Modality
mAb
MOA
CAR-T CD19
Target
JAK2
Pathway
Apoptosis
Crohn's
Development Pipeline
Preclinical
~May 2013
→ ~Aug 2014
Phase 1
~Nov 2014
→ ~Feb 2016
Phase 2
~May 2016
→ ~Aug 2017
Phase 3
~Nov 2017
→ ~Feb 2019
NDA/BLA
May 2019
→ Jul 2028
NDA/BLACurrent
NCT04794195
1,474 pts·Crohn's
2019-05→2028-07·Not yet recruiting
1,474 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-07-149mo agoPDUFA· Crohn's
2025-08-088mo agoEnrollment Complete· Crohn's
2028-07-102.3y awayPh3 Readout· Crohn's
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Not yet…
Catalysts
PDUFA
2025-07-14 · 9mo ago
Crohn's
Enrollment Complete
2025-08-08 · 8mo ago
Crohn's
Ph3 Readout
2028-07-10 · 2.3y away
Crohn's
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04794195 | NDA/BLA | Crohn's | Not yet recr... | 1474 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| GMA-5010 | Genmab | Phase 3 | JAK2 | |
| Talasotorasib | Exelixis | Preclinical | APOC3 | |
| Teravorutinib | Illumina | Phase 2 | JAK2 | |
| AXS-4984 | Axsome | Preclinical | JAK2 | |
| Capirapivir | TG Therapeutics | Approved | JAK2 | |
| Elracapivasertib | Kymera | Phase 3 | PRMT5 |