CLINICAL TRIALS PROFILE FOR GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00671528 ↗	Safety and Efficacy of Quadriderme® in the Treatment of Impetiginous Eczema (Study P05134AM4)	Terminated	Merck Sharp & Dohme Corp.	Phase 4	2009-07-01	This is a parallel-group, randomized, active-controlled, double-blind, Phase 4 trial comparing three creams in the treatment of impetiginous eczema: - Arm A: QUADRIDERME® cream (betamethasone diproprionate, clotrimazole, and gentamicin sulfate) - Arm B: Combination of betamethasone diproprionate cream and gentamicin sulfate cream - Arm C: Betamethasone diproprionate cream At 7 sites, in Portugal, a total of 207 subjects will be randomized using a 1:1:1 randomization ratio to receive one of the three possible treatments for a maximum period of 28 days or until 5 days after total remission of the signs and symptoms, but never more than 28 days. Assessments will be made of level of improvement of the target area in each treatment group, number of days for total remission, and safety profile. Note: This study was terminated early due to lack of recruitment (only 3 of the 207 planned participants were enrolled). Statistical analyses were not performed. Further, 7 sites were planned, but only 4 sites were approved out of which 3 sites were initiated.
NCT01878643 ↗	Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit	Completed	Stony Brook University	Early Phase 1	2001-12-01	The purpose of this study was : - to determine the effect of inhaled antibiotics on airway bacteria in ventilated patients - to determine the effect of inhaled antibiotics on respiratory infection
NCT02036528 ↗	Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers	Terminated	Royer Biomedical, Inc.	Phase 1/Phase 2	2014-01-01	The purpose of this study is to determine whether AppliGel-G (Gentamicin topical gel) plus oral Ciprofloxacin / Doxycycline are safe and effective in the treatment of mild to moderately infected foot ulcers in diabetic patients.
NCT03012191 ↗	Gentamicin for RDEB	Completed	University of Southern California	Phase 1/Phase 2	2017-02-02	Recessive dystrophic epidermolysis bullosa (RDEB) is an incurable, devastating, inherited skin disease caused by mutations in the COL7A1 gene that encodes for type VII collagen (C7), the major component of anchoring fibrils (AFs), structures that mediate epidermal-dermal adherence. Thirty percent of RDEB patients have nonsense mutations. The investigators recently demonstrated in 5 such patients that intradermal and topical gentamicin induced "read-through" of their nonsense mutations and created robust and sustained new C7 and AFs at the dermal-epidermal junction (DEJ) of their skin and also stimulated wound closure and reduced new blister formation. No untoward side effects occurred. Herein, the investigators propose evaluating the safety and efficacy of intravenous gentamicin in these patients. In theory, this intravenous administration has the possibility of treating simultaneously all of the patients' skin wounds. The investigators also propose optimizing the concentration and manner of delivery of topical gentamicin. The unambiguous milestones will be increased C7 and AFs in the patients' DEJ, improved EB Disease Activity Scores, and absence of significant gentamicin side effects.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Condition Name

Condition Name for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Neurogenic Bladder	2
Recessive Dystrophic Epidermolysis Bullosa	2
Spinal Cord Injuries	2
Metastatic Cancer	1

Condition MeSH

Condition MeSH for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Intervention	Trials
Epidermolysis Bullosa	4
Infections	3
Infection	3
Urinary Tract Infections	3

Clinical Trial Locations for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
United States	13
Kenya	1
China	1
Norway	1

Trials by US State

Trials by US State for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Location	Trials
California	4
Michigan	2
Kentucky	1
Utah	1
Maryland	1

Clinical Trial Progress for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Recruiting	5
Terminated	2
Completed	2

Clinical Trial Sponsors for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
University of Southern California	3
Royer Biomedical, Inc.	1
National Institute for Health Research, United Kingdom	1

Sponsor Type

Sponsor Type for GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Sponsor	Trials
Other	20
Industry	2

Last updated: April 28, 2026

Gentamicin Sulfate in 0.9% Sodium Chloride (Plastic Container): Clinical, Market, and Projection Update

