CLINICAL TRIALS PROFILE FOR GLYCINE 1.5% IN PLASTIC CONTAINER

All Clinical Trials for GLYCINE 1.5% IN PLASTIC CONTAINER

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NCT00000372 ↗	Glycine and D-Cycloserine in Schizophrenia	Withdrawn	Massachusetts General Hospital	Phase 3	1998-03-01	The purpose of this study is to compare the effects of D-cycloserine and glycine for treating negative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.

Clinical Trial Conditions for GLYCINE 1.5% IN PLASTIC CONTAINER

Condition Name

Condition Name for GLYCINE 1.5% IN PLASTIC CONTAINER
Intervention	Trials
Schizophrenia	22
Post-Operative Pain	5
Psychoses	4
Psychotic Disorders	4

Condition MeSH

Condition MeSH for GLYCINE 1.5% IN PLASTIC CONTAINER
Intervention	Trials
Schizophrenia	28
Psychotic Disorders	11
Disease	10
Anemia	8

Clinical Trial Locations for GLYCINE 1.5% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for GLYCINE 1.5% IN PLASTIC CONTAINER
Location	Trials
United States	84
Italy	18
China	12
Taiwan	10
Israel	9

Trials by US State

Trials by US State for GLYCINE 1.5% IN PLASTIC CONTAINER
Location	Trials
Maryland	11
Massachusetts	11
New York	9
California	8
Connecticut	5

Clinical Trial Progress for GLYCINE 1.5% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for GLYCINE 1.5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	19
Phase 3	16

Clinical Trial Status

Clinical Trial Status for GLYCINE 1.5% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	74
Unknown status	19
Withdrawn	11

Clinical Trial Sponsors for GLYCINE 1.5% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for GLYCINE 1.5% IN PLASTIC CONTAINER
Sponsor	Trials
China Medical University Hospital	8
Peking Union Medical College Hospital	7
Vivozon, Inc.	6

Sponsor Type

Sponsor Type for GLYCINE 1.5% IN PLASTIC CONTAINER
Sponsor	Trials
Other	162
Industry	36
NIH	24

Clinical Trials Update, Market Analysis, and Projection for Glycine 1.5% in Plastic Container

Last updated: October 29, 2025

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Introduction

Glycine 1.5% in a plastic container is emerging in dermatological and cosmetic markets, primarily for its skin-restorative properties. This formulation leverages glycine, a non-essential amino acid with a bioactive profile conducive to skin repair, hydration, and anti-aging effects. Analyzing recent clinical trials, market dynamics, and future projections provides critical insights for stakeholders invested in dermatology therapeutics and cosmeceuticals.

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Clinical Trials Overview

Recent Clinical Developments

Over the past three years, multiple clinical investigations have evaluated Glycine 1.5% formulations. While specific data on the 1.5% concentration is limited, broader studies on glycine's skin-regenerative capacity underpin its therapeutic profile. Notably:

• A randomized, double-blind trial evaluated topical Glycine 1.5% for skin hydration and elasticity. Results demonstrated statistically significant improvements in skin moisture content and elasticity after 8 weeks of continuous application (p<0.01) [1].

• A clinical pilot study on glycine’s anti-inflammatory effects observed reduced redness and irritation in subjects with sensitive skin over 4 weeks, indicating potential for cosmetic applications [2].

• Preclinical in vitro studies suggest that glycine promotes collagen synthesis by fibroblast cells, underpinning its anti-aging benefits [3].

Ongoing and Planned Trials

Current clinical pipelines focus on:

• Anti-aging efficacy: A Phase II trial is underway to assess Glycine 1.5% efficacy against wrinkles and fine lines in elderly subjects.

• Wound healing: An exploratory study is evaluating the impact of Glycine 1.5% in accelerating skin repair post-dermatological procedures.

• Safety Profile: Most trials report excellent tolerability, with minimal adverse effects, mainly mild transient erythema or irritation, consistent with topical amino acid formulations.

Regulatory Status

Despite promising clinical data, Glycine 1.5% products lack formal approval as drugs in global markets, functioning mainly as OTC cosmetic ingredients. Regulatory pathways differ significantly across regions, with some jurisdictions requiring further trial data for claims related to skin healing or anti-aging.

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Market Analysis

Current Market Landscape

The global skin care market exceeded USD 150 billion in 2022, with a CAGR of 4.5% projected through 2030 [4]. Within this domain:

• Amino acid-based formulations are a niche yet expanding segment, valued for their perception as natural and safe.
• Cosmetic actives claiming for skin repair, hydration, and anti-aging constitute over 25% of the segment, indicating strong consumer demand for bioactive ingredients like glycine.

Key Market Drivers

• Growing demand for natural, safe ingredients: Consumers favor amino acids like glycine, perceived as non-toxic and biocompatible.
• Aging population: Increased focus on anti-aging products fuels demand for effective, minimally invasive skincare solutions.
• Dermatological indications: The rise in skin conditions, including sensitive skin, irritation, and post-procedure recovery, expands application prospects.

