Modality
Small Molecule
MOA
GLP-1/GIP
Target
HER2
Pathway
Wnt
CMLGISTPV
Development Pipeline
Preclinical
~Jan 2013
→ ~Apr 2014
Phase 1
~Jul 2014
→ ~Oct 2015
Phase 2
~Jan 2016
→ ~Apr 2017
Phase 3
~Jul 2017
→ ~Oct 2018
NDA/BLA
Jan 2019
→ Oct 2030
NDA/BLACurrent
NCT06572007
2,199 pts·PV
2019-01→2030-06·Recruiting
NCT05610478
738 pts·GIST
2019-09→2030-10·Active
2,937 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-06-114.2y awayPh3 Readout· PV
2030-10-124.5y awayPh3 Readout· GIST
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Active
Catalysts
Ph3 Readout
2030-06-11 · 4.2y away
PV
Ph3 Readout
2030-10-12 · 4.5y away
GIST
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06572007 | NDA/BLA | PV | Recruiting | 2199 | ORR |
| NCT05610478 | NDA/BLA | GIST | Active | 738 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zanuderotide | Johnson & Johnson | Phase 2/3 | TIGIT | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| Pemiinavolisib | Sarepta | NDA/BLA | CD47 | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 | |
| BEA-4274 | Beam | Phase 1/2 | ALK | |
| ELV-1411 | Enliven | NDA/BLA | HER2 | |
| PST-2276 | Poseida | Approved | Aβ |