Last reviewed 2026-04-20 · How we verify

TYRUKO (NATALIZUMAB-SZTN)

TYRUKO (generic name: NATALIZUMAB-SZTN) is a Integrin Receptor Antagonist [EPC] drug developed by SANDOZ INC. It is currently FDA-approved for Multiple Sclerosis, Crohn's Disease.

Natalizumab-sztn (Tyruko), marketed by Sandoz Inc., is a biosimilar approved for the treatment of multiple sclerosis, positioning it in a competitive but well-established therapeutic area. A key strength of Tyruko is its mechanism of action, which aligns with the original drug's efficacy and safety profile, potentially offering cost savings to patients and payers. The primary risk facing Tyruko is the key composition patent expiry in 2028, which could lead to increased competition from other biosimilars or generics.

At a glance

Approved indications

• Multiple Sclerosis
• Crohn's Disease

Boxed warnings

• WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYRUKO [see Warnings and Precautions ( 5.1 )] . - Healthcare professionals should monitor patients on TYRUKO for any new sign or symptom that may be suggestive of PML. TYRUKO dosing should be withheld immediately at the first sign or symptom suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance imaging (MRI) scan of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . - Because of the risk of PML, TYRUKO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TYRUKO REMS Program [see Warnings and Precautions ( 5.2 )] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning • Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability ( 5.1 ). • Risk factors for the development of PML include the presence of anti-JCV antibodies, duration of therapy, and prior use of immunosuppressants. These factors should be considered in the context of expected benefit when initiating and continuing treatment with TYRUKO ( 5.1 ). • Monitor patients, and withhold TYRUKO immediately at the first sign or symptom suggestive of PML ( 4 , 5.1 ). • Because of the risk of PML, TYRUKO is available only through a restricted distribution program called the TYRUKO REMS Program ( 5.1 , 5.2 ).

Common side effects

• Headache
• Fatigue
• Arthralgia
• Depression
• Urinary tract infection
• Lower respiratory tract infection
• Gastroenteritis
• Vaginitis
• Abdominal discomfort
• Diarrhea NOS
• Rash
• Tooth infections

Serious adverse events

• Infections
• Acute hypersensitivity reactions
• Depression with suicidal ideation or attempt
• Cholelithiasis
• Appendicitis
• Anaphylaxis/anaphylactoid reaction
• Pneumonia
• Urticaria
• Exacerbation of Crohn's disease

Key clinical trials

• AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (Phase 2)
• A Pragmatic Trial to Evaluate the Intermediate-term Effects of Early, Aggressive Versus Escalation Therapy in People With Multiple Sclerosis (NA)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• TYRUKO CI brief — competitive landscape report
• TYRUKO updates RSS · CI watch RSS
• SANDOZ INC portfolio CI

Frequently asked questions about TYRUKO

Related

• Drug class: All Integrin Receptor Antagonist [EPC] drugs
• Manufacturer: SANDOZ INC — full pipeline
• Therapeutic area: All drugs in Other
• Indication: Drugs for Multiple Sclerosis
• Indication: Drugs for Crohn's Disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing