Spectrum Disorder

Clinical Trial

NCT04660539

Last updated: 1/9/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA6/24/2021

Enspryng

Satralizumab (Enspryng) is indicated as a monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients from 12 years of age who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.

Orphan

View on EMA

Drug Science

Mechanism of action & safety profile

Developer

RHHBY

Roche Holding AG

Biotechnology•Europe•NYSE

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