You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR REGLAN


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Reglan

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 ReglanĀ® 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.
NCT00274170 ↗ Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache Unknown status C.R.Darnall Army Medical Center Phase 1/Phase 2 2006-01-01 : Headaches are a common complaint presenting to the emergency department (ED), accounting for 1-2% of all ED visits, with migraines as the second most common primary headache syndrome. Patients that ultimately present to the ED have failed outpatient therapy and exhibit severe and persistent symptoms. Treatment options have been traditionally with a parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as standard therapy in the treatment of migrainne headache in the ED. Today, there are a number of nonopioid treatment options, but not without their own individual concerns. Ergotamine and dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used as an anti-emetic agent, has been widely studied for use with acute migraines. Its side effects include drowsiness and dystonic reactions. Compazine has been successfully used to treat migraine headaches for the past several decades, and has been accepted as standard treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects, dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have no addictive properties, few side effects, quick onset, be highly effective and have a low rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of neuropetides, which have been implicated in migraine. Native somatostatin is an unstable compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches associated with growth hormone secreting tumor has been established. 4 Five somatostatin receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The distribution of sst2 within the central nervous system strongly suggests that this particular somatostatin receptor has a role in cranial nociception, being highly expressed in the trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double blind study comparing octreotide to placebo in treating migraine. They found there to be a significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo (76% vs 25%, p<0.02). They noted that 47% of those in the octreotide group had complete relief compared to no patients in the placebo group. They went on to note that those patients in the octreotide group had earlier relief of symptoms and no side effects. The only minor adverse event related to the administration of octreotide was a local reaction in 3 patients (18%). In a study performed recently in Netherlands, no clinically relevant changes in vital signs, routine chemistry, and urinalysis were observed with octreotide use. Electrocardiogram analyses showed no newly occurring or worsening of known cardiac abnormalities 2 and 24 h after injection with octreotide. 5 Levy et. al also compared octreotide to placebo in a double blinded study but found no difference. This was a poorly designed study, in that the patients treated themselves at home with an injection of either placebo or octreotide for 2 episodes of headache and recorded their level of pain relief at 2 hours. Matharu et. al also performed a double blind study comparing octreotide to placebo, but looking at cluster headaches rather than migraines. They found there to be a significant improvement with the use of octreotide over placebo (52% vs 36%). At Darnall Army Community Hospital the cost of 100 mcg Octreotide and10 mg Compazine, is $10.46, $2.02-8.00, respectively.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Reglan

Condition Name

Condition Name for Reglan
Intervention Trials
Gastroparesis 3
Diabetic Gastroparesis 2
Anesthesia 2
Nausea 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Reglan
Intervention Trials
Headache 11
Migraine Disorders 8
Vomiting 5
Emergencies 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Reglan

Trials by Country

Trials by Country for Reglan
Location Trials
United States 60
India 1
Canada 1
Nepal 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Reglan
Location Trials
New York 8
Pennsylvania 4
California 3
North Carolina 3
Tennessee 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Reglan
Clinical Trial Phase Trials
Completed 18
Unknown status 5
Terminated 4
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Reglan
Sponsor Trials
Other 43
NIH 4
Industry 3
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Last updated: January 7, 2025

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.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.