Modality
Nanobody
MOA
CGRPant
Target
KRASG12C
Pathway
JAK/STAT
EpilepsyHNSCCPsoriasis
Development Pipeline
Preclinical
~Mar 2011
→ ~Jun 2012
Phase 1
~Sep 2012
→ ~Dec 2013
Phase 2
~Mar 2014
→ ~Jun 2015
Phase 3
~Sep 2015
→ ~Dec 2016
NDA/BLA
~Mar 2017
→ ~Jun 2018
Approved
Sep 2018
→ Mar 2030
ApprovedCurrent
NCT04217569
2,544 pts·HNSCC
2025-02→2025-02·Active
NCT05258048
2,211 pts·Epilepsy
2018-09→2026-12·Terminated
NCT03100265
1,191 pts·Psoriasis
2021-10→2030-03·Recruiting
+1 more trial
7,363 total pts3 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-02-251.1y agoPh3 Readout· HNSCC
2026-03-034w agoPh3 Readout· HNSCC
2026-12-199mo awayPh3 Readout· Epilepsy
2030-03-164.0y awayPh3 Readout· Psoriasis
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Termina…
Approved
Recruit…
Approved
Recruit…
Approved
Active
Catalysts
Ph3 Readout
2025-02-25 · 1.1y ago
HNSCC
Ph3 Readout
2026-03-03 · 4w ago
HNSCC
Ph3 Readout
2026-12-19 · 9mo away
Epilepsy
Ph3 Readout
2030-03-16 · 4.0y away
Psoriasis
RecruitingActiveTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04217569 | Approved | HNSCC | Active | 2544 | OS |
| NCT05258048 | Approved | Epilepsy | Terminated | 2211 | EFS |
| NCT03100265 | Approved | Psoriasis | Recruiting | 1191 | LiverFat |
| NCT04321420 | Approved | HNSCC | Recruiting | 1417 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| JNJ-179 | Johnson & Johnson | Approved | KRASG12C | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Doxarapivir | Bristol-Myers Squibb | Phase 3 | KRASG12C | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C |