#1 Clinical Trials Search in Europe

Baxdrostat

Baxdrostat, also known as CIN-107, is a novel drug being studied in clinical trials for the treatment of hypertension (high blood pressure). This aldosterone synthase inhibitor is showing promise in helping patients with uncontrolled and resistant hypertension who have not responded adequately to other medications. The trials are evaluating Baxdrostat’s safety, efficacy, and how it interacts with other drugs in the body.

Table of Contents

What is Baxdrostat?

Baxdrostat, also known as CIN-107, is a new medication being developed to treat high blood pressure (hypertension)[1]. It belongs to a class of drugs called aldosterone synthase inhibitors[2]. Baxdrostat is currently undergoing clinical trials to evaluate its effectiveness and safety in treating various forms of hypertension, including uncontrolled hypertension and resistant hypertension[3].

How Baxdrostat Works

Baxdrostat works by inhibiting an enzyme called aldosterone synthase[2]. Aldosterone is a hormone that plays a crucial role in regulating blood pressure by controlling the balance of salt and water in the body. By blocking the production of aldosterone, Baxdrostat aims to lower blood pressure in patients who have not responded well to other treatments[3].

Conditions Treated by Baxdrostat

Baxdrostat is being studied for the treatment of several types of hypertension:

  • Uncontrolled Hypertension: This refers to high blood pressure that remains above target levels despite treatment with two or more medications, including a diuretic[3].
  • Resistant Hypertension: This is a more severe form of hypertension that persists despite treatment with three or more medications, including a diuretic[4].

Clinical Trials and Research

Several clinical trials are currently underway to evaluate Baxdrostat’s effectiveness and safety:

  • Phase 3 studies are examining the drug’s ability to lower systolic blood pressure (the top number in a blood pressure reading) in patients with uncontrolled and resistant hypertension[3][5].
  • Researchers are investigating the effects of Baxdrostat on 24-hour ambulatory blood pressure monitoring, which provides a more comprehensive picture of a person’s blood pressure throughout the day and night[4].
  • Studies are also looking at how Baxdrostat affects various aspects of heart function, including heart rate and electrical activity of the heart (as measured by ECG)[6].

Dosage and Administration

In clinical trials, Baxdrostat is being tested at different doses, typically ranging from 1 mg to 2 mg taken orally once daily[3][5]. The optimal dosage may vary depending on individual patient factors and will be determined based on the results of ongoing studies.

Potential Side Effects and Safety Considerations

As with any medication, Baxdrostat may cause side effects. While the full safety profile is still being established through clinical trials, some potential areas of concern include:

  • Effects on cortisol levels: Researchers are studying how Baxdrostat might affect the body’s stress hormone, cortisol[7].
  • Changes in electrolyte balance: Given its mechanism of action, Baxdrostat could potentially affect levels of potassium and sodium in the body[6].
  • Blood pressure changes: While the goal is to lower high blood pressure, monitoring is important to ensure blood pressure doesn’t drop too low[6].

It’s important to note that as Baxdrostat is still in clinical trials, not all potential side effects may be known at this time. Patients participating in trials are closely monitored for any adverse events.

Drug Interactions

Researchers are studying how Baxdrostat interacts with other medications. Some specific interactions being investigated include:

  • Itraconazole: This antifungal medication is being used to study how drugs that affect certain liver enzymes might interact with Baxdrostat[8].
  • Oral contraceptives: Studies are examining whether Baxdrostat affects the levels of hormones in birth control pills[9].

These studies will help determine if any special precautions or dosage adjustments are needed when taking Baxdrostat with other medications.

Aspect Details
Drug Name Baxdrostat (also known as CIN-107)
Drug Class Aldosterone synthase inhibitor
Target Condition Uncontrolled hypertension and resistant hypertension
Dosages Studied 1 mg, 2 mg, 3 mg, 10 mg oral tablets
Administration Once daily oral dose
Primary Outcomes Changes in systolic and diastolic blood pressure
Secondary Outcomes Pharmacokinetics, safety, tolerability
Study Populations Adults with uncontrolled or resistant hypertension, healthy volunteers
Trial Phases Phase 1 and Phase 3 studies
Key Measurements Office blood pressure, 24-hour ambulatory blood pressure, plasma drug concentrations, adverse events

