Modality
Vaccine
MOA
PI3Ki
Target
FXIa
Pathway
mTOR
PBCCKD
Development Pipeline
Preclinical
~Mar 2013
→ ~Jun 2014
Phase 1
~Sep 2014
→ ~Dec 2015
Phase 2
~Mar 2016
→ ~Jun 2017
Phase 3
~Sep 2017
→ ~Dec 2018
NDA/BLA
Mar 2019
→ Apr 2029
NDA/BLACurrent
NCT07889190
990 pts·PBC
2020-10→2029-04·Recruiting
NCT07428003
3,000 pts·CKD
2019-03→2026-08·Recruiting
3,990 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-024mo awayPh3 Readout· CKD
2029-04-113.0y awayPh3 Readout· PBC
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
NDA/BLA
Recruit…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-08-02 · 4mo away
CKD
Ph3 Readout
2029-04-11 · 3.0y away
PBC
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07889190 | NDA/BLA | PBC | Recruiting | 990 | LiverFat |
| NCT07428003 | NDA/BLA | CKD | Recruiting | 3000 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 |