FB102
Phase 2 in 126 adults protected the gut lining during gluten exposure. Moving to phase 3.
Gluten makes the immune system attack the gut. No drug has been approved; the leading candidates aim to protect the gut from accidental exposure.
The latest developments, newest first.
In 126 adults exposed to gluten, it protected the villi better than placebo. Analysts project a launch around 2031.
One dose protected the gut through six weeks of daily gluten. Teva plans a dose-finding study.
Having dropped zamaglutenase in 2025, Takeda is left with only TAK-227.
Each column is a step on the road to the pharmacy. Colors show the type of treatment.
Phase 2 in 126 adults protected the gut lining during gluten exposure. Moving to phase 3.
Phase 2a in 50 adults: prevented gut damage over 6 weeks of daily gluten.
Taken with meals. The company says it is ready for phase 3, no date yet.
Aims to teach the body to tolerate gluten. Fewer symptoms at every dose in phase 2.
Blocks the enzyme that makes gluten visible to the immune system.
For people still symptomatic on the diet. Enrollment complete.
For gut damage despite a strict diet.
Tests damage prevention and gut healing.
Injection of gluten peptides plus rapamycin. No serious effects in stage one.
Candidates that looked promising and were stopped. Most treatments tested never reach the market.
2026 · Tolerance nanoparticle (Takeda), after phase 2.
2025 · Gluten-digesting enzyme (Takeda), in phase 2.
2022 · Phase 3 showed no benefit.
2019 · Therapeutic vaccine; did not beat placebo.
None yet. Current treatment: Lifelong gluten-free diet.
Fasevia tracks 9 candidates: FB102 (Phase 2 complete); Latiglutenase (Phase 2 complete); TEV-53408 (Phase 2); KAN-101 (Phase 2); TAK-227 (Phase 2); Amlitelimab (Phase 2); DONQ52 (Phase 2); ANB033 (Phase 1); VTP-1000 (Phase 1).
The furthest along today is FB102 (argenx (ex-Forte)), in phase 2 complete. Phase 2 in 126 adults protected the gut lining during gluten exposure. Moving to phase 3.
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 2 complete.