Modality
Bispecific Ab
MOA
MDM2i
Target
KRASG12D
Pathway
Autophagy
CLLLN
Development Pipeline
Preclinical
~Apr 2011
→ ~Jul 2012
Phase 1
~Oct 2012
→ ~Jan 2014
Phase 2
~Apr 2014
→ ~Jul 2015
Phase 3
~Oct 2015
→ ~Jan 2017
NDA/BLA
~Apr 2017
→ ~Jul 2018
Approved
Oct 2018
→ Jan 2029
ApprovedCurrent
NCT06869190
2,615 pts·CLL
2020-10→TBD·Completed
NCT07607014
2,154 pts·CLL
2018-10→2029-01·Completed
NCT07161792
2,090 pts·LN
2020-12→2026-03·Not yet recruiting
6,859 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2026-03-172w agoPh3 Readout· LN
2029-01-182.8y awayPh3 Readout· CLL
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Complet…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2026-03-17 · 2w ago
LN
Ph3 Readout
2029-01-18 · 2.8y away
CLL
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06869190 | Approved | CLL | Completed | 2615 | UPDRS |
| NCT07607014 | Approved | CLL | Completed | 2154 | EDSS |
| NCT07161792 | Approved | LN | Not yet recr... | 2090 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D | |
| Rimasertib | Exelixis | Phase 3 | B7-H3 |