Modality
Fusion Protein
MOA
MALT1i
Target
USP1
Pathway
Ferroptosis
CholangiocarcinomaEwing Sarcoma
Development Pipeline
Preclinical
~Jun 2011
→ ~Sep 2012
Phase 1
~Dec 2012
→ ~Mar 2014
Phase 2
~Jun 2014
→ ~Sep 2015
Phase 3
~Dec 2015
→ ~Mar 2017
NDA/BLA
~Jun 2017
→ ~Sep 2018
Approved
Dec 2018
→ Jan 2031
ApprovedCurrent
NCT03304604
367 pts·Cholangiocarcinoma
2018-12→2027-07·Not yet recruiting
NCT07920530
2,095 pts·Cholangiocarcinoma
2019-05→2030-11·Active
NCT08389770
1,926 pts·Ewing Sarcoma
2024-08→2031-01·Completed
+1 more trial
4,849 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2027-07-211.3y awayPh3 Readout· Cholangiocarcinoma
2029-04-213.1y awayPh3 Readout· Cholangiocarcinoma
2030-11-164.6y awayPh3 Readout· Cholangiocarcinoma
2031-01-124.8y awayPh3 Readout· Ewing Sarcoma
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Not yet…
Approved
Active
Approved
Active
Approved
Complet…
Catalysts
Ph3 Readout
2027-07-21 · 1.3y away
Cholangiocarcinoma
Ph3 Readout
2029-04-21 · 3.1y away
Cholangiocarcinoma
Ph3 Readout
2030-11-16 · 4.6y away
Cholangiocarcinoma
Ph3 Readout
2031-01-12 · 4.8y away
Ewing Sarcoma
ActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03304604 | Approved | Cholangiocarcinoma | Not yet recr... | 367 | HAM-D |
| NCT07920530 | Approved | Cholangiocarcinoma | Active | 2095 | FEV1 |
| NCT08389770 | Approved | Ewing Sarcoma | Completed | 1926 | Safety |
| NCT07984141 | Approved | Cholangiocarcinoma | Active | 461 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| Sovarelsin | Alnylam | Phase 2/3 | LAG-3 | |
| ITC-6153 | Intra-Cellular | Phase 3 | KRASG12C | |
| Gelisertib | Samsung Biologics | Approved | IL-23 | |
| RVM-7089 | Revolution Medicines | Phase 3 | IL-17A |