Modality
Gene Therapy
MOA
PCSK9i
Target
CDK4/6
Pathway
Ferroptosis
NASHHS
Development Pipeline
Preclinical
~Aug 2020
→ ~Nov 2021
Phase 1
~Feb 2022
→ ~May 2023
Phase 2
Aug 2023
→ Jun 2028
Phase 2Current
NCT08022724
322 pts·NASH
2023-08→2028-06·Completed
322 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-12-144mo agoPh1 Dose Esc· HS
2028-06-232.2y awayPh3 Readout· NASH
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
P2/3
Complet…
Catalysts
Ph1 Dose Esc
2025-12-14 · 4mo ago
HS
Ph3 Readout
2028-06-23 · 2.2y away
NASH
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08022724 | Phase 2/3 | NASH | Completed | 322 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |