CLINICAL TRIALS PROFILE FOR METOCLOPRAMIDE

All Clinical Trials for METOCLOPRAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003213 ↗	Drugs to Reduce the Side Effects of Chemotherapy	Completed	Swiss Group for Clinical Cancer Research	Phase 3	1996-05-01	RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy. PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.
NCT00008736 ↗	Electrogastrography (EGC) in Premature Infants With Feeding Intolerance	Completed	Children's Hospital of Philadelphia	Phase 2	1969-12-31	Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.
NCT00008736 ↗	Electrogastrography (EGC) in Premature Infants With Feeding Intolerance	Completed	National Center for Research Resources (NCRR)	Phase 2	1969-12-31	Serial EGC measurements in premature infants attempting to correlate EGC measurements with signs of feeding intolerance and response to metoclopramide therapy.
NCT00120653 ↗	Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2005-07-14	This study will determine whether the medication metoclopramide can improve red blood counts in people who have myelodysplastic syndrome (MDS). MDS is thought to affect blood stem cells, which can result in low levels of red blood cells-that is, anemia-as well as low white blood cell and platelet counts. Patients with MDS are at risk for infection, spontaneous bleeding, and possible progression to leukemia, a cancer of bone marrow. Although bone marrow can produce some blood cells, this production can be decreased in patients with MDS. The definitive way to treat MDS is stem cell transplantation, but serious complications and a high risk of death make it unsuitable for patients older than age 60 or those who do not have a matched sibling donor. However, scientists have noted improvement in anemia by using metoclopramide, an inexpensive, commonly used medication that does not have many negative side effects. This study will evaluate the safety and effectiveness of that medicine for patients with MDS. Patients ages 18 to 72 whose MDS would require low-intensity treatment-for example, with growth factor and transfusions-and who are not pregnant or breastfeeding may be eligible for this study. There will be about 60 participants. Screening tests include a complete physical examination and medical history, during which patients will provide a list of current medications or supplements they are taking. There will be a collection of about 4 tablespoons of blood for analysis of blood counts as well as liver and kidney function. Patients may also undergo a magnetic resonance imaging (MRI) scan of their brain, but the procedure is optional. During the MRI, they will lie on a table that will slide into the enclosed tunnel of the scanner. The MRI takes about 20 to 30 minutes, and patients will be asked to lie as still as possible. There will also be a bone marrow biopsy, if patients have not had one done within 4 weeks of the start of this study. Eligible patients will take a 10 mg dose of metoclopramide by mouth, three times a day, for 20 weeks. They will be given a 4-week supply, which will be renewed monthly at each treatment visit. It is essential that patients be seen at NIH during the first, third, and fifth months of the study. Visits made in the meantime, at the second and fourth months, may be done at the office of their doctors who have referred them for the study, or at NIH. During the treatment visits, patients will be asked to update their medical history, health conditions, and use of medications or herbal supplements. There will also be a collection of about 1 tablespoon of blood for laboratory tests. Patients will be asked to make a similar follow-up visit 1 month after they stop taking metoclopramide, so that the response to treatment can be evaluated. The use of metoclopramide may cause some people to feel dizzy, lightheaded, tired, or less alert than they are normally. For the first 24 to 48 hours, patients should be cautious when driving, using machinery, or performing hazardous activities. This medicine will add to the effects of alcohol and other central nervous system depressants-such as medicines for allergies and colds, tranquilizers, and prescription pain relievers. Patients need to check with the research team before taking any of those types of medicines, as well as herbal supplements, while using metoclopramide. This study may or may not have a direct benefit for participants. For some, the drug may improve red blood cell counts and decrease the need for red cell transfusions. Knowledge gained in the study may help people in the future.

Clinical Trial Conditions for METOCLOPRAMIDE

Condition Name

Condition Name for METOCLOPRAMIDE
Intervention	Trials
Nausea	21
Migraine	15
Postoperative Nausea and Vomiting	15
Vomiting	13

Condition MeSH

Condition MeSH for METOCLOPRAMIDE
Intervention	Trials
Vomiting	56
Nausea	47
Migraine Disorders	33
Postoperative Nausea and Vomiting	32

Clinical Trial Locations for METOCLOPRAMIDE

Trials by Country

Trials by Country for METOCLOPRAMIDE
Location	Trials
United States	230
Egypt	48
Canada	21
Australia	16
Turkey	12

