Telitacicept
An investigational treatment for Sjögren's Syndrome.
The same compound appears under different names depending on the context. Here is how to identify Telitacicept wherever you encounter it, plus the key facts at a glance.
- Generic name
- Telitacicept
- Development code
- RC18
- Drug class
- Dual BAFF/APRIL inhibitor (TACI-Fc fusion protein)
- Manufacturer
- RemeGen / Vor Bio
- How it's taken
- Given as a subcutaneous injection.
A dual BAFF/APRIL inhibitor in Phase 3 trials for Sjögren's syndrome. Telitacicept blocks two survival signals (BAFF and APRIL) that keep autoreactive B cells alive, providing broader B-cell suppression than agents targeting BAFF alone.
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Where Telitacicept fits
One of several investigational disease-modifying therapies for Sjögren's syndrome. The dual BAFF/APRIL mechanism differentiates it from ianalumab (BAFF-R only). Already approved in China for lupus, rheumatoid arthritis and generalized myasthenia gravis, and since June 2026 for Sjögren's disease and, under conditional approval, IgA nephropathy. Phase 3 data in Sjögren's is promising, with global expansion underway. Competes with deucravacitinib (TYK2 inhibitor) and dazodalibep (CD40L blocker) alongside pilocarpine and cevimeline for symptom management.
How Telitacicept works
B cells in Sjögren's syndrome depend on two survival signals: BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). Both signals help autoreactive B cells survive and produce the autoantibodies that attack salivary and tear glands. Most B-cell-targeting therapies block only one of these signals.
Telitacicept is a fusion protein that acts as a decoy receptor, capturing both BAFF and APRIL simultaneously. By blocking both survival signals at once, telitacicept may provide more complete suppression of autoreactive B-cell populations than single-target approaches.
Phase 3 trials are ongoing globally, with a Phase 3 trial in China producing positive results reported in August 2025. A global Phase 3 trial was launched in March 2026.
Mechanism: Dual inhibitor of BAFF and APRIL, two B-cell survival factors that drive the autoimmune B-cell hyperactivity underlying Sjögren's syndrome
Side effects and safety
Based on available trial data, the most commonly reported side effects include injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because telitacicept suppresses B-cell function through two pathways, monitoring of immunoglobulin levels and infection surveillance is important.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Telitacicept
Given as a subcutaneous injection. Dosing frequency is being optimized in Phase 3 trials. The injection can potentially be self-administered at home.
Availability and cost
Only available as the brand-name product.
Clinical trial results
A Phase 3 trial in China reported positive top-line results in August 2025, meeting its primary endpoint for Sjögren's syndrome. China's NMPA approved telitacicept for adults with Sjögren's disease in June 2026. Outside China, Vor Bio holds the rights and dosed the first patient in the global Phase 3 UPSTREAM SjD trial (about 250 patients) on March 30, 2026. Earlier-phase studies showed improvements in disease activity scores and biomarkers of B-cell activity.
Development history
Developed by RemeGen (China), telitacicept represents a novel dual-target approach to B-cell modulation. It received conditional approval in China for systemic lupus erythematosus in 2021, with full approval granted in 2023. The positive Phase 3 results in Sjögren's from China have accelerated global development, with the worldwide trial launched in early 2026.
Explore Sjögren's Syndrome trials
Other Sjögren's Syndrome treatments
Where to access Telitacicept
Investigational: available only through clinical trial enrollment
Telitacicept has not been approved by the FDA and is not available by prescription. The only way for a patient to receive Telitacicept today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT07404865
View full trial record on ClinicalTrials.gov →Trial status, site list, and eligibility are pulled from ClinicalTrials.gov. Confirm current recruitment status and nearest site directly with the study team before traveling.
Common questions about Telitacicept
▸What is Telitacicept?
A dual BAFF/APRIL inhibitor in Phase 3 trials for Sjögren's syndrome. Telitacicept blocks two survival signals (BAFF and APRIL) that keep autoreactive B cells alive, providing broader B-cell suppression than agents targeting BAFF alone.
