Modality
Bispecific Ab
MOA
AHRant
Target
BTK
Pathway
Apoptosis
FSGSPVPSP
Development Pipeline
Preclinical
~Feb 2018
→ ~May 2019
Phase 1
~Aug 2019
→ ~Nov 2020
Phase 2
Feb 2021
→ Feb 2031
Phase 2Current
NCT06024357
2,188 pts·PSP
2023-10→2031-02·Recruiting
NCT05643774
2,564 pts·PV
2021-02→2028-01·Terminated
4,752 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-01-281.8y awayPh2 Data· PV
2031-02-214.9y awayPh2 Data· PSP
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2
Termina…
P2
Recruit…
Catalysts
Ph2 Data
2028-01-28 · 1.8y away
PV
Ph2 Data
2031-02-21 · 4.9y away
PSP
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06024357 | Phase 2 | PSP | Recruiting | 2188 | EDSS |
| NCT05643774 | Phase 2 | PV | Terminated | 2564 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| AZN-5978 | AstraZeneca | Phase 2/3 | GIP-R | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| BII-5449 | Biogen | Phase 3 | FXIa | |
| Elratapinarof | Halozyme | Phase 2 | C5 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 | |
| 369-8021 | Hansoh Pharma | Approved | BTK | |
| NTL-2576 | Intellia | NDA/BLA | SGLT2 | |
| Pemitinib | Xenon Pharma | Preclinical | BTK |