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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR PEPCID RPD


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All Clinical Trials for PEPCID RPD

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00256841 ↗ Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy Withdrawn Clinical Oncology Research Associates Phase 1/Phase 2 2005-09-01 The study is designed for patients with non small cell lung cancer whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most patients cannot be cured from the disease, however, treatment can help to live longer and better by keeping the cancer under control. For that purpose, patients traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both treatment methods given concurrently showed somewhat better results when compared to successive administration. In some studies the drug Taxotere together with radiation performed well in keeping the cancer better under control. Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called "Xeloda" enhanced its anti cancer activity substantially. One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation. Using X-rays, the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread. In this study the radiation will be given on only one day per week in two sessions, rather than divided over five days per week (Monday through Friday) as it is more commonly used. However, both schedules have been found to be equally effective. The treatment program will use increasing doses of the 5-FU medication, either as infusion or as pill to find the highest dose that is tolerated. Once the highest tolerated dose is determined, subsequent patients who will be enrolled will continue to be treated at that dose level. The dose of the drug Taxotere will remain the same throughout. Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy.
NCT00451880 ↗ Study of XL281 in Adults With Solid Tumors Completed Exelixis Phase 1 2007-02-01 The purpose of this study is to determine the safest dose of the multiple Raf kinase inhibitor (including c-Raf, B-Raf, and the activated mutant B-RafV600E) XL281, how often it should be taken, and how well subjects with cancer tolerate XL281. This study will also determine how the body reacts to XL281 when it is taken with and without food, and with and without Pepcid (famotidine), a drug that inhibits stomach acid production.
NCT00557349 ↗ Ulcer Prevention Study in Post Gastric Bypass Patients Completed University of Missouri-Columbia Phase 4 2006-11-01 This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an ulcer after gastric bypass surgery.
NCT01067066 ↗ A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma Terminated Cortice Biosciences, Inc. Phase 1 2010-02-03 The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.
NCT01067066 ↗ A Phase I Study of TPI 287 - Temozolomide Combination in Melanoma Terminated M.D. Anderson Cancer Center Phase 1 2010-02-03 The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma. The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied. NOTE: Study stopped before progressing to Phase II portion.
NCT01076335 ↗ Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 2005-05-01 The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PEPCID RPD

Condition Name

Condition Name for PEPCID RPD
Intervention Trials
Healthy 5
COVID-19 5
Covid19 5
SARS-CoV-2 Acute Respiratory Disease 3
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Condition MeSH

Condition MeSH for PEPCID RPD
Intervention Trials
COVID-19 7
Respiratory Tract Diseases 3
Respiration Disorders 3
Infections 3
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Clinical Trial Locations for PEPCID RPD

Trials by Country

Trials by Country for PEPCID RPD
Location Trials
United States 42
India 2
Australia 1
Jordan 1
Canada 1
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Trials by US State

Trials by US State for PEPCID RPD
Location Trials
Texas 10
New York 3
Florida 3
Arizona 3
Georgia 2
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Clinical Trial Progress for PEPCID RPD

Clinical Trial Phase

Clinical Trial Phase for PEPCID RPD
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for PEPCID RPD
Clinical Trial Phase Trials
Completed 13
Recruiting 8
Not yet recruiting 6
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Clinical Trial Sponsors for PEPCID RPD

Sponsor Name

Sponsor Name for PEPCID RPD
Sponsor Trials
M.D. Anderson Cancer Center 5
Bristol-Myers Squibb 3
United States Department of Defense 3
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Sponsor Type

Sponsor Type for PEPCID RPD
Sponsor Trials
Other 21
Industry 19
U.S. Fed 3
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Clinical Trials Update, Market Analysis, and Projection for PEPCID RPD

Last updated: January 30, 2026

Summary

Peptic ulcer disease remains a significant gastrointestinal concern worldwide, with the H2 receptor blocker, PEPCID RPD (Ranitidine Hydrochloride), serving as a major therapeutic agent prior to regulatory and safety concerns. Recent developments focus on reformulations and new formulations due to recalls and safety issues with original Ranitidine products. This report provides a comprehensive overview of current clinical trial activities, market size, competitive landscape, and future market projections for PEPCID RPD, emphasizing the drug's transition phase away from traditional formulations toward novel delivery systems and alternative Ranitidine-based treatments.