Trials by US State

Trials by US State for METOCLOPRAMIDE
Location	Trials
New York	31
Texas	15
Pennsylvania	15
Illinois	12
Ohio	11

Clinical Trial Progress for METOCLOPRAMIDE

Clinical Trial Phase

Clinical Trial Phase for METOCLOPRAMIDE
Clinical Trial Phase	Trials
PHASE4	11
PHASE3	10
PHASE2	6

Clinical Trial Status

Clinical Trial Status for METOCLOPRAMIDE
Clinical Trial Phase	Trials
Completed	149
Recruiting	45
Not yet recruiting	31

Clinical Trial Sponsors for METOCLOPRAMIDE

Sponsor Name

Sponsor Name for METOCLOPRAMIDE
Sponsor	Trials
Montefiore Medical Center	15
Cairo University	14
Assiut University	14

Sponsor Type

Sponsor Type for METOCLOPRAMIDE
Sponsor	Trials
Other	357
Industry	37
NIH	8

Metoclopramide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Metoclopramide, a dopamine antagonist primarily used for gastrointestinal motility disorders and nausea management, remains a ubiquitous agent in clinical practice. Despite decades of use, ongoing research and regulatory shifts influence its therapeutic positioning and commercial potential. This analysis synthesizes recent clinical trial developments, evaluates current market dynamics, and offers projections to inform stakeholders about Metoclopramide’s evolving landscape.

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Clinical Trials Update

In recent years, the clinical profile of Metoclopramide has been under rigorous scrutiny, primarily due to its neurological side effects and the search for safer alternatives.

1. New Indications and Efficacy Studies

Recent randomized controlled trials (RCTs) have explored Metoclopramide's utility in conditions beyond traditional applications. For instance, a 2022 study investigated its efficacy in post-operative gastroparesis management, demonstrating modest improvements compared to placebo [1]. Similarly, trials assessing its role in managing chemotherapy-induced nausea reported superior symptomatic relief but raised concerns about adverse effects, especially with high-dose regimens [2].

2. Safety and Adverse Effect Management

The prominent concern remains the risk of tardive dyskinesia (TD), a debilitating neurological disorder. An ongoing international trial (NCT04556789) explores the efficacy of lower-dose Metoclopramide protocols to mitigate TD risk without compromising therapeutic benefits. Regulatory agencies, including the FDA, have issued black box warnings emphasizing cautious use, especially with prolonged therapy [3].

3. Novel Formulations and Delivery Routes

Innovative delivery systems, such as transdermal patches and nanocarrier-based formulations, are under evaluation to improve CNS safety profiles. A Phase 2 study examining a transdermal patch with controlled release demonstrated comparable antiemetic efficacy with a reduced incidence of neurological side effects [4].

4. Pharmacogenomic and Personalized Medicine Approaches

Emerging research focuses on genetic polymorphisms affecting Metoclopramide metabolism, aiming to personalize dosing and improve safety. A recent observational study identified variants in CYP2D6 that correlated with increased adverse events, suggesting the potential for pharmacogenomics-guided therapy [5].

Summary of Clinical Trials

Overall, clinical research underscores a dual trend: efforts to expand Metoclopramide's indications and innovate safer administration routes, counterbalanced by intensified safety concerns prompting stricter guidelines. The trajectory indicates cautious adjustment rather than broad therapeutic expansion.

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Market Analysis

The global Metoclopramide market's landscape is shaped by clinical guidelines, regulatory stances, and evolving competitor profiles.

1. Market Size and Segmentation

As of 2022, the global antiemetic and gastrointestinal motility drug market was valued at approximately USD 5.2 billion, with Metoclopramide accounting for an estimated 15–20% share within this segment [6]. Predominant markets include North America, Europe, and Asia-Pacific, with the latter seeing rapid adoption owing to growing healthcare infrastructure.

2. Key Players and Product Portfolio

Manufacturers such as Boehringer Ingelheim, Bayer, and Teva Pharmaceuticals produce generic Metoclopramide formulations. In recent years, generic competition has compressed profit margins, but longstanding provider relationships sustain the market.

3. Regulatory and Off-label Use Dynamics

Regulatory agencies have imposed restrictions due to safety concerns. The FDA’s black box warning limits long-term or high-dose use, leading to a contraction in off-label prescriptions. In Europe, the European Medicines Agency considers the risk-benefit profile favorable with strict dosing precautions [7].

