CLINICAL TRIALS PROFILE FOR METOCLOPRAMIDE HYDROCHLORIDE

All Clinical Trials for METOCLOPRAMIDE HYDROCHLORIDE

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NCT00120653 ↗	Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)	Withdrawn	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2005-07-14	This study will determine whether the medication metoclopramide can improve red blood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.
NCT00122278 ↗	Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines	Completed	Montefiore Medical Center	Phase 3	2005-07-01	Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
NCT00130026 ↗	Caffeine in the Prevention of Post-operative Nausea and Vomiting	Completed	Beth Israel Deaconess Medical Center	N/A	2005-03-01	The objective of this study is to determine if caffeine 500 mg intravenously is efficacious when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.
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 METOCLOPRAMIDE HYDROCHLORIDE

Condition Name

Condition Name for METOCLOPRAMIDE HYDROCHLORIDE
Intervention	Trials
Nausea	21
Postoperative Nausea and Vomiting	16
Migraine	15
Vomiting	13

Condition MeSH

Condition MeSH for METOCLOPRAMIDE HYDROCHLORIDE
Intervention	Trials
Vomiting	56
Nausea	47
Postoperative Nausea and Vomiting	34
Migraine Disorders	33

Clinical Trial Locations for METOCLOPRAMIDE HYDROCHLORIDE

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for METOCLOPRAMIDE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for METOCLOPRAMIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	12
PHASE3	10
PHASE2	6

Clinical Trial Status

Clinical Trial Status for METOCLOPRAMIDE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	149
Recruiting	46
Not yet recruiting	31

Clinical Trial Sponsors for METOCLOPRAMIDE HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

Sponsor Type for METOCLOPRAMIDE HYDROCHLORIDE
Sponsor	Trials
Other	358
Industry	37
NIH	8

Metoclopramide Hydrochloride: Clinical Trials Update, Market Analysis, and Projection (2026-2036)

Last updated: April 26, 2026

What is metoclopramide hydrochloride and how is it used?

Metoclopramide hydrochloride is a dopamine D2 receptor antagonist used for gastrointestinal motility disorders and off-label antiemetic indications. In the US and EU it is supported by decades of clinical use, with dosing and safety constraints shaped by the risk of extrapyramidal symptoms and tardive dyskinesia.

Commercially, metoclopramide is not a “new molecule” market. It is a mature generic product segment whose pricing, volume, and channel mix depend on regulatory risk management, formulary access, and replacement by newer antiemetics and motility agents.

What is the clinical trials update for metoclopramide?

No new, sponsor-confirmable phase 3 or registrational breakthroughs for metoclopramide were identified in publicly indexed trial registries within this response’s scope. Current activity in metoclopramide typically concentrates on:

• Comparative effectiveness trials against newer antiemetics in acute care settings (ED, postoperative, chemotherapy-induced nausea and vomiting)
• Formulation work (routes and delivery formats)
• Safety and pharmacovigilance studies focused on neurologic adverse events in higher-risk populations

Because metoclopramide is an established generic, most “trials” that appear are either small comparative studies, observational pharmacovigilance work, or studies tied to specific formulations and dosing regimens.

Clinical development inference for business planning: market incumbency is driven less by trial-driven label expansions and more by (1) safety-risk controls in regulatory labeling, (2) supply stability, and (3) switching dynamics between antiemetic classes.

What does the competitive landscape look like?

Metoclopramide competes across several therapeutic “use cases,” not a single disease code:

1. Acute nausea and vomiting (ED, postoperative, gastroenteritis-associated nausea)
   • Competitors: serotonin 5-HT3 antagonists, NK1 antagonists, dopamine antagonists with different profiles, antihistamines
2. Gastroparesis and other dysmotility syndromes
   • Competitors: prokinetics and emerging motility agents (class-dependent)
3. Chemotherapy-induced nausea and vomiting (CINV)
   • Competitors: regimen-based antiemetic combinations where metoclopramide may appear as a component rather than the core agent

In practice, the majority of metoclopramide commercial demand is tied to generic procurement, hospital formularies, and payer reimbursement patterns rather than to patent-backed differentiation.

How big is the metoclopramide market and what is driving it?

Market structure

Metoclopramide is widely marketed as:

• Oral tablets
• Oral solution
• Injectable formulations (including IV/IM in acute settings)

The market’s economics follow generic-drug patterns:

• Price erosion over time
• Fragmented brand and label-holder ownership
• Volume concentration in institutional supply chains
• Tender-based procurement in hospitals

Key demand drivers

• Persistent clinical need for antiemetic and prokinetic use cases where metoclopramide remains guideline-compatible
• Broad availability and low cost relative to newer agents
• Formulary inertia and substitution costs within hospital pharmacy systems

Key headwinds

• Safety labeling that restricts duration and raises monitoring expectations due to neurologic adverse events
• Substitution by newer antiemetic classes that have different safety and efficacy profiles
• Stewardship actions in some regions as clinicians weigh risk-benefit in outpatient settings

What are the regulatory and safety constraints that affect uptake?

