Modality
mRNA
MOA
HPK1i
Target
PLK4
Pathway
Neuroinflam
ACCMDD
Development Pipeline
Preclinical
~Mar 2016
→ ~Jun 2017
Phase 1
~Sep 2017
→ ~Dec 2018
Phase 2
~Mar 2019
→ ~Jun 2020
Phase 3
Sep 2020
→ Jan 2028
Phase 3Current
NCT03162673
2,073 pts·MDD
2020-09→2026-08·Terminated
NCT04418595
1,391 pts·MDD
2024-01→2025-04·Not yet recruiting
NCT04410694
1,582 pts·MDD
2023-07→2028-01·Active
5,046 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-04-1711mo agoPh3 Readout· MDD
2026-08-144mo awayPh3 Readout· MDD
2028-01-201.8y awayPh3 Readout· MDD
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028
P3
Termina…
P3
Active
P3
Not yet…
Catalysts
Ph3 Readout
2025-04-17 · 11mo ago
MDD
Ph3 Readout
2026-08-14 · 4mo away
MDD
Ph3 Readout
2028-01-20 · 1.8y away
MDD
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03162673 | Phase 3 | MDD | Terminated | 2073 | LiverFat |
| NCT04418595 | Phase 3 | MDD | Not yet recr... | 1391 | VA |
| NCT04410694 | Phase 3 | MDD | Active | 1582 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1944 | Pfizer | NDA/BLA | APOC3 | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| ABB-7516 | AbbVie | Phase 3 | PD-L1 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 | |
| ILM-2412 | Illumina | Phase 3 | PLK4 | |
| Semasacituzumab | Illumina | Phase 3 | Nectin-4 | |
| ROI-3353 | Roivant Sciences | Phase 1/2 | PLK4 |