Modality
Vaccine
MOA
EGFRi
Target
FcRn
Pathway
STING
Bladder CaCrohn's
Development Pipeline
Preclinical
~Oct 2009
→ ~Jan 2011
Phase 1
~Apr 2011
→ ~Jul 2012
Phase 2
~Oct 2012
→ ~Jan 2014
Phase 3
~Apr 2014
→ ~Jul 2015
NDA/BLA
~Oct 2015
→ ~Jan 2017
Approved
Apr 2017
→ Jul 2031
ApprovedCurrent
NCT06055652
2,523 pts·Bladder Ca
2017-04→2027-12·Active
NCT08116969
723 pts·Bladder Ca
2025-03→2029-01·Not yet recruiting
NCT06136251
2,119 pts·Bladder Ca
2023-02→2031-07·Terminated
+1 more trial
5,887 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2027-12-251.7y awayPh3 Readout· Bladder Ca
2029-01-032.8y awayPh3 Readout· Bladder Ca
2031-07-075.3y awayPh3 Readout· Bladder Ca
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Active
Approved
Not yet…
Approved
Termina…
Approved
Not yet…
Catalysts
Ph3 Readout
2027-12-25 · 1.7y away
Bladder Ca
Ph3 Readout
2029-01-03 · 2.8y away
Bladder Ca
Ph3 Readout
2031-07-07 · 5.3y away
Bladder Ca
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06055652 | Approved | Bladder Ca | Active | 2523 | 6MWD |
| NCT08116969 | Approved | Bladder Ca | Not yet recr... | 723 | ORR |
| NCT06136251 | Approved | Bladder Ca | Terminated | 2119 | VA |
| NCT03749374 | Approved | Bladder Ca | Not yet recr... | 522 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| JNJ-5094 | Johnson & Johnson | Phase 2/3 | GIP-R | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |