Modality
Radioligand
MOA
WRNi
Target
CD38
Pathway
Ferroptosis
CTCLWilms
Development Pipeline
Preclinical
~Jun 2015
→ ~Sep 2016
Phase 1
~Dec 2016
→ ~Mar 2018
Phase 2
~Jun 2018
→ ~Sep 2019
Phase 3
Dec 2019
→ Sep 2028
Phase 3Current
NCT04169497
1,776 pts·Wilms
2023-04→2027-08·Recruiting
NCT05985972
357 pts·CTCL
2019-12→2027-01·Terminated
NCT04685542
394 pts·CTCL
2022-01→TBD·Terminated
+1 more trial
4,593 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2027-01-029mo awayPh3 Readout· CTCL
2027-08-161.4y awayPh3 Readout· Wilms
2028-09-012.4y awayPh3 Readout· Wilms
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P3
Termina…
P3
Not yet…
P3
Termina…
P3
Recruit…
Catalysts
Ph3 Readout
2027-01-02 · 9mo away
CTCL
Ph3 Readout
2027-08-16 · 1.4y away
Wilms
Ph3 Readout
2028-09-01 · 2.4y away
Wilms
RecruitingTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04169497 | Phase 3 | Wilms | Recruiting | 1776 | ORR |
| NCT05985972 | Phase 3 | CTCL | Terminated | 357 | SRI-4 |
| NCT04685542 | Phase 3 | CTCL | Terminated | 394 | UPCR |
| NCT06615945 | Phase 3 | Wilms | Not yet recr... | 2066 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| AMG-2752 | Amgen | Preclinical | MDM2 |