Modality
ERT
MOA
TNFi
Target
HER2
Pathway
Cell Cycle
ThymomaNASHCSU
Development Pipeline
Preclinical
~Apr 2016
→ ~Jul 2017
Phase 1
~Oct 2017
→ ~Jan 2019
Phase 2
~Apr 2019
→ ~Jul 2020
Phase 3
Oct 2020
→ May 2031
Phase 3Current
NCT03074714
794 pts·Thymoma
2020-10→TBD·Not yet recruiting
NCT04786632
1,512 pts·NASH
2025-05→2028-01·Terminated
NCT08752315
1,195 pts·Thymoma
2023-05→2031-05·Completed
3,501 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-01-131.8y awayPh3 Readout· NASH
2031-05-265.2y awayPh3 Readout· Thymoma
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Not yet…
P3
Complet…
P3
Termina…
Catalysts
Ph3 Readout
2028-01-13 · 1.8y away
NASH
Ph3 Readout
2031-05-26 · 5.2y away
Thymoma
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03074714 | Phase 3 | Thymoma | Not yet recr... | 794 | 6MWD |
| NCT04786632 | Phase 3 | NASH | Terminated | 1512 | EFS |
| NCT08752315 | Phase 3 | Thymoma | Completed | 1195 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| Ribozanubrutinib | Genmab | Approved | GPRC5D | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 | |
| ELV-1411 | Enliven | NDA/BLA | HER2 | |
| Rimatinib | Ventyx Bio | Phase 1 | CD20 |