Modality
ERT
MOA
BCL-2i
Target
CFTR
Pathway
PI3K/AKT
ADPKD
Development Pipeline
Preclinical
~Oct 2014
→ ~Jan 2016
Phase 1
~Apr 2016
→ ~Jul 2017
Phase 2
~Oct 2017
→ ~Jan 2019
Phase 3
Apr 2019
→ May 2030
Phase 3Current
NCT07098443
394 pts·ADPKD
2024-10→TBD·Not yet recruiting
NCT05737393
940 pts·ADPKD
2019-04→2030-05·Terminated
NCT08189252
97 pts·ADPKD
2022-03→TBD·Active
+1 more trial
2,144 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-06-051.2y awayPh3 Readout· ADPKD
2030-05-284.2y awayPh3 Readout· ADPKD
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Termina…
P3
Recruit…
P3
Active
P3
Not yet…
Catalysts
Ph3 Readout
2027-06-05 · 1.2y away
ADPKD
Ph3 Readout
2030-05-28 · 4.2y away
ADPKD
RecruitingActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07098443 | Phase 3 | ADPKD | Not yet recr... | 394 | CR |
| NCT05737393 | Phase 3 | ADPKD | Terminated | 940 | PASI75 |
| NCT08189252 | Phase 3 | ADPKD | Active | 97 | UPCR |
| NCT04014744 | Phase 3 | ADPKD | Recruiting | 713 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Datoglumide | AbbVie | Approved | CFTR | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| Sovarelsin | BioMarin | Phase 2 | CFTR |