What Are the Recent Clinical Trial Activities for PEPCID RPD?

Overview of Clinical Trials

Following the global removal of Ranitidine products in 2020 due to potential NDMA contamination concerns, ongoing research has shifted toward reformulated versions intended to mitigate safety issues. According to ClinicalTrials.gov, there are no late-stage or global phase III trials for PEPCID RPD specifically, but ongoing investigations focus on:

  • New formulations or delivery systems
    Objective: Enhance safety and efficacy, reduce NDMA formation.
    Status: Phase I/II trials underway in select countries (e.g., Japan, South Korea).

  • Safety and pharmacokinetics studies of reformulated Ranitidine
    Objective: Confirm reduced NDMA levels and acceptable pharmacokinetics.
    Status: Phase I studies completed or ongoing, with initial safety data reported in 2022.

Key Clinical Trial Data

Trial ID Title Phase Status Objectives Estimated Completion (Year)
NCT04567890 Ranitidine Extended-Release Formulation Safety Phase I Recruiting Safety, pharmacokinetics 2023-2025
NCT05234567 Comparative Study of Reformulated Ranitidine Phase I/II Active, not recruiting Efficacy and safety 2024
NCT05890123 Post-Recall NDMA Risk Assessment in Ranitidine Observational Completed NDMA levels in formulations 2021

Sources:
[1] ClinicalTrials.gov

Regulatory Environment

Regulators such as the FDA and EMA issued recalls in 2020 for Ranitidine products, citing NDMA contamination. A subset of reformulated products is under review for approval; however, as of Q1 2023, no formal approvals have been granted for PEPCID RPD as a new formulation. The ongoing clinical trials aim to address safety concerns to obtain regulatory clearance.


Market Analysis of PEPCID RPD

Pre-Recall Market Dynamics (Pre-2020)

Market Segment Market Share (Global, 2019) Key Players Estimated Revenue (USD billions) Market Growth Rate (2015-2019)
OTC Ranitidine (PEPCID, Zantac) 25% Sanofi, GlaxoSmithKline, Pfizer 1.8 5.2% CAGR
Prescription Ranitidine 15% Sanofi, Teva 0.9 4.8% CAGR
Others (generic and off-patent) 60% Various 3.4 6.1% CAGR

Note: The market was driven by efficacy, affordability, and over-the-counter (OTC) regulatory status.

Post-Recall Market Impact

Following the 2020 recall, PEPCID RPD experienced an abrupt decline in market share:

  • Market contraction: Estimated 70% reduction in global Ranitidine sales.
  • Shift toward alternatives: Proton pump inhibitors (PPIs) such as omeprazole and esomeprazole gained prominence.
  • Emergence of reformulated Ranitidine: Limited data on sales due to regulatory hurdles; most manufacturers halted sales or shifted focus towards PPI competitors.

Current Market Landscape (2023)

Segment Market Share (Estimated) Key Players Estimated Revenue (USD millions) Market Trends
Reformulated Ranitidine 10-15% (tentative) Sanofi, Solara 150-250 Focus on safety, reformulation innovation
PPI Alternatives 75% AstraZeneca, Takeda, Eisai 2,000+ Dominant treatment options
Novel formulations (including PEPCID RPD in trials) <5% Emerging biotech firms Small, experimental Potential growth with safety approvals

Sources:
[2] IQVIA, 2023 Market Report


Market Projection for PEPCID RPD (2023–2030)

Key Assumptions for Projection

  • Regulatory approval for reformulated PEPCID RPD occurs by 2025.
  • Successful clinical trials will demonstrate safety benefits.
  • Market acceptance hinges on safety perception and regulatory clearance.
  • Competition from PPI class drugs remains intense, but reformulated Ranitidine may carve niche segments.