▸How does Telitacicept work?
B cells in Sjögren's syndrome depend on two survival signals: BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). Both signals help autoreactive B cells survive and produce the autoantibodies that attack salivary and tear glands. Most B-cell-targeting therapies block only one of these signals.
Telitacicept is a fusion protein that acts as a decoy receptor, capturing both BAFF and APRIL simultaneously. By blocking both survival signals at once, telitacicept may provide more complete suppression of autoreactive B-cell populations than single-target approaches.
Phase 3 trials are ongoing globally, with a Phase 3 trial in China producing positive results reported in August 2025. A global Phase 3 trial was launched in March 2026.
▸What are the side effects of Telitacicept?
Based on available trial data, the most commonly reported side effects include injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because telitacicept suppresses B-cell function through two pathways, monitoring of immunoglobulin levels and infection surveillance is important.
▸How is Telitacicept taken?
Given as a subcutaneous injection. Dosing frequency is being optimized in Phase 3 trials. The injection can potentially be self-administered at home.
▸Is Telitacicept FDA approved?
Telitacicept is currently in phase 3 clinical trials for Sjögren's Syndrome. It has not yet received FDA approval.
▸What is telitacicept for Sjogrens?
Telitacicept is a dual BAFF/APRIL inhibitor in Phase 3 trials for Sjogren's syndrome. It is a fusion protein that acts as a decoy receptor, blocking two B-cell survival signals simultaneously, which may provide more complete suppression of the autoimmune B-cell activity than single-target agents. [1][2]
▸Is telitacicept FDA approved?
No. Telitacicept is not FDA-approved. It is in Phase 3 development for Sjogren's syndrome, and the global Phase 3 UPSTREAM SjD trial dosed its first patient on March 30, 2026. China's NMPA approved telitacicept for adults with Sjogren's disease in June 2026, and it is also approved in China for systemic lupus erythematosus, rheumatoid arthritis and generalized myasthenia gravis. China also gave it conditional approval for IgA nephropathy in June 2026. [3][4][5]
▸What did the telitacicept Phase 3 trial show?
A Phase 3 trial of telitacicept in China reported positive top-line results in August 2025, meeting its primary endpoint for Sjogren's syndrome, and earlier-phase studies showed improvements in disease activity scores and biomarkers of B-cell activity. China's NMPA then approved telitacicept for adults with Sjogren's disease in June 2026. Outside China, Vor Bio holds the rights and is running the global Phase 3 UPSTREAM SjD trial of about 250 patients, which began dosing in March 2026. [1][3][6]
▸What are the side effects of telitacicept?
Based on available trial data, the most commonly reported side effects of telitacicept are injection site reactions, upper respiratory infections, and decreased immunoglobulin levels. Because telitacicept suppresses B cells through both the BAFF and APRIL pathways, monitoring immunoglobulin levels and watching for infections is important. It is given as a subcutaneous injection, with dosing frequency still being optimized in Phase 3 trials. [1][2]
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- RemeGen. Telitacicept in Sjögren's Syndrome. https://www.remegen.com
- U.S. National Library of Medicine. Telitacicept in Primary Sjögren's Syndrome. https://clinicaltrials.gov
- Vor Bio · 2026-06-08. Telitacicept Receives NMPA Approval for the Treatment of Sjögren's Disease in China. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-receives-nmpa-approval-treatment-sjogrens-disease
- Vor Bio · 2026-03-30. Vor Bio Doses First Patient in Global Phase 3 UPSTREAM SjD Registrational Trial of Telitacicept. https://ir.vorbio.com/news-releases/news-release-details/vor-bio-doses-first-patient-global-phase-3-upstream-sjd
- Vor Bio · 2026-06-08. Telitacicept Receives NMPA Conditional Approval for the Treatment of IgA Nephropathy in China. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-receives-nmpa-conditional-approval-treatment-iga
- ClinicalTrials.gov. UPSTREAM SjD: telitacicept in primary Sjögren's disease (Phase 3). https://clinicaltrials.gov/study/NCT07404865