Modality
ASO
MOA
Menini
Target
WRN
Pathway
Sphingolipid
CSU
Development Pipeline
Preclinical
~Dec 2017
→ ~Mar 2019
Phase 1
~Jun 2019
→ ~Sep 2020
Phase 2
~Dec 2020
→ ~Mar 2022
Phase 3
~Jun 2022
→ ~Sep 2023
NDA/BLA
Dec 2023
→ Jul 2027
NDA/BLACurrent
NCT08337500
483 pts·CSU
2023-12→2027-07·Active
483 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-07-131.3y awayPh3 Readout· CSU
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
NDA/BLA
Active
Catalysts
Ph3 Readout
2027-07-13 · 1.3y away
CSU
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08337500 | NDA/BLA | CSU | Active | 483 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| Olpafutibatinib | Immunocore | Approved | SMN2 | |
| TSH-7567 | Taysha Gene | Phase 1/2 | WRN |