Where lupus treatment is heading

Lupus is an autoimmune disease that can affect the skin, joints, kidneys and other organs; about 16,000 people in the US are diagnosed each year, mostly women. Treatment relies on hydroxychloroquine, steroids and immune-suppressing drugs, with a few targeted biologics. More new drugs are reading out now than at any time before, and CAR T-cell therapy is producing drug-free remissions in severe cases.

• 498studies open or running
• 45phase 3 trials
• 3,999papers published this year
• 40NIH-funded projects

1. Now

   Nov 2026

   A new drug for lupus kidney diseaseHappened 46.4% kidney response

   Obinutuzumab: complete kidney response in 46.4% vs 33.1%.

   46.4%: complete kidney response at 76 weeks, vs 33.1%.

   • REGENCY trial

   CAR T cells produce drug-free remissionHappened 9 of 10 in remission

   In a small trial, 9 of 10 people with severe lupus reached remission after one infusion.

   9 of 10: people with lupus reached remission.

   • CASTLE CAR T trial

   A dual B-cell blocker doubles responseHappened +34.5 pts more responders

   Telitacicept: 34.5 percentage points more responders than placebo in a Chinese phase 3.

   +34.5 pts: percentage points more responders than placebo.

   • Telitacicept phase 3

2. 6 months

   by May 2027

   FDA decision on obinutuzumab for general lupusLikely +23.1 pts more responders

   A decision is expected by December 2026 after ALLEGORY.

   +23.1 pts: percentage points more people responded than with placebo.

   • ALLEGORY trial

   Pill results from two big trialsPossible

   Deucravacitinib (two phase 3s) and litifilimab (TOPAZ) finish in late 2026.

   • POETYK SLE-1
   • TOPAZ-1

3. 12 months

   by Nov 2027

   JAK pill and S1P pill resultsPossible

   SELECT-SLE (upadacitinib, 1,014 people) and OPUS-1 (cenerimod) finish in early 2027.

   • SELECT-SLE
   • OPUS-1

4. 3 years

   by late 2029

   Antibody-clearing and co-stimulation blockersPossible

   Nipocalimab (600 people) and dapirolizumab pegol (450 people) phase 3s report in 2028.

   • GARDENIA-SLE
   • PHOENYCS FLY

5. 5 years

   by late 2031

   Cell therapy for more peopleLong shot 9 of 10 in remission

   Off-the-shelf CAR T cells and T-cell engagers that avoid chemotherapy could widen access if early results hold.

   9 of 10: people with lupus reached remission.

   • CASTLE CAR T trial

The research paths

Borrowed from other conditions

Open to join now

• Moderate to severe SLE

  Nipocalimab

  Phase 3 · 272 sites

  Locations and eligibility →

• Active SLE

  Dapirolizumab pegol

  Phase 3 · 245 sites

  Locations and eligibility →

See every recruiting Lupus trial →

When the trials finish

Completion dates the trials registered. Results usually follow 3 to 12 months later.

What just happened

Standard treatment today

• All patientsHydroxychloroquine; sun protection; lowest effective steroid dose.
• Active despite basicsMethotrexate, azathioprine or mycophenolate; belimumab or anifrolumab.
• Lupus nephritisMycophenolate or cyclophosphamide with belimumab, voclosporin or obinutuzumab.
• Severe, resistantRituximab or cyclophosphamide; CAR T-cell therapy in trials.

See Lupus trials recruiting now →