Modality
ASO
MOA
TNFi
Target
GPRC5D
Pathway
Fibrosis
LNGBMLGS
Development Pipeline
Preclinical
~Dec 2009
→ ~Mar 2011
Phase 1
~Jun 2011
→ ~Sep 2012
Phase 2
~Dec 2012
→ ~Mar 2014
Phase 3
~Jun 2014
→ ~Sep 2015
NDA/BLA
~Dec 2015
→ ~Mar 2017
Approved
Jun 2017
→ Jan 2029
ApprovedCurrent
NCT03632014
1,987 pts·GBM
2017-06→2026-05·Terminated
NCT06600219
544 pts·LGS
2017-12→2026-06·Active
NCT05185046
1,721 pts·LGS
2025-12→2029-01·Active
4,252 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2026-05-232mo awayPh3 Readout· GBM
2026-06-183mo awayPh3 Readout· LGS
2029-01-282.8y awayPh3 Readout· LGS
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Termina…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2026-05-23 · 2mo away
GBM
Ph3 Readout
2026-06-18 · 3mo away
LGS
Ph3 Readout
2029-01-28 · 2.8y away
LGS
ActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03632014 | Approved | GBM | Terminated | 1987 | PFS |
| NCT06600219 | Approved | LGS | Active | 544 | EASI-75 |
| NCT05185046 | Approved | LGS | Active | 1721 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα |