Modality
ERT
MOA
USP1i
Target
WRN
Pathway
RAS/MAPK
HNSCC
Development Pipeline
Preclinical
~May 2019
→ ~Aug 2020
Phase 1
~Nov 2020
→ ~Feb 2022
Phase 2
~May 2022
→ ~Aug 2023
Phase 3
Nov 2023
→ Jun 2031
Phase 3Current
NCT04973149
2,980 pts·HNSCC
2025-06→2026-04·Active
NCT04750175
2,731 pts·HNSCC
2023-11→2031-06·Terminated
5,711 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-04-122w awayPh3 Readout· HNSCC
2026-08-155mo awayEMA Filing· HNSCC
2031-06-265.2y awayPh3 Readout· HNSCC
Trial Timeline
Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P3
Termina…
P3
Active
Catalysts
Ph3 Readout
2026-04-12 · 2w away
HNSCC
EMA Filing
2026-08-15 · 5mo away
HNSCC
Ph3 Readout
2031-06-26 · 5.2y away
HNSCC
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04973149 | Phase 3 | HNSCC | Active | 2980 | FEV1 |
| NCT04750175 | Phase 3 | HNSCC | Terminated | 2731 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 |