For people living with Sjögren’s disease, treatment has often meant managing individual problems—dry eyes, dry mouth, joint pain, fatigue, or complications affecting other organs—rather than using a medication specifically approved to control the disease itself.
That is why new Phase 3 results for an experimental drug called dazodalibep are getting attention.
On September 22, 2026, Amgen announced that a large Phase 3 trial of dazodalibep met its main goal in adults with moderate-to-severe systemic Sjögren’s disease. Participants receiving the drug experienced greater improvement in overall disease activity than those receiving placebo.
The findings are encouraging, but they do not mean dazodalibep is an approved treatment for Sjögren’s disease—or that patients can expect to receive it immediately.
Table of Contents
- What Is Dazodalibep?
- What Did the Phase 3 Trial Find?
- Why Could This Matter for Sjögren’s Care?
- What Do We Still Not Know?
- When Could Dazodalibep Become Available?
- What Should Patients Do Now?
- Frequently Asked Questions
- The Bottom Line
What Is Dazodalibep?
Dazodalibep is an experimental immune-targeting therapy known as a CD40 ligand, or CD40L, antagonist.
CD40L is involved in communication among several types of immune cells, including T cells, B cells, and antigen-presenting cells. These interactions can contribute to the abnormal immune activity involved in autoimmune diseases.
Dazodalibep is designed to interrupt that signaling rather than broadly shutting down the entire immune system. Researchers hope this can reduce some of the immune activity driving Sjögren’s disease.
Earlier Phase 2 research had already produced encouraging findings. In a randomized trial published in Nature Medicine in 2024, dazodalibep improved disease activity in participants with systemic Sjögren’s and improved symptoms in another group whose main problems included dryness, fatigue, and pain despite relatively limited systemic organ involvement.
Those results helped move the drug into larger Phase 3 studies.
What Did the Phase 3 Trial Find?
The newly announced results come from OASIZ 301, a randomized, double-blind, placebo-controlled Phase 3 study involving approximately 621 adults with moderate-to-severe systemic Sjögren’s disease.
The study’s primary goal was to measure changes in the EULAR Sjögren’s Syndrome Disease Activity Index, commonly called ESSDAI.
ESSDAI is a tool doctors and researchers use to measure disease activity across different organ systems.
According to Amgen, dazodalibep produced a statistically significant and clinically meaningful improvement in ESSDAI scores at 48 weeks compared with placebo. Improvements were reportedly detectable as early as Week 4 and continued through Week 48.
That is an important finding because a successful Phase 3 trial generally provides much stronger evidence than an early-stage study.
Still, only topline results have been released so far. Detailed data have not yet been presented in a peer-reviewed publication.
Why Could This Matter for Sjögren’s Care?
Sjögren’s is sometimes described mainly as a condition that causes dry eyes and dry mouth, but the disease can be much broader.
Some people experience severe fatigue, joint and muscle pain, nerve problems, lung involvement, kidney complications, or other systemic manifestations.
Despite that burden, there is currently no FDA-approved medication specifically designed to modify the underlying course of Sjögren’s disease. Current treatment for Sjögren’s often focuses on relieving individual symptoms or using immune-modifying medications originally approved for other conditions.
A successful targeted therapy could therefore fill a significant treatment gap.
Dazodalibep is also notable because researchers are studying it in two different Sjögren’s populations: people with substantial systemic disease activity and people whose greatest burden comes from symptoms such as dryness, fatigue, and pain despite relatively low systemic disease activity.
That distinction matters because Sjögren’s can look very different from one person to another.
What Do We Still Not Know?
Positive Phase 3 results are important, but several questions remain.
First, the full OASIZ 301 results have not yet been released. Researchers will want to examine the size of the treatment effect, how consistently people responded, which symptoms improved, and whether certain groups benefited more than others.
Safety will also remain closely watched.
