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Last Updated: March 27, 2025

CLINICAL TRIALS PROFILE FOR CETYLEV


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All Clinical Trials for CETYLEV

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04013555 ↗ The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia Recruiting University of Maryland Phase 1/Phase 2 2020-01-20 Kynurenic acid (KYNA) is a naturally occurring chemical in the brain. Studies with rodents indicate that levels of KYNA can impact levels of the neurotransmitters glutamate and dopamine. One way to reliably increase KYNA levels is by ingesting the amino acid tryptophan. Tryptophan is a normal part of the human diet. Tryptophan gets metabolized/changed to other chemicals in the body- including KYNA. By giving people 6 grams of tryptophan, the investigators will be able to increase the KYNA level in a controlled way. The investigators will then be able to study the effects of KYNA on neurotransmitters by using cognitive tests and magnetic resonance imaging techniques (measuring brain activity and brain chemistry using the MRI magnet). The overall goal of the study is to examine how the medication N-acetylcysteine (NAC), when added to tryptophan, affects various cognitive functions, such as verbal and visual memory. The investigators will also use magnetic resonance imaging (MRI) to examine how NAC affects brain activity and chemicals.
NCT04013555 ↗ The Effects of Kynurenine Aminotransferase Inhibition in People With Schizophrenia Recruiting University of Maryland, Baltimore Phase 1/Phase 2 2020-01-20 Kynurenic acid (KYNA) is a naturally occurring chemical in the brain. Studies with rodents indicate that levels of KYNA can impact levels of the neurotransmitters glutamate and dopamine. One way to reliably increase KYNA levels is by ingesting the amino acid tryptophan. Tryptophan is a normal part of the human diet. Tryptophan gets metabolized/changed to other chemicals in the body- including KYNA. By giving people 6 grams of tryptophan, the investigators will be able to increase the KYNA level in a controlled way. The investigators will then be able to study the effects of KYNA on neurotransmitters by using cognitive tests and magnetic resonance imaging techniques (measuring brain activity and brain chemistry using the MRI magnet). The overall goal of the study is to examine how the medication N-acetylcysteine (NAC), when added to tryptophan, affects various cognitive functions, such as verbal and visual memory. The investigators will also use magnetic resonance imaging (MRI) to examine how NAC affects brain activity and chemicals.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for CETYLEV

Condition Name

1110-0.100.10.20.30.40.50.60.70.80.911.1Schizoaffective DisorderSchizophreniaSchizophreniform Disorder[disabled in preview]
Condition Name for CETYLEV
Intervention Trials
Schizoaffective Disorder 1
Schizophrenia 1
Schizophreniform Disorder 1
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Condition MeSH

1110-0.100.10.20.30.40.50.60.70.80.911.1DiseaseSchizophreniaPsychotic Disorders[disabled in preview]
Condition MeSH for CETYLEV
Intervention Trials
Disease 1
Schizophrenia 1
Psychotic Disorders 1
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Clinical Trial Locations for CETYLEV

Trials by Country

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Trials by Country for CETYLEV
Location Trials
United States 1
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Trials by US State

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Trials by US State for CETYLEV
Location Trials
Maryland 1
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Clinical Trial Progress for CETYLEV

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 1/Phase 2[disabled in preview]
Clinical Trial Phase for CETYLEV
Clinical Trial Phase Trials
Phase 1/Phase 2 1
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Recruiting[disabled in preview]
Clinical Trial Status for CETYLEV
Clinical Trial Phase Trials
Recruiting 1
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Clinical Trial Sponsors for CETYLEV

Sponsor Name

trials000001111111University of MarylandUniversity of Maryland, Baltimore[disabled in preview]
Sponsor Name for CETYLEV
Sponsor Trials
University of Maryland 1
University of Maryland, Baltimore 1
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Other[disabled in preview]
Sponsor Type for CETYLEV
Sponsor Trials
Other 2
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CETYLEV: Clinical Trials, Market Analysis, and Projections

Introduction to CETYLEV

CETYLEV, also known as acetylcysteine, is a medication primarily used as an antidote to prevent or lessen hepatic injury following the ingestion of a potentially hepatotoxic quantity of acetaminophen. Here, we will delve into the current clinical trials, market analysis, and future projections for CETYLEV.

Clinical Use and Indications

CETYLEV is indicated for patients with acute or repeated supratherapeutic ingestion of acetaminophen, aiming to prevent or reduce liver damage. The treatment involves administering acetylcysteine in a specific dosing regimen to counteract the toxic effects of acetaminophen overdose[2][4].

Current Clinical Trials

While there are no ongoing clinical trials specifically focused on CETYLEV for new indications, the existing body of research and clinical guidelines support its use in acetaminophen overdose. The efficacy and safety of CETYLEV have been well-established through numerous studies and clinical practice over the years.

