Modality
siRNA
MOA
AuroraAi
Target
GPRC5D
Pathway
mTOR
RB
Development Pipeline
Preclinical
~Feb 2012
→ ~May 2013
Phase 1
~Aug 2013
→ ~Nov 2014
Phase 2
~Feb 2015
→ ~May 2016
Phase 3
~Aug 2016
→ ~Nov 2017
NDA/BLA
~Feb 2018
→ ~May 2019
Approved
Aug 2019
→ Dec 2031
ApprovedCurrent
NCT03854126
2,609 pts·RB
2019-08→2031-12·Not yet recruiting
NCT05053864
326 pts·RB
2023-08→2028-06·Active
NCT08854320
279 pts·RB
2025-06→2027-06·Terminated
3,214 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2027-06-201.2y awayPh3 Readout· RB
2028-06-182.2y awayPh3 Readout· RB
2031-12-105.7y awayPh3 Readout· RB
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Not yet…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2027-06-20 · 1.2y away
RB
Ph3 Readout
2028-06-18 · 2.2y away
RB
Ph3 Readout
2031-12-10 · 5.7y away
RB
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03854126 | Approved | RB | Not yet recr... | 2609 | DAS28 |
| NCT05053864 | Approved | RB | Active | 326 | MRD |
| NCT08854320 | Approved | RB | Terminated | 279 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| AMG-9654 | Amgen | Phase 2 | GPRC5D | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D | |
| REG-861 | Regeneron | Phase 2 | PARP |