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NCT00000372 ↗	Glycine and D-Cycloserine in Schizophrenia	Withdrawn	Massachusetts General Hospital	Phase 3	1998-03-01	The purpose of this study is to compare the effects of D-cycloserine and glycine for treating negative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

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
Schizophrenias	4
Schizophrenic 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

Last updated: May 22, 2026

Glycine 1.5% In Plastic Container: Clinical Trial Update, Market Analysis, and Forecast

Glycine 1.5% in plastic container is a sterilized, aqueous, isotonic solution used as a surgical irrigation/instillation fluid in procedures including transurethral endoscopic surgery. Current market visibility is limited because this product often competes on hospital procurement, tender pricing, and supply reliability more than on branded “drug-like” differentiation. Clinical-trial activity for this exact concentration and container format is typically sparse in public registries.

No complete, verifiable dataset was provided in the prompt to support a specific clinical-trials update (trial registry IDs, endpoints, enrollment, status dates), a product-level market sizing base (units, dosage volumes, price points, geography), or an evidence-based projection model (assumptions, competitor mapping, reimbursement/tender dynamics). Under the operating constraints, a complete and accurate response cannot be produced.

Are any clinical trials registered for “glycine 1.5% in plastic container”?

A product-level clinical-trials update requires confirmable registry matches (ClinicalTrials.gov / EU CTR / WHO ICTRP) for the exact medicinal product description, including concentration, route, and presentation. Without those identifiers, an accurate status summary cannot be compiled.

What trial endpoints are typically tracked for glycine irrigation solutions?

When glycine solutions are studied, endpoints usually relate to:

• procedural efficacy (surgical visualization quality, operating time)
• safety outcomes (fluid absorption, serum glycine levels)
• adverse events linked to TUR syndrome risk (hyponatremia, neurologic status)
• need for rescue interventions or monitoring intensity
  Public registries must be matched to the specific product to summarize any “update.”

What is the market size for glycine 1.5% solution irrigation, and where is demand concentrated?

Market analysis at this specificity level requires:

• a defined market scope (surgical irrigation fluids vs urology-specific fluids vs sterile irrigation solutions)
• a mapping of substitutable SKUs (different concentrations, premixed vs custom compounding, glass vs plastic containers)
• geography and channel split (hospital tenders vs distributor sales)
• price and volume by seasonality and procedure volume
  Without a product-level scope and source dataset, any market size or share statement would not meet the accuracy requirement.

Which segments typically drive use?

Demand is usually linked to procedural volumes in:

• urology endoscopy (TUR-B, TURP, diagnostic resections)
• other endoscopic settings where irrigation is used
  A defensible projection needs procedure volumes by region and an irrigation-fluid substitution model.

When does glycine 1.5% lose exclusivity for competition or substitution?

Exclusivity questions depend on whether the marketed item is:

• a patented drug with granted approvals and Orange Book exclusivity periods, or
• an unpatented/“essentially generic” sterile solution where competition is primarily supply-based and tied to manufacturing filings.
  A product-level exclusivity timeline requires branded approval identifiers or listing records.

What patent estate barriers typically affect irrigation solutions?

If patents exist, they usually target:

• manufacturing methods
• container/closure systems
• stability and sterilization processes
• packaging configurations
  No patent numbers or approval/listing identifiers were provided to support an estate map.

How do generics and hospital tender pricing affect forecasts for glycine 1.5%?

Forecasting requires:

• competitor set and their installed supply
• historical tender clearing prices
• contract duration, switching costs, and substitution policy
• regulatory constraints for interchangeable presentations
  No such procurement or competitive data was provided.

What regulatory pathway governs glycine 1.5% solutions in the US and EU?

A pathway analysis requires:

• the FDA application type (NDA vs ANDA vs 505(b)(2))
• Orange Book listing details
• EU authorization type and renewal history
  No FDA/EU approval identifiers were supplied.

What generic entry risks exist for glycine 1.5% in plastic containers?

Generic entry risk assessment needs evidence of:

• existing paragraph IV challenges (US) or equivalent exclusivity conflicts
• manufacturing readiness and sterile facility capabilities
• stability data acceptance for the exact container
  Absent product identifiers and filings, a risk rating cannot be stated.

How does glycine 1.5% compare with alternative irrigation solutions (water, mannitol, sorbitol, glycine 2.0%)?

Comparative market modeling needs:

• clinical preference and guideline positioning by procedure type
• safety profiles (including absorption-related electrolyte effects)
• procurement constraints and formulary adoption
  No clinical guideline or reimbursement mapping was provided.

Key Takeaways

A reliable clinical-trial update and product-level market projection for “Glycine 1.5% In Plastic Container” cannot be produced from the information provided. A complete and accurate response requires specific registry, approval/listing, patent, and market datasets.

FAQs

1. What are common clinical adverse events associated with glycine irrigation solutions used in endoscopic urology?
2. How do hospital tender purchasing policies typically select between glycine irrigation SKUs and alternatives?
3. Does container material (plastic vs glass) change stability, shelf life, or regulatory handling for glycine solutions?
4. What manufacturing and quality system requirements usually constrain supply for sterile irrigation fluids?
5. How do procedure volumes (TURP/TURBT) translate into demand for sterile irrigation solutions by concentration?

References

(No sources were cited because no verifiable clinical, regulatory, patent, or market inputs were provided in the prompt.)