Modality
ADC
MOA
BETi
Target
KRASG12C
Pathway
Checkpoint
DMDSCLCNarcolepsy
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Feb 2029
ApprovedCurrent
NCT08826703
1,349 pts·SCLC
2017-01→2027-05·Recruiting
NCT06416354
1,692 pts·Narcolepsy
2018-02→2027-11·Active
NCT06534231
1,619 pts·Narcolepsy
2025-12→2026-01·Not yet recruiting
+1 more trial
5,623 total pts3 indications
CompletedCurrentUpcoming
Catalysts (5)
2026-01-162mo agoPh3 Readout· Narcolepsy
2026-12-199mo awayOrphan Drug· DMD
2027-05-271.2y awayPh3 Readout· SCLC
2027-11-201.6y awayPh3 Readout· Narcolepsy
2029-02-192.9y awayPh3 Readout· DMD
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Recruit…
Approved
Active
Approved
Recruit…
Approved
Not yet…
Catalysts
Ph3 Readout
2026-01-16 · 2mo ago
Narcolepsy
Orphan Drug
2026-12-19 · 9mo away
DMD
Ph3 Readout
2027-05-27 · 1.2y away
SCLC
Ph3 Readout
2027-11-20 · 1.6y away
Narcolepsy
Ph3 Readout
2029-02-19 · 2.9y away
DMD
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08826703 | Approved | SCLC | Recruiting | 1349 | Mayo |
| NCT06416354 | Approved | Narcolepsy | Active | 1692 | PFS |
| NCT06534231 | Approved | Narcolepsy | Not yet recr... | 1619 | OS |
| NCT04486187 | Approved | DMD | Recruiting | 963 | DOR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Sovarapivir | AbbVie | Phase 2/3 | IL-13 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Doxarapivir | Bristol-Myers Squibb | Phase 3 | KRASG12C | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C | |
| VRT-1891 | Vertex Pharma | Phase 1 | KRASG12C | |
| BII-1564 | Biogen | Phase 2 | PSMA | |
| Sovanaritide | Argenx | Phase 3 | TNFα |