In short
AZD8965 is an investigational medicine being studied for idiopathic pulmonary fibrosis (IPF), a serious lung disease that causes progressive scarring of the lungs. The clinical trial data currently available includes one authorised Phase 2b study with a planned enrollment of 360 participants. The trial compares AZD8965 taken by mouth with a placebo over 24 weeks, measuring the change in forced vital capacity (FVC), a key measure of lung function.
Key points
- AZD8965 is an investigational substance with no marketing authorisation in the available records.
- The only registered trial is a Phase 2b study in idiopathic pulmonary fibrosis (IPF).
- The trial plans to enroll 360 participants and is currently authorised.
- Participants receive AZD8965 or placebo by oral use.
- The main outcome is the change in forced vital capacity (FVC) from baseline at Week 24.
- The trial record is available in the EU Clinical Trials Information System under number 2025-525016-41-00.
What is AZD8965?
AZD8965 is an investigational medicine, which means it is not yet authorised as a medicine for any condition. The substance is studied in the therapeutic area of respiratory diseases. It is a chemically synthesised substance, given by oral use as a pharmaceutical form in the registered trial. The trial record does not provide other names, development codes, or trade names for AZD8965, and no marketing authorisation is listed in the available data.
How does AZD8965 work?
The available clinical trial record does not describe the mechanism of action of AZD8965. No molecular target, pathway, or pharmacological class is stated in the data provided. The trial is designed to evaluate the clinical efficacy of AZD8965 compared with placebo on lung function in idiopathic pulmonary fibrosis, but the biological mechanism by which AZD8965 might act is not described in the source material.
Which conditions is AZD8965 studied for?
The only condition for which AZD8965 is studied in the available trial data is:
- Idiopathic pulmonary fibrosis (IPF) — a chronic lung disease in which the tissue around the air sacs of the lungs becomes thickened and scarred, making it progressively harder to breathe. The term "idiopathic" means the cause is unknown.
How is AZD8965 given?
In the registered trial, AZD8965 is given by oral use, meaning it is taken by mouth. The trial record lists the dose as 00 mg, which indicates that the specific dose was not reported in the register. The pharmaceutical form is not described in detail in the available data.
What do the clinical trials show?
There is one registered clinical trial for AZD8965, a Phase 2b study in participants with idiopathic pulmonary fibrosis (IPF). The trial is currently authorised, meaning it has received regulatory approval to proceed but results are not yet available. The study plans to enroll 360 participants.
The trial compares AZD8965 with a placebo, an inactive substance that looks like the study medicine but contains no active ingredient. Participants are assigned to receive either AZD8965 or placebo by oral use.
The main outcome measured in the trial is the change from baseline in forced vital capacity (FVC), expressed in millilitres (mL), at Week 24. Forced vital capacity is the total amount of air a person can exhale forcefully after taking a deep breath; a decline in FVC is a key indicator of disease progression in IPF. The study will compare the change in FVC between participants receiving AZD8965 and those receiving placebo.
What side effects are known?
The available clinical trial record does not provide information on side effects of AZD8965. No safety data, adverse event reports, or tolerability findings are included in the source material. As AZD8965 is an investigational medicine in Phase 2b development, safety information would typically be collected during the trial, but none is reported in the data provided.