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Telitacicept

Alternative Names: telitacicept, rc-18, rc18, rc 18
Latest Update: 2025-04-08
Latest Update Note: News Article

Product Description

Telitacicept (Tai'ai®) is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept is being developed by Yantai Rongchang Pharmaceutical through its subsidiary RemeGen for the treatment of B cell-mediated autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and multiple sclerosis (MS). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34463932/)

Mechanisms of Action: BLyS Inhibitor,APRIL Inhibitor

Novel Mechanism: Yes

Modality: Fusion Protein

Route of Administration: Subcutaneous

FDA Designation:
Fast Track - Erythema|Lupus Erythematosus|Lupus Erythematosus, Systemic
Fast Track - Sjogren's Syndrome
Orphan Drug - Myasthenia Gravis|Asthenia *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: RemeGen
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Telitacicept

Countries in Clinic: Argentina, Australia, Belgium, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Guatemala, Hungary, Italy, Mauritius, Mexico, Philippines, Poland, Puerto Rico, Romania, Spain, United States

Active Clinical Trial Count: 22

Highest Development Phases

Phase 3: Glomerulonephritis|IgA Nephropathy|Kidney Diseases|Lupus Erythematosus, Systemic|Muscle Weakness|Myasthenia Gravis|Neuromyelitis Optica|Sjogren's Syndrome

Phase 2: Lupus Nephritis|Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting

Phase 1: Healthy Volunteers

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

18C022

P3

Active, not recruiting

Sjogren's Syndrome

2027-12-01

RC18G002

P3

Unknown Status

Lupus Erythematosus, Systemic

2027-08-10

RC18G006

P3

Recruiting

Myasthenia Gravis

2027-05-14

REMESLE-2

P3

Recruiting

Lupus Erythematosus, Systemic

2027-04-01

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