Modality
Gene Therapy
MOA
BCL-2i
Target
PCSK9
Pathway
Neuroinflam
FSGS
Development Pipeline
Preclinical
~Jun 2017
→ ~Sep 2018
Phase 1
~Dec 2018
→ ~Mar 2020
Phase 2
~Jun 2020
→ ~Sep 2021
Phase 3
Dec 2021
→ Jun 2031
Phase 3Current
NCT08853348
420 pts·FSGS
2021-12→2031-06·Not yet recruiting
420 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-09-206mo agoPh1 Dose Esc· FSGS
2031-06-185.2y awayPh3 Readout· FSGS
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Not yet…
Catalysts
Ph1 Dose Esc
2025-09-20 · 6mo ago
FSGS
Ph3 Readout
2031-06-18 · 5.2y away
FSGS
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08853348 | Phase 3 | FSGS | Not yet recr... | 420 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| BMR-8377 | BioMarin | Phase 1/2 | PCSK9 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 |