Modality
Vaccine
MOA
CDK4/6i
Target
SMN2
Pathway
STING
MDDADPKD
Development Pipeline
Preclinical
~Mar 2015
→ ~Jun 2016
Phase 1
~Sep 2016
→ ~Dec 2017
Phase 2
~Mar 2018
→ ~Jun 2019
Phase 3
~Sep 2019
→ ~Dec 2020
NDA/BLA
~Mar 2021
→ ~Jun 2022
Approved
Sep 2022
→ May 2026
ApprovedCurrent
NCT03953076
1,501 pts·ADPKD
2022-09→2026-05·Completed
1,501 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2026-05-192mo awayPh3 Readout· ADPKD
Trial Timeline
Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2
Approved
Complet…
Catalysts
Ph3 Readout
2026-05-19 · 2mo away
ADPKD
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03953076 | Approved | ADPKD | Completed | 1501 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| RHH-1969 | Roche | Approved | BET | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 |