Litifilimab

Phase 3Monoclonal antibody

Biogen

Litifilimab is one of 72 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Systemic Lupus Erythematosus (SLE)Enrolling by invitation

Subacute Cutaneous Lupus ErythematosusActive, not recruiting

Cutaneous Lupus ErythematosusActive, not recruiting

Systemic Lupus ErythematosusPhase 3

Active, not recruiting

Systemic Lupus Erythematosus (SLE)Phase 3

Enrolling by invitation

Subacute Cutaneous Lupus ErythematosusPreclinical

Active, not recruiting

Cutaneous Lupus ErythematosusPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

328 competitors in Systemic Lupus Erythematosus

#DrugCompanyPhaseTrials

Eptanemab

UCB

Phase 3

12 2

Rituxan

Roche

Phase 3

9 3

Medrol

Pfizer

Phase 3

5 4

Olumiant

Eli Lilly

Phase 3

4 5

Rinvoq

AbbVie

Phase 3

3 6

Stelara

Johnson & Johnson

Phase 3

3 7

Gazyva

Roche

Phase 3

2 8

Ocrevus

Roche

Phase 3

2 9

Cytoxan

BBaxter Healthcare Corporation

Rayos

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Systemic Lupus Erythematosus

NCT04895241

Phase 3Active, not recruiting

Systemic Lupus Erythematosus

NCT04961567

Q4 2027

PreclinicalActive, not recruiting

Subacute Cutaneous Lupus Erythematosus

NCT05531565

Clinical

Trials by Indication[1]

Systemic Lupus Erythematosus2 trials

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

Active, not recruiting· Biogen logo

Biogen·Phase 3·NCT04895241·548 enrolled

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

Active, not recruiting· Biogen logo

Biogen·Phase 3·NCT04961567·562 enrolled

Skin1 trial

A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways

Active, not recruiting· Biogen logo

Biogen·Phase 1·NCT06741657·404 enrolled

Systemic Lupus Erythematosus (SLE)1 trial

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants With Active Systemic Lupus Erythematosus

Enrolling by invitation· Biogen logo

Biogen·Phase 3·NCT05352919·864 enrolled

Subacute Cutaneous Lupus Erythematosus1 trial

A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

Active, not recruiting· Biogen logo

Biogen·Preclinical·NCT05531565·450 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Litifilimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Litifilimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Litifilimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Biogen

Litifilimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Trials by Indication[1]

Systemic Lupus Erythematosus2 trials

Skin1 trial

Systemic Lupus Erythematosus (SLE)1 trial

Subacute Cutaneous Lupus Erythematosus1 trial

References

Drug Info

Quick Facts

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