Metoclopramide labeling in major jurisdictions includes boxed warnings and restrictions related to tardive dyskinesia and extrapyramidal symptoms. Those controls affect:

• Outpatient prescribing duration caps
• Clinical monitoring requirements
• Pharmacy and prescriber workflows for high-risk patients

These elements directly shape adoption in settings where a safer alternative is available and where reimbursement pressures favor standardized regimens.

What is the market projection through 2036?

Projection framework

Given metoclopramide’s generic status, projections should be interpreted as:

• Volume trajectory driven by clinical need and substitution dynamics
• Revenue trajectory driven by price erosion, procurement contracting, and mix shifts across routes (injectable vs oral)

Base-case (2026-2036)

• Volume: low-to-moderate contraction or flat growth, with periodic declines where newer antiemetics displace dopamine antagonists in acute nausea pathways.
• Unit price: continued erosion, with occasional stabilization due to supply constraints in specific manufacturers or procurement cycles.
• Revenue: generally stable-to-declining over the decade in mature markets, with the possibility of regional resilience where newer agents are priced higher or where formularies retain older standards.

Bull-case (2026-2036)

• Volume: growth in injectable use in settings that continue to use metoclopramide-based protocols for acute nausea
• Revenue: less decline if price erosion slows due to supply concentration or contractual procurement premiums

Bear-case (2026-2036)

• Volume: accelerated substitution in ED and postoperative care by serotonin 5-HT3 antagonists, NK1 antagonists, and other guideline-favored options
• Revenue: steeper decline if multiple major suppliers exit or if procurement pushes further down-price

Route and channel outlook

Injectable formulations

• Demand is linked to inpatient and ED throughput, postoperative protocols, and acute care pathways.
• Injectable use is less exposed to outpatient duration restrictions but is still affected by safety labeling and prescriber governance.

Oral formulations

• Oral demand correlates with outpatient dyspepsia-like symptom care, gastroparesis prescribing patterns, and use in lower acuity nausea.
• Outpatient restrictions and substitution pressures drive slower growth than inpatient injectable.

Institutional channel

Hospital tendering and formulary access dominate revenue outcomes. A supplier’s share depends on:

• Contracting power and logistics reliability
• Product availability and replacement lead times
• Compatibility with formulary restrictions (administration protocols, monitoring requirements)

What does this mean for investors and R&D planners?

Metoclopramide is a mature generic asset class. A “clinical trials update” does not typically translate into market-shaping differentiation unless:

• A new delivery format improves therapeutic index and reduces neurologic risk in routine use
• A formulation or dosing strategy expands practical adoption within labeling constraints
• A region-specific guideline change increases institutional utilization

For new entrants, commercial traction is most likely to come from manufacturing reliability, formulation improvements that clear local regulatory pathways, and procurement-aligned supply strategies rather than from brand-new clinical effect claims.

Competitive positioning map (use-case based)

Use case	Metoclopramide role	Substitution pressure	Primary purchase driver
Acute nausea/vomiting	Common dopamine antagonist option	Moderate to high in many settings	ED/inpatient protocol and tender price
Gastroparesis/dysmotility	Prokinetic option within constraints	Moderate	Specialist prescribing patterns and payer access
CINV	Possible part of regimen in selected pathways	High in many protocols	Guideline-driven regimen selection

Key takeaways

• Metoclopramide remains widely used for antiemetic and prokinetic indications, but it is a mature generic market with clinical activity skewed toward comparative, safety, and formulation studies rather than registrational breakthroughs.
• Market dynamics are driven by formulary access, procurement contracting, and substitution by other antiemetics rather than patent-driven innovation.
• Through 2036, the base-case is stable-to-declining revenue in mature markets due to ongoing price erosion, with volume likely flat to slightly down as newer agents displace some dopamine-antagonist use cases.
• Institutional channel strategy and supply reliability are more determinative of share than incremental clinical trial readouts for this product category.

FAQs

1. Does metoclopramide have major ongoing late-stage (phase 3/registrational) trials?
   Publicly indexed activity in scope is not characterized by identifiable registrational phase 3 breakthroughs for new label expansion in this response.

2. What most limits metoclopramide adoption in outpatient settings?
   Safety labeling constraints tied to extrapyramidal symptoms and tardive dyskinesia risk, which affect duration and monitoring practices.

3. Where is metoclopramide demand typically strongest?
   Institutional settings (inpatient and ED) where acute nausea and postoperative protocols use generic antiemetics.

4. What are the biggest substitutes for metoclopramide?
   Serotonin 5-HT3 antagonists, NK1 antagonists, and other guideline-favored antiemetic classes that can displace dopamine antagonists in common nausea pathways.

5. How should revenue forecasts be modeled for metoclopramide?
   Model separately: volume trends (clinical pathway utilization and substitution) and price trends (generic erosion and procurement contracting).

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Metoclopramide prescribing information and safety communications (boxed warning regarding tardive dyskinesia). FDA. https://www.fda.gov/