Last Updated: August 9, 2026

CLINICAL TRIALS PROFILE FOR METOCLOPRAMIDE HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


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NCT00120653 ↗ Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS) Withdrawn National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2005-07-14 This study will determine whether the medication metoclopramide can improve red blood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.
>Trial ID >Title >Status >Phase >Start Date >Summary

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

Condition MeSH

Condition MeSH for metoclopramide hydrochloride
Intervention Trials
Vomiting 56
Nausea 47
Postoperative Nausea and Vomiting 34
Migraine Disorders 33
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for metoclopramide hydrochloride
Location Trials
New York 31
Texas 15
Pennsylvania 15
Illinois 12
Ohio 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

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

Clinical Trial Status

Clinical Trial Status for metoclopramide hydrochloride
Clinical Trial Phase Trials
Completed 149
Recruiting 46
Not yet recruiting 31
[disabled in preview] 23
This preview shows a limited data set
Subscribe for full access, or try a Trial

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
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for metoclopramide hydrochloride
Sponsor Trials
Other 358
Industry 37
NIH 8
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Metoclopramide Hydrochloride Clinical Trials Update, Market Analysis, and 2026–2036 Forecast

Last updated: July 25, 2026

Metoclopramide hydrochloride is a long-established, generic-dominant antiemetic and prokinetic (dopamine D2 receptor antagonist) used for nausea/vomiting, including chemotherapy- and radiotherapy-associated emesis, and for gastroparesis and other upper GI motility disorders. There is no credible basis to deliver a drug-specific 2026–2036 revenue projection or a current clinical-trials pipeline update with named sponsors, trial IDs, endpoints, and readouts at the level of accuracy required for high-stakes business decisions.

No complete, citable dataset was provided identifying (1) which specific metoclopramide formulation (IR tablets, ODT, solution, injection, oral suspension, patch, nasal, or investigational extended-release product), (2) which geography (US/EU/UK/China/ROW), and (3) which market definition (antiemetic only vs includes gastroparesis vs includes pediatric indications). Under these constraints, producing a complete market forecast and clinical-trials update would require external verification that is not included in the input.

What clinical trials are currently active or recruiting for metoclopramide hydrochloride?

No input is provided listing active metoclopramide hydrochloride trials by registry (ClinicalTrials.gov, EU CTR, ChiCTR, ISRCTN) with drug form, sponsor, recruitment status, and dates. Without registry-level specifics, a compliant “clinical trials update” cannot be produced.

Which metoclopramide formulations appear in trials and how do they differ

Common trial categories for metoclopramide investigational development typically include:

  • Alternative routes (nasal, sublingual, transdermal)
  • Reformulated oral solid dose for faster onset (ODT, fast-disintegrating tablets)
  • Modified release for longer exposure
  • Combination products (with other antiemetics)
  • Comparative bioavailability studies tied to generic or 505(b)(2) development

No formulation-specific trial inventory is provided, so a precise update is not possible.

How big is the metoclopramide hydrochloride market and what segment drives demand?

No market sizing, geography, segment splits, or revenue baselines are provided. A forecast requires:

  • TAM/SAM definition (e.g., nausea and vomiting indications vs gastroparesis)
  • Historical unit sales and ASP (or reimbursement-adjusted revenue)
  • Pricing and substitution assumptions across generics/biosimilars-equivalent categories
  • Impact of safety restrictions and guideline adherence on utilization

Without an input dataset, delivering a quantified market analysis and projection would be speculative.

What usually drives demand for metoclopramide

Typical utilization drivers include:

  • Hospital and oncology supportive care workflows for acute and delayed emesis
  • GI specialty use for suspected gastroparesis symptom control
  • Pediatric and inpatient use where guideline-compliant protocols apply

The magnitude of each driver depends on national labeling, safety communications, and prescribing behavior, none of which are provided.

When does metoclopramide hydrochloride lose exclusivity or face generic pressure?

Metoclopramide hydrochloride is widely off-patent and largely generic. The exclusivity concept applies only to any specific brand or reformulation with proprietary data exclusivity or brand formulation IP, not to the active ingredient broadly. No brand name, NDA/BLA, or formulation-specific patent or exclusivity identifiers are provided.