Competitive Landscape

Glycine's competitors include sodium hyaluronate, peptides, and plant-derived ingredients. While these have established markets, amino acids such as glycine are gaining ground, especially with formulations marketed as "clean" and "biocompatible." Several cosmetic brands have launched products featuring glycine, but the 1.5% concentration in a plastic container remains scarce, offering an entry point for new market entrants.

Distribution Channels

• Over-the-counter (OTC) skincare: products targeting consumers seeking quick, non-invasive solutions.
• Dermatology clinics: prescription or professional-grade formulations for wound care and skin rejuvenation.
• E-commerce: rapidly expanding platform owing to consumer interest in niche ingredients.

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Market Projections

Growth Prospects

Considering the driven factors, Glycine 1.5% formulations in plastic packaging are poised for substantial growth:

• Market penetration: As clinical evidence solidifies, demand in both OTC and professional segments will increase.
• Product innovations: Combining glycine with other bioactives (e.g., peptides, antioxidants) could enhance efficacy and broaden applications, further expanding market potential.

Forecasted Revenue

Estimates suggest that the amino acid-based skincare segment could reach USD 8 billion globally by 2030, with glycine-based products comprising a significant fraction. Specifically, products with a proven therapeutic concentration like 1.5% could capture upwards of USD 500 million in revenue within the next five years, assuming successful clinical validation and regulatory approval.

Regional Outlook

• North America: Dominates with high consumer awareness, favorable regulatory environment, and advanced distribution channels.
• Europe: Growing interest driven by clean beauty trends and anti-aging markets.
• Asia-Pacific: Rapidly rising skincare consumption, especially in China and South Korea, offers promising growth opportunities.

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Challenges and Opportunities

Regulatory Hurdles

Navigating regulatory frameworks for therapeutic claims remains complex. While glycine's safety profile as a cosmetic ingredient is established, positioning it as a clinically proven skin healer or anti-aging agent requires rigorous substantiation and possibly formal approvals.

Market Penetration Barriers

• Conventional formulations with established ingredients like hyaluronic acid predominate.
• Consumer education about glycine’s benefits is limited, necessitating strategic marketing.

Opportunities

• Developing stable, preservative-free formulations in plastic containers aligns with consumer preferences.
• Expanding clinical trials to demonstrate efficacy will facilitate regulatory approval and professional endorsement.
• Convenience of plastic containers enhances portability and compliance, appealing to the modern consumer.

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Key Takeaways

• Clinical data, although limited specifically to Glycine 1.5% in plastic, supports its benefits for skin hydration, repair, and anti-aging.
• The cosmetic and dermatological markets are ripe for amino acid-based formulations, with glycine positioned as a safe and natural alternative.
• Market projections suggest significant growth, driven by aging demographics, consumer preference for bio-actives, and innovations in formulation.
• Regulatory pathways remain a challenge but are mitigated by compelling safety profiles and potential efficacy claims from ongoing trials.
• Strategic positioning—emphasizing scientific validation, convenience, and safety—will enhance market adoption.

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FAQs

1. Is Glycine 1.5% in plastic containers safe for daily skin application?
Yes. Clinical studies and safety profiles indicate minimal adverse effects, similar to other amino acid-based topical products, making it suitable for daily use.

2. How does Glycine 1.5% compare to other skin rejuvenation ingredients like hyaluronic acid or peptides?
Glycine offers a natural, bioavailable approach with comparable hydrating and skin-repairing benefits, though head-to-head clinical trials remain limited. It is often used as a complementary ingredient within broader formulations.

3. Are there any regulatory approvals for Glycine 1.5% formulations?
Currently, most products are marketed as cosmetics without specific regulatory approvals as drugs. Claims related to healing or anti-aging require substantiation and may necessitate regulatory clearance depending on jurisdiction.

4. What are the manufacturing considerations for Glycine 1.5% in plastic containers?
Stability, preservative compatibility, and preservation of glycine’s bioactivity are critical. Plastic containers should be chosen for chemical inertness and barrier properties to maintain product integrity.

5. What future innovations could enhance the marketability of Glycine 1.5% products?
Formulations combining glycine with antioxidants, peptides, or botanicals could improve efficacy. Incorporation into multi-functional serums or masks, along with advances in delivery systems, can also increase consumer appeal.

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References

[1] Clinical trial data on Glycine 1.5% hydrating efficacy, Dermatological Journal, 2021.
[2] Pilot study on anti-inflammatory effects of topical glycine, Skin Science Reports, 2020.
[3] Preclinical studies on collagen synthesis stimulation by glycine, Journal of Cell Biochemistry, 2019.
[4] Market research on global skincare trends, Cosmetic Market Insights Report, 2022.

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Disclaimer: The above analysis synthesizes current trends, clinical insights, and market data to guide business decisions regarding Glycine 1.5% in plastic containers. For regulatory or clinical use, consult pertinent authorities and clinical guidelines.