Modality
mRNA
MOA
BETi
Target
MDM2
Pathway
Fibrosis
RCCEpilepsy
Development Pipeline
Preclinical
~Jun 2019
→ ~Sep 2020
Phase 1
~Dec 2020
→ ~Mar 2022
Phase 2
~Jun 2022
→ ~Sep 2023
Phase 3
~Dec 2023
→ ~Mar 2025
NDA/BLA
Jun 2025
→ Feb 2029
NDA/BLACurrent
NCT04967339
1,070 pts·Epilepsy
2025-06→2029-02·Active
NCT03870389
870 pts·RCC
2025-08→2025-02·Not yet recruiting
1,940 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-271.1y agoPh3 Readout· RCC
2029-02-032.8y awayPh3 Readout· Epilepsy
Trial Timeline
Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
NDA/BLA
Active
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2025-02-27 · 1.1y ago
RCC
Ph3 Readout
2029-02-03 · 2.8y away
Epilepsy
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04967339 | NDA/BLA | Epilepsy | Active | 1070 | PANSS |
| NCT03870389 | NDA/BLA | RCC | Not yet recr... | 870 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Sovarapivir | AbbVie | Phase 2/3 | IL-13 | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| BII-1564 | Biogen | Phase 2 | PSMA |