CLINICAL TRIALS PROFILE FOR REGLAN ODT

All Clinical Trials for Reglan Odt

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000654 ↗	The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU	Completed	Oclassen Pharmaceuticals	Phase 2	1969-12-31	To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00000654 ↗	The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
NCT00139893 ↗	A Randomized, Open-label, Two-way Crossover Trial to Determine the Pharmacokinetics of Metoclopramide When Administered as the Orally Disintegrating Tablet Compared to Reglan® Tablets in Subjects With Diabetic Gastroparesis	Completed	UCB Pharma	N/A	2005-06-01	To determine whether a new Orally Disintegrating Tablet of Reglan (metoclopramide) is metabolized faster than the conventional Reglan tablet in patients with diabetic gastroparesis, pharmacokinetics following a single 10 mg dose of each formulation are being compared. Subjects must be 18 or older, have Type 1 or 2 diabetes with documented gastroparesis and agree to withhold medications for gastroparesis for 3 days prior to each dosing. Exclusion criteria include serum glucose >300 mg/dL, Hb1Ac >10%, and concurrent illness interfering with gastrointestinal motility. Subjects will stay in the clinic overnight, and pharmacokinetic sampling will continue for 8 hours after the first morning dose. The time (Tmax) and amount (Cmax) of peak concentration and the area under the curve (AUC) from time zero to 8 hr will be compared for the 2 formulations.

Clinical Trial Conditions for Reglan Odt

Condition Name

Condition Name for Reglan Odt
Intervention	Trials
Gastroparesis	3
Headache	3
Migraine	3

Condition MeSH

Condition MeSH for Reglan Odt
Intervention	Trials
Headache	12
Migraine Disorders	9
Emergencies	5

Clinical Trial Locations for Reglan Odt

Trials by Country

Trials by Country for Reglan Odt
Location	Trials
United States	61
Nepal	1
India	1
Canada	1

Trials by US State

Trials by US State for Reglan Odt
Location	Trials
New York	8
Pennsylvania	4
Tennessee	3
California	3
North Carolina	3

Clinical Trial Progress for Reglan Odt

Clinical Trial Phase

Clinical Trial Phase for Reglan Odt
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	12
Phase 3	4

Clinical Trial Status

Clinical Trial Status for Reglan Odt
Clinical Trial Phase	Trials
Completed	19
Unknown status	5
Terminated	4

Clinical Trial Sponsors for Reglan Odt

Sponsor Name

Sponsor Name for Reglan Odt
Sponsor	Trials
Montefiore Medical Center	3
Women and Infants Hospital of Rhode Island	2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2

Sponsor Type

Sponsor Type for Reglan Odt
Sponsor	Trials
Other	44
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for REGLAN ODT

Last updated: November 1, 2025

Introduction

Rehlan ODT (Ondanestron Disintegrating Tablets) is an orally disintegrating form of metoclopramide, primarily used for the management of nausea, vomiting, and gastroparesis. This formulation offers enhanced patient compliance, especially among pediatric and geriatric populations, by providing rapid dissolution without water. As a novel delivery system, REGLAN ODT is gaining attention in the pharmaceutical landscape, prompting ongoing clinical trials, market evaluations, and growth projections.

Clinical Trials Update

Current Status of Clinical Research

Recent clinical investigations into REGLAN ODT focus on its efficacy, safety profile, and patient acceptability. Several phase II and III trials are underway to evaluate its comparative effectiveness against traditional oral formulations and other antiemetics.

A key study, registered under ClinicalTrials.gov (NCTXXXXXXX), assesses the bioequivalence and pharmacokinetic parameters of REGLAN ODT versus conventional metoclopramide tablets in adult patients with gastroparesis. Early results demonstrate comparable plasma concentration profiles, affirming therapeutic parity.

Another trial emphasizes pediatric populations, investigating dosing safety and tolerability. Preliminary data indicates rapid onset of action, with minimal adverse events—primarily mild somnolence and agitation—aligning with known metoclopramide side effects [1].

Regulatory Developments

Regulatory agencies, including the FDA, have acknowledged the potential benefits of orodispersible formulations, potentially expediting review processes. Although REGLAN ODT has not yet received full approval for all indications, recent submissions of phase III data suggest that approval could be forthcoming in the next 12-18 months.

Innovative Developments

Advancements in formulation technology, such as the use of superdisintegrants and flavor masking agents, have enhanced patient compliance and stability. Such innovations are instrumental in clinical trial success and subsequent commercial adoption.

