For people with Sjögren's disease
The first Sjögren's drug is awaiting FDA decision. Get the alert the hour it lands.
Ianalumab would be the first treatment for the disease itself, not just the dryness. Two Phase 3 trials, FDA Breakthrough Therapy designation in January, a decision expected in the coming months, and at least four more drugs behind it in late-stage trials. We read every update and send you only what changed: the decision the hour it lands, and every real change after it.
We call it Sjögren's disease, not syndrome, because the international consensus does and because it is one.
For information only. Not medical advice. Bring what you learn to your care team.
What ianalumab is
Until now, nothing treated the disease itself.
The available options for Sjögren's ease symptoms such as dry eyes and mouth. None changes the course of the disease. Ianalumab is the first drug to show, in two large Phase 3 trials, an effect on disease activity rather than on dryness alone.
What it does.
It is an antibody that removes B cells, the immune cells that drive much of the damage in Sjögren's, and blocks the signal (the BAFF receptor) that keeps them alive. It is given as an injection under the skin.
Where it stands.
Novartis reported that both Phase 3 trials (NEPTUNUS-1 and NEPTUNUS-2) met their primary endpoint. The FDA granted Breakthrough Therapy designation on 16 January 2026. A decision is expected in the coming months. Approval is not the same as availability or coverage, and not everyone with Sjögren's will be a candidate.
Enrolling in the US now
Four treatment trials, and four that only look like one.
A raw registry search returns eight studies. Half are registries and a cancer trial. These are the four that test a treatment for Sjögren's, checked 2026-09-25.
- CLN-978 · Early (Phase 1)
- AlloNK with rituximab · In trials (Phase 2)
- Tofacitinib · In trials (Phase 2)
- Acoltremon eye drops (Tryptyr) · Approved drug, new setting (Phase 4)
When the FDA decides, hear it within the hour.
For information only. Not medical advice. Bring what you learn to your care team.