Modality
Fusion Protein
MOA
CDK2i
Target
CD20
Pathway
PI3K/AKT
Cervical CaHeart FailureNSCLC
Development Pipeline
Preclinical
~Jul 2017
→ ~Oct 2018
Phase 1
~Jan 2019
→ ~Apr 2020
Phase 2
~Jul 2020
→ ~Oct 2021
Phase 3
~Jan 2022
→ ~Apr 2023
NDA/BLA
Jul 2023
→ Apr 2031
NDA/BLACurrent
NCT07474659
2,927 pts·Cervical Ca
2023-07→2031-04·Completed
NCT04619190
536 pts·Heart Failure
2024-02→2026-08·Not yet recruiting
3,463 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-034mo awayPh3 Readout· Heart Failure
2031-04-135.0y awayPh3 Readout· Cervical Ca
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
NDA/BLA
Complet…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2026-08-03 · 4mo away
Heart Failure
Ph3 Readout
2031-04-13 · 5.0y away
Cervical Ca
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07474659 | NDA/BLA | Cervical Ca | Completed | 2927 | OS |
| NCT04619190 | NDA/BLA | Heart Failure | Not yet recr... | 536 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| JNJ-8637 | Johnson & Johnson | NDA/BLA | CD20 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| Lisolucimab | Novartis | Approved | CD20 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| DSN-3066 | Daiichi Sankyo | Phase 3 | IL-13 |