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Ozanimod

Ozanimod is a novel drug being investigated in clinical trials for the treatment of multiple sclerosis (MS) and ulcerative colitis (UC). This article summarizes key information about ongoing and completed clinical trials evaluating the efficacy, safety, and pharmacokinetics of ozanimod in these conditions. The trials aim to assess ozanimod’s effects on disease activity, symptoms like fatigue, cognitive function, and quality of life in patients with MS and UC.

Table of Contents

What is Ozanimod?

Ozanimod is a medication that has been developed to treat certain autoimmune conditions. It’s also known by its brand name Zeposia® and has been referred to in research as RPC1063 or BMS-986374[1]. Ozanimod belongs to a class of drugs called sphingosine 1-phosphate (S1P) receptor modulators, which work by affecting the immune system[2].

What Conditions Does Ozanimod Treat?

Ozanimod has been studied and approved for use in treating two main conditions:

  • Multiple Sclerosis (MS): Specifically, ozanimod is used for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease[3].
  • Ulcerative Colitis (UC): Ozanimod is also used to treat moderate to severe active ulcerative colitis in adults[4].

Both of these conditions are autoimmune diseases, where the body’s immune system mistakenly attacks healthy tissues.

How Does Ozanimod Work?

Ozanimod works by modulating the immune system. It binds to specific receptors (S1P receptors) on immune cells, which prevents these cells from leaving the lymph nodes. This action reduces the number of immune cells circulating in the blood and entering the central nervous system (in MS) or the intestines (in UC). By doing so, ozanimod helps to decrease the inflammatory response that causes damage in these conditions[2].

How is Ozanimod Administered?

Ozanimod is taken orally in the form of capsules. The typical dosing schedule involves a gradual increase in dose over time:

  • Days 1-4: 0.23 mg once daily
  • Days 5-7: 0.46 mg once daily
  • Day 8 and onwards: 0.92 mg once daily[5]

This gradual increase helps to reduce the risk of certain side effects. It’s important to take ozanimod exactly as prescribed by your healthcare provider.

Efficacy of Ozanimod

Clinical trials have shown promising results for ozanimod in both MS and UC:

  • In MS, ozanimod has been found to reduce the rate of relapses and slow the progression of disability[3].
  • For UC, studies have shown that ozanimod can help achieve and maintain clinical remission in patients with moderate to severe active disease[4].

Researchers are also investigating whether ozanimod might have positive effects on fatigue and cognitive function in MS patients[6].

Potential Side Effects

Like all medications, ozanimod can cause side effects. Some of the most common include:

  • Upper respiratory infections
  • Elevated liver enzymes
  • Low blood pressure
  • Back pain
  • Headache

More serious but less common side effects can include increased risk of infections, changes in heart rhythm, and vision problems. It’s important to discuss all potential risks with your healthcare provider[1].

Ongoing Research

Researchers continue to study ozanimod to better understand its effects and potential uses. Some areas of ongoing research include:

  • Use in pediatric patients with ulcerative colitis[4]
  • Effects on fatigue and cognitive function in MS patients[6]
  • Development of new formulations, such as a granule formulation for patients who have difficulty swallowing capsules[2]
  • Long-term safety and efficacy in real-world clinical practice[1]

These ongoing studies will help to further our understanding of ozanimod and potentially expand its use to benefit more patients.

Aspect Details
Conditions Studied Multiple Sclerosis, Ulcerative Colitis
Main Outcomes Clinical remission, disease activity on MRI, fatigue, cognitive function
Administration Oral capsules or tablets, once daily
Special Populations Pediatric patients, patients with liver impairment
Safety Assessments Adverse events, laboratory tests, vital signs
Biomarkers Brain volume changes, neurofilament light, GFAP
Quality of Life Measures Fatigue scales, cognitive assessments, patient-reported outcomes

FAQ

  • What is ozanimod? Ozanimod is an investigational drug being studied for the treatment of multiple sclerosis and ulcerative colitis. It works by modulating certain receptors in the immune system.
  • What conditions is ozanimod being studied for? Ozanimod is primarily being studied for relapsing forms of multiple sclerosis and moderate to severe active ulcerative colitis.
  • How is ozanimod administered? Ozanimod is taken orally as a capsule or tablet, typically once daily. Some trials are also evaluating a granule formulation for pediatric use.
  • What are some of the main outcomes being measured in ozanimod trials? Key outcomes include clinical remission and response rates, changes in disease activity on MRI, effects on fatigue and cognitive function, and safety/tolerability measures.
  • Are there any trials looking at ozanimod in special populations? Yes, there are trials evaluating ozanimod in pediatric patients with ulcerative colitis, as well as studies looking at its use in patients with mild to moderate liver impairment.

Ongoing Clinical Trials on Ozanimod

  • Study on the Effects of Ozanimod on Inflammation in Patients with Relapsing Multiple Sclerosis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effectiveness of Ozanimod for Children with Moderate to Severe Ulcerative Colitis Not Responding to Usual Treatment

    Recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Poland Spain

  • Study of Lactobacillales and Lacidofil in Multiple Sclerosis Patients: Comparing Effectiveness of Probiotic Therapy

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on the Long-Term Safety and Effectiveness of Ozanimod for Adults with Moderate to Severe Ulcerative Colitis

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium Bulgaria Czechia Hungary Italy Poland +1

  • Study on the Effects of Ozanimod for Children with Moderate to Severe Crohn’s Disease Not Responding to Usual Treatments

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Poland Spain

  • Study of Oral Ozanimod as Maintenance Treatment for Adults with Moderate to Severe Crohn’s Disease

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia France Germany +8

  • Study on the Long-Term Safety and Efficacy of Oral Ozanimod for Patients with Moderate to Severe Crohn’s Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Czechia France Germany Hungary +9

  • Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Pharmacokinetics: The study of how a drug moves through the body, including how it is absorbed, distributed, metabolized and excreted.
  • Clinical remission: The absence of disease symptoms, often defined by specific criteria in clinical trials.
  • Relapsing multiple sclerosis: A form of MS characterized by periods of new or worsening symptoms followed by periods of recovery.
  • Ulcerative colitis: A chronic inflammatory bowel disease that causes inflammation and ulcers in the colon and rectum.
  • MRI: Magnetic Resonance Imaging, a technique used to create detailed images of the body's internal structures.
  • Biomarker: A measurable indicator of a biological state or condition, often used to assess disease activity or treatment response.
  • Fatigue: A feeling of extreme tiredness or lack of energy, which is a common symptom in multiple sclerosis.
  • Cognitive function: Mental processes including thinking, memory, attention, and problem-solving abilities.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease that occurs during a clinical trial, whether or not it is related to the treatment being studied.

References

  1. https://clinicaltrials.gov/study/NCT05369832
  2. https://clinicaltrials.gov/study/NCT04528290
  3. https://clinicaltrials.gov/study/NCT06334094
  4. https://clinicaltrials.gov/study/NCT05076175
  5. https://clinicaltrials.gov/study/NCT04639115
  6. https://clinicaltrials.gov/study/NCT05319093