Asset profile

Telitacicept

Protein / enzyme therapeutic

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Reliablesignal

Evidence outlook · lead readout

NCT04082416 · Systemic Lupus Erythematosus

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT04082416: This randomised, quadruple-blind, placebo-controlled trial in 335 patients with systemic lupus erythematosus reported a modified SRI-4 response of 67.1% with telitacicept against 32.7% with placebo at week 52 (P<0.001), measured on a validated composite of lupus disease activity.

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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
Telitacicept: this drugPhase 3Protein / enzyme therapeuticBAFF / APRIL
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

(20 total)

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

2026 (7)
October 2026 (3)
Phase 3Nephrotic Syndrome in Children, TelitaciceptRecruiting
Est. primary completion 2026-10-24 · NCT06125405 · CT.gov ↗
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Phase 4Systemic Lupus ErythematosusRecruiting
Est. primary completion 2026-10-25 · NCT07077486 · CT.gov ↗
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Phase 4Systemic Lupus ErythematosusActive not recruiting
Est. primary completion 2026-10-31 · NCT06677801 · CT.gov ↗
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December 2026 (4)
Early phase / not applicableIgA Nephropathy (IgAN), Kidney Diseases, Telitacicept, GlucocorticoidRecruiting
Est. primary completion 2026-12 · NCT06654596 · CT.gov ↗
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Phase 2/3Inflammatory MyopathyNot yet recruiting
Est. primary completion 2026-12-30 · NCT07355257 · CT.gov ↗
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Phase 3Myasthenia Gravis, OcularRecruiting
Est. primary completion 2026-12-31 · NCT07249632 · CT.gov ↗
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Phase 4ANCA Associated VasculitisRecruiting
Est. primary completion 2026-12-31 · NCT05962840 · CT.gov ↗
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2027 (9)
January 2027 (1)
Phase 2Diffuse Cutaneous Systemic SclerosisRecruiting
Est. primary completion 2027-01-06 · NCT06375005 · CT.gov ↗
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May 2027 (2)
Phase 3Generalized Myasthenia GravisRecruiting
Est. primary completion 2027-05 · NCT06456580 · CT.gov ↗
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Phase 2Proliferative Glomerulonephritis With Monoclonal Immunoglobulin DepositsActive not recruiting
Est. primary completion 2027-05-29 · NCT07111338 · CT.gov ↗
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June 2027 (3)
Phase 2Systemic Lupus ErythematosusRecruiting
Est. primary completion 2027-06 · NCT07340463 · CT.gov ↗
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Phase 3IgA Nephropathy (IgAN), IgAVNNot yet recruiting
Est. primary completion 2027-06-30 · NCT07052981 · CT.gov ↗
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Early phase / not applicableSystemic Lupus ErythematosusRecruiting
Est. primary completion 2027-06-30 · NCT06394063 · CT.gov ↗
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August 2027 (1)
Early phase / not applicableRefractory Chronic Inflammatory Demyelinating PolyneuropathyActive not recruiting
Est. primary completion 2027-08-31 · NCT07597733 · CT.gov ↗
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November 2027 (1)
Phase 2Sjögren's DiseaseNot yet recruiting
Est. primary completion 2027-11-01 · NCT07836660 · CT.gov ↗
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December 2027 (1)
Phase 2Difficult-to-treat Rheumatoid Arthritis, Rheumatoid ArthritisRecruiting
Est. primary completion 2027-12-30 · NCT07796516 · CT.gov ↗
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2028 (3)
July 2028 (1)
Phase 2Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), IC-MPGNRecruiting
Est. primary completion 2028-07-10 · NCT07522099 · CT.gov ↗
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December 2028 (2)
Phase 3Primary Sjogren's DiseaseRecruiting
Est. primary completion 2028-12 · NCT07404865 · CT.gov ↗
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Early phase / not applicableEffectivenessNot yet recruiting
Est. primary completion 2028-12 · NCT07298928 · CT.gov ↗
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2029 (1)
May 2029 (1)
Phase 3CTD-ILDNot yet recruiting
Est. primary completion 2029-05-31 · NCT07495033 · CT.gov ↗
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See the full readout calendar ↗

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 (16)
Phase 2/3 (2)
Phase 2 (20)
Phase 1/2 (1)
Phase 1 (4)
Phase 4 (9)
Early phase / not applicable (5)
Appears in other studies (1)