CLINICAL TRIALS PROFILE FOR MUCOMYST

All Clinical Trials for MUCOMYST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00131521 ↗	Comparison of Different Mucoactive Agents for the Care of the Intubated Patient in a Surgical Trauma Intensive Care Unit	Completed	The University of Texas Health Science Center at San Antonio	N/A	2005-01-01	This study compares N-acetylcysteine (mucomyst) and sodium chloride to determine their efficacy in the prevention of pulmonary mucus obstruction and retention in intubated patients admitted to the surgical trauma intensive care unit (STICU).
NCT00122018 ↗	An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery	Completed	Abbott	Phase 2	2002-05-01	Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
NCT00122018 ↗	An Investigation of N-acetylcysteine and Fenoldopam as Renal Protection Agents for Cardiac Surgery	Completed	Linda F. Barr, M.D.	Phase 2	2002-05-01	Patients with abnormal kidney function are at increased risk for complications following heart surgery, including worsening kidney function possibly requiring dialysis, a prolonged stay in the critical care unit and hospital, and the increased risk of death. Prior attempts at kidney protection for heart surgery patients have had mixed results. Two medicines, fenoldopam and N-acetylcysteine, have been shown to protect kidney function in other circumstances that cause kidney stress. The purpose of this study is to determine whether these medications will help to maintain the function of diseased kidneys during heart surgery.
NCT00028262 ↗	Cystagon to Treat Infantile Neuronal Ceroid Lipofuscinosis	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2001-02-01	This study will examine the effectiveness of a drug called Cystagon in treating infantile neuronal ceroid lipofuscinosis (INCL), a progressive neurological disease affecting children. At around 11 to 13 months of age, patients develop slowed head growth, mild brain atrophy (wasting), electroencephalographic (EEG) changes and retinal deterioration, with symptoms worsening over time. The disease results from an enzyme deficiency that causes fatty compounds called ceroid to accumulate in cells. In laboratory experiments, Cystagon has helped remove ceroid from cells of patients with INCL. Children with INCL between 6 months and 3 years of age may be eligible for this study. Participants take Cystagon daily by mouth every 6 hours. They are admitted to the NIH Clinical Center for a 4- to 5-day period every 6 months for the following tests and evaluations: - Review of medical history, including a detailed record of seizures, physical examination, blood tests and clinical photographs. For the initial baseline studies, examinations may also be scheduled with pediatric neurology, ophthalmology and anesthesia services. - Magnetic resonance imaging (MRI) of the brain MRI uses a powerful magnet, radio waves, and computers to provide detailed images of the brain without the use of X-rays. The patient lies on a table that slides inside a donut-shaped machine containing a magnetic field. The child requires general anesthesia for the procedure. - Electroretinogram (ERG) measures the function of the retina, the light-sensitive tissue in the back of the eye. To record the flash ERG, a special contact lens is placed on the eye s surface and the eye is stimulated with flashes of light. Infants and very young children require general anesthesia for the procedure. - Visual evoked potential (VEP) measures the function of the visual pathway from the eye to the brain. To record the VEP, five electrodes are placed on the scalp and the eye is stimulated with flashes of light. Infants and very young children must be anesthetized for the procedure. - Electroencephalogram (EEG) measures brain electrical activity, using electrodes placed on the scalp. The test is useful in defining seizures. The child may need to be sedated to keep still during the test. - Skin biopsy A small piece of skin is removed (usually from the upper arm or shoulder) under local anesthetic to grow cells in the laboratory. This procedure is done at the start of the study and is repeated after 1 year if therapy results are promising. Children s condition may improve, stabilize or worsen during this study. Life may be prolonged without significant improvement in quality. The information gained from the study may help scientists develop more potent drugs to treat INCL.
NCT00248625 ↗	N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	2000-01-01	We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.

Clinical Trial Conditions for MUCOMYST

Condition Name

Condition Name for MUCOMYST
Intervention	Trials
Contrast Induced Nephropathy	4
Asthma	3
Acute Liver Failure	2
Intubation	1

Condition MeSH

Condition MeSH for MUCOMYST
Intervention	Trials
Kidney Diseases	6
Liver Failure, Acute	2
Liver Failure	2
Hepatic Insufficiency	2

Clinical Trial Locations for MUCOMYST

Trials by Country

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Trials by Country for MUCOMYST
Location	Trials
United States	42
Canada	2
United Kingdom	1
Israel	1
Korea, Republic of	1

Trials by US State

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−

Trials by US State for MUCOMYST
Location	Trials
California	7
Ohio	4
Texas	3
Virginia	3
Washington	2

Clinical Trial Progress for MUCOMYST

Clinical Trial Phase

Clinical Trial Phase for MUCOMYST
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MUCOMYST
Clinical Trial Phase	Trials
Completed	10
Unknown status	4
Terminated	2

Clinical Trial Sponsors for MUCOMYST

Sponsor Name

Sponsor Name for MUCOMYST
Sponsor	Trials
University of California, San Francisco	3
West Virginia University	2
US Department of Veterans Affairs	2

Sponsor Type

Sponsor Type for MUCOMYST
Sponsor	Trials
Other	23
U.S. Fed	5
NIH	4

N-Acetylcysteine (Mucomyst): Clinical Trials, Market Analysis, and Projections

Introduction

N-Acetylcysteine (NAC), commonly known by the brand name Mucomyst, is a versatile drug with a wide range of therapeutic applications. It is primarily used as a mucolytic agent to treat respiratory conditions, but its uses extend to other medical areas as well. This article will delve into the current clinical trials, market analysis, and future projections for NAC.

Clinical Trials Update

Respiratory Conditions: Asthma and COPD

A significant clinical trial currently underway is the "Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)" study. This phase 4 clinical trial, sponsored by the University of California, San Francisco, aims to determine the optimal method of delivering aerosolized NAC to patients with mucus-associated lung diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD). The trial investigates whether the use of positive inspiratory pressure during aerosol inhalation enhances the penetration of NAC into airway mucus plugs, thereby improving lung function and reducing mucus burden[1].

Retinitis Pigmentosa

Another notable clinical trial is the "NAC Attack" study conducted by Johns Hopkins University. This phase 3 clinical trial evaluates the effectiveness and safety of oral NAC in patients with retinitis pigmentosa (RP), a genetic disorder leading to progressive vision loss. The study involves approximately 438 patients and is funded by the National Eye Institute. Researchers believe that NAC can mitigate the damage caused by reactive oxygen species (ROS) in the retina, potentially slowing down vision loss in RP patients[4].

Market Analysis

Global Market Size and Growth

The global NAC market is experiencing significant growth driven by the increasing prevalence of chronic diseases such as COPD, cystic fibrosis, and other respiratory conditions. As of 2023, the global NAC market was valued at approximately USD 1.74 billion and is projected to reach USD 14.69 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 21.4% from 2024 to 2034[5].

Regional Dominance

North America currently holds the largest market share, accounting for about 39% of the global market in 2023. This dominance is attributed to the high prevalence of respiratory conditions in the region and the extensive use of NAC for treating acetaminophen overdose and as a mucolytic agent in inhalation form[5].

Key Players

The NAC market is competitive, with several key players including Zambon, Moehs, Pharmazell, Nippon Rika, and others. These companies are investing heavily in research and development to expand the therapeutic applications of NAC[2].

Therapeutic Applications

Respiratory Conditions

NAC is widely recognized for its mucolytic properties, which help in reducing the viscosity of mucus and facilitating its expulsion from the lungs. This makes it a cornerstone treatment for conditions like COPD, cystic fibrosis, and bronchitis. Its effectiveness in alleviating symptoms and improving respiratory function underscores its significance in pharmaceutical formulations aimed at treating chronic lung diseases[5].

Antioxidant Properties

In addition to its mucolytic effects, NAC is also valued for its antioxidant properties. It is being explored for its potential in treating various conditions, including liver failure, cancer, and other oxidative stress-related diseases. The ongoing investigational studies highlight the expanding therapeutic applications of NAC[5].

Market Projections

Future Growth

The NAC market is expected to witness substantial growth in the coming years, driven by the increasing demand for respiratory treatments and the expanding therapeutic applications of the drug. The market is projected to reach USD 4,100 million in the U.S. alone by 2034, up from USD 480 million in 2023[5].

Emerging Trends

The market is also influenced by emerging trends such as the development of modified forms of NAC, like NACA, which is designed to be more potent and bioavailable to the retina. Such innovations are likely to further boost the market growth and diversify the use of NAC in various medical conditions[4].

Key Takeaways

• Clinical Trials: Ongoing trials are focusing on optimizing the delivery of NAC for respiratory conditions and exploring its potential in treating retinitis pigmentosa.
• Market Growth: The global NAC market is projected to grow significantly, driven by the increasing prevalence of chronic diseases and expanding therapeutic applications.
• Regional Dominance: North America holds the largest market share due to high demand for respiratory treatments.
• Therapeutic Applications: NAC is crucial in treating respiratory conditions and is being explored for its antioxidant properties in other medical areas.
• Future Projections: The market is expected to reach USD 14.69 billion by 2034, with a CAGR of 21.4% from 2024 to 2034.

FAQs

What is the primary use of N-Acetylcysteine (NAC)?

NAC is primarily used as a mucolytic agent to treat respiratory conditions such as COPD, cystic fibrosis, and bronchitis by reducing the viscosity of mucus.

What is the current status of the "NAC Attack" clinical trial?

The "NAC Attack" is a phase 3 clinical trial evaluating the effectiveness and safety of oral NAC in patients with retinitis pigmentosa. It is currently enrolling participants and is expected to run for 45 months.

How is the global NAC market projected to grow?

The global NAC market is projected to grow from USD 1.74 billion in 2023 to USD 14.69 billion by 2034, with a CAGR of 21.4% from 2024 to 2034.

Which region dominates the NAC market?

North America currently holds the largest market share, accounting for about 39% of the global market, due to the high prevalence of respiratory conditions in the region.

What are some emerging trends in the NAC market?

Emerging trends include the development of modified forms of NAC, such as NACA, designed to be more potent and bioavailable, particularly for retinal conditions.

Who are the key players in the NAC market?

Key players include Zambon, Moehs, Pharmazell, Nippon Rika, and others, who are investing in research and development to expand the therapeutic applications of NAC.

Sources

1. ClinicalTrials.gov: Positive Airway Pressure on the Mucolytic Effects of NAC (TEAM)
2. Data Insights Market: N-acetylcysteine Competitive Strategies: Trends and Forecasts 2025
3. Mayo Clinic: Oral N-acetylcysteine for Retinitis Pigmentosa
4. Fighting Blindness: Phase 3 Clinical Trial of NAC Launched for RP Patients
5. Precedence Research: Acetylcysteine Market Size, Share, Demand | CAGR Of 21.4%