FAQ

  • What is Baxdrostat and how does it work? Baxdrostat is an aldosterone synthase inhibitor being studied for treating hypertension. It works by reducing the production of aldosterone, a hormone that can increase blood pressure.
  • Who might benefit from Baxdrostat? Baxdrostat is being studied in patients with uncontrolled hypertension (high blood pressure not adequately controlled by current medications) and resistant hypertension (high blood pressure resistant to multiple medications).
  • What dosages of Baxdrostat are being studied? Clinical trials are evaluating various dosages, including 1 mg, 2 mg, 3 mg, and 10 mg tablets taken orally once daily.
  • What are the main outcomes being measured in Baxdrostat trials? The trials are primarily measuring changes in systolic and diastolic blood pressure, both in clinical settings and through 24-hour ambulatory blood pressure monitoring. They are also assessing safety, tolerability, and how the body processes the drug.
  • Are there any known side effects of Baxdrostat? While specific side effects are still being studied, the trials are monitoring for any adverse events. Safety and tolerability are key aspects being evaluated in all the clinical trials of Baxdrostat.

Ongoing Clinical Trials on Baxdrostat

  • A study to evaluate the effect of baxdrostat and dapagliflozin in reducing protein in the urine for patients with chronic kidney disease and high blood pressure

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Spain

  • Study of baxdrostat compared to placebo to treat adults with primary aldosteronism

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • Study on Baxdrostat and Dapagliflozin for Preventing Heart Failure in Patients at High Risk

    Recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Czechia Denmark France Germany Greece +8

  • Study on the Effects of Baxdrostat and Dapagliflozin in Adults with Chronic Kidney Disease and High Blood Pressure

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +9

  • Study on Baxdrostat for Reducing Blood Pressure in Patients with Uncontrolled or Resistant Hypertension

    Not recruiting

    1 1
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark France +8

  • Study on Baxdrostat for Lowering Blood Pressure in Patients with Resistant Hypertension

    Not recruiting

    1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Germany Greece Hungary +3

  • Study on Baxdrostat and Dapagliflozin for Adults with Chronic Kidney Disease and High Blood Pressure

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +9

Glossary

  • Aldosterone synthase inhibitor: A type of medication that blocks the production of aldosterone, a hormone that can increase blood pressure by causing the body to retain salt and water.
  • Uncontrolled hypertension: High blood pressure that remains above target levels despite treatment with multiple antihypertensive medications.
  • Resistant hypertension: High blood pressure that remains uncontrolled despite the use of at least three different types of antihypertensive medications, including a diuretic.
  • Systolic blood pressure (SBP): The pressure in the arteries when the heart beats, typically the higher number in a blood pressure reading.
  • Diastolic blood pressure (DBP): The pressure in the arteries between heartbeats, typically the lower number in a blood pressure reading.
  • Ambulatory blood pressure monitoring (ABPM): A method of measuring blood pressure at regular intervals over 24 hours while patients go about their normal daily activities.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • Pharmacodynamics (PD): The study of the biochemical and physiological effects of drugs on the body and the mechanisms of drug action.
  • Area under the curve (AUC): A measure of the total exposure to a drug over time, used in pharmacokinetic studies.
  • Maximum plasma concentration (Cmax): The highest concentration of a drug in the blood plasma after administration, used in pharmacokinetic studies.
  • Time to maximum concentration (Tmax): The time it takes for a drug to reach its maximum concentration in the blood plasma after administration.
  • Half-life: The time it takes for the concentration of a drug in the body to decrease by half.
  • Adrenocorticotropic hormone (ACTH) stimulation test: A test used to measure how well the adrenal glands respond to ACTH by producing cortisol.
  • Cortisol: A hormone produced by the adrenal glands that helps regulate metabolism and helps the body respond to stress.

References

  1. https://clinicaltrials.gov/study/NCT05966324
  2. https://clinicaltrials.gov/study/NCT05961384
  3. https://clinicaltrials.gov/study/NCT06344104
  4. https://clinicaltrials.eu/trial/study-on-baxdrostat-for-lowering-blood-pressure-in-patients-with-resistant-hypertension/
  5. https://clinicaltrials.eu/trial/study-on-baxdrostat-for-reducing-blood-pressure-in-patients-with-uncontrolled-or-resistant-hypertension/
  6. https://clinicaltrials.gov/study/NCT06194032
  7. https://clinicaltrials.gov/study/NCT06336356
  8. https://clinicaltrials.gov/study/NCT06357520
  9. https://clinicaltrials.gov/study/NCT06657105