Modality
Gene Therapy
MOA
PLK4i
Target
KRASG12D
Pathway
Apoptosis
ObesityMDD
Development Pipeline
Preclinical
~Apr 2012
→ ~Jul 2013
Phase 1
~Oct 2013
→ ~Jan 2015
Phase 2
~Apr 2015
→ ~Jul 2016
Phase 3
~Oct 2016
→ ~Jan 2018
NDA/BLA
~Apr 2018
→ ~Jul 2019
Approved
Oct 2019
→ May 2031
ApprovedCurrent
NCT07156694
2,497 pts·MDD
2019-10→2026-11·Active
NCT06015276
1,287 pts·Obesity
2024-07→2031-05·Not yet recruiting
NCT08530263
1,750 pts·Obesity
2021-07→2025-07·Recruiting
5,534 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-07-039mo agoPh3 Readout· Obesity
2026-11-158mo awayPh3 Readout· MDD
2031-05-175.1y awayPh3 Readout· Obesity
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Active
Approved
Recruit…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-07-03 · 9mo ago
Obesity
Ph3 Readout
2026-11-15 · 8mo away
MDD
Ph3 Readout
2031-05-17 · 5.1y away
Obesity
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07156694 | Approved | MDD | Active | 2497 | Safety |
| NCT06015276 | Approved | Obesity | Not yet recr... | 1287 | EFS |
| NCT08530263 | Approved | Obesity | Recruiting | 1750 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D | |
| 207-2754 | Samsung Biologics | Phase 1/2 | KRASG12D | |
| Liravorutinib | Biomea Fusion | Phase 1/2 | GPRC5D |