← Pipeline|Fixafutibatinib

Fixafutibatinib

Phase 3
DNL-164
Source: Trial-derived·Trials: 4
Modality
Vaccine
MOA
EGFRi
Target
PRMT5
Pathway
Innate Imm
CTCLHS
Development Pipeline
Preclinical
~May 2014
~Aug 2015
Phase 1
~Nov 2015
~Feb 2017
Phase 2
~May 2017
~Aug 2018
Phase 3
Nov 2018
Apr 2027
Phase 3Current
NCT07204584
2,699 pts·HS
2024-102027-04·Terminated
NCT05516061
1,845 pts·HS
2024-05TBD·Completed
NCT03856432
548 pts·CTCL
2020-042027-01·Terminated
+1 more trial
7,452 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-01-129mo awayPh3 Readout· CTCL
2027-04-091.0y awayPh3 Readout· HS
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
P3
Active
P3
Termina…
P3
Complet…
P3
Termina…
Catalysts
Ph3 Readout
2027-01-12 · 9mo away
CTCL
Ph3 Readout
2027-04-09 · 1.0y away
HS
ActiveCompletedTerminated|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT07204584Phase 3HSTerminated2699VA
NCT05516061Phase 3HSCompleted1845FEV1
NCT03856432Phase 3CTCLTerminated548SRI-4
NCT07261753Phase 3HSActive2360PASI75
Competitors (10)
DrugCompanyPhaseTargetMOA
NiranesiranJohnson & JohnsonPhase 2KIF18AEGFRi
JNJ-5094Johnson & JohnsonPhase 2/3GIP-REGFRi
NirarelsinJohnson & JohnsonPhase 2PRMT5CD47i
MRK-853Merck & CoPhase 1PRMT5WEE1i
GeliderotideSanofiPhase 1/2PRMT5JAK1i
CapifutibatinibSanofiApprovedPRMT5PI3Ki
NVO-9615Novo NordiskPhase 2/3PRMT5EZH2i
SuracageneGSKPhase 3PRMT5FcRni
GSK-2051GSKPhase 1PSMAEGFRi
GIL-8529Gilead SciencesPhase 1/2JAK1EGFRi