Gentamicin sulfate in 0.9% sodium chloride (0.9% NS) in plastic containers is an established parenteral antibiotic offering dosed-volume flexibility for hospital use. Public clinical-trial and labeling evidence is fragmented across multiple NDCs and container formats, while market performance is driven more by hospital formularies, generic substitution, supply continuity, and regulatory compliance than by new chemical-entity innovation. The category’s forward outlook is shaped by (1) ongoing demand for broad-spectrum aminoglycoside use in complicated infections, (2) margin pressure from generic competition, and (3) procurement constraints tied to sterile manufacturing and container supply.

What clinical-trial signal exists for this specific formulation?

There is no consistent public clinical-trial record that tracks “gentamicin sulfate in 0.9% sodium chloride in plastic container” as a distinct investigational product in the way that an NDA/BLA new molecular entity would. What is observable is category-level activity for gentamicin (antibiotic drug substance) and comparator trials for aminoglycosides in clinical practice settings. For decision-grade product-specific updates, the most reliable public-trial linkage is via:

• Drug substance evidence (gentamicin efficacy/safety in relevant infections).
• Bioequivalence/sterility equivalence work for generic injectable versions, which typically does not generate new clinical endpoints.

Practical implication for R&D and investment: the formulation is treated in the market as a line-extension/generic injectable delivery format rather than a trial-seeded innovation. Clinical-trial “update” is therefore dominated by post-approval safety surveillance and substitution dynamics rather than novel efficacy signals.

What does the regulatory and label landscape indicate about ongoing product evolution?

For FDA-regulated injectables, container type and solution composition affect:

• Stability and shelf-life (drug concentration and degradation profile in the specific container).
• Leachables/extractables risk assessment for plastic container materials.
• Compatibility claims with infusion workflows.
• Sterility assurance and manufacturing controls.

For this category, evolution typically occurs through:

• Generic approvals (ANDA pathways) and labeling updates.
• Container/packaging changes after manufacturing tech transfer or supplier shifts.
• Lot-level safety signals handled through routine pharmacovigilance rather than new clinical trials.

Decision-grade takeaway: any “clinical update” is usually operational (stability, container equivalence, supply chain) rather than clinical efficacy re-evaluation.

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How large is the market and what drives demand?

The relevant commercial market is the parenteral gentamicin segment, with formulation and container format affecting purchasing specs but not the core antimicrobial demand driver.

Demand drivers (hospital and ID practice)

• Hospital inpatient use in complicated infections (where aminoglycosides remain part of guideline-based regimens or are used in culture-directed therapy).
• Compounding and pharmacy integration (infusion workflows often prefer standardized premixed formats).
• Acquisition economics (low-cost generics win unless procurement restricts based on container constraints).

Supply and procurement drivers

• Sterile injectable manufacturing capacity and batch release reliability.
• Plastic container availability and secondary packaging compatibility with hospital formulary logistics.
• Regulatory compliance and inspection outcomes affecting continuity of supply.

Competitive structure

• Dominated by generic injectable manufacturers.
• Competition occurs on net price, availability, and formulary position (contracting), with brand history less decisive than procurement terms.

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What is the near-term market outlook (2026 to 2029)?

A projection for this specific dosage-form category must be anchored in structural market forces:

1. Persistent base demand for aminoglycoside coverage in hospital settings.
2. Ongoing margin compression due to multiple generic players and tender-based purchasing.
3. Supply shocks risk (sterile manufacturing outages or container supply constraints) that can temporarily improve pricing but do not change structural growth rates.
4. Substitution elasticity: procurement frequently swaps between equivalent gentamicin presentations based on:
   • total daily dose needs,
   • concentration availability,
   • infusion time and compatibility requirements,
   • price and supply continuity.

Projection framework (category-level, formulation-specific for procurement positioning)

Because clinical-trial data for the exact packaging is not a principal growth lever, the forecast is primarily a function of:

• hospital volume trends,
• generics pricing dynamics,
• share-of-shelf across NDCs,
• and supply continuity.

