Modality
ADC
MOA
AuroraAi
Target
HER2
Pathway
Apoptosis
RCC
Development Pipeline
Preclinical
~Dec 2009
→ ~Mar 2011
Phase 1
~Jun 2011
→ ~Sep 2012
Phase 2
~Dec 2012
→ ~Mar 2014
Phase 3
~Jun 2014
→ ~Sep 2015
NDA/BLA
~Dec 2015
→ ~Mar 2017
Approved
Jun 2017
→ Nov 2031
ApprovedCurrent
NCT04485214
1,391 pts·RCC
2022-12→TBD·Active
NCT05712042
2,081 pts·RCC
2020-02→TBD·Terminated
NCT08901744
2,722 pts·RCC
2017-06→2031-11·Active
+1 more trial
8,763 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2031-10-185.5y awayPh3 Readout· RCC
2031-11-195.6y awayPh3 Readout· RCC
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Active
Approved
Termina…
Approved
Recruit…
Approved
Active
Catalysts
Ph3 Readout
2031-10-18 · 5.5y away
RCC
Ph3 Readout
2031-11-19 · 5.6y away
RCC
RecruitingActiveTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04485214 | Approved | RCC | Active | 1391 | VA |
| NCT05712042 | Approved | RCC | Terminated | 2081 | EFS |
| NCT08901744 | Approved | RCC | Active | 2722 | VA |
| NCT07398305 | Approved | RCC | Recruiting | 2569 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR | |
| ILM-2412 | Illumina | Phase 3 | PLK4 |