Modality
mRNA
MOA
Menini
Target
WEE1
Pathway
STING
Crohn's
Development Pipeline
Preclinical
~May 2011
→ ~Aug 2012
Phase 1
~Nov 2012
→ ~Feb 2014
Phase 2
~May 2014
→ ~Aug 2015
Phase 3
~Nov 2015
→ ~Feb 2017
NDA/BLA
~May 2017
→ ~Aug 2018
Approved
Nov 2018
→ Jun 2031
ApprovedCurrent
NCT06788475
2,530 pts·Crohn's
2019-02→2031-06·Completed
NCT06689723
991 pts·Crohn's
2025-11→2031-04·Terminated
NCT07000019
984 pts·Crohn's
2018-11→2027-01·Completed
4,505 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2027-01-2210mo awayPh3 Readout· Crohn's
2031-04-185.0y awayPh3 Readout· Crohn's
2031-06-165.2y awayPh3 Readout· Crohn's
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Complet…
Approved
Complet…
Approved
Termina…
Catalysts
Ph3 Readout
2027-01-22 · 10mo away
Crohn's
Ph3 Readout
2031-04-18 · 5.0y away
Crohn's
Ph3 Readout
2031-06-16 · 5.2y away
Crohn's
CompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06788475 | Approved | Crohn's | Completed | 2530 | PASI75 |
| NCT06689723 | Approved | Crohn's | Terminated | 991 | UPCR |
| NCT07000019 | Approved | Crohn's | Completed | 984 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| Bemavorutinib | Acadia Pharma | Phase 1/2 | WEE1 | |
| Olpafutibatinib | Immunocore | Approved | SMN2 | |
| Talazumab | Zealand Pharma | Phase 1/2 | WEE1 |