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← Pipeline|BRK-679

BRK-679

Approved
By Bruker
Source: Trial-derived·Trials: 4
Modality
Gene Therapy
MOA
FXIai
Target
PRMT5
Pathway
Sphingolipid
Endometrial CaSCLCMCC
Development Pipeline
Preclinical
~Aug 2010
→ ~Nov 2011
Phase 1
~Feb 2012
→ ~May 2013
Phase 2
~Aug 2013
→ ~Nov 2014
Phase 3
~Feb 2015
→ ~May 2016
NDA/BLA
~Aug 2016
→ ~Nov 2017
Approved
Feb 2018
→ Feb 2030
ApprovedCurrent
NCT07947436
2,838 pts·SCLC
2025-02→2027-03·Active
NCT03301781
2,519 pts·SCLC
2018-02→2030-02·Not yet recruiting
NCT04009609
1,828 pts·Endometrial Ca
2025-11→2025-09·Terminated
+1 more trial
7,972 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-09-077mo agoPh3 Readout· Endometrial Ca
2025-12-213mo agoPh3 Readout· Endometrial Ca
2027-03-0711mo awayPh3 Readout· SCLC
2030-02-123.9y awayPh3 Readout· SCLC
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Not yet…
Approved
Active
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2025-09-07 · 7mo ago
Endometrial Ca
Ph3 Readout
2025-12-21 · 3mo ago
Endometrial Ca
Ph3 Readout
2027-03-07 · 11mo away
SCLC
Ph3 Readout
2030-02-12 · 3.9y away
SCLC
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT07947436ApprovedSCLCActive2838PASI75
NCT03301781ApprovedSCLCNot yet recr...2519EFS
NCT04009609ApprovedEndometrial CaTerminated1828DAS28
NCT06594281ApprovedEndometrial CaActive787PFS
Competitors (10)
DrugCompanyPhaseTargetMOA
NirarelsinJohnson & JohnsonPhase 2PRMT5CD47i
NVS-6360NovartisApprovedCD38FXIai
MRK-853Merck & CoPhase 1PRMT5WEE1i
MRK-3745Merck & CoPhase 2WRNFXIai
AZN-1715AstraZenecaPhase 3AHRFXIai
BMY-9931Bristol-Myers SquibbPhase 1GPRC5DFXIai
GeliderotideSanofiPhase 1/2PRMT5JAK1i
CapifutibatinibSanofiApprovedPRMT5PI3Ki
NVO-7877Novo NordiskPreclinicalGPRC5DFXIai
NVO-9615Novo NordiskPhase 2/3PRMT5EZH2i