Modality
Peptide
MOA
Menini
Target
CD123
Pathway
PI3K/AKT
ALSProstate CaHemophilia A
Development Pipeline
Preclinical
~Dec 2019
→ ~Mar 2021
Phase 1
~Jun 2021
→ ~Sep 2022
Phase 2
Dec 2022
→ Apr 2027
Phase 2Current
NCT03850365
1,066 pts·ALS
2022-12→2027-04·Recruiting
1,066 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-165mo awayPh1 Dose Esc· ALS
2027-04-121.0y awayPh3 Readout· ALS
Trial Timeline
2023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
P2/3
Recruit…
Catalysts
Ph1 Dose Esc
2026-08-16 · 5mo away
ALS
Ph3 Readout
2027-04-12 · 1.0y away
ALS
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03850365 | Phase 2/3 | ALS | Recruiting | 1066 | SeizFreq |
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 | |
| TXG-6755 | 10x Genomics | Approved | CD123 | |
| Zoricapivasertib | CSL Limited | Phase 2 | HER2 |