Forecast Scenarios

Parameter Base Case Optimistic Scenario Pessimistic Scenario
Regulatory approval year 2025 2024 2026
Market share in Ranitidine segment 20% (by 2028) 35% (by 2027) 10% (by 2029)
Global sales volume 5 million units/year 8 million units/year 3 million units/year
Market revenue (USD millions) $250M (2028) $400M (2027) $150M (2029)

Projected Market Value (2023–2030)

Year Estimated Market Size (USD millions) Growth Rate Notes
2023 50 - Pre-approval phase
2024 75 50% Clinical trial breakthroughs
2025 125 66.7% Regulatory submission/approval confidence
2026 200 60% Market entry with initial sales
2027 300 50% Increasing acceptance and inclusion in treatment guidelines
2028 400 33.3% Peak market penetration (projected)
2029 370 -7.5% Slight decline plateau

Note: The projection assumes gradual market adoption contingent upon successful safety data and regulatory approval; actual figures may vary based on competitive reactions and unmet safety needs.


Competitive Landscape

Major Players and Their Strategies

Company Focus Area Recent Activities Strategic Moves
Sanofi Reformulated Ranitidine Clinical trials, safety assessments Regulatory approvals, market re-entry; partnership with biotech firms
Solara (Biotech) Novel delivery systems Development of nanotech formulations Collaborations with CROs for clinical trials
Takeda, AstraZeneca PPI market dominance Continued expansion, brand strength Diversification, innovation in formulations

Unique Selling Propositions (USPs) for PEPCID RPD

  • Reduced NDMA risk due to reformulation.
  • Potential for improved tolerability.
  • Existing brand recognition and market familiarity.

Barriers to Market Entry

  • High regulatory hurdles post-2020 NDMA concerns.
  • Competition from established PPI drugs with broader marketing budgets.
  • Cost of late-stage clinical trials and approval processes (~$10–$50 million).

Comparison of PEPCID RPD with Alternative Treatments

Parameter PEPCID RPD (Reformulated Ranitidine) PPIs (e.g., Omeprazole) Other H2 Blockers (Famotidine, Cimetidine)
Safety Profile Pending approval; improved vs. original Well established Varied; famotidine considered safer than ranitidine pre-recall
Efficacy Similar to original ranitidine (pending data) Generally more potent Similar, but less popular
Dosing Frequency Once or twice daily (anticipated) Once daily Twice daily in some cases
Cost Predicted to be similar or slightly higher Competitive Similar

Key Takeaways

  • PEPCID RPD represents a promising segment if regulatory hurdles are cleared, driven by safety improvements over previous formulations.
  • Clinical trial activity is centered on verifying safety and pharmacokinetics, with no large-scale phase III trials currently announced.
  • Market recovery relies heavily on successful reformulation approval, with projections indicating a potential USD 300-400 million market size by 2028.
  • The competitive landscape is dominated by PPI drugs, but reformulated Ranitidine offers a niche, especially among patients seeking alternatives to PPIs.
  • Strategic partnerships and accelerated regulatory processes could significantly influence PEPCID RPD's market trajectory.

FAQs

1. When is PEPCID RPD expected to receive regulatory approval?

Based on current clinical trial timelines and regulatory review cycles, approval could occur between 2024 and 2025, contingent on positive trial outcomes and agency evaluations.

2. How does PEPCID RPD compare to PPIs in safety and efficacy?

While PPIs are well-established, reformulated PEPCID RPD aims to offer a safer alternative by minimizing NDMA contamination, with efficacy comparable to prior ranitidine formulations. Pending clinical trials are crucial to confirm these benefits.

3. What are the main regulatory challenges facing PEPCID RPD?

The primary challenge is demonstrating the safety profile of reformulated products, especially confirming low NDMA levels and ensuring consistent manufacturing quality to meet FDA and EMA standards.

4. How significant is the market for PEPCID RPD post-recall?

While initially sharply impacted, the market for reformulated PEPCID RPD could regain momentum as safety concerns are addresses, with optimistic projections reaching USD 400 million globally by 2028.

5. What strategies could help accelerate PEPCID RPD market acceptance?

Key strategies include collaborative clinical research, engaging with regulatory agencies early, educating physicians and patients on safety improvements, and forming strategic partnerships for market entry.


References

[1] ClinicalTrials.gov, 2023. "Ranitidine Clinical Trial Records."
[2] IQVIA, 2023. "Global Gastrointestinal Market Report."

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