In short
EP395 is an investigational oral substance currently being studied for chronic obstructive pulmonary disease (COPD). The available clinical trial record is a completed Phase 1 study in 36 healthy participants that assessed how EP395 interacts with other medicines rather than its effect on COPD itself. This early-stage research focuses on the substance's drug interaction profile and how it is processed by the body.
Key points
- EP395 is an investigational substance studied in chronic obstructive pulmonary disease (COPD).
- One Phase 1 trial is available, completed with 36 healthy participants.
- The trial assessed drug interactions with verapamil, midazolam and digoxin, not COPD symptoms.
- EP395 was given orally at a dose of 375 mg in the study.
- The study measured pharmacokinetic (PK) parameters, meaning how the drug is absorbed, distributed, metabolised and excreted.
What is EP395?
EP395 is an investigational substance, meaning it has not been authorised as a medicine. The available trial record places it in the therapeutic area of respiratory tract diseases, specifically chronic obstructive pulmonary disease (COPD). No marketing authorisation, trade name or other development code is listed in the registry data for this substance.
How does EP395 work?
The available trial record does not describe the mechanism of action of EP395. No information is provided about the molecular target, the biological pathway affected, or how the substance might influence COPD. The only clinical data available concerns how EP395 is processed by the body and how it interacts with other medicines, not how it works against disease.
Which conditions is EP395 studied for?
- Chronic obstructive pulmonary disease (COPD) — a long-term lung condition that makes breathing difficult. The trial record lists COPD as the condition under study, although the trial itself enrolled healthy participants to investigate drug interactions rather than COPD symptoms.
How is EP395 given?
In the available trial, EP395 was administered orally at a dose of 375 mg. The pharmaceutical form is not further specified in the registry record. No information is available about other formulations, strengths, or routes of administration.
What do the clinical trials show?
One clinical trial of EP395 is available in the registry. It is a Phase 1 study that has been completed. The trial enrolled 36 healthy participants and was designed as an open-label, two-part study. Part A assessed the effect of verapamil at steady state on systemic exposure of EP395. Part B assessed the effect of EP395 at steady state on systemic exposure of midazolam and digoxin.
The primary outcome of the trial was the pharmacokinetic (PK) parameters of EP395 in Part A, and the PK parameters of midazolam and digoxin in Part B. Pharmacokinetic parameters describe how much of a drug is in the blood over time, how quickly it is absorbed, and how it is broken down and removed from the body. This type of study is common in early drug development to understand potential interactions with other medicines.
No trial results, efficacy data in COPD patients, or safety findings from this study are reported in the registry record. The study was conducted in healthy volunteers, not in people with COPD.
What side effects are known?
No side effect information for EP395 is available in the registry record. The available trial data does not report adverse events or safety outcomes.