Modality
Bispecific Ab
MOA
PRMT5i
Target
Menin
Pathway
Tau
MMCKDLGS
Development Pipeline
Preclinical
~Aug 2010
→ ~Nov 2011
Phase 1
~Feb 2012
→ ~May 2013
Phase 2
~Aug 2013
→ ~Nov 2014
Phase 3
~Feb 2015
→ ~May 2016
NDA/BLA
~Aug 2016
→ ~Nov 2017
Approved
Feb 2018
→ Jun 2031
ApprovedCurrent
NCT05893778
1,577 pts·LGS
2021-06→2026-09·Not yet recruiting
NCT06227369
1,755 pts·CKD
2018-02→2027-12·Terminated
NCT05242991
2,024 pts·LGS
2021-05→2029-06·Completed
+1 more trial
5,874 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2026-09-216mo awayPh3 Readout· LGS
2027-12-021.7y awayPh3 Readout· CKD
2029-06-233.2y awayPh3 Readout· LGS
2031-06-155.2y awayPh3 Readout· LGS
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Termina…
Approved
Recruit…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2026-09-21 · 6mo away
LGS
Ph3 Readout
2027-12-02 · 1.7y away
CKD
Ph3 Readout
2029-06-23 · 3.2y away
LGS
Ph3 Readout
2031-06-15 · 5.2y away
LGS
RecruitingCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05893778 | Approved | LGS | Not yet recr... | 1577 | HbA1c |
| NCT06227369 | Approved | CKD | Terminated | 1755 | EFS |
| NCT05242991 | Approved | LGS | Completed | 2024 | ACR20 |
| NCT08536600 | Approved | LGS | Recruiting | 518 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-8369 | Eli Lilly | Approved | Menin | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa | |
| Semainavolisib | Gilead Sciences | Phase 2 | PARP | |
| VRT-1891 | Vertex Pharma | Phase 1 | KRASG12C |