TYSABRI (natalizumab)
Tysabri (natalizumab) is an integrin receptor antagonist indicated as monotherapy for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is also used to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease who show evidence of inflammation and have failed or cannot tolerate conventional therapies and TNF-α inhibitors. Because the drug increases the risk of progressive multifocal leukoencephalopathy (PML), physicians must determine if the expected benefits outweigh this risk. In the treatment of Crohn's disease, Tysabri must not be used in combination with other immunosuppressants or TNF-α inhibitors.
How TYSABRI Works
Natalizumab binds to the α4-subunit of α4β1 and α4β7 integrins expressed on the surface of most leukocytes, excluding neutrophils. This binding inhibits the adhesion of leukocytes to their receptors, such as VCAM-1 on the vascular endothelium and MAdCAM-1 in the gastrointestinal tract. By disrupting these molecular interactions, the drug prevents inflammatory cells from migrating across the endothelium into parenchymal tissue. In multiple sclerosis, this mechanism is believed to block activated inflammatory cells from crossing the blood-brain barrier, thereby reducing inflammatory activity in the brain.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-11-23
- Patent Cliff
- 2027
- Revenue
- $398M (Q4-2025)
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
TYSABRI Approval History
What TYSABRI Treats
2 indicationsTYSABRI is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease)
- Moderately to severely active Crohn's disease
TYSABRI Boxed Warning
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases 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 TYSABRI [ see Warnings...
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases 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 TYSABRI [ see Warnings and Precautions ( 5.1 ) ]. Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI 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, TYSABRI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the TOUCH ® Prescribing Program [ see Warnings and Precautions ( 5.2 ) ]. WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning TYSABRI increases 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 TYSABRI ( 5.1 ) Monitor patients, and withhold TYSABRI immediately at the first sign or symptom suggestive of PML ( 4 , 5.1 ) Because of the risk of PML, TYSABRI is available only through a restricted distributi
TYSABRI Biosimilars
1 FDA-approvedThese 1 alternatives require prescriber approval to substitute for TYSABRI.
What are biosimilars? Lower-cost alternatives to TYSABRI with no clinically meaningful differences.
Auto-substitute OK = FDA "interchangeable" designation — pharmacist can switch without calling the doctor.
TYSABRI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TYSABRI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TYSABRI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TYSABRI
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05265728 results posted | 101MS330 | Ph 3 | terminated | A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Natalizumab (BG00002) Administered Subcutaneously to Japanese Participants With Relapsing-Remitting Multiple Sclerosis |
| NCT05618301 | 202302190 | Ph 1 | completed | Motixafortide and Natalizumab to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD) |
| NCT03046251 NAPPREMS results posted | US-TYS-14-10720 | Ph 4 | completed | Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis |
| NCT03811886 | CASE1718 | Ph 1, Ph 2 | withdrawn | Natalizumab in Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma |
| NCT05532163 | DE-TYS-12072 2022-001820-14 | Ph 4 | terminated | A Study to Investigate the Radiological Onset of Action After Treatment Initiation With Subcutaneous (SC) Natalizumab in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) |
| NCT03689972 results posted | 101MS329 2018-002145-11 | Ph 3 | completed | A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration |
| NCT02142192 SIMPLIFY | 101MS207 2014-000917-30 | Ph 2 | terminated | Natalizumab Subcutaneous Immunogenicity and Safety Study |
| NCT03093064 IRIS | 208083 | Ph 1 | completed | Inflammatory Response In Schizophrenia |
| NCT02133924 results posted | GCO 15-1624 | Ph 2 | completed | Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host Disease |
| NCT03283371 OPUS results posted | 101EP201 2017-001995-45 | Ph 2 | completed | Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy |
| NCT02176031 results posted | 14-140 | Ph 2 | completed | Phase II Trial of Natalizumab + Prednisone for Initial Therapy of Acute GI GVHD |
| NCT03516526 PDNMS | NL56584.029.16 | Ph 4 | completed | Towards Personalized Dosing of Natalizumab in Multiple Sclerosis |
| NCT02730455 ACTION2 results posted | 101SK202 2015-004783-11 | Ph 2 | completed | Safety and Efficacy of Intravenous Natalizumab in Acute Ischemic Stroke |
| NCT01416181 ASCEND in SPMS results posted | 101MS326 2010-021978-11 | Ph 3 | terminated | A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple Sclerosis |
| NCT02342704 REVEAL results posted | 101MS408 2013-004622-29 | Ph 4 | terminated | Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants |
| NCT02241785 ESCALATE results posted | 101MS409 2013-005586-39 | Ph 4 | terminated | Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other Therapies |
| NCT01955707 ACTION results posted | 101SK201 EUDRA CT NO: 2013-001514-15 | Ph 2 | completed | Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke |
| NCT01884935 | 101MS328 2012-005082-13 | Ph 1 | completed | PK and PD Study of Natalizumab in Pediatric Subjects With RRMS |
| NCT00801125 | ELN51-309-503 CD FACTOR | Ph 4 | withdrawn | Study of Tysabri (Natalizumab) in Patients Who Failed Anti-TNF-α Therapy |
| NCT01416155 results posted | 101MS204 | Ph 2 | completed | Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis |
| NCT00744679 | 101MS406 | Ph 4 | completed | A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State |
| NCT01144052 results posted | EOC.NC.09.01 | Ph 4 | completed | Natalizumab De-escalation With Interferon Beta-1b |
| NCT01071083 RESTORE results posted | 101MS205 | Ph 2 | completed | Treatment Interruption of Natalizumab |
| NCT01077466 NAPMS | NAPMS version 3.4 | Ph 2 | completed | Natalizumab Treatment of Progressive Multiple Sclerosis |
| NCT00942214 Bionat2 | 0811001 | Ph 4 | completed | Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TYSABRI FDA Label Details
Indications & Usage
FDA Label (PDF)TYSABRI is indicated for the treatment of Relapsing forms of multiple sclerosis (clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease); Moderately to severely active Crohn's disease.
WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY TYSABRI increases 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...
Pro Intelligence Preview
Deep insights for TYSABRI
Revenue Insights
- • Q4-2025: $398M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • Generic/biosimilar risk
Trial Analysis
- • 26 total trials
- • Stage: Declining
Competitive Landscape
- • 3 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment