Modality
Bispecific Ab
MOA
CDK4/6i
Target
MDM2
Pathway
STING
CRC
Development Pipeline
Preclinical
~Aug 2011
→ ~Nov 2012
Phase 1
~Feb 2013
→ ~May 2014
Phase 2
~Aug 2014
→ ~Nov 2015
Phase 3
~Feb 2016
→ ~May 2017
NDA/BLA
~Aug 2017
→ ~Nov 2018
Approved
Feb 2019
→ Jul 2030
ApprovedCurrent
NCT05936137
1,639 pts·CRC
2019-02→2028-04·Completed
NCT03223003
1,086 pts·CRC
2022-04→2030-07·Active
2,725 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-10-086mo agoNDA· CRC
2028-04-062.0y awayPh3 Readout· CRC
2030-07-244.3y awayPh3 Readout· CRC
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Complet…
Approved
Active
Catalysts
NDA
2025-10-08 · 6mo ago
CRC
Ph3 Readout
2028-04-06 · 2.0y away
CRC
Ph3 Readout
2030-07-24 · 4.3y away
CRC
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05936137 | Approved | CRC | Completed | 1639 | LiverFat |
| NCT03223003 | Approved | CRC | Active | 1086 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-1969 | Roche | Approved | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 |