Modality
Gene Therapy
MOA
Anti-Aβ
Target
IL-17A
Pathway
T-cell
CeliacCSU
Development Pipeline
Preclinical
~Mar 2014
→ ~Jun 2015
Phase 1
~Sep 2015
→ ~Dec 2016
Phase 2
~Mar 2017
→ ~Jun 2018
Phase 3
Sep 2018
→ May 2031
Phase 3Current
NCT06030580
2,856 pts·Celiac
2018-09→TBD·Completed
NCT07350682
1,792 pts·CSU
2020-04→TBD·Active
NCT04885141
971 pts·CSU
2020-11→2031-05·Recruiting
+1 more trial
6,137 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-07-023.3y awayPh3 Readout· CSU
2031-05-175.1y awayPh3 Readout· CSU
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Complet…
P3
Not yet…
P3
Active
P3
Recruit…
Catalysts
Ph3 Readout
2029-07-02 · 3.3y away
CSU
Ph3 Readout
2031-05-17 · 5.1y away
CSU
RecruitingActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06030580 | Phase 3 | Celiac | Completed | 2856 | OS |
| NCT07350682 | Phase 3 | CSU | Active | 1792 | DOR |
| NCT04885141 | Phase 3 | CSU | Recruiting | 971 | Mayo |
| NCT08114866 | Phase 3 | CSU | Not yet recr... | 518 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-8369 | Eli Lilly | Approved | Menin | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| RVM-7089 | Revolution Medicines | Phase 3 | IL-17A | |
| Adagrarapivir | Ideaya Bio | Phase 1/2 | IL-17A | |
| RLA-6817 | Relay Therapeutics | Phase 3 | TIGIT |