Modality
Multispecific
MOA
USP1i
Target
HER2
Pathway
mTOR
DLBCLAsthmaEpilepsy
Development Pipeline
Preclinical
~Oct 2012
→ ~Jan 2014
Phase 1
~Apr 2014
→ ~Jul 2015
Phase 2
~Oct 2015
→ ~Jan 2017
Phase 3
~Apr 2017
→ ~Jul 2018
NDA/BLA
~Oct 2018
→ ~Jan 2020
Approved
Apr 2020
→ Oct 2025
ApprovedCurrent
NCT04947003
2,003 pts·Epilepsy
2020-04→2025-10·Terminated
2,003 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2025-10-225mo agoPh3 Readout· Epilepsy
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
Approved
Termina…
Catalysts
Ph3 Readout
2025-10-22 · 5mo ago
Epilepsy
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04947003 | Approved | Epilepsy | Terminated | 2003 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 | |
| ITO-535 | iTeos | NDA/BLA | MDM2 | |
| Tezeratamab | Prime Medicine | Phase 3 | CGRP |