METOCLOPRAMIDE (metoclopramide hydrochloride)
METOCLOPRAMIDE is indicated for the treatment of Gastroesophageal Reflux; Diabetic Gastroparesis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-12-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
METOCLOPRAMIDE Approval History
What METOCLOPRAMIDE Treats
2 indicationsMETOCLOPRAMIDE is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gastroesophageal Reflux
- Diabetic Gastroparesis
METOCLOPRAMIDE Boxed Warning
TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Trea...
WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped. Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia. See WARNINGS
METOCLOPRAMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
51 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06379217 | CAAA617H12101 2023-505655-43 | Ph 1 | active not recruiting | NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. |
| NCT07208305 | AHQU-2025003 | Ph 3 | recruiting | Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting |
| NCT03970720 | IRB_00118549 1R01DK118082-01A1 | Ph 2 | recruiting | Restoration of Hypoglycemia Awareness With Metoclopramide |
| NCT04726592 CLORMIG | P170903J | Ph 3 | terminated | Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room |
| NCT07100691 GEM-GLP1RA | GEM-GLP1RA | Ph 4 | not yet recruiting | Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery |
| NCT05102591 results posted | REB21-0408 | Ph 3 | completed | A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents |
| NCT06297954 | GA22-00011 | Ph 3 | completed | Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding |
| NCT05731960 | 1028461 | Ph 4 | recruiting | Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean Delivery |
| NCT06390787 | 007 | Ph 2, Ph 3 | completed | The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics |
| NCT05496179 | Future University in Egypt | Ph 1, Ph 2 | completed | The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients |
| NCT05533281 | Nausea and vomiting | Ph 4 | completed | Efficacy of Three Antiemetics in Preventing Nausea and Vomiting |
| NCT05098067 results posted | 1763191-1 | Ph 2 | completed | Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy |
| NCT04771481 | RP021 | Ph 4 | completed | Metoclopramide for Acute Upper GI Bleeding |
| NCT05641051 | 35298/2/22 | Ph 4 | completed | Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients |
| NCT02163434 results posted | 496486-3 1R01HD076313-01A1 | Ph 2 | completed | Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum |
| NCT04027348 results posted | I 74018 | Ph 2 | terminated | Palliative Management of Inoperable Malignant Bowel Obstruction |
| NCT03220958 results posted | 2017-7898 | Ph 3 | completed | Metoclopramide for Post Traumatic Headache |
| NCT05087615 PONV | ManoochehrEbrahimian | Ph 3 | completed | Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery |
| NCT03269435 results posted | 2017-8249 | Ph 4 | completed | Greater Occipital Nerve Block Versus Metoclopramide |
| NCT02459275 results posted | PEP uP Surgical RCT | Ph 4 | terminated | PEP uP Protocol in Surgical Patients |
| NCT02907632 | 2015/71 | Ph 4 | completed | Methoclopramide for Gastroesophageal Reflux in Premature Infants |
| NCT02135510 MEDEA | 2011/366 | Ph 3 | completed | MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy |
| NCT01953081 results posted | 0082 | Ph 1, Ph 2 | completed | A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance |
| NCT03932578 | MSA10 | Ph 4 | completed | Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS |
| NCT03477903 results posted | TAK-954-2002 U1111-1208-1831, 2017-003206-41 | Ph 2 | terminated | TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI) |
| NCT02627950 MonAMI | ESR-14-10498 | Ph 4 | completed | Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction |
| NCT02847494 results posted | 2016-6342 | Ph 4 | completed | Corticosteroids for Acute Migraine in the Emergency Department |
| NCT02972502 results posted | 13-0078 | Ph 4 | terminated | Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department |
| NCT01825941 results posted | 13-02-071 | Ph 4 | completed | Diphenhydramine for Acute Migraine |
| NCT03056352 results posted | 2017-7511 | Ph 1, Ph 2 | completed | Metoclopramide for Post-Traumatic Headache. A Pilot Study |
| NCT01267864 results posted | 10-01-009 | Ph 4 | completed | Valproate Versus Ketorolac Versus Metoclopramide |
| NCT00682734 MDFS results posted | 07-11-405 | Ph 3 | completed | Metoclopramide for Migraine: A Dose Finding Study |
| NCT01011673 results posted | 09-08-249 | Ph 4 | completed | Metoclopramide Versus Ketorolac for Tension-type Headache |
| NCT02784392 PROMOTE | LP101-CL-201 2016-000723-94 | Ph 2 | completed | Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE Trial |
| NCT03081416 THINK | C.2016.072 | Ph 3 | completed | "THINK Trial: Treatment of Headache With IntraNasal Ketamine: A Randomized Controlled Trial Evaluating the Efficacy of Intranasal Ketamine Versus Standard Therapy in the Management of Primary Headache Syndromes in the Emergency Department" |
| NCT03383315 | NMRR-16-1688-32638 | Ph 2 | completed | Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients |
| NCT02959840 results posted | Pro20140000517 | Ph 4 | completed | Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean |
| NCT00557544 | rc 32/07 | Ph 3 | withdrawn | Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood |
| NCT01937234 | AFHSR-13-7-2013 | Ph 4 | completed | Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women |
| NCT01289938 MalD | IKP231 2008-003778-16 | Ph 1 | terminated | Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine |
| NCT01148264 COMFORT | KKSH 079 2010-018665-30 | Ph 2 | terminated | Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis |
| NCT01596166 EDMigraine-4 | EDMIGR-004-01 | Ph 4 | completed | Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department |
| NCT01781377 | 1632/08 COET | Ph 4 | completed | Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia. |
| NCT02253524 | PAU-1179 | Ph 4 | completed | Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo |
| NCT02222220 | VLAK-14 | Ph 3 | completed | Metoclopramide as Treatment of Clozapine-induced Hypersalivation |
| NCT00845858 results posted | METO-IN-002 | Ph 2 | completed | Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis |
| NCT01630109 results posted | GRMC120006 | Ph 4 | completed | Study of Metoclopramide in Small Bowel Capsule Endoscopy |
| NCT01837394 | H-2-2011-029 | Ph 4 | completed | Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy |
| NCT01858090 | KA08/48 | Ph 3 | completed | Intrathecal Levobupivacaine With Opioids for Caesarean Section |
| NCT00632606 MagHead | IRB#08-0006 | Ph 2, Ph 3 | withdrawn | MgSO4 vs Metoclopramide for Headache in Pregnant Women |
Showing 50 of 51 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METOCLOPRAMIDE FDA Label Details
Indications & Usage
METOCLOPRAMIDE is indicated for the treatment of Gastroesophageal Reflux; Diabetic Gastroparesis.
WARNING: TARDIVE DYSKINESIA Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dose. Metoclopramide therapy should be discontinued in p...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment