Modality
Fusion Protein
MOA
MALT1i
Target
C5
Pathway
PD-1/PD-L1
EoESCLCLGS
Development Pipeline
Preclinical
~Feb 2011
→ ~May 2012
Phase 1
~Aug 2012
→ ~Nov 2013
Phase 2
~Feb 2014
→ ~May 2015
Phase 3
~Aug 2015
→ ~Nov 2016
NDA/BLA
~Feb 2017
→ ~May 2018
Approved
Aug 2018
→ Jun 2031
ApprovedCurrent
NCT06867681
2,251 pts·EoE
2021-06→2027-03·Not yet recruiting
NCT08496474
1,025 pts·SCLC
2018-08→2031-06·Not yet recruiting
3,276 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2027-03-2412mo awayPh3 Readout· EoE
2031-06-145.2y awayPh3 Readout· SCLC
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2027-03-24 · 12mo away
EoE
Ph3 Readout
2031-06-14 · 5.2y away
SCLC
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06867681 | Approved | EoE | Not yet recr... | 2251 | EDSS |
| NCT08496474 | Approved | SCLC | Not yet recr... | 1025 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| Sovarelsin | Alnylam | Phase 2/3 | LAG-3 |