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← Pipeline|DIV-9629

DIV-9629

Phase 3
By Divi's Laboratories
Source: Trial-derived·Trials: 4
Modality
Peptide
MOA
CDK4/6i
Target
HER2
Pathway
Fibrosis
Urothelial Ca
Development Pipeline
Preclinical
~Jul 2013
→ ~Oct 2014
Phase 1
~Jan 2015
→ ~Apr 2016
Phase 2
~Jul 2016
→ ~Oct 2017
Phase 3
Jan 2018
→ Oct 2031
Phase 3Current
NCT05448433
1,365 pts·Urothelial Ca
2019-07→2027-03·Active
NCT04409663
2,506 pts·Urothelial Ca
2021-11→2025-01·Not yet recruiting
NCT08498078
729 pts·Urothelial Ca
2018-01→2029-03·Terminated
+1 more trial
5,864 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-01-051.2y agoPh3 Readout· Urothelial Ca
2027-03-0511mo awayPh3 Readout· Urothelial Ca
2029-03-273.0y awayPh3 Readout· Urothelial Ca
2031-10-275.6y awayPh3 Readout· Urothelial Ca
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Termina…
P3
Active
P3
Not yet…
P3
Complet…
Catalysts
Ph3 Readout
2025-01-05 · 1.2y ago
Urothelial Ca
Ph3 Readout
2027-03-05 · 11mo away
Urothelial Ca
Ph3 Readout
2029-03-27 · 3.0y away
Urothelial Ca
Ph3 Readout
2031-10-27 · 5.6y away
Urothelial Ca
ActiveCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT05448433Phase 3Urothelial CaActive1365CfB
NCT04409663Phase 3Urothelial CaNot yet recr...2506NT-proBNP
NCT08498078Phase 3Urothelial CaTerminated729Biomarker
NCT08375222Phase 3Urothelial CaCompleted1264CR
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-5767PfizerPhase 1/2BETCDK4/6i
RHH-1969RocheApprovedBETCDK4/6i
IvocapivasertibBristol-Myers SquibbPhase 1BETCDK4/6i
GozesotorasibBristol-Myers SquibbNDA/BLAHER2IL-13i
ZorimavacamtenBristol-Myers SquibbPreclinicalCl18.2CDK4/6i
FixatenlimabGSKPhase 1/2JAK1CDK4/6i
VRT-4938Vertex PharmaPreclinicalHER2CDK4/6i
VRT-5441Vertex PharmaPhase 3GLP-1RCDK4/6i
AdagracapivasertibBeiGeneNDA/BLABETCDK4/6i
NBI-3153NeurocrineApprovedAβCDK4/6i