Modality
Gene Editing
MOA
USP1i
Target
KRASG12D
Pathway
NF-κB
ADHD
Development Pipeline
Preclinical
~Dec 2014
→ ~Mar 2016
Phase 1
~Jun 2016
→ ~Sep 2017
Phase 2
~Dec 2017
→ ~Mar 2019
Phase 3
Jun 2019
→ Apr 2029
Phase 3Current
NCT04076949
1,869 pts·ADHD
2023-01→2029-04·Recruiting
NCT08146255
1,747 pts·ADHD
2023-09→TBD·Completed
NCT03415788
1,305 pts·ADHD
2019-06→2026-08·Terminated
4,921 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-144mo awayPh3 Readout· ADHD
2029-04-103.0y awayPh3 Readout· ADHD
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
P3
Termina…
P3
Recruit…
P3
Complet…
Catalysts
Ph3 Readout
2026-08-14 · 4mo away
ADHD
Ph3 Readout
2029-04-10 · 3.0y away
ADHD
RecruitingCompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04076949 | Phase 3 | ADHD | Recruiting | 1869 | PANSS |
| NCT08146255 | Phase 3 | ADHD | Completed | 1747 | eGFR |
| NCT03415788 | Phase 3 | ADHD | Terminated | 1305 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 | |
| 207-2754 | Samsung Biologics | Phase 1/2 | KRASG12D |