Modality
Peptide
MOA
CDK2i
Target
GLP-1R
Pathway
Autophagy
MCL
Development Pipeline
Preclinical
~Apr 2010
→ ~Jul 2011
Phase 1
~Oct 2011
→ ~Jan 2013
Phase 2
~Apr 2013
→ ~Jul 2014
Phase 3
~Oct 2014
→ ~Jan 2016
NDA/BLA
~Apr 2016
→ ~Jul 2017
Approved
Oct 2017
→ Feb 2030
ApprovedCurrent
NCT08099138
2,052 pts·MCL
2017-10→2030-02·Completed
NCT03866311
953 pts·MCL
2019-02→2028-03·Active
NCT03233804
2,087 pts·MCL
2020-11→TBD·Active
5,092 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2028-03-081.9y awayPh3 Readout· MCL
2030-02-273.9y awayPh3 Readout· MCL
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Complet…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2028-03-08 · 1.9y away
MCL
Ph3 Readout
2030-02-27 · 3.9y away
MCL
ActiveCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08099138 | Approved | MCL | Completed | 2052 | FEV1 |
| NCT03866311 | Approved | MCL | Active | 953 | CfB |
| NCT03233804 | Approved | MCL | Active | 2087 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| Tirzepatide | Eli Lilly | Approved | GLP-1R | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| MRK-5413 | Merck & Co | Phase 1 | GLP-1R | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R |