Modality
Fusion Protein
MOA
PRMT5i
Target
BET
Pathway
RNA Splicing
LGSPSP
Development Pipeline
Preclinical
~Aug 2013
→ ~Nov 2014
Phase 1
~Feb 2015
→ ~May 2016
Phase 2
~Aug 2016
→ ~Nov 2017
Phase 3
Feb 2018
→ Jul 2030
Phase 3Current
NCT05899289
2,852 pts·LGS
2018-02→2030-07·Active
NCT06052627
2,690 pts·PSP
2020-01→2030-07·Active
NCT03628963
1,607 pts·PSP
2025-04→TBD·Not yet recruiting
+1 more trial
9,275 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-05-1910mo agoPh3 Readout· LGS
2030-07-014.3y awayPh3 Readout· PSP
2030-07-274.3y awayPh3 Readout· LGS
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Active
P3
Active
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2025-05-19 · 10mo ago
LGS
Ph3 Readout
2030-07-01 · 4.3y away
PSP
Ph3 Readout
2030-07-27 · 4.3y away
LGS
ActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05899289 | Phase 3 | LGS | Active | 2852 | PFS |
| NCT06052627 | Phase 3 | PSP | Active | 2690 | ORR |
| NCT03628963 | Phase 3 | PSP | Not yet recr... | 1607 | BodyWt |
| NCT05531166 | Phase 3 | LGS | Completed | 2126 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-1969 | Roche | Approved | BET | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| NVS-5439 | Novartis | Preclinical | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa |