Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PKN605 · 2 trials · 2 indications
Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time
Cmax: The maximum (peak) observed plasma concentration
AUClast: The AUC from time zero to the last measurable concentration sampling time (Tlast)
AUCinf: The AUC from time zero to infinity
Tmax: The time to reach maximum (peak) plasma concentration
AUC0-t: The AUC from time zero to time t
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi-logarithmic concentration-time curve (time)
Tlast: The last measurable concentration sampling time
CL/F: The apparent total body clearance of drug from the plasma
Vz/F: The apparent volume of distribution during terminal phase (associated with λz)
| Arm | Type | Description |
|---|---|---|
| PKN605 lower dose | EXPERIMENTAL | PKN605 is an oral formulation |
| PKN605 higher dose | EXPERIMENTAL | PKN605 is an oral formulation |
| Placebo | PLACEBO_COMPARATOR | Placebo is an oral formulation |
| Group 1 | EXPERIMENTAL | PKN605 in participants with moderate renal impairment |
| Group 2 | EXPERIMENTAL | PKN605 in participants with severe renal impairment |
| Group 3 | EXPERIMENTAL | PKN605 in healthy participants with normal renal function |
| Name | Type | Description |
|---|---|---|
| PKN605 | DRUG | PKN605 is an oral formulation |
| Placebo | OTHER | Matching placebo |
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...
PKN605 is an investigational small molecule being developed for the treatment of atrial fibrillation, a condition characterized by an irregular and often rapid heart rate. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
PKN605 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 2 clinical trial to evaluate the drug's efficacy, safety, tolerability, and pharmacokinetics in participants with atrial fibrillation.
PKN605 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for any use. The ongoing Phase 2 trial is actively recruiting participants to study its effects in people with atrial fibrillation.
PKN605 is being studied in a Phase 2 clinical trial registered as NCT07217067. This randomized, double-blind, placebo-controlled study is investigating the efficacy, safety, tolerability, and pharmacokinetics of PKN605 in participants with atrial fibrillation. The trial aims to enroll 165 participants across multiple countries, including the United States, Canada, China, Germany, Netherlands, Singapore, and the United Kingdom.
No, PKN605 is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials. The ongoing study is designed to evaluate its safety and efficacy in patients with atrial fibrillation, but it has not yet completed the clinical development process required for regulatory approval.