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PKN605

Phase 2

Atrial Fibrillation | Small molecule | Cardiovascular |Novartis AG|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment165
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07217067A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial FibrillationPHASE2 RECRUITING 165Oct 28, 2025Sep 9, 2027May 18, 202638 United States, Canada +5
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Study Endpoints
Primary Endpoints
Atrial fibrillation burden from ECG patch monitors
24 weeks

Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time

Secondary Endpoints
Time from the date of randomization to first atrial fibrillation recurrence
24 weeks
Presence of atrial fibrillation recurrence after randomization
24 weeks
Pharmacokinetic Parameter: concentration
24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PKN605 lower doseEXPERIMENTALPKN605 is an oral formulation
PKN605 higher doseEXPERIMENTALPKN605 is an oral formulation
PlaceboPLACEBO_COMPARATORPlacebo is an oral formulation
Interventions
NameTypeDescription
PKN605DRUGPKN605 is an oral formulation
PlaceboOTHERMatching placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Inclusions at Screening * Signed informed consent must be obtained prior to participation in the study * Male and female participants ≥ 18 years of age * History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fi...

Countries:United StatesCanadaChinaGermanyNetherlandsSingaporeUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07217067primaryCompletionDate: changed
LOWMay 24, 2026NCT07217067studyFirstPostDate: changed