Dazodalibep
An investigational treatment for Sjögren's Syndrome.
Drug facts
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 (non-antibody fusion protein)
- 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.
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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.
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 a high symptom burden and low systemic disease activity, is still running, and Amgen expects it to finish in the fourth quarter of 2026[4].
Side effects and safety
In the Phase 2 trial, the most common side effects included COVID-19, diarrhea, headache, common colds, upper respiratory infections, joint pain, constipation and urinary tract infections[1]. In the Phase 3 OASIZ 301 trial, the most common side effects seen more often with dazodalibep than placebo were common colds, urinary tract infections, high blood pressure and infusion reactions, mostly mild to moderate[4].
Dazodalibep is not an antibody and has no Fc region, a design meant to avoid the platelet-related clotting problems seen with earlier anti-CD40L antibodies[3]. 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.
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 has no Fc region, a design meant to avoid the platelet-related clotting problems that stopped earlier CD40L-targeting antibodies. Positive Phase 2 results, announced in September 2022 and January 2023, advanced it into Phase 3 for Sjögren's syndrome.
Availability and cost
Only available as the brand-name product.
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 the specialist who manages the patient's condition and knows their current treatment.
Primary active trial
ClinicalTrials.gov record NCT06245408
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 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?
In the Phase 2 trial, the most common side effects included COVID-19, diarrhea, headache, common colds, upper respiratory infections, joint pain, constipation and urinary tract infections[1]. In the Phase 3 OASIZ 301 trial, the most common side effects seen more often with dazodalibep than placebo were common colds, urinary tract infections, high blood pressure and infusion reactions, mostly mild to moderate[4]. Dazodalibep is not an antibody and has no Fc region, a design meant to avoid the platelet-related clotting problems seen with earlier anti-CD40L antibodies[3]. 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 used for?
Dazodalibep is an investigational CD40 ligand blocker in Phase 3 trials for Sjogren's syndrome and is not FDA-approved. It disrupts the communication between T cells and B cells that drives autoantibody production and glandular destruction, a mechanism distinct from B-cell depleting agents like ianalumab or B-cell survival blockers like telitacicept. [2]
▸What did the dazodalibep Phase 3 trial show?
On September 22, 2026, Amgen announced that the Phase 3 OASIZ 301 trial of dazodalibep, in about 621 people with moderate-to-severe systemic Sjogren's disease, met its primary endpoint of reduced disease activity (ESSDAI) at Week 48. A second Phase 3 trial, OASIZ 303, in people with a high symptom burden and low systemic disease activity, is still running, and Amgen expects it to finish in the fourth quarter of 2026. Earlier Phase 2 results, published in Nature Medicine in 2024, showed significant ESSDAI improvement versus placebo in people with systemic disease and better symptom scores (dryness, fatigue and pain) in people with a high symptom burden. [4][1][2]
▸How is dazodalibep given?
Dazodalibep is given as an intravenous infusion. The dosing schedule is still being optimized in the Phase 3 trials, so there is no final approved regimen yet. [2]
▸What are the side effects of dazodalibep?
Phase 2 data for dazodalibep showed generally manageable side effects, with upper respiratory infections, headache, and gastrointestinal symptoms among the most commonly reported. In the Phase 3 OASIZ 301 trial, the side effects seen more often than on placebo were common colds, urinary tract infections, high blood pressure and infusion reactions, mostly mild to moderate, and Amgen reported no imbalance in blood clots. The drug has no Fc region, a design meant to avoid the platelet-related clotting problems seen with earlier anti-CD40L antibodies. [1][4]
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.
- Nature Medicine · 2024-06. CD40 ligand antagonist dazodalibep in Sjögren's disease: a randomized, double-blinded, placebo-controlled, phase 2 trial. https://pubmed.ncbi.nlm.nih.gov/38839899/
- U.S. National Library of Medicine. Dazodalibep in Sjögren's Syndrome. https://clinicaltrials.gov/search?intr=dazodalibep
- Science Translational Medicine · 2019-04. A CD40L-targeting protein reduces autoantibodies and improves disease activity in patients with autoimmunity. https://pubmed.ncbi.nlm.nih.gov/31019027/
- 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