Dazodalibep
An investigational treatment for Sjögren's Syndrome.
The same compound appears under different names depending on the context. Here is how to identify Dazodalibep wherever you encounter it, plus the key facts at a glance.
- Generic name
- Dazodalibep
- Development codes
- HZN-4920, VIB4920
- Drug class
- CD40 ligand blocker (Fc-silent anti-CD40L)
- Manufacturer
- Horizon Therapeutics / Amgen
- How it's taken
- Given as an intravenous infusion.
An investigational CD40 ligand blocker in Phase 3 trials for Sjögren's syndrome. Dazodalibep disrupts the interaction between T cells and B cells that drives autoantibody production, representing a novel mechanism distinct from other pipeline therapies.
Where Dazodalibep fits
One of several investigational disease-modifying therapies for Sjögren's syndrome. The CD40L-blocking mechanism is unique among the pipeline, targeting T-cell/B-cell co-stimulation rather than B-cell depletion or survival. Competes with ianalumab (anti-BAFF-R), telitacicept (dual BAFF/APRIL), and deucravacitinib (TYK2 inhibitor) in the Sjögren's pipeline. Existing approved options are limited to symptom management with pilocarpine (Salagen) and cevimeline (Evoxac).
How Dazodalibep works
The autoimmune attack in Sjögren's syndrome depends on cooperation between T cells and B cells. T cells provide a co-stimulatory signal to B cells through a protein called CD40 ligand (CD40L), which tells B cells to activate, multiply, and produce autoantibodies. Without this signal, B cells cannot mount the sustained autoimmune response that destroys glands.
Dazodalibep blocks CD40L, cutting off this T-cell-to-B-cell communication. This is a fundamentally different approach from agents that deplete B cells directly (like ianalumab) or block B-cell survival signals (like telitacicept). By intervening at the co-stimulatory step, dazodalibep may preserve more normal immune function while specifically suppressing the autoimmune response.
Phase 2 results showed significant improvements in disease activity and patient-reported symptoms, supporting advancement to Phase 3 trials.
Mechanism: Fusion protein that blocks CD40 ligand (CD40L) on T cells, preventing the T-cell/B-cell co-stimulatory interaction that drives autoantibody production and glandular inflammation in Sjögren's syndrome
Side effects and safety
Phase 2 data showed generally manageable side effects. Upper respiratory infections, headache, and gastrointestinal symptoms were among the most commonly reported. The Fc-silent design was engineered to avoid the thromboembolic risks associated with earlier generations of anti-CD40L antibodies. Full safety data will emerge from the Phase 3 program.
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 Dazodalibep
Given as an intravenous infusion. Dosing schedule is being optimized in Phase 3 trials.
Availability and cost
Only available as the brand-name product.
Clinical trial results
A Phase 2 randomized trial showed statistically significant improvements in the ESSDAI (disease activity index) compared to placebo. Patient-reported outcomes including dryness, fatigue, and pain also improved. On September 22, 2026, Amgen announced that the Phase 3 OASIZ 301 trial, in about 621 people with moderate-to-severe systemic Sjögren's disease, met its primary endpoint, a reduction in disease activity (ESSDAI) at Week 48. A second Phase 3 trial, OASIZ 303, in people with symptomatic disease, is still running.
Development history
Originally developed by Viela Bio as VIB4920, the drug was acquired by Horizon Therapeutics (now part of Amgen following their 2023 acquisition). The compound uses a novel Fc-silent design to avoid the blood clotting risks that derailed earlier CD40L-targeting therapies. Positive Phase 2 results in 2023 advanced it into Phase 3 for Sjögren's syndrome.
Explore Sjögren's Syndrome trials
Other Sjögren's Syndrome treatments
Where to access Dazodalibep
Investigational — available only through clinical trial enrollment
Dazodalibep has not been approved by the FDA and is not available by prescription. The only way for a patient to receive Dazodalibep today is by enrolling in an active clinical trial and meeting that trial's eligibility criteria. Decisions about trial participation should be made with a nephrologist familiar with the patient's current treatment and kidney function.
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 Dazodalibep
▸What is Dazodalibep?
An investigational CD40 ligand blocker in Phase 3 trials for Sjögren's syndrome. Dazodalibep disrupts the interaction between T cells and B cells that drives autoantibody production, representing a novel mechanism distinct from other pipeline therapies.
▸How does Dazodalibep work?
The autoimmune attack in Sjögren's syndrome depends on cooperation between T cells and B cells. T cells provide a co-stimulatory signal to B cells through a protein called CD40 ligand (CD40L), which tells B cells to activate, multiply, and produce autoantibodies. Without this signal, B cells cannot mount the sustained autoimmune response that destroys glands.
Dazodalibep blocks CD40L, cutting off this T-cell-to-B-cell communication. This is a fundamentally different approach from agents that deplete B cells directly (like ianalumab) or block B-cell survival signals (like telitacicept). By intervening at the co-stimulatory step, dazodalibep may preserve more normal immune function while specifically suppressing the autoimmune response.
Phase 2 results showed significant improvements in disease activity and patient-reported symptoms, supporting advancement to Phase 3 trials.
▸What are the side effects of Dazodalibep?
Phase 2 data showed generally manageable side effects. Upper respiratory infections, headache, and gastrointestinal symptoms were among the most commonly reported. The Fc-silent design was engineered to avoid the thromboembolic risks associated with earlier generations of anti-CD40L antibodies. Full safety data will emerge from the Phase 3 program.
▸How is Dazodalibep taken?
Given as an intravenous infusion. Dosing schedule is being optimized in Phase 3 trials.
▸Is Dazodalibep FDA approved?
Dazodalibep is currently in phase 3 clinical trials for Sjögren's Syndrome. It has not yet received FDA approval.
▸What is dazodalibep for Sjogrens?
Dazodalibep is an investigational CD40 ligand blocker in Phase 3 trials for Sjogren's syndrome. It disrupts the communication between T cells and B cells that drives autoantibody production and glandular destruction.
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.
- The Lancet. Dazodalibep in Primary Sjögren's Syndrome — Phase 2 Trial. https://www.thelancet.com
- U.S. National Library of Medicine. Dazodalibep in Sjögren's Syndrome. https://clinicaltrials.gov
- Amgen · 2026-09-22. Amgen Announces Positive Topline Phase 3 Results for Dazodalibep in Moderate-to-Severe Systemic Sjögren's Disease. https://www.amgen.com/newsroom/press-releases/2026/09/amgen-announces-positive-topline-phase-3-results-for-dazodalibep-in-moderatetosevere-systemic-sjgrens-disease
- ClinicalTrials.gov. OASIZ 301: dazodalibep in moderate-to-severe Sjögren's disease (Phase 3). https://clinicaltrials.gov/study/NCT06104124
- ClinicalTrials.gov. OASIZ 303: dazodalibep in symptomatic Sjögren's disease (Phase 3). https://clinicaltrials.gov/study/NCT06245408