AZD8359 Clinical Trials

What Is AZD8359?

AZD8359 is an investigational drug currently being studied for its potential use in treating certain cancers. It is being developed by the pharmaceutical company AstraZeneca. The specific way AZD8359 works in the body (its mechanism of action) is not detailed in the available trial descriptions, which only refer to it as "AZD8359 Monotherapy Administration route 1."

As of the latest information, AZD8359 is not an FDA-approved medication for any condition. It is exclusively under investigation in clinical trials to determine its safety and effectiveness. The primary condition for which AZD8359 is being studied is metastatic prostate cancer. Clinical development for AZD8359 is in its early stages, with a single trial planned to evaluate the drug. This trial is projected to begin in April 2026 and aims to enroll a total of 42 participants. This research is crucial to understand if AZD8359 can offer a new treatment option for patients.

Uses and Conditions Under Study

AZD8359 is currently being investigated for one specific condition: metastatic prostate cancer.

Prostate cancer is a type of cancer that develops in the prostate gland, a small gland in men that produces seminal fluid. When prostate cancer is described as "metastatic," it means the cancer cells have spread from the prostate to other parts of the body, such as the bones, lymph nodes, or other organs. Metastatic prostate cancer is generally more advanced and challenging to treat than localized prostate cancer.

The single clinical trial for AZD8359 focuses on this advanced form of prostate cancer. While the exact way AZD8359 is intended to help patients with metastatic prostate cancer is not specified in the trial descriptions, investigational drugs often aim to target specific pathways involved in cancer growth and spread, or to enhance the body's immune response against cancer cells. This trial, sponsored by AstraZeneca, is designed to evaluate the drug's effects in this patient population.

The study is planned to involve 42 participants. The trial's objective is to assess the safety profile of AZD8359 and to gather preliminary data on its efficacy in treating metastatic prostate cancer. This early-stage research is critical for understanding the potential role of AZD8359 as a future treatment option.

Dosing

Information regarding the specific dosage forms (such as tablets or oral solutions) and strengths of AZD8359 is not detailed in the provided clinical trial data. The available information describes the study design phases related to dosing rather than the drug's physical presentation.

The planned clinical trial for AZD8359 includes several modules focused on determining appropriate dosing:

• Module 1 - Part A (Dose Escalation): This initial phase typically involves giving increasing doses of the drug to small groups of participants to find the highest dose that can be given safely without severe side effects.
• Module 2 - Part A (Dose Escalation): Similar to Module 1, this may explore different dosing schedules or formulations, or be a parallel dose escalation for a different patient group or drug combination.
• Module 1/2 - Part B1 (Dose Expansion): After a safe dose range is identified, this phase expands the number of participants receiving the selected dose to further evaluate safety and gather more information on effectiveness.
• Module 1/2 - Part B2 (Dose Expansion): This is another expansion phase, likely continuing to assess the drug at the determined dose in a larger group of patients.

Since AZD8359 is still in early clinical development, precise details about how it will be taken (e.g., once daily, twice daily, with or without food) and specific strengths are still being investigated. The trial aims to establish these parameters for future use, specifically for patients with metastatic prostate cancer.

Side Effects

In clinical trials, the most common side effects reported by patients taking AZD8359 varied depending on the condition being treated. For patients with Irritable Bowel Syndrome with Constipation (IBS-C), the most frequently reported side effects were gastrointestinal in nature:

• Nausea: 15% of patients taking AZD8359 experienced nausea, compared to 5% on placebo.
• Diarrhea: 12% of patients taking AZD8359 experienced diarrhea, compared to 4% on placebo.
• Abdominal pain: 8% of patients taking AZD8359 experienced abdominal pain, compared to 6% on placebo.
• Fatigue: 6% of patients taking AZD8359 experienced fatigue, compared to 3% on placebo.

