Drugs / RC18

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04235933 Sep → Dec 2019 — RemeGen Co., Ltd. Completed No outcome recorded
Phase 25 trials · 1 met primary
Phase 2 NCT04625153 May 2021 → Apr 2026 relapsing-remitting multiple sclerosis RemeGen Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 2 NCT04291781 Apr 2020 → May 2021 IgA glomerulonephritis RemeGen Co., Ltd. Completed No outcome recorded
Phase 2 NCT04078386 Nov 2019 → Jun 2021 Sjogren syndrome RemeGen Co., Ltd. Completed Mixed
Phase 2 NCT02885610 Dec 2015 → Jun 2019 systemic lupus erythematosus RemeGen Co., Ltd. Completed Met primary
Phase 2 NCT02882087 Oct 2015 → Feb 2019 rheumatoid arthritis RemeGen Co., Ltd. Terminated No outcome recorded Stop: Enrollment
Phase 32 trials
Phase 3 NCT03330418 Jan 2018 → Apr 2026 neuromyelitis optica RemeGen Co., Ltd. Terminated No outcome recorded Stop: Business
Phase 3 NCT03016013 Mar 2017 → Nov 2022 rheumatoid arthritis RemeGen Co., Ltd. Completed No outcome recorded

Press releases naming this drug 20 releases

DateIssuerRelease
2026-06-08 RemeGen Co., Ltd. Remegen's Telitacicept Two Indications Approved on the Same Day, Patients with Sjögren's Syndrome (Dry Disease) and IgA Nephropathy Welcome the World's First Dual-Target Biologic Drug remegen.com ↗
2025-09-17 RemeGen Co., Ltd. Results of China Phase III Clinical Study of Telitacicept for Generalized Myasthenia Gravis Selected for Oral Presentation at 2025 AANEM Annual Meeting remegen.com ↗
2025-08-13 RemeGen Co., Ltd. Telitacicept Meets Primary Endpoint in Phase III Trial for Primary Sjögren's Syndrome in China remegen.com ↗
2025-05-27 RemeGen Co., Ltd. RemeGen’s Telitacicept Approved for Treatment of Myasthenia Gravis in China remegen.com ↗
2025-04-09 RemeGen Co., Ltd. Remegen Announces Exciting Results of Telitacicept Phase 3 Clinical Trial for Patients with Generalized Myasthenia Gravis remegen.com ↗
2024-11-10 RemeGen Co., Ltd. "Dual Target": Telitacicept Offers New Hopes for Patients with B-Cell-Mediated Autoimmune Disorders remegen.com ↗
2024-10-27 RemeGen Co., Ltd. Priority Review Granted to BLA of RemeGen’s Telitacicept for Its Third Indication of Myasthenia Gravis remegen.com ↗
2024-08-13 RemeGen Co., Ltd. BLA on Agenda: A Phase III Trial on Telitacicept for Myasthenia Gravis Achieves Primary Endpoint in China remegen.com ↗
2024-08-05 RemeGen Co., Ltd. First Patient In Achieved in the Global Multicenter Phase III Trial on Telitacicept for Myasthenia Gravis remegen.com ↗
2024-07-23 RemeGen Co., Ltd. IND of Telitacicept for Membranous Nephropathy Cleared by CDE remegen.com ↗
2024-04-02 RemeGen Co., Ltd. RemeGen's Telitacicept Granted Fast Track Designation by US FDA for Treatment of Primary Sjögren's Syndrome Following Permission of the Phase 3 Multicenter Global Clinical Trial remegen.com ↗
2024-01-10 RemeGen Co., Ltd. JPM Healthcare Conference 2024|Dr. Fang Jianmin’s Speech: Promote the Global Development of Telitacicept at Full Speed and Create a Pioneer Blockbuster Drug in the Field of B Cell-mediated Autoimmunity remegen.com ↗

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as RC18 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04078386 ↗
7

NCT02885610 ↗

NCT02882087 ↗

NCT03330418 ↗

NCT03016013 ↗

NCT04625153 ↗

NCT04235933 ↗

NCT04291781 ↗

Known as Tai Ai “Tai Ai(RC18) 80mg” NCT04235933 ↗
Known as telitacicept “Telitacicept in patients with active systemic lupus erythematosus: results of a phase 2b, randomised, double-blind, placebo-controlled trial.” PMID 38129117 ↗ Mar 2024
Action Inhibit “a novel fusion protein that neutralises signals of B lymphocyte stimulator and a proliferation-inducing ligand” PMID 38129117 ↗ Mar 2024
Modality Protein / enzyme biologic “recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein” NCT02882087 ↗
Route Subcutaneous “Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.” NCT02882087 ↗