CLINICAL TRIALS PROFILE FOR TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

All Clinical Trials for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	Genentech, Inc.	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00038402 ↗	Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer	Completed	M.D. Anderson Cancer Center	Phase 3	2001-04-01	The purpose of this study is to evaluate the addition of Herceptin to standard chemotherapy treatment of patients newly diagnosed with operable breast cancer. Other objectives: 1) to evaluate the potential of this therapy to reduce the size of the tumor and increase the possibility of breast conservative surgery, 2) evaluate the ability of this regimen to prevent recurrence of breast cancer and impact on survival, 3) determine side effect profile with the addition of Herceptin, and 4) evaluate significance of HER2 expression by two different methods.
NCT00233935 ↗	Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus	Completed	National Cancer Institute (NCI)	Phase 1	2005-11-01	The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	Food and Drug Administration (FDA)	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	University of Maryland	Phase 4	2011-03-01	The purpose of this research is to see if non-drug ingredients in capsules and oral solutions affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by mouth, such as capsules and solutions, need to be absorbed into the body in order to do any good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are called excipients or fillers. Excipients in the capsules and solutions can impact how much drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in this research contain the drug cimetidine. This drug is being used since it has high water solubility (can dissolve in water) and low ability to be absorbed.

Clinical Trial Conditions for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Condition Name

Condition Name for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Intervention	Trials
Prognostic Stage IA Breast Cancer AJCC v8	1
Anatomic Stage 0 Breast Cancer AJCC v8	1
Anatomic Stage IV Breast Cancer AJCC v8	1
Prognostic Stage IB Breast Cancer AJCC v8	1

Condition MeSH

Condition MeSH for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Intervention	Trials
Breast Neoplasms	2
Barrett Esophagus	1
Breast Carcinoma In Situ	1
Ulcer	1

Clinical Trial Locations for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Trials by Country

Trials by Country for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Location	Trials
United States	7
China	1

Trials by US State

Trials by US State for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Location	Trials
Washington	2
Texas	2
Ohio	1
Maryland	1
New York	1

Clinical Trial Progress for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Clinical Trial Phase	Trials
Completed	4
Recruiting	3

Clinical Trial Sponsors for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container

Sponsor Name

Sponsor Name for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
National Institutes of Health (NIH)	1
Washington State University	1

Sponsor Type

Sponsor Type for Tagamet Hydrochloride In Sodium Chloride 0.9% In Plastic Container
Sponsor	Trials
Other	6
NIH	4
Industry	2

Last updated: April 28, 2026

Tagamet Hydrochloride in Sodium Chloride 0.9% in Plastic Container: Clinical Trials, Market Readout, and Forward Projection

What is the product and where does it sit commercially?

“Tagamet Hydrochloride in Sodium Chloride 0.9% in Plastic Container” is an injectable formulation of cimetidine (Tagamet brand) supplied in 0.9% sodium chloride and packaged in a plastic container. Cimetidine is a histamine H2-receptor antagonist used for acid-related indications and is typically deployed in hospital settings where IV administration is required (for example, where oral dosing is not feasible).

Commercial implication: The product is a hospital-infusion line item rather than a high-growth outpatient branded franchise. Market outcomes usually track (1) hospital formulary positioning for IV H2 antagonists, (2) competition from PPIs for many acid indications, and (3) the pace of IV substitution and supply chain stability for legacy IV therapies.

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What clinical trial signals exist for this exact IV combination?

No clinically informative trial update is specific to the exact combination string “Tagamet Hydrochloride in Sodium Chloride 0.9% in Plastic Container” as a unique development program. Cimetidine’s clinical base is mature, and recent publicly indexed studies tend to be either:

• Pharmacology/biopharm work that does not target this specific container composition, or
• Reformulations of cimetidine generally, without programmatic differentiation by container type.

Practical read-through for R&D: If the label target is acid suppression in acute settings, the development signal for this specific IV container is unlikely to be driven by brand-new efficacy trials. Any forward activity is more likely to be regulatory lifecycle (CMC, packaging, sourcing) and supply continuity, rather than new pivotal efficacy datasets.

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What is the market structure for IV cimetidine therapies?

1) Likely buyer profile

• Hospital pharmacies and acute care systems
• Procurement through group purchasing organizations (GPOs) and contract pharmacies
• Use concentrated around perioperative, ER, inpatient GI, and ICU dosing pathways where IV H2 blockers remain available

2) Competitive set

• Other IV H2 antagonists (legacy basket)
• PPIs in IV form for many indications where they dominate guideline pathways
• Generic cimetidine IV products where available, typically competing on price, availability, and contract terms

3) Key market drivers

• Formulary decisions: whether IV H2 blockers stay on formulary for specific indications
• Guideline alignment: PPI preference for many GERD and ulcer indications reduces addressable use for H2 blockers
• Supply reliability: shortages of specific IV presentations can temporarily shift market share
• Switching behavior: IV to oral transition often occurs quickly; IV cimetidine use depends on inpatient pathways

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What is the projection: base case, downside, and upside?

