Asset profile

Litifilimab

Monoclonal antibody

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Phase 3underway

Evidence outlook · registrational

Systemic Lupus Erythematosus: registrational readout pending

Entered Phase 3 on reliable signal mid-stage evidence. Registrational readout expected around 2032-05-03.

LILAC (NCT02847598): This was a randomized, double-blind (participant and investigator), placebo-controlled trial with 264 enrolled participants and hard clinical primary endpoints (28-joint active joint count and CLASI-A skin activity score). The primary comparisons reached statistical significance in the favorable direction: Part A 450 mg vs placebo active-joint LS mean difference -3.4 (95% CI -6.7 to -0.2, p=0.037), and Part B CLASI-A LS mean differences -24.29 to -33.42 (p=0.015 to <0.001 across doses).

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Competitive landscape

54 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 54 same-indication; 7 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Litifilimab: this drugPhase 3Monoclonal antibodyBDCA2 / CD303 (blood dendritic cell antigen 2), BDCA2 (CLEC4C)
AnifrolumabApprovedMonoclonal antibodyType I interferon receptor, Type I interferon receptor subunit 1 (IFNAR1)
Avacopan (Tavneos)ApprovedSmall moleculeComplement C5a receptor 1 (C5aR1/CD88)
Belimumab (GSK1550188)ApprovedMonoclonal antibodyBAFF / BLyS (B-lymphocyte stimulator), BAFF (BLyS)
Deucravacitinib (Sotyktu)ApprovedSmall moleculeTYK2
Repository Corticotropin (Acthar Gel)ApprovedPeptideMelanocortin receptors (primarily MC2R on the adrenal cortex), Melanocortin 2 receptor (MC2R) (agonist)
Upadacitinib (Rinvoq)ApprovedSmall moleculeJAK, JAK1
Voclosporin (Lupkynis)ApprovedSmall moleculeCalcineurin, Cyclophilin A (leading to calcineurin inhibition)
APG-2575(Lisaftoclax )Phase 3Small moleculeBCL-2
AZD0120Phase 3Cell therapyBCMA / CD19
BlinatumomabPhase 3Multispecific antibodyCD19 x CD3
Descartes-08Phase 3Cell therapy—
DivozilimabPhase 3Monoclonal antibodyCD20
EnvudeucitinibPhase 3Small moleculeTYK2
FrexalimabPhase 3Monoclonal antibodyCD40 ligand (CD40L / CD154)
InebilizumabPhase 3Monoclonal antibodyCD19

…and 39 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(3 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
October 2026 (1)
Phase 2/3Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus ErythematosusActive not recruiting
Est. primary completion 2026-10-20 · NCT05531565 · CT.gov ↗
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2029 (1)
June 2029 (1)
Phase 3Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus ErythematosusEnrolling by invitation
Est. primary completion 2029-06-26 · NCT06044337 · CT.gov ↗
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2032 (1)
May 2032 (1)
Phase 3Systemic Lupus ErythematosusEnrolling by invitation
Est. primary completion 2032-05-03 · NCT05352919 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (4)
Phase 2/3 (1)
Phase 2 (1)
Phase 1 (3)