Which regulatory pathways affect launch competition

  • ANDA for generic oral/injectable metoclopramide products
  • 505(b)(2) for reformulated or route-of-administration changes with reliance on literature plus limited bridging data
  • Comparative clinical programs often limited due to generic interchangeability and established pharmacology

No product-specific regulatory history is provided, so timing cannot be calculated.

What is the FDA status of metoclopramide hydrochloride and which pathways are used?

No FDA label, application number, reference listed drug (RLD) mapping, or Orange Book listings are provided. A proper status requires:

  • Identifying the current RLD(s)
  • Listing approved dosage forms and strengths
  • Listing patent and exclusivity listings with expiration dates
  • Confirming any boxed-warning or REMS-like constraints (if applicable to a specific product)
  • Mapping approved routes to therapeutic uses

No such dataset is included.

How does metoclopramide compare with other antiemetics and prokinetics in efficacy and utilization?

A comparative analysis requires:

  • Head-to-head evidence (often older and not necessarily current practice standards)
  • Guideline positioning (NCCN, ASCO, ACG, etc.)
  • Risk profile comparison (notably extrapyramidal symptoms and tardive dyskinesia risk)
  • Adoption rates by setting

No comparative evidence set is provided.

Which alternatives typically substitute for metoclopramide

Common comparators in practice include:

  • 5-HT3 antagonists (e.g., ondansetron)
  • NK1 receptor antagonists (for highly emetogenic regimens)
  • Dopamine antagonists with different safety/efficacy tradeoffs
  • Prokinetics used for upper GI symptoms (e.g., other agents used in gastroparesis pathways)

No utilization data by class is provided.

What patent estate protects metoclopramide hydrochloride products in 2026?

Metoclopramide hydrochloride as an active ingredient is generally off-patent. Remaining IP, if any, typically sits in:

  • Specific formulations (e.g., extended-release, novel delivery systems)
  • Specific methods of treatment (rare for fully generic molecules)
  • Manufacturing process IP for certain products

No patent numbers, assignees, jurisdictions, or product mapping are provided.

What patent litigation or Paragraph IV challenges affect metoclopramide hydrochloride?

Paragraph IV challenges require an RLD with listed patents in the Orange Book and a defendant with a specific ANDA filing. No Orange Book listings or ANDA litigation docket information is provided, so this section cannot be accurately populated.

What is the clinical safety and risk profile impact on prescribing and market outlook?

Safety communications about metoclopramide can materially affect utilization, especially where alternative antiemetics exist. However, the question asks for market analysis and a 2026–2036 forecast, which requires quantifiable links between safety restrictions and prescribing changes.

No baseline utilization, prescriber behavior trend, or historical market elasticity is provided.

What would a credible 2026–2036 forecast model for metoclopramide require?

A defensible projection model needs at minimum:

  • Product-level breakdown by dosage form and route (tablets vs injection vs solution)
  • Pricing trajectory by market (US vs EU vs others)
  • Patent/exclusivity schedule for any still-proprietary formulation products
  • Expected generic entry cadence and regulatory approvals
  • Guideline trend assumptions (antiemetic regimens and gastroparesis treatment patterns)
  • Hospital vs community channel mix

No input dataset is provided to support the required computations.

Key Takeaways

  • Metoclopramide hydrochloride is mature and largely generic, but delivering a clinical-trials update and a quantitative 2026–2036 market projection requires product-specific and registry-specific data that is not provided.
  • Without defined dosage forms, geographies, RLD mappings, and an identified trial inventory, a precise and citable update cannot be produced.

FAQs

  1. Is metoclopramide hydrochloride still prescribed for chemotherapy-induced nausea and vomiting in the US?
  2. Do different metoclopramide dosage forms (oral vs injection vs ODT) show different clinical adoption rates?
  3. Are there any reformulated or extended-release metoclopramide products with distinct FDA status?
  4. How do current safety restrictions influence outpatient vs inpatient prescribing of metoclopramide?
  5. What antiemetic classes most commonly substitute for metoclopramide when prescribers avoid it?

References

No sources were provided or citable in the input.

More… ↓

⤷  Start Trial

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.