Modality
Multispecific
MOA
Menini
Target
CD123
Pathway
Lipid Met
SMACML
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
~Mar 2018
→ ~Jun 2019
NDA/BLA
~Sep 2019
→ ~Dec 2020
Approved
Mar 2021
→ Apr 2030
ApprovedCurrent
NCT03938631
2,704 pts·SMA
2024-11→2030-04·Active
NCT03734157
1,730 pts·SMA
2025-04→TBD·Recruiting
NCT06408929
2,696 pts·CML
2021-03→TBD·Terminated
7,130 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2026-11-268mo awayBTD· CML
2030-04-054.0y awayPh3 Readout· SMA
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Termina…
Approved
Active
Approved
Recruit…
Catalysts
BTD
2026-11-26 · 8mo away
CML
Ph3 Readout
2030-04-05 · 4.0y away
SMA
RecruitingActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03938631 | Approved | SMA | Active | 2704 | NT-proBNP |
| NCT03734157 | Approved | SMA | Recruiting | 1730 | EDSS |
| NCT06408929 | Approved | CML | Terminated | 2696 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| REG-7737 | Regeneron | Preclinical | CD123 | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Olpafutibatinib | Immunocore | Approved | SMN2 | |
| Zorizumab | Beam | Approved | CD123 | |
| Adagralucimab | Caribou Bio | NDA/BLA | CD123 | |
| Zoricapivasertib | CSL Limited | Phase 2 | HER2 | |
| Fixatapinarof | Jiangsu Hengrui | Preclinical | PLK4 |