Modality
mRNA
MOA
CDK4/6i
Target
CD47
Pathway
Cell Cycle
CholangiocarcinomaHS
Development Pipeline
Preclinical
~Jul 2012
→ ~Oct 2013
Phase 1
~Jan 2014
→ ~Apr 2015
Phase 2
~Jul 2015
→ ~Oct 2016
Phase 3
~Jan 2017
→ ~Apr 2018
NDA/BLA
Jul 2018
→ Apr 2031
NDA/BLACurrent
NCT06117218
2,491 pts·HS
2020-03→2031-04·Recruiting
NCT03080257
2,539 pts·HS
2018-07→2028-09·Terminated
5,030 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-09-242.5y awayPh3 Readout· HS
2031-04-235.1y awayPh3 Readout· HS
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
NDA/BLA
Termina…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2028-09-24 · 2.5y away
HS
Ph3 Readout
2031-04-23 · 5.1y away
HS
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06117218 | NDA/BLA | HS | Recruiting | 2491 | VA |
| NCT03080257 | NDA/BLA | HS | Terminated | 2539 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| 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-4334 | GSK | Preclinical | CD47 | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| VRT-5441 | Vertex Pharma | Phase 3 | GLP-1R |