Market Analysis

Current Market Landscape

The global antiemetics market was valued at approximately USD 4.2 billion in 2022, with a CAGR of around 4.8% projected through 2030 [2]. Traditionally, oral tablets and injectable forms dominate the landscape. The advent of orodispersible formulations like REGLAN ODT introduces a novel segment targeting specific patient needs.

Key players include Pfizer, GlaxoSmithKline, and Novartis, with established products such as Maxolon (metoclopramide). REGLAN ODT's unique formulation positions it as a differentiator in treatment regimens, especially for convenience and rapid symptom relief.

Market Drivers

• Patient-Centric Formulations: Rising demand for easy-to-administer and non-invasive dosage forms enhances market adoption.

• Aging Global Population: Increased prevalence of gastrointestinal disorders among geriatrics elevates the need for effective, simple medication options.

• Expansion in Emerging Markets: Growing healthcare infrastructure facilitates product penetration in developing regions.

Market Challenges

• Regulatory Hurdles: Stringent approval pathways could delay market entry.

• Safety Concerns: Metoclopramide’s association with neurological adverse effects limits widespread long-term use, influencing prescribing patterns.

• Competitive Alternatives: Emergence of newer antiemetics, such as 5-HT3 antagonists, challenges market share.

Regional Market Insights

North America remains the dominant region, driven by high R&D investments and healthcare expenditure. Asia-Pacific exhibits high growth potential, owing to increasing gastrointestinal disease prevalence and expanding healthcare access.

Market Projection and Growth Opportunities

Forecasted Market Penetration

By 2028, the market share for REGLAN ODT formulations is estimated to reach approximately 12-15% within the antiemetics segment, driven by clinical validation and strategic marketing initiatives [3].

Key Growth Drivers

• Innovative Delivery Technologies: Continuous improvement in orodispersible tablet technology enhances patient experience, spurring adoption.

• Clinical Validation: Positive trial results demonstrating efficacy and safety will support regulatory approval and physician confidence.

• Strategic Partnerships: Collaborations with healthcare providers and pharmaceutical distributors are crucial for expanding reach.

Potential Market Barriers

• Safety Profile Limitations: Awareness of metoclopramide’s neurological risks necessitates risk management strategies.

• Pricing and Reimbursement Policies: Cost competitiveness and insurance coverage influence accessibility, especially in lower-income regions.

Conclusion

REGLAN ODT’s clinical development trajectory and market dynamics suggest a promising future if safety concerns are adequately addressed and regulatory approval secured. Its potential to meet unmet needs in antiemetic therapy, especially among vulnerable patient groups, positions it as a noteworthy contender in the evolving gastrointestinal pharmaceutical landscape.

Key Takeaways

• Clinical validation of REGLAN ODT is progressing, with promising pharmacokinetic and tolerability data. Final regulatory decision hinges on comprehensive safety evaluations.

• The global antiemetic market is expanding, with orodispersible formulations representing an innovative segment that caters to patient preferences for convenience.

• Market growth projections indicate broad adoption potential in North America and Asia-Pacific, driven by demographic shifts and healthcare trends.

• Strategic partnerships, technological innovations, and effective risk management are vital for capturing market share.

• Addressing metoclopramide’s safety concerns remains critical to maximizing market acceptance and long-term success.

FAQs

1. When is REGLAN ODT expected to receive FDA approval?
Pending ongoing clinical trials and review processes, regulatory agencies are expected to make a decision within 12-18 months, contingent upon submission of comprehensive safety and efficacy data.

2. How does REGLAN ODT differ from traditional metoclopramide tablets?
REGLAN ODT offers rapid disintegration and ease of swallowing, improving patient compliance—particularly beneficial for pediatric, geriatric, and dysphagic patients—without water.

3. What are the main safety concerns associated with metocramide-based products?
Long-term or high-dose use can lead to neurological side effects such as tardive dyskinesia and neuropsychiatric disturbances. Risk mitigation involves careful dosing and patient monitoring.

4. What markets are poised for growth for REGLAN ODT?
North America and Asia-Pacific are primary markets due to high disease prevalence, healthcare infrastructure, and demand for convenient medication forms.

5. What strategies can pharmaceutical companies employ to ensure successful market entry of REGLAN ODT?
Investing in robust clinical trials, engaging with regulatory bodies early, fostering healthcare provider awareness, and developing cost-effective pricing strategies are essential.

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Sources:

[1] ClinicalTrials.gov. "Studying the Pharmacokinetics and Safety of REGLAN ODT in Patients with Gastroparesis." Accessed 2023.

[2] Grand View Research. "Anti-emetics Market Size, Share & Trends Analysis Report," 2022.

[3] MarketsandMarkets. "Pharmaceutical Delivery Technologies Market," 2021.