CLINICAL TRIALS PROFILE FOR REGLAN

All Clinical Trials for REGLAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

Clinical Trial Conditions for REGLAN

Condition Name

Condition Name for REGLAN
Intervention	Trials
Gastroparesis	3
Diabetic Gastroparesis	2
Nausea	2

Condition MeSH

Condition MeSH for REGLAN
Intervention	Trials
Headache	11
Migraine Disorders	8
Emergencies	5

Clinical Trial Locations for REGLAN

Trials by Country

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−

Trials by Country for REGLAN
Location	Trials
United States	60
Nepal	1
India	1
Canada	1

Trials by US State

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−

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

Clinical Trial Progress for REGLAN

Clinical Trial Phase

Clinical Trial Phase for REGLAN
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for REGLAN
Clinical Trial Phase	Trials
Completed	18
Unknown status	5
Terminated	4

Clinical Trial Sponsors for REGLAN

Sponsor Name

Sponsor Name for REGLAN
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
Sponsor	Trials
Other	43
NIH	4
Industry	3

Reglan (Metoclopramide): Clinical Trials, Market Analysis, and Projections

Introduction

Reglan, known generically as metoclopramide, is a medication used to treat various gastrointestinal disorders, including diabetic gastroparesis and gastroesophageal reflux disease. This article will delve into the recent clinical trials, market analysis, and future projections for Reglan, particularly focusing on its nasal spray formulation, Gimoti.

Clinical Trials: Gimoti (Metoclopramide Nasal Spray)

Phase 3 Study Overview

A significant Phase 3 study was conducted to evaluate the efficacy and safety of Gimoti, a metoclopramide nasal spray, in women with diabetic gastroparesis. This study involved 205 women aged 18-75 years with type 1 or type 2 diabetes and documented delayed gastric emptying. Participants were randomized to receive either Gimoti 10 mg or a placebo four times a day for 28 days[1][4].

Efficacy Results

The primary objective was to assess the reduction in symptoms of diabetic gastroparesis. While the overall results did not show a significant reduction in symptoms for all enrolled patients, women with moderate-to-severe symptoms at baseline experienced significant relief. Specifically, Gimoti provided statistically significant symptom relief for nausea and upper abdominal pain from Weeks 1 to 4 compared to the placebo group[1][4].

Safety Profile

The safety profile of Gimoti was found to be similar to that of the placebo. Treatment-emergent adverse events were primarily mild to moderate, with headache and abdominal pain being the most frequently reported. Serious adverse events were rare and not related to the study drug[1][4].

Market Analysis

Current Market

Reglan, in its oral form, has been a staple in the treatment of gastrointestinal disorders since its approval in 1980. However, the introduction of Gimoti, the nasal spray formulation, offers a new delivery method that could expand the market reach.

Antiemetics Market

The global antiemetics drugs market, which includes Reglan and its formulations, was valued at USD 7.49 billion in 2023. This market is expected to grow at a CAGR of 5.98% from 2024 to 2030. The growth is driven by increasing demand for effective treatments for nausea and vomiting associated with various conditions, including chemotherapy, pregnancy, and gastrointestinal disorders[5].

Competitive Landscape

The gastrointestinal drugs market is competitive, with several other medications available for similar indications. However, Gimoti's unique delivery method and targeted efficacy in diabetic gastroparesis could position it as a preferred option for certain patient populations.

Market Projections

Growth Drivers

The market for Reglan and its formulations is expected to grow due to several factors:

• Increasing Incidence of Diabetic Gastroparesis: The rising prevalence of diabetes and associated complications will drive the demand for effective treatments like Gimoti.
• Convenience and Efficacy: The nasal spray formulation offers a convenient and potentially more effective delivery method compared to oral tablets, which could increase patient compliance and satisfaction.
• Targeted Therapies: The focus on targeted therapies in the gastrointestinal market is expected to continue, with Gimoti being a part of this trend due to its specific efficacy in moderate-to-severe diabetic gastroparesis symptoms[1][4].

Regional Market

The market for antiemetics, including Reglan and Gimoti, varies by region. North America and Europe are significant markets due to high healthcare spending and a large patient population. However, emerging markets in Asia Pacific, particularly China, are expected to grow rapidly due to increasing healthcare access and a rising incidence of gastrointestinal disorders[5].

Regulatory Considerations

FDA Approval

Gimoti received FDA approval for the treatment of acute and recurrent diabetic gastroparesis in adults. The approval was based on the Phase 3 study results that demonstrated its efficacy and safety in women with moderate-to-severe symptoms[3].

Pharmacokinetic Bridge

One of the critical regulatory considerations was the pharmacokinetic bridge between Gimoti and the oral Reglan formulation. Although initial submissions faced deficiencies, subsequent data provided sufficient justification for the safety and efficacy of Gimoti compared to Reglan[3].

Key Takeaways

• Efficacy in Diabetic Gastroparesis: Gimoti has shown significant symptom relief in women with moderate-to-severe diabetic gastroparesis symptoms.
• Safety Profile: The safety profile of Gimoti is similar to that of the placebo, with most adverse events being mild to moderate.
• Market Growth: The antiemetics market, including Reglan and Gimoti, is expected to grow at a CAGR of 5.98% from 2024 to 2030.
• Convenience and Compliance: The nasal spray formulation of Gimoti offers a convenient delivery method that could improve patient compliance.
• Regulatory Approval: Gimoti has received FDA approval for the treatment of diabetic gastroparesis, providing a new treatment option for patients.

FAQs

What is Gimoti, and how is it different from Reglan?

Gimoti is a metoclopramide nasal spray, while Reglan is the oral tablet form of metoclopramide. Gimoti offers a convenient and potentially more effective delivery method for treating diabetic gastroparesis.

What were the key findings of the Phase 3 study for Gimoti?

The Phase 3 study showed that Gimoti provided significant symptom relief for nausea and upper abdominal pain in women with moderate-to-severe diabetic gastroparesis symptoms.

What is the expected market growth for antiemetics drugs, including Reglan and Gimoti?

The global antiemetics drugs market is expected to grow at a CAGR of 5.98% from 2024 to 2030.

What are the main drivers of growth for the Reglan and Gimoti market?

The main drivers include the increasing incidence of diabetic gastroparesis, the convenience and efficacy of the nasal spray formulation, and the focus on targeted therapies.

Has Gimoti received FDA approval?

Yes, Gimoti has received FDA approval for the treatment of acute and recurrent diabetic gastroparesis in adults.

What are the common adverse events associated with Gimoti?

The common adverse events associated with Gimoti are primarily mild to moderate and include headache and abdominal pain.

Sources

1. Results of a Phase 3 Study with Metoclopramide Nasal Spray. Evoke Pharma Inc.
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. GlobalData.
3. APPLICATION NUMBER: 209388Orig1s000 OTHER REVIEW(S). FDA.
4. A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. PubMed.
5. Antiemetics Drugs Market Size & Share Analysis Report 2030. Grand View Research.