However, it is worth noting that the broader context of clinical trials, such as those conducted by the National Institutes of Health (NIH) for other conditions, highlights the importance of rigorous clinical research in validating treatment options. For instance, the ACTIV-6 trial, although not related to CETYLEV, demonstrates the commitment to evidence-based medicine in treating conditions like COVID-19[1].

Market Analysis

Current Market Status

The market for antidotes like CETYLEV is relatively stable, driven by the consistent need for treatments in cases of acetaminophen overdose. The demand is not subject to significant fluctuations, as it is tied to the incidence of acetaminophen overdoses rather than market trends.

Competitive Landscape

The market for acetylcysteine is not highly competitive, as it is a well-established treatment with a clear indication. However, other companies may produce generic versions of acetylcysteine, which could affect the market share of branded products like CETYLEV.

Pricing and Accessibility

The pricing of CETYLEV is generally stable, and it is widely available in healthcare settings. The cost is typically covered by insurance, making it accessible to patients who need it.

Market Projections

Growth Opportunities

While the market for CETYLEV itself may not see significant growth due to its established use, there are opportunities in related areas:

  • Emergency Care: The demand for emergency treatments, including antidotes like CETYLEV, is expected to remain steady.
  • Pharmaceutical Innovations: Advances in pharmaceutical formulations or delivery methods could enhance the market position of CETYLEV or similar products.
  • Global Health Initiatives: Expanding access to healthcare in emerging markets could increase the overall demand for essential medications like CETYLEV.

Challenges

  • Generic Competition: The introduction of generic versions of acetylcysteine could reduce the market share of branded products.
  • Regulatory Changes: Any changes in regulatory requirements or guidelines could impact the manufacturing, distribution, and pricing of CETYLEV.
  • Public Health Initiatives: Efforts to reduce acetaminophen overdose through public health campaigns might decrease the demand for CETYLEV over time.

Financial Projections

Given the stable nature of the market, financial projections for CETYLEV are likely to show steady revenue without significant growth or decline. The revenue will be influenced by the consistent demand for the drug in emergency and clinical settings.

Conclusion

CETYLEV remains a crucial medication in the treatment of acetaminophen overdose, with a well-established clinical use and market presence. While there are no new clinical trials specifically for CETYLEV, the existing evidence supports its continued use. The market analysis indicates a stable demand, though it may face challenges from generic competition and regulatory changes.

Key Takeaways

  • Established Use: CETYLEV is a well-established treatment for acetaminophen overdose.
  • Stable Market: The market demand for CETYLEV is consistent and driven by medical need rather than market trends.
  • Competitive Landscape: The market is not highly competitive, but generic versions could impact market share.
  • Growth Opportunities: Opportunities exist in emergency care and pharmaceutical innovations.
  • Challenges: Generic competition, regulatory changes, and public health initiatives could affect demand.

FAQs

  1. What is CETYLEV used for?

    • CETYLEV is used to prevent or lessen hepatic injury after the ingestion of a potentially hepatotoxic quantity of acetaminophen.
  2. Are there any ongoing clinical trials for CETYLEV?

    • There are no ongoing clinical trials specifically focused on new indications for CETYLEV, but its efficacy and safety have been well-established through existing research.
  3. How does the market for CETYLEV look?

    • The market for CETYLEV is stable, driven by the consistent need for treatments in cases of acetaminophen overdose.
  4. What are the potential growth opportunities for CETYLEV?

    • Growth opportunities exist in emergency care and pharmaceutical innovations, as well as expanding access to healthcare in emerging markets.
  5. What challenges might CETYLEV face in the market?

    • CETYLEV might face challenges from generic competition, regulatory changes, and public health initiatives aimed at reducing acetaminophen overdose.

Sources

  1. National Center for Advancing Translational Sciences (NCATS). Large Clinical Trial to Study Repurposed Drugs to Treat COVID-19 Symptoms. Retrieved from https://ncats.nih.gov/news-events/news/large-clinical-trial-to-study-repurposed-drugs-to-treat-covid-19-symptoms
  2. Drugs.com. Cetylev: Package Insert / Prescribing Information. Retrieved from https://www.drugs.com/pro/cetylev.html
  3. Cytokinetics, Incorporated. Cytokinetics Reports Third Quarter 2024 Financial Results. Retrieved from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-reports-third-quarter-2024-financial-results
  4. U.S. Food and Drug Administration. CETYLEV (acetylcysteine) effervescent tablets for oral solution. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207916s003lbl.pdf
  5. GlobeNewswire. Cetylpyridinium Chloride Market Report 2025-2030: Analysis of Trends, Investment Opportunities, and Competitive Strategies. Retrieved from https://www.globenewswire.com/news-release/2024/11/28/2988656/28124/en/Cetylpyridinium-Chloride-Market-Report-2025-2030-Analysis-of-Trends-Investment-Opportunities-and-Competitive-Strategies.html

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