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← Pipeline|NUW-6701

NUW-6701

Approved
By Nuwellis (fka CHF Sol)
Source: Trial-derived·Trials: 3
Modality
Gene Therapy
MOA
PI3Ki
Target
TROP-2
Pathway
Angiogenesis
Urothelial CaProstate CaDLBCL
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
→ Aug 2028
ApprovedCurrent
NCT08580571
232 pts·Urothelial Ca
2022-08→2025-09·Active
NCT04898242
1,158 pts·Urothelial Ca
2020-11→2028-08·Active
NCT04772053
2,097 pts·DLBCL
2017-06→2028-05·Terminated
3,487 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-09-246mo agoPh3 Readout· Urothelial Ca
2028-05-012.1y awayPh3 Readout· DLBCL
2028-08-132.4y awayPh3 Readout· Urothelial Ca
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Termina…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2025-09-24 · 6mo ago
Urothelial Ca
Ph3 Readout
2028-05-01 · 2.1y away
DLBCL
Ph3 Readout
2028-08-13 · 2.4y away
Urothelial Ca
ActiveTerminated|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT08580571ApprovedUrothelial CaActive232FEV1
NCT04898242ApprovedUrothelial CaActive1158OS
NCT04772053ApprovedDLBCLTerminated2097PANSS
Competitors (10)
DrugCompanyPhaseTargetMOA
TiramavacamtenRochePreclinicalSGLT2PI3Ki
NVS-4076NovartisPreclinicalTROP-2DLL3 ADC
NVS-5126NovartisPhase 3SHP2PI3Ki
NVS-8902NovartisPreclinicalTROP-2IL-13i
VoxacilimabAstraZenecaPhase 1/2GLP-1RPI3Ki
CapifutibatinibSanofiApprovedPRMT5PI3Ki
RimatenlimabNovo NordiskPhase 2/3SGLT2PI3Ki
ZanumavacamtenGSKPhase 2/3TROP-2BTKi
REG-3155RegeneronPhase 1/2MDM2PI3Ki
SRP-3270SareptaPhase 1/2SGLT2PI3Ki