Modality
Multispecific
MOA
FcRni
Target
WRN
Pathway
Fibrosis
SCLCADPKD
Development Pipeline
Preclinical
~Oct 2013
→ ~Jan 2015
Phase 1
~Apr 2015
→ ~Jul 2016
Phase 2
~Oct 2016
→ ~Jan 2018
Phase 3
Apr 2018
→ Oct 2030
Phase 3Current
NCT04103386
35 pts·ADPKD
2022-09→2030-10·Terminated
NCT06260699
1,472 pts·ADPKD
2018-10→2026-06·Completed
NCT06797973
622 pts·ADPKD
2018-04→TBD·Terminated
2,129 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-06-243mo awayPh3 Readout· ADPKD
2030-10-184.6y awayPh3 Readout· ADPKD
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Termina…
P3
Complet…
P3
Termina…
Catalysts
Ph3 Readout
2026-06-24 · 3mo away
ADPKD
Ph3 Readout
2030-10-18 · 4.6y away
ADPKD
CompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04103386 | Phase 3 | ADPKD | Terminated | 35 | UPCR |
| NCT06260699 | Phase 3 | ADPKD | Completed | 1472 | MRD |
| NCT06797973 | Phase 3 | ADPKD | Terminated | 622 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Zanufutibatinib | Intra-Cellular | NDA/BLA | CD38 | |
| Cevinaritide | Praxis Precision | Phase 3 | AuroraA |