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BIIB059 (litifilimab)
Litifilimab is a monoclonal antibody that blocks B7-related protein 1 (BR1), an immune checkpoint molecule that suppresses T cell activation.
Litifilimab is a monoclonal antibody that blocks B7-related protein 1 (BR1), an immune checkpoint molecule that suppresses T cell activation. Used for Systemic lupus erythematosus (SLE).
At a glance
| Generic name | BIIB059 (litifilimab) |
|---|---|
| Also known as | litifilimab |
| Sponsor | Biogen |
| Drug class | Immune checkpoint inhibitor (B7-related protein 1 antagonist) |
| Target | BR1 (B7-related protein 1) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By inhibiting BR1, litifilimab removes an inhibitory signal on T cells, thereby enhancing immune responses against self-antigens in autoimmune diseases. This mechanism is designed to restore immune tolerance or shift the balance of immune regulation in conditions where BR1-mediated suppression is pathologically dominant, such as systemic lupus erythematosus (SLE).
Approved indications
- Systemic lupus erythematosus (SLE)
Common side effects
- Infection
- Infusion reactions
- Nasopharyngitis
Key clinical trials
- A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways (PHASE1)
- A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (PHASE2, PHASE3)
- A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (PHASE3)
- An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (PHASE3)
- A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (PHASE3)
- A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus (PHASE3)
- Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE) (PHASE2)
- Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 (Litifilimab) in Healthy Volunteers and Participants With Systemic Lupus Erythematosus (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BIIB059 (litifilimab) CI brief — competitive landscape report
- BIIB059 (litifilimab) updates RSS · CI watch RSS
- Biogen portfolio CI