Modality
mAb
MOA
HPK1i
Target
BTK
Pathway
Lipid Met
Wilms
Development Pipeline
Preclinical
~Apr 2012
→ ~Jul 2013
Phase 1
~Oct 2013
→ ~Jan 2015
Phase 2
~Apr 2015
→ ~Jul 2016
Phase 3
~Oct 2016
→ ~Jan 2018
NDA/BLA
~Apr 2018
→ ~Jul 2019
Approved
Oct 2019
→ Dec 2031
ApprovedCurrent
NCT08698537
1,397 pts·Wilms
2025-04→2029-09·Completed
NCT06316519
2,800 pts·Wilms
2021-03→2031-12·Not yet recruiting
NCT03386686
629 pts·Wilms
2019-10→2030-07·Not yet recruiting
+1 more trial
7,628 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2029-09-123.5y awayPh3 Readout· Wilms
2030-07-174.3y awayPh3 Readout· Wilms
2030-12-214.7y awayPh3 Readout· Wilms
2031-12-265.7y awayPh3 Readout· Wilms
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Not yet…
Approved
Not yet…
Approved
Termina…
Approved
Complet…
Catalysts
Ph3 Readout
2029-09-12 · 3.5y away
Wilms
Ph3 Readout
2030-07-17 · 4.3y away
Wilms
Ph3 Readout
2030-12-21 · 4.7y away
Wilms
Ph3 Readout
2031-12-26 · 5.7y away
Wilms
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08698537 | Approved | Wilms | Completed | 1397 | BodyWt |
| NCT06316519 | Approved | Wilms | Not yet recr... | 2800 | DAS28 |
| NCT03386686 | Approved | Wilms | Not yet recr... | 629 | Biomarker |
| NCT04840400 | Approved | Wilms | Terminated | 2802 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| PFE-1944 | Pfizer | NDA/BLA | APOC3 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| ABB-7516 | AbbVie | Phase 3 | PD-L1 | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| 369-8021 | Hansoh Pharma | Approved | BTK | |
| Semasacituzumab | Illumina | Phase 3 | Nectin-4 |