Modality
Radioligand
MOA
AuroraAi
Target
CGRP
Pathway
JAK/STAT
HNSCCLGS
Development Pipeline
Preclinical
~Nov 2015
→ ~Feb 2017
Phase 1
~May 2017
→ ~Aug 2018
Phase 2
Nov 2018
→ Feb 2030
Phase 2Current
NCT05538263
1,423 pts·HNSCC
2020-12→2029-02·Recruiting
NCT05131275
2,098 pts·HNSCC
2018-11→2030-02·Completed
3,521 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-02-282.9y awayPh3 Readout· HNSCC
2030-02-143.9y awayPh3 Readout· HNSCC
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P2/3
Complet…
P2/3
Recruit…
Catalysts
Ph3 Readout
2029-02-28 · 2.9y away
HNSCC
Ph3 Readout
2030-02-14 · 3.9y away
HNSCC
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05538263 | Phase 2/3 | HNSCC | Recruiting | 1423 | PFS |
| NCT05131275 | Phase 2/3 | HNSCC | Completed | 2098 | SRI-4 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA |