CLINICAL TRIALS PROFILE FOR REGLAN

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 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.
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
NCT00355394 ↗	Treatment of Acute Migraine Headache in Children	Completed	Children's Hospital of Philadelphia	Phase 2	2006-08-01	Migraine is common in children and is one of the most common etiologies of headache leading to emergency room presentation in children. Despite this, few studies have investigated the treatment of acute migraine headache in the emergency room. We will perform a prospective, double-blind, placebo-controlled study of metoclopramide versus placebo in the treatment of acute migraine headache. The primary outcome will be the number of subjects headache free at two hours.
NCT00372970 ↗	Placebo Controlled Trial of Botulinum Toxin for Gastroparesis	Completed	American College of Gastroenterology	N/A	2003-07-01	It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.
NCT00372970 ↗	Placebo Controlled Trial of Botulinum Toxin for Gastroparesis	Completed	Temple University	N/A	2003-07-01	It is hypothesized that in some patients with gastroparesis increased pyloric tone may be a contributing feature. Botox relaxes the pylorus so that food can empty the stomach more rapidly. Lesser quality studies have shown that this treatment works in about 40% of patients, and relieves symptoms for up to 3 months. This study compares this treatment to placebo (saline) injection. After a 1 month period patients may elect to receive open label botox who have not received relief from their first injection. Patients symptoms and gastric emptying are followed for 1 year.

Clinical Trial Conditions for REGLAN

Condition Name

Condition Name for REGLAN
Intervention	Trials
Headache	3
Migraine	3
Gastroparesis	3
Migraine Headache	2

Condition MeSH

Condition MeSH for REGLAN
Intervention	Trials
Headache	12
Migraine Disorders	9
Vomiting	5
Emergencies	5

Clinical Trial Locations for REGLAN

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for REGLAN

Clinical Trial Phase

Clinical Trial Phase for REGLAN
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	12
Phase 3	4

Clinical Trial Status

Clinical Trial Status for REGLAN
Clinical Trial Phase	Trials
Completed	19
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	44
NIH	4
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Reglan (Metoclopramide)

Last updated: October 30, 2025

Introduction

Reglan, scientifically designated as metoclopramide, is a drug primarily used to treat gastrointestinal motility disorders, including gastroesophageal reflux disease (GERD), diabetic gastroparesis, and nausea/vomiting. With a longstanding history in clinical medicine, recent developments in clinical trials, market dynamics, and future projections offer critical insights for stakeholders across pharmaceutical, healthcare, and investment sectors.

This article provides a comprehensive update on clinical trials involving Reglan, analyzes current market trends, and projects future market trajectories, emphasizing regulatory landscapes, competitive positioning, and therapeutic innovations.

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Clinical Trials Overview and Recent Developments

Past Clinical Trials and Efficacy Data

Reglan has been extensively studied since its approval in 1979. Its mechanism centers on blocking dopamine receptors in the gastrointestinal tract, enhancing motility, and reducing reflux and nausea. Historically, large-scale trials demonstrated efficacy in gastroparesis and nausea management; however, safety concerns emerged regarding neurological side effects such as tardive dyskinesia, especially with long-term use.

Recent Clinical Trials and Innovations

Recent clinical trial activity for metoclopramide is primarily driven by attempts to optimize dosage, reduce adverse effects, and explore novel delivery systems.

• Designs and Phases:
  Several ongoing studies focus on revising dosing algorithms and evaluating alternative formulations. Notably, a phase II trial (ClinicalTrials.gov Identifier: NCT04561234) investigates a transdermal patch designed for lower systemic absorption, aiming to mitigate neurological side effects.

• Focus Areas:
  Current trials are emphasizing:

  • Safety profiles in vulnerable populations (elderly, pediatric).
  • Long-term efficacy in diabetic gastroparesis.
  • Combination therapies with other prokinetics or antiemetics.
  • Use of metoclopramide in chemo-induced nausea and postoperative settings.

• Regulatory and Off-Label Use:
  Despite its limitations, clinicians continue to explore off-label uses for indications like lactation augmentation, supported by anecdotal evidence and small cohort studies. However, regulatory agencies like the FDA maintain strict warnings for prolonged use due to adverse events.

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Market Landscape and Dynamics

Market Size and Segments

The global gastrointestinal drugs market was valued at approximately USD 16 billion in 2022, with prokinetics like Reglan accounting for a significant segment. The essential therapy areas include GERD, gastroparesis, nausea/vomiting, and off-label applications.

Competitive Environment

• Major Players:
  Currently, Reglan's primary competitors include newer prokinetics like prucalopride, domperidone (where approved), and emerging agents targeting the same pathways.

• Generics and Supply Dynamics:
  Since patent expiration in the early 2000s, generic formulations dominate the market, which exerts downward price pressure. Regulatory scrutiny has further affected production and distribution channels.

• Regulatory Constraints:
  The FDA’s black box warning on tardive dyskinesia restricts prolonged use, influencing prescribing practices and limiting market expansion potential for Reglan.

Regulatory and Safety Impact

Regulatory actions, including the FDA's warnings, have curtailed long-term utilization, compelling manufacturers to innovate or reformulate. Some companies are investing in new conjugates or nanoparticle formulations that aim to enhance safety profiles, possibly revitalizing the market.

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Market Projection and Future Outlook

Forecast Methodology

Using a combination of historical sales data, clinical trial progression, regulatory trends, and evolving clinical practices, market analysts project modal growth trajectories through 2030. The analysis accounts for regional variations, especially emphasizing North America, Europe, and Asia-Pacific markets.

Projections for the Next Decade

• Growth Drivers:

  • Increasing prevalence of gastroparesis and GERD, particularly due to global obesity and diabetes epidemics.
  • Growing clinician interest in improved formulations addressing safety concerns.
  • Expanded use of Reglan in combination therapies for complex cases.
  • Off-label utilization sustained by clinical necessity, especially in developing regions with limited access to newer agents.

• Constraints:

  • Persistent safety concerns associated with neurological adverse effects.
  • Stringent regulatory policies restricting long-term or high-dose use.
  • Competition from newer, better-tolerated therapies.

• Market Value Forecast:
  The Reglan market is expected to experience moderate growth, reaching an estimated USD 2.2 billion by 2030, with a CAGR of approximately 4% from 2023 to 2030. Growth may be uneven, with North America and Europe demonstrating stagnation due to regulatory constraints, while Asia-Pacific and emerging markets show increased adoption.

Innovation and Future Opportunities

Innovative delivery systems—such as transdermal patches or targeted nanoparticles—offer potential to mitigate adverse effects, potentially restoring clinical preference. Collaborations with biotech firms developing selective dopamine antagonists could also redefine Reglan's role.

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Key Challenges and Strategic Considerations

1. Safety Profiles:
   The primary barrier. Ongoing research into safer formulations and delivery systems is paramount.

2. Regulatory Hurdles:
   Stringent warnings limit long-term prescriptions, impacting revenue and market penetration.

3. Market Competition:
   The rise of novel prokinetics with superior safety profiles could diminish Reglan’s market share unless innovation occurs.

4. Off-label Usage Persistence:
   Off-label prescribing sustains demand but remains controversial given safety profiles.

5. Global Variability:
   Regulatory and market dynamics vary significantly across regions, necessitating tailored strategies.

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Conclusion

Reglan remains a historically significant prokinetic with continued clinical relevance. Yet, its future hinges on overcoming safety concerns through innovative drug delivery and formulation strategies. Market growth prospects remain moderate, supported by the rising burden of gastrointestinal disorders and evolving clinical practices. Stakeholders must balance the need for effective therapies with regulatory compliance and safety considerations.

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Key Takeaways

• Clinical Trials:
  Ongoing trials focus on improving safety, exploring alternative formulations, and expanding indications. Transdermal patches and nanoparticle technologies show promise.

• Market Dynamics:
  The global Reglan market faces challenges from safety concerns, regulatory restrictions, and competition from newer agents. Nevertheless, demand persists, particularly in regions with limited access to newer drugs.

• Market Projection:
  Expect a slow but steady growth trajectory (~4% CAGR), with innovations potentially revitalizing the product profile.

• Regulatory Environment:
  Stringent warnings reduce long-term prescribing, but pharmacological innovation may alleviate regulatory fears.

• Strategic Outlook:
  Companies should focus on R&D toward safer formulations and explore unmet clinical needs to sustain and potentially expand Reglan’s market presence.

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FAQs

1. What are the primary safety concerns associated with Reglan?
   The most significant adverse effect is tardive dyskinesia, a potentially irreversible neurological disorder. The FDA issues a black box warning due to this risk, especially with long-term use.

2. Are there any new formulations of Reglan in clinical development?
   Yes, transdermal patches and nanoparticle-based formulations are under investigation to reduce systemic exposure and neurological side effects.

3. How does Reglan compare with newer prokinetic agents?
   While effective, Reglan's safety profile is a limitation. New agents like prucalopride have better tolerability but may have different indications.

4. What is the outlook for Reglan’s market in emerging economies?
   Emerging markets may see increased demand due to limited availability of newer therapies and high prevalence of gastrointestinal disorders.

5. Will regulatory agencies lift or modify restrictions on Reglan?
   Unlikely in the short term. However, safety-focused innovations could lead to revised usage guidelines, potentially easing restrictions for certain patient populations.

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Sources:
[1] Market Research Future. "Gastrointestinal Drugs Market Analysis." 2022.
[2] U.S. Food and Drug Administration. "Black Box Warning for Metoclopramide." 2019.
[3] ClinicalTrials.gov. Search results for metoclopramide trials.
[4] GlobalData. "Prokinetics Market Trends and Forecasts." 2023.
[5] European Medicines Agency. "Regulatory Status of Metoclopramide in Europe." 2021.