Modality
Fusion Protein
MOA
KRASG12Ci
Target
WEE1
Pathway
Epigenetic
PVRBEndometrial Ca
Development Pipeline
Preclinical
~Feb 2013
→ ~May 2014
Phase 1
~Aug 2014
→ ~Nov 2015
Phase 2
~Feb 2016
→ ~May 2017
Phase 3
~Aug 2017
→ ~Nov 2018
NDA/BLA
~Feb 2019
→ ~May 2020
Approved
Aug 2020
→ Oct 2030
ApprovedCurrent
NCT03546630
1,255 pts·PV
2021-04→TBD·Not yet recruiting
NCT04723722
309 pts·RB
2025-08→2029-09·Active
NCT08151827
840 pts·PV
2022-11→2027-06·Active
+1 more trial
5,205 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2027-06-011.2y awayPh3 Readout· PV
2029-09-283.5y awayPh3 Readout· RB
2030-10-284.6y awayPh3 Readout· PV
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Termina…
Approved
Not yet…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2027-06-01 · 1.2y away
PV
Ph3 Readout
2029-09-28 · 3.5y away
RB
Ph3 Readout
2030-10-28 · 4.6y away
PV
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03546630 | Approved | PV | Not yet recr... | 1255 | Safety |
| NCT04723722 | Approved | RB | Active | 309 | SeizFreq |
| NCT08151827 | Approved | PV | Active | 840 | CfB |
| NCT08651605 | Approved | PV | Terminated | 2801 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Lisolucimab | Novartis | Approved | CD20 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| ALN-6288 | Alnylam | Approved | LAG-3 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| BMR-9762 | BioMarin | Phase 3 | Aβ |