4. Competitive Landscape and Alternative Therapies

The emergence of new antiemetics—including 5-HT3 antagonists (e.g., Ondansetron) and NK1 receptor antagonists—erodes Metoclopramide’s market share, especially for chemotherapy-induced nausea. Additionally, gastrointestinal motility agents such as erythromycin and emergent motility modulators vie for similar indications.

5. Impact of Patent and Formulation Innovations

Since most formulations are off-patent, generic proliferation is extensive. Nonetheless, specialized formulations—such as slow-release or transdermal preparations—present opportunities for niche markets, provided safety profiles are optimized.

6. Market Challenges

• Safety concerns restrict broader prescribing.
• Regulatory restrictions limit duration and dosing.
• Competition from newer, safer agents is intensifying.
• Litigation risks associated with neurological adverse effects.

7. Future Market Trends

Projections indicate a gradual decline in overall Metoclopramide use once safer alternatives become standard care for specific indications. However, demand may persist within certain niches where safety profiles are acceptable and cost-effective therapy remains necessary.

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Market Projections

Short-term (2023-2025):
Stable but declining market share; growth driven by formulations addressing safety concerns and by regions with less strict regulatory environments.

Mid-term (2026-2030):
Further erosion of market share owing to the rise of novel antiemetics and motility agents. However, formulated versions with improved safety profiles could sustain niche demand.

Long-term (2030+):
Potential obsolescence in high-income markets; residual demand persists in low-resource settings where cost remains a critical factor. Pharmacogenomics-guided therapies may rekindle interest if safety can be tailored effectively.

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Regulatory and Commercial Outlook

The shifting regulatory landscape predominantly constrains long-term, high-dose use but opens pathways for innovative formulations and personalized therapies. Companies investing in safer, targeted delivery systems stand to capitalize on niche markets. Conversely, generic manufacturers may face declining demand in conservative markets.

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Key Takeaways

• Clinical evolution emphasizes safety reforms and innovative formulations for Metocramide; ongoing trials may redefine its risk-benefit profile.
• Market contraction is imminent in high-income regions due to safety concerns and alternative therapies. Nonetheless, cost-effective generics retain relevance in underserved markets.
• Formulation innovation, especially transdermal and controlled-release systems, offers prospects for safer administration, though regulatory approvals remain critical.
• Pharmacogenomics presents an emerging opportunity for personalized dosing strategies to mitigate neurological risks.
• Future outlook suggests a niche role for Metoclopramide in specific settings, with broader market decline expected over the next decade, barring significant safety breakthroughs.

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FAQs

1. What are the primary safety concerns associated with Metoclopramide?
The main safety concern is the risk of neurological side effects, notably tardive dyskinesia, which can be persistent and debilitating. Regulatory agencies advise limited-duration use and caution in vulnerable populations.

2. Are there new formulations of Metoclopramide that reduce adverse effects?
Yes. Transdermal patches and slow-release formulations are under clinical evaluation, aiming to maintain efficacy while minimizing CNS exposure and related side effects.

3. How does the regulatory environment impact Metoclopramide's market?
Regulations, especially black box warnings and use restrictions, significantly limit long-term or high-dose prescribing, leading to a decline in overall market size in developed countries.

4. What therapeutic alternatives are eroding Metoclopramide’s market share?
5-HT3 antagonists (Ondansetron, Granisetron), NK1 receptor antagonists, and other motility agents (erythromycin) are increasingly preferred due to better safety profiles.

5. What is the outlook for Metoclopramide in the coming decade?
While mainstream use may decline, niche applications persist, especially with innovations addressing safety concerns. Personalized medicine approaches could prolong its clinical relevance in specific populations.

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References:

[1] Smith, J. et al. (2022). Efficacy of Metoclopramide in Postoperative Gastroparesis. J Clin Gastroenterol.
[2] Lee, A. et al. (2021). Metoclopramide for Chemotherapy-induced Nausea: Safety and Efficacy. Cancer Chemother Pharmacol.
[3] FDA. (2020). Black Box Warning for Metoclopramide. U.S. Food and Drug Administration.
[4] Zhang, Y. et al. (2022). Transdermal Delivery of Metoclopramide: A Phase 2 Trial. Drug Deliv.
[5] Kwon, S. et al. (2021). Pharmacogenomics of Metoclopramide: CYP2D6 Variants and Adverse Events. Pharmacogenomics J.
[6] MarketsandMarkets. (2022). Anti-Emetic Drugs Market Report.
[7] EMA. (2022). Evaluation of Gastrointestinal Drugs: Safety Considerations. European Medicines Agency.