In the topline announcement, the most common adverse events occurring more often with dazodalibep than placebo included nasopharyngitis, urinary tract infections, high blood pressure, and infusion-related reactions. These events were generally described as mild to moderate. Treatment discontinuations due to side effects were reportedly uncommon and similar between groups.
Longer-term safety is being evaluated through an extension study.
Researchers are also waiting for results from OASIZ 303, another Phase 3 trial focused on people who have a substantial symptom burden but relatively low systemic disease activity. ClinicalTrials.gov lists that study as involving 434 participants, with completion expected in late 2026.
Those results could help determine how broadly dazodalibep might eventually be useful.
When Could Dazodalibep Become Available?
There is no confirmed approval date.
A successful Phase 3 trial can provide evidence needed for a company to seek regulatory approval, but several steps generally come first.
The complete results must be analyzed, regulators may review data from multiple studies, and manufacturing and safety information must also be evaluated.
Amgen has said it plans to present detailed OASIZ 301 data at an upcoming medical meeting.
Until regulators such as the U.S. Food and Drug Administration review the evidence and approve the medication, dazodalibep remains investigational.
In other words, a promising clinical trial is not the same thing as an available prescription.
What Should Patients Do Now?
People living with Sjögren’s generally should not change their current medications because of these trial results.
Instead, the findings may be worth discussing with a rheumatologist, particularly for patients whose symptoms or systemic disease remain difficult to control.
A doctor can explain which established treatments are appropriate now and whether participation in a clinical trial might be an option.
It is also worth remembering that managing Sjögren’s disease is rarely one-size-fits-all. Someone whose biggest problem is severe dry eye may need a different approach from someone with inflammatory arthritis, neuropathy, lung disease, or other systemic complications.
The strongest message from the dazodalibep results is not that Sjögren’s suddenly has a new treatment. It is that researchers may be getting closer to one.
Frequently Asked Questions
Is dazodalibep approved for Sjögren’s disease?
No. Dazodalibep remains an experimental treatment. Positive Phase 3 results can support a future regulatory application, but the drug must still go through the regulatory review process before it could become routinely available.
How does dazodalibep work?
Dazodalibep blocks CD40 ligand, a molecule involved in communication between immune cells. Researchers believe interrupting this pathway may reduce some of the abnormal immune activity involved in Sjögren’s disease.
Did the Phase 3 trial succeed?
According to topline results released by Amgen on September 22, 2026, the OASIZ 301 trial met its primary endpoint. Patients receiving dazodalibep experienced statistically significant and clinically meaningful improvement in systemic disease activity at Week 48 compared with placebo.
Does dazodalibep help dry eyes and dry mouth?
That remains less clear from the newly announced Phase 3 results. The OASIZ 301 study primarily focused on systemic disease activity. Another Phase 3 trial, OASIZ 303, is specifically studying patients with substantial symptoms—including dryness, fatigue, and pain—but lower systemic disease activity.
Are there already treatments for Sjögren’s disease?
Yes, but current care largely focuses on managing symptoms and complications. Treatments can include artificial tears, saliva-supporting therapies, medications for pain or inflammation, and immune-modifying drugs for systemic disease. At present, there is no FDA-approved disease-modifying medication specifically for Sjögren’s disease.
Should I ask my doctor about dazodalibep?
You can ask about the research, particularly if your Sjögren’s disease is difficult to control. However, dazodalibep is not yet available as a routinely prescribed medication.
The Bottom Line
The latest dazodalibep results represent a meaningful milestone in the search for better treatments for Sjögren’s disease.
A large Phase 3 study found that the experimental therapy improved systemic disease activity compared with placebo, building on encouraging earlier research.
But important steps remain. Full trial results still need closer scientific scrutiny, another Phase 3 study is underway, and regulatory review would be required before the drug could reach routine clinical care.
For now, dazodalibep is best viewed not as a new treatment patients can request tomorrow, but as one of the strongest signs yet that more targeted Sjögren’s therapies may be moving closer to reality.
This content is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.