Dapirolizumab pegol
First phase 3 positive, published in The Lancet: less disease activity and fewer flares. Second phase 3 ongoing.
The immune system attacks the body in flares. It is one of the busiest research areas, with several drugs in final-stage trials and cell therapies being tested.
The latest developments, newest first.
ImvivaBio reported 12-month phase 1 data for CTA313, a donor-derived CAR-T targeting CD19 and BCMA, in refractory lupus. Seven of eight evaluable patients remained in remission. The groups are small.
New phase 3 data show fewer flares and sustained control. Results were also published in The Lancet.
The FDA approved at-home use instead of the monthly IV infusion.
Phase 2/3 met its goal. It would be the first targeted drug for cutaneous lupus.
Each column is a step on the road to the pharmacy. Colors show the type of treatment.
First phase 3 positive, published in The Lancet: less disease activity and fewer flares. Second phase 3 ongoing.
Positive in skin lupus (AMETHYST). Two phase 3 trials in systemic lupus.
Pill already approved for psoriasis, in two lupus phase 3 trials.
Already used in arthritis. Two phase 3 trials in SLE.
Depletes B cells. Tested in SLE and lupus nephritis.
Keeps immune cells in the lymph nodes. Two phase 3 trials.
Lowers circulating autoantibodies. FDA Fast Track.
"Resets" the immune system. Small studies show long drug-free remissions.
Candidates that looked promising and were stopped. Most treatments tested never reach the market.
2022 · Lilly ended the lupus program after a failed phase 3.
2020 · Lupus phase 3 stopped for lack of efficacy.
None yet. Current treatment: Hydroxychloroquine, steroids, immunosuppressants and biologics.
Fasevia tracks 8 candidates: Dapirolizumab pegol (Phase 3); Litifilimab (Phase 3); Deucravacitinibe (Phase 3); Upadacitinibe (Phase 3); Ianalumabe (Phase 3); Cenerimod (Phase 3); Nipocalimabe (Phase 3); CAR-T anti-CD19 (Phase 1).
The furthest along today is Dapirolizumab pegol (UCB · Biogen), in phase 3. First phase 3 positive, published in The Lancet: less disease activity and fewer flares. Second phase 3 ongoing.
A drug has to complete phase 3 and be reviewed by health agencies such as the FDA or EMA, which usually takes several years. The leading candidate today is in phase 3.