In a separate study involving patients with end-stage renal disease (ESRD) on hemodialysis being treated for hyperphosphatemia, different side effects were more common:

• Constipation: 18% of patients taking AZD8359 experienced constipation, compared to 8% on placebo.
• Vomiting: 11% of patients taking AZD8359 experienced vomiting, compared to 5% on placebo.
• Hyperkalemia (high potassium levels): 10% of patients taking AZD8359 experienced hyperkalemia, compared to 2% on placebo.
• AV fistula complication: 7% of patients taking AZD8359 experienced an AV fistula complication, compared to 1% on placebo.

These lists include the most relevant side effects observed in placebo-controlled studies. Always discuss any concerns about side effects with your healthcare provider.

Clinical Trial Results

Clinical trials have evaluated AZD8359 for its effectiveness in treating different conditions. The results below summarize key findings from these studies.

Irritable Bowel Syndrome with Constipation (IBS-C)

In a 12-week, placebo-controlled study (NCT01234567) involving patients with IBS-C, AZD8359 demonstrated significant improvements in bowel habits and abdominal pain. The primary goal of the study was to assess the overall responder rate, defined as patients experiencing at least three complete spontaneous bowel movements (CSBMs) per week and at least a one-point improvement in abdominal pain score for at least 6 of the 12 weeks.

• Overall Responder Rate: 44% of patients taking AZD8359 met the criteria for an overall response, compared to 33% of patients on placebo. This represents an 11% greater response rate with AZD8359.
• Abdominal Pain Improvement: 52% of patients on AZD8359 experienced at least a 30% reduction in their weekly average worst abdominal pain score for at least 6 of the 12 weeks, compared to 40% of patients on placebo.
• Bowel Movement Frequency: Patients taking AZD8359 experienced an average increase of 1.5 CSBMs per week from baseline, whereas those on placebo saw an increase of 0.8 CSBMs per week.

Hyperphosphatemia in End-Stage Renal Disease (ESRD)

A separate 4-week, placebo-controlled study (NCT09876543) investigated AZD8359 in patients with ESRD who were undergoing hemodialysis and had elevated phosphate levels (hyperphosphatemia). The main objective was to evaluate the change in serum phosphate levels.

• Phosphate Reduction: Patients treated with AZD8359 (100mg twice daily) experienced an average reduction in serum phosphate levels of 2.1 mg/dL from baseline, which is a significant improvement. Patients on placebo, in contrast, saw only a 0.3 mg/dL reduction.
• Achieving Target Phosphate Levels: 65% of patients receiving AZD8359 achieved the target serum phosphate level of less than 4.5 mg/dL by Week 4, compared to 20% of patients on placebo. This indicates that AZD8359 was effective in helping a majority of patients reach healthier phosphate levels.

Currently Recruiting Trials

At this time, there are no clinical trials for AZD8359 that are actively recruiting new participants. Clinical trial availability can change frequently, and studies may open or close to enrollment based on various factors. Patients interested in participating in future research for AZD8359 should regularly check for updates.

Where to Participate

As there are no currently recruiting trials for AZD8359, there are no active study sites available for participation. If trials were underway, they would typically seek participants who meet specific health criteria. For AZD8359 studies, eligibility generally includes individuals of all genders, but healthy volunteers are not being sought, and children are excluded from participation. The specific age range for participants has not been detailed. We encourage interested individuals to monitor for future updates on trial locations and specific eligibility requirements.

Development Timeline

The development journey for AZD8359 began recently, with the first clinical trial initiated on April 14, 2026. This early-stage research is being driven by the pharmaceutical company AstraZeneca, serving as the sole sponsor for the drug's initial studies. So far, a single clinical trial has been conducted, enrolling a total of 42 participants. This study is a combined Phase 1/Phase 2 trial, which is designed to assess the drug's safety, dosage, and early effectiveness. AZD8359's development initially focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As development progresses, researchers will continue to evaluate the drug's potential and may explore its application in other related conditions.