Base-case outcome: modest category value growth with structurally constrained margins. Growth is more likely to be volume-stable than volume-expanding.

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What adoption and share trends matter most for this plastic-container line?

For hospitals, adoption of premixed or packaged gentamicin presentations in plastic containers tends to be governed by:

• Formulary inclusion under group purchasing organization (GPO) contracts.
• Compatibility requirements with infusion sets and standard IV admixture workflows.
• Reduced pharmacy handling versus vials that require dilution and compounding.
• Procurement specifications that favor certain container dimensions for infusion pumps and storage layouts.

These factors determine share more effectively than incremental clinical endpoints.

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Where do risks and opportunities sit in 2026-2029?

Key risks

• Generic price erosion: increased tender competition can reduce net revenue per unit.
• Manufacturing disruptions: sterile injectable supply is sensitive to plant utilization and regulatory inspection cycles.
• Container supply constraints: packaging ingredient availability and plastic container availability can drive backorders and pricing volatility.

Key opportunities

• Contract wins based on reliability of supply and stable pricing.
• Formulary repositioning through demonstrated stability and compatibility documentation tied to the specific plastic container.
• Hospital consolidation of procurement: standardized package formats win during ID pharmacy standardization.

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What actionable signals should investors and R&D teams track?

Commercial signals

• GPO contract awards and rebids for injectable gentamicin lines.
• Net pricing movements in tenders (often more informative than list price).
• Availability indicators: backorder duration and substitution frequency.

Regulatory and operational signals

• Labeling updates tied to stability or packaging changes.
• Inspection outcomes for relevant sterile manufacturing facilities.
• Batch release disruptions and distribution constraints.

Clinical/safety signals

• Pharmacovigilance trends in aminoglycosides (renal toxicity monitoring, dosing errors).
• Guideline updates affecting aminoglycoside usage patterns in key infection categories.

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Key Takeaways

• This formulation is a procurement-driven generic injectable, not a clinical-trial-led innovation category; trial activity is mostly reflected at the drug-substance level, while product equivalence and stability govern packaging acceptance.
• Market growth is constrained by generic price competition, with value gains more likely from contract coverage and supply continuity than from new clinical efficacy.
• Near-term (2026-2029) outlook is best modeled as modest value growth with margin pressure, supported by steady hospital demand and occasionally influenced by sterile supply shocks and container availability.
• Competitive advantage is operational: reliable supply, stable net pricing, and plastic-container compatibility documentation decide formulary share.

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FAQs

1. Is this product likely to drive new clinical efficacy claims?
   No. It is generally positioned as a formulation and packaging variant where clinical evidence is maintained by established gentamicin efficacy plus bioequivalence and compatibility/stability documentation.

2. What matters more for market performance: clinical trials or procurement?
   Procurement and supply continuity. Hospitals buy by tender economics, availability, and workflow fit (container and infusion compatibility).

3. What are the main margin risks for investors?
   Ongoing generic competition and contract rebids that pressure net price, offset only partially by volume coverage and supply reliability.

4. Can supply disruptions change the outlook?
   They can shift short-term pricing and volume allocation, but they typically do not permanently change structural growth unless they cause sustained capacity reallocation or market consolidation.

5. What operational documentation most influences uptake of plastic-container versions?
   Stability/shelf-life evidence and compatibility guidance tied to the specific plastic container and handling conditions used by hospital infusion workflows.

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References

[1] FDA. “ANDA (Abbreviated New Drug Application) Overview.” U.S. Food and Drug Administration.
[2] FDA. “Drug Development and the ANDA Process.” U.S. Food and Drug Administration.
[3] FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).” U.S. Food and Drug Administration.
[4] European Medicines Agency (EMA). “Aminoglycosides: product information and risk considerations” (category-level guidance and EPAR materials relevant to gentamicin use). European Medicines Agency.
[5] Infectious Diseases Society of America (IDSA). Guideline documents on management of infections where aminoglycosides are used (category-level practice references).