Modality
Small Molecule
MOA
MDM2i
Target
PLK4
Pathway
Amyloid
NSCLC
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
~Mar 2018
→ ~Jun 2019
NDA/BLA
~Sep 2019
→ ~Dec 2020
Approved
Mar 2021
→ Apr 2031
ApprovedCurrent
NCT04729242
1,960 pts·NSCLC
2025-12→2031-04·Terminated
NCT07272870
776 pts·NSCLC
2022-09→2031-01·Active
NCT03289096
2,480 pts·NSCLC
2021-03→2027-11·Recruiting
5,216 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2027-11-011.6y awayPh3 Readout· NSCLC
2031-01-194.8y awayPh3 Readout· NSCLC
2031-04-145.0y awayPh3 Readout· NSCLC
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Recruit…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2027-11-01 · 1.6y away
NSCLC
Ph3 Readout
2031-01-19 · 4.8y away
NSCLC
Ph3 Readout
2031-04-14 · 5.0y away
NSCLC
RecruitingActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04729242 | Approved | NSCLC | Terminated | 1960 | OS |
| NCT07272870 | Approved | NSCLC | Active | 776 | PANSS |
| NCT03289096 | Approved | NSCLC | Recruiting | 2480 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Rimasertib | Exelixis | Phase 3 | B7-H3 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 |