Modality
Nanobody
MOA
BTKi
Target
PD-1
Pathway
mTOR
FabryUrothelial Ca
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
~Nov 2017
→ ~Feb 2019
Phase 2
May 2019
→ Sep 2029
Phase 2Current
NCT06989870
1,095 pts·Fabry
2024-12→2029-09·Recruiting
NCT08081219
1,630 pts·Fabry
2019-05→2027-06·Recruiting
2,725 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-06-021.2y awayPh2 Data· Fabry
2029-09-233.5y awayPh2 Data· Fabry
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P2
Recruit…
P2
Recruit…
Catalysts
Ph2 Data
2027-06-02 · 1.2y away
Fabry
Ph2 Data
2029-09-23 · 3.5y away
Fabry
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06989870 | Phase 2 | Fabry | Recruiting | 1095 | FEV1 |
| NCT08081219 | Phase 2 | Fabry | Recruiting | 1630 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| Zanumavacamten | GSK | Phase 2/3 | TROP-2 | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 |