Because the product is a mature, legacy IV brand (cimetidine) and not a novel mechanism, forward projection is driven more by usage attrition and supply/contract dynamics than by reinvention.

Projection framework (in market value terms)

• Base case (flat-to-declining): slow volume erosion as PPIs maintain guideline preference; steady hospital uptake where IV H2 blockers remain. Pricing compresses toward generics.
• Downside (decline + substitution): further formulary tightening reduces eligible indications; procurement shifts to lower-cost alternatives; marginal supply events reduce consistency.
• Upside (localized share capture): contract wins with better availability, short-term supply constraints in competing IV H2 presentations, or rebundled inpatient protocols that maintain IV H2 use.

Directional forecast (qualitative):

• Volume: mild decline over the medium term; residual demand persists in acute hospital pathways.
• Revenue: declines more than volume in typical tender-driven markets as discounts deepen.
• Share: stable to slowly shrinking for branded Tagamet unless brand holds a strong contract premium in specific hospital networks.

This is the standard trajectory for legacy IV acid-suppression products when therapeutic preference shifts toward alternatives (notably PPIs) and when generic supply expands.

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How does regulatory and product lifecycle affect forward performance?

For legacy IV products, commercial durability depends on non-efficacy factors:

• Label and dosing stability: cimetidine’s core IV use does not change quickly absent new contraindications or major safety updates.
• CMC and packaging continuity: the plastic container presentation impacts manufacturability and distribution logistics.
• Substitution and contracts: generics and alternative IV acid suppressants drive pricing and formulary access.
• Cold chain and administration protocols: IV handling requirements can affect switching decisions within hospital workflows.

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What clinical or safety outcomes could change the trajectory?

The highest-impact variables for a mature H2 antagonist are not new efficacy signals; they are:

• Safety signals (class-wide tolerability and contraindications)
• Drug interaction profile shifts in practice (for example, management of interactions in inpatient prescribing)
• Supply disruptions affecting availability and forcing temporary protocol changes
• Regulatory action (label restrictions or manufacturing site changes)

Absent a new class-breaking efficacy outcome, these factors tend to create short-cycle impacts rather than durable growth.

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What to watch in the next cycle (actionable monitoring checklist)

Clinical-development watch

• No expectation of phase 3 data tied to this exact container formulation
• Any new trials would likely be label-expansion or comparative studies, but such programs are uncommon for mature cimetidine

Commercial watch

• Contract award cycles for inpatient formularies
• GPO pricing revisions and conversions to lowest net cost
• Availability signals (allocation, recalls, manufacturing pauses)
• Hospital protocol updates on IV-to-oral transitions

R&D watch

• If a manufacturer invests, it usually shows up in CMC filings, packaging changes, and manufacturing site qualifications rather than novel clinical endpoints

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Key Takeaways

• “Tagamet Hydrochloride in Sodium Chloride 0.9% in Plastic Container” is a mature IV cimetidine product; forward value is shaped by formulary positioning, contracting, and substitution rather than new efficacy trials.
• Public clinical-trial updates are unlikely to be specific to this exact container presentation; any meaningful new evidence is more likely to be lifecycle or packaging/CMC rather than renewed pivotal trials.
• Market outlook is flat-to-declining in base case due to persistent PPI preference and generic competition, with upside possible only through contract wins or supply constraints among alternatives.
• The most actionable forecasting inputs are hospital procurement outcomes, GPO pricing, and supply continuity.

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FAQs

1. Is this product seeking new indications in clinical trials?
   Not in any program-level, container-specific way; cimetidine development is mature and new pivotal efficacy trials for this exact IV formulation are not a common pattern.

2. What drives inpatient demand for IV cimetidine?
   Where IV administration is required, IV-to-oral transition timing, and whether hospital protocols keep IV H2 blockers on formularies.

3. How does PPIs competition affect the market?
   PPIs typically cover many ulcer and reflux indications with higher guideline alignment, reducing eligible use for H2 antagonists.

4. What are the commercial levers beyond clinical efficacy?
   Contract pricing, formulary listings, interchangeability with generics, and consistent availability for hospital dispensing workflows.

5. What would signal an upside scenario?
   Sustained contract awards with favorable net pricing, and/or competitor IV supply disruptions that temporarily elevate IV H2 blocker use.

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References

[1] FDA. “Cimetidine (Tagamet) Drug Label Information.” U.S. Food and Drug Administration. https://www.accessdata.fda.gov/ (accessed 2026-04-28).
[2] DailyMed. “Tagamet (Cimetidine) Injection Information.” U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/ (accessed 2026-04-28).
[3] ClinicalTrials.gov. “Cimetidine (IV) Clinical Trials.” U.S. National Library of Medicine. https://clinicaltrials.gov/ (accessed 2026-04-28).