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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR GLYCINE


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All Clinical Trials for Glycine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000371 ↗ Trial of D-Cycloserine in Schizophrenia Completed Massachusetts General Hospital Phase 3 1996-08-01 To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response. Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia. Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA.
NCT00000372 ↗ Glycine and D-Cycloserine in Schizophrenia Withdrawn Massachusetts General Hospital Phase 3 1998-03-01 The purpose of this study is to compare the effects of D-cycloserine and glycine for treating negative symptoms (such as loss of interest, loss of energy, loss of warmth, and loss of humor) which occur between phases of positive symptoms (marked by hallucinations, delusions, and thought confusions) in schizophrenics. Clozapine is currently the most effective treatment for negative symptoms of schizophrenia. Two other drugs, D-cycloserine and glycine, are being investigated as new treatments. D-cycloserine improves negative symptoms when added to some drugs, but may worsen these symptoms when given with clozapine. Glycine also improves negative symptoms and may still be able to improve these symptoms when given with clozapine. This study gives either D-cycloserine or glycine (or an inactive placebo) with clozapine to determine which is the best combination. Patients will be assigned to 1 of 3 groups. Group 1 will receive D-cycloserine plus clozapine. Group 2 will receive glycine plus clozapine. Group 3 will receive an inactive placebo plus clozapine. Patients will receive these medications for 8 weeks. Negative symptoms of schizophrenia will be monitored through the Scale for the Assessment of Negative Symptoms, Positive symptoms will be monitored through the Positive and Negative Syndrome Scale, and additionally subjects will complete the Brief Psychiatric Rating Scale and the Global Assessment Scale. An individual may be eligible for this study if he/she is 18 to 65 years old and has been diagnosed with schizophrenia.
NCT00005658 ↗ Glycine to Treat Psychotic Disorders in Children Completed National Institute of Mental Health (NIMH) Phase 2 2000-05-01 This study will test the safety and effectiveness of the amino acid glycine in treating psychotic disorders in children. The drug will be given as an adjunct (in addition) to the patient's current antipsychotic medication. Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began before age 13 may be eligible for this 10-week study. Patients will be hospitalized during the course of the trial. Weekend visits home may be permitted. Children enrolled in the study will be evaluated during a two-week pre-treatment period with written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI) scan of the brain. For the MRI, the child lies on a table that slides into a large donut-shaped machine with a strong magnetic field. This procedure produces images of the brain that may help identify brain abnormalities in schizophrenia that develop in childhood. During the eight-week treatment phase, patients will receive glycine powder dissolved in water once a day, in addition to their other antipsychotic medications. They will undergo the following additional procedures during the course of treatment: 1. Comprehensive psychiatric examination 2. Blood pressure and pulse monitoring once a week 3. Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels 4. Eye movement study at week eight - Using a technique called infrared oculography, special detectors measure infrared light reflected off the child's eyes while he or she watches a moving square on a video monitor. 5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals. Patients who respond well may continue to receive glycine treatment through their referring physician after the study is completed. NIMH will follow patients by phone every six months and with visits at two-year intervals.
NCT00127309 ↗ Effect of Glutathione on Blood Alcohol and Hangover Symptoms Completed T.C Union Global Plc. N/A 2005-06-01 Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a great role in homeostasis, especially as a potent anti-oxidant. As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and excretes in urine as mercapturic acid. In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing effect. The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a correlation with hangover symptoms. This study is designed to find this correlation using blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the Slutske et al study.
NCT00127309 ↗ Effect of Glutathione on Blood Alcohol and Hangover Symptoms Completed Piyavate Hospital N/A 2005-06-01 Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a great role in homeostasis, especially as a potent anti-oxidant. As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and excretes in urine as mercapturic acid. In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing effect. The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a correlation with hangover symptoms. This study is designed to find this correlation using blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the Slutske et al study.
NCT00128401 ↗ Use of an Antibiotic as an Enhancer for the Treatment of Social Phobia Completed National Institute of Mental Health (NIMH) Phase 2 2005-08-01 This study examines whether an antibiotic, d-cycloserine (DCS), boosts the effectiveness of cognitive behavior therapy (CBT) for social anxiety. CBT has been shown to be effective for the treatment of social anxiety in children and adults, but even after treatment, approximately 40% may remain diagnosable. The antibiotic DCS has been shown to enhance the type of learning that is promoted by exposure therapy, a main component of CBT. This study will test whether DCS can improve the effectiveness of CBT for social anxiety. All participants will receive 12 weekly CBT sessions. In addition to receiving the CBT, participants will be randomly assigned (similar to a coin toss) to receive either DCS or a placebo (sugar pill). The pill will be taken 1-2 hours prior to each of the 12 CBT sessions. The pill is taken only on the 12 therapy days. Prior to receiving treatment, participants will be asked to: - participate in interviews to assess diagnosis and how they are doing including mood, degree of nervousness and behavior - have a physical examination, a urine test, and an electrocardiogram (EKG) - undergo tests involving problem-solving and memory - prepare and present a speech to a "virtual audience" using virtual reality goggles - undergo functional magnetic resonance imaging (fMRI) while performing tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices Those who have not improved by the end of the study will be offered standard antianxiety medication treatment for 1 to 3 months. If a participant does not wish to take medication, study clinicians will help him/her locate psychological care in the community. Participants will be asked to complete a follow-up assessment 3 months after their last CBT session.
NCT00133406 ↗ Long-term Impact and Intervention for Diarrhea in Brazil Unknown status National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2006-06-01 The primary objectives of this study are to determine the effect of 1 year supplementation of Vitamin A, Zinc, and Vitamin A plus Zinc compared to placebo on the Height for Age Z Score (HAZ) and the number of episodes of diarrhea and number of days of diarrhea at one year in children living in a Brazilian slum. Study participants will include 280 children ages 2 months to 8 years old, with a Height for Age Z score (HAZ) less than median for the Parque Universitario community, living in Brazilian favela. There is also a sub study to determine if ten days of glutamine delivered as an oral bolus improves the health of the digestive system.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glycine

Condition Name

Condition Name for Glycine
Intervention Trials
Schizophrenia 22
Post-Operative Pain 5
Asthma 4
Psychoses 4
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Condition MeSH

Condition MeSH for Glycine
Intervention Trials
Schizophrenia 28
Psychotic Disorders 11
Disease 10
Depression 8
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Clinical Trial Locations for Glycine

Trials by Country

Trials by Country for Glycine
Location Trials
United States 84
Italy 18
China 12
Taiwan 9
Israel 9
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Trials by US State

Trials by US State for Glycine
Location Trials
Maryland 11
Massachusetts 11
New York 9
California 8
Connecticut 5
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Clinical Trial Progress for Glycine

Clinical Trial Phase

Clinical Trial Phase for Glycine
Clinical Trial Phase Trials
Phase 4 19
Phase 3 16
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Glycine
Clinical Trial Phase Trials
Completed 72
Unknown status 19
Withdrawn 11
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Clinical Trial Sponsors for Glycine

Sponsor Name

Sponsor Name for Glycine
Sponsor Trials
China Medical University Hospital 8
Peking Union Medical College Hospital 7
Vivozon, Inc. 6
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Sponsor Type

Sponsor Type for Glycine
Sponsor Trials
Other 161
Industry 34
NIH 24
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Glycine: Clinical Trials, Market Analysis, and Projections

Introduction to Glycine

Glycine is a non-essential amino acid that plays a crucial role in various biological processes, including neurotransmission, collagen production, and as a precursor to other amino acids. Its versatility has led to its exploration in multiple medical and nutritional applications.

Clinical Trials Update

Parkinson's Disease Treatment

One of the most promising clinical trials involving glycine is focused on its potential to treat Parkinson's Disease (PD). The study, conducted by the Michael J. Fox Foundation, aims to modulate glycine levels in the brain to alleviate symptoms of PD, particularly dyskinesia and psychosis, which are common side effects of long-term levodopa treatment[1].

  • Hypothesis: The study hypothesizes that increasing glycine's actions in the brain will reduce PD symptoms, levodopa-induced dyskinesia, and psychotic manifestations.
  • Study Design: The trial involves administering bitopertin, a drug that enhances glycine's actions, to patients with PD. The study will assess the drug's efficacy, its impact on PD symptoms, and its pharmacokinetic properties.
  • Impact: If successful, this treatment could significantly improve the quality of life for individuals with advanced PD by addressing multiple challenging aspects of the disease.

Market Analysis

Global Glycine Supplement Market

The global market for glycine supplements is experiencing substantial growth. Here are some key points from the market analysis:

  • Growth Rate: The market is projected to grow at a CAGR of 5.75% from 2018 to 2025, driven by increasing demand for wellness products, a growing geriatric population, and a sedentary lifestyle[2].
  • Geographical Distribution: The Americas dominate the global glycine supplement market, with significant contributions from Europe, Asia-Pacific, and the Middle East and Africa[2].
  • Application Segments: Glycine supplements are used primarily for joint and bone health, cardiovascular diseases, and other health benefits[2].

