Reglan

(Metoclopramide)

ApprovedSmall molecule

Metoclopramide is used to relieve nausea and vomiting, and to help food move more easily through the stomach in people with certain digestive problems.[2] Reglan is currently approved and in use across 27 indications[4].[1]

Reglan is one of 512 small molecule programs targeting Gastroparesis. It is currently in Approved.

Indications

113

Total Trials

Active Trials

511

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GastroparesisActive, not recruiting

HIV InfectionApproved

Migraine DisorderApproved

Acute Myocardial InfarctionActive, not recruiting

VertigoActive, not recruiting

Tension-Type HeadacheActive, not recruiting

GastroenