CLINICAL TRIALS PROFILE FOR TAGAMET HB 200

All Clinical Trials for TAGAMET HB 200

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.
NCT01256879 ↗	Cimetidine Biowaivers	Completed	University of Maryland, Baltimore	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 HB 200

Condition Name

Condition Name for TAGAMET HB 200
Intervention	Trials
Interaction	1
Prognostic Stage IIIB Breast Cancer AJCC v8	1
Anatomic Stage III Breast Cancer AJCC v8	1
Lactation	1

Condition MeSH

Condition MeSH for TAGAMET HB 200
Intervention	Trials
Breast Neoplasms	2
Breast Carcinoma In Situ	1
Ulcer	1
Barrett Esophagus	1

Clinical Trial Locations for TAGAMET HB 200

Trials by Country

Trials by Country for TAGAMET HB 200
Location	Trials
United States	7
China	1

Trials by US State

Trials by US State for TAGAMET HB 200
Location	Trials
Washington	2
Texas	2
Ohio	1
Maryland	1
New York	1

Clinical Trial Progress for TAGAMET HB 200

Clinical Trial Phase

Clinical Trial Phase for TAGAMET HB 200
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for TAGAMET HB 200
Clinical Trial Phase	Trials
Completed	4
Recruiting	3

Clinical Trial Sponsors for TAGAMET HB 200

Sponsor Name

Sponsor Name for TAGAMET HB 200
Sponsor	Trials
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2
University of Maryland, Baltimore	1
AstraZeneca	1

Sponsor Type

Sponsor Type for TAGAMET HB 200
Sponsor	Trials
Other	6
NIH	4
Industry	2

Tagamet HB 200 (cimetidine) clinical trials update, market analysis and market projection

Last updated: July 28, 2026

Executive summary: Tagamet HB 200 is an oral cimetidine (H2-receptor antagonist) product positioned for acid-related gastrointestinal conditions (eg, heartburn/GERD-related symptoms). Cimetidine is an older, off-patent active ingredient with long-established marketing history; current competitive dynamics are dominated by generic cimetidine pricing, pharmacy channel rebates, and substitution at the brand-to-generic level rather than late-stage clinical differentiation. A “clinical trials update” for the specific finished product is not determinable from provided inputs, and therefore is not produced.

What is Tagamet HB 200 (cimetidine 200 mg) used for and how is it positioned commercially?

Drug identity and class

• Active ingredient: cimetidine
• Strength: 200 mg (HB 200 product)
• Class: H2-receptor antagonist (H2RA)
• Primary role: suppresses gastric acid secretion; used for symptomatic relief of acid-related disorders (labeling varies by country).

Commercial positioning

• Brand value is driven by:
  • Established clinician familiarity and historical prescribing
  • Patient preference and pharmacy substitution rules
  • Formulation attributes (eg, tablet type, excipients) that can affect tolerability
• Core market reality: because cimetidine is mature and widely genericized, branded “HB” products usually compete as price anchors or channel-managed brands rather than IP-protected innovations.

What is the current clinical trials status for cimetidine products like Tagamet HB 200?

No complete, verifiable clinical-trials dataset for Tagamet HB 200 specifically is provided, and without a source-backed registry snapshot (eg, ClinicalTrials.gov record linkage to the finished product name or NCT aggregation for cimetidine 200 mg formulations), a precise “latest status” update cannot be produced.

Which trials and study types still matter for old H2 blockers like cimetidine in 2025–2026?

Where new studies occur for mature H2 blockers, they typically fall into:

• Comparative effectiveness against PPIs for specific subpopulations or step-down regimens
• Safety and tolerability studies in older adults with polypharmacy risk
• Pharmacokinetic/pharmacodynamic (PK/PD) studies for bioequivalence and formulation changes
• Drug-drug interaction mapping, given cimetidine’s known CYP inhibition profile

A credible update requires registry-level identification of ongoing and completed studies by active ingredient, dose, route, and formulation, which is not provided.

How big is the cimetidine market and what share does brand Tagamet-like inventory typically hold?

A market-sizing and share estimate for a specific “Tagamet HB 200” finished product requires:

• Country scope (US vs EU vs ROW)
• Channel basis (retail pharmacy vs institutional)
• Whether analysis includes all cimetidine strengths or only 200 mg
• Whether “Tagamet” brand includes the HB line or includes other Tagamet formulations

No market dataset or region scope is provided. As a result, a quantified market model is not generated.

What generic entry risks exist for Tagamet HB 200 and how fast does price erosion occur?

Generic substitution

• Cimetidine’s age and broad generic availability make generic substitution the dominant risk for branded tablets.
• Price erosion is usually driven by:
  • Multiple ANDA approvals (where applicable by jurisdiction)
  • Pharmacy benefit manager (PBM) preferred-drug lists
  • Tendering and hospital formulary inclusion policies

Regulatory/IP posture

• For old H2 blockers, IP risk is generally low relative to newer agents; the main economic risk is channel switching to low-cost equivalents.

A precise Paragraph IV / exclusivity / Orange Book map is not produced because Tagamet HB 200-specific patent and listing data are not supplied.

How does Tagamet HB 200 compare with OTC H2 blockers and PPIs in treatment outcomes and payer preferences?

Therapeutic comparison (market-level)

• PPIs typically dominate chronic GERD management due to stronger acid suppression and guideline preference.
• H2 blockers retain share for:
  • Intermittent symptoms
  • Nocturnal breakthrough symptoms in select regimens
  • Patient preference for lower-intensity options or step-down approaches

Payer/channel preference

• Formularies often prefer lowest acquisition cost within class unless clinical pathways require otherwise.
• Cimetidine-specific utilization can be influenced by drug interaction concerns relative to other H2 blockers (eg, famotidine), which can shift prescribing and dispensing patterns.

What is the likely revenue trajectory for Tagamet HB 200 under generic competition?

For mature, off-patent acid-suppression products:

• Near-term outlook: revenue is typically stable only where a branded SKU retains channel placement, otherwise it declines with ongoing substitution.
• Medium-term: continued erosion with increasing generic penetration and consolidation of preferred SKUs.
• Long-term: branded revenues typically plateau at a low level (distribution footprint persists) or exit in markets where the brand cannot maintain price concessions.

A quantified projection is not produced because no baseline revenues, geography, or dispensing volume inputs are provided.

What manufacturing and supply-chain factors affect supply stability for oral cimetidine 200 mg tablets?

Common supply-chain drivers for genericized oral tablets include:

• API sourcing stability and cost volatility
• Contract manufacturing capacity for small-to-medium volume strengths
• Regulatory compliance costs (GMP, stability testing, post-approval changes)
• Packaging format standardization and shelf-life management

No supply interruption, recalls, or manufacturing constraints tied to Tagamet HB 200 are provided, so no event-driven forecast is generated.

How do clinical safety considerations influence demand for cimetidine products?

Key market effects (class-level):

• Drug-drug interaction profile can deter prescribing in polypharmacy patients.
• Older adult safety and tolerability considerations affect clinician choice.
• Competition with better tolerated or lower-interaction H2 blockers can compress share.

Tagamet HB 200 demand is therefore more sensitive to clinician perception and formulary policies than to new efficacy endpoints.

Key takeaways

• Tagamet HB 200 is a cimetidine 200 mg H2-receptor antagonist; commercial dynamics are shaped primarily by generic substitution and channel pricing rather than ongoing IP-driven differentiation.
• A specific “clinical trials update” for Tagamet HB 200 cannot be produced without registry-backed, product-linked trial identification.
• Without baseline market size by geography and current sales/dispensing, a quantified market projection cannot be credibly stated.

FAQs

1. Is Tagamet HB 200 prescription-only or OTC, and how does that change market demand?
2. How does cimetidine compare with famotidine and nizatidine in formulary adoption?
3. What patient groups are most likely to choose cimetidine over PPIs?
4. Do pharmacies substitute Tagamet HB 200 automatically, and what drives brand retention?
5. What are the most common safety-related prescribing triggers for cimetidine in polypharmacy patients?

References

1. No source material was provided in the prompt to support citations.