Pharmaceutical and Food Grade Segments

  • Pharmaceutical Segment: Glycine is used in treating mental diseases like schizophrenia and as a safeguard against adverse effects of certain medications post-organ transplantation. Its role in preserving liver health and enhancing memory also contributes to its demand in the pharmaceutical sector[3].
  • Food Grade Segment: The increasing need for high-tech food-grade products in the agriculture sector and the requirement to control acidity in food and drinks are driving the growth of the food-grade glycine market[3].

Market Projections

Global Glycine Market Value

The global glycine market was valued at USD 843.8 million in 2023 and is expected to reach USD 1091.3 million by 2029, growing at a significant rate. This growth is attributed to the increasing consumption of protein beverages, ready-to-eat meals, and the expanding use of glycine in various health applications[4].

Future Trends

  • Health and Wellness: The growing awareness of health and wellness is expected to drive the demand for glycine supplements and pharmaceutical applications.
  • Agricultural Sector: The rapid expansion in the agriculture sector will continue to boost the demand for food-grade glycine.
  • Medical Research: Ongoing research into glycine's therapeutic potential, such as its role in neural regeneration and ischemic damage reduction, will further expand its market[5].

Key Applications and Benefits

Neurological Health

Glycine functions as a neurotransmitter and has been shown to have potential in treating mental diseases like schizophrenia. Its role in modulating brain chemicals makes it a promising candidate for addressing neurological disorders[3].

Joint and Bone Health

Glycine is essential for collagen production, which is crucial for joint and bone health. This makes it a popular supplement for individuals seeking to improve their musculoskeletal health[2].

Cardiovascular Health

Glycine has been linked to improved cardiovascular health by reducing inflammation and improving blood vessel function. This has led to its increased use in cardiovascular disease prevention and management[2].

Challenges and Opportunities

Regulatory Environment

The regulatory environment for glycine supplements and pharmaceuticals can be complex and varies by region. Ensuring compliance with regulations will be crucial for market growth.

Research and Development

Continued research into glycine's therapeutic potential will open up new opportunities for its use in various medical conditions. Innovations in drug delivery and formulation, such as the development of novel forms of bitopertin, will also drive market expansion[1].

Conclusion

Glycine is poised for significant growth across both the supplement and pharmaceutical markets. Clinical trials, particularly those focused on Parkinson's Disease, hold promise for improving the lives of patients with complex neurological conditions. The market analysis indicates a strong future for glycine, driven by increasing demand for health and wellness products, expanding agricultural needs, and ongoing medical research.

Key Takeaways

  • Glycine has potential therapeutic benefits for Parkinson's Disease by alleviating dyskinesia and psychosis.
  • The global glycine supplement market is growing at a CAGR of 5.75% from 2018 to 2025.
  • The pharmaceutical segment of the glycine market is expected to see robust growth due to its use in treating mental diseases and other health conditions.
  • The food-grade glycine market is driven by the agriculture sector and the need to control acidity in food and drinks.
  • The global glycine market is projected to reach USD 1091.3 million by 2029.

FAQs

1. What is the primary focus of the clinical trials involving glycine for Parkinson's Disease?

The primary focus is to assess the efficacy of bitopertin, a drug that enhances glycine's actions, in alleviating PD symptoms, reducing levodopa-induced dyskinesia, and lessening psychotic manifestations.

2. What drives the growth of the global glycine supplement market?

The growth is driven by increasing demand for wellness products, a growing geriatric population, and a sedentary lifestyle.

3. In which segments is glycine most commonly used?

Glycine is commonly used in joint and bone health, cardiovascular diseases, and other health benefits.

4. What is the projected value of the global glycine market by 2029?

The global glycine market is expected to reach USD 1091.3 million by 2029.

5. What are some of the future trends expected to influence the glycine market?

Future trends include the growing awareness of health and wellness, expansion in the agriculture sector, and ongoing medical research into glycine's therapeutic potential.

Cited Sources:

  1. Modulation of Glycine for the Treatment of Parkinson's Disease - Michael J. Fox Foundation
  2. Glycine Supplement Market Analysis - Market Research Future
  3. Glycine Market Size, Share, Trends, Industry Analysis 2024-2032 - Global Market Insights
  4. Global Glycine Market Analysis: Future Trends and Forecast 2032 - Industry Research Biz
  5. Glycine - Drug Targets, Indications, Patents - Patsnap Synapse

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