Modality
Degrader
MOA
USP1i
Target
HER2
Pathway
Apoptosis
IPF
Development Pipeline
Preclinical
~Jun 2017
→ ~Sep 2018
Phase 1
~Dec 2018
→ ~Mar 2020
Phase 2
~Jun 2020
→ ~Sep 2021
Phase 3
~Dec 2021
→ ~Mar 2023
NDA/BLA
Jun 2023
→ Jun 2028
NDA/BLACurrent
NCT04449029
541 pts·IPF
2023-06→2028-06·Completed
541 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-06-022.2y awayPh3 Readout· IPF
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2028-06-02 · 2.2y away
IPF
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04449029 | NDA/BLA | IPF | Completed | 541 | Mayo |
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 | |
| ITO-535 | iTeos | NDA/BLA | MDM2 | |
| Tezeratamab | Prime Medicine | Phase 3 | CGRP | |
| ELV-1411 | Enliven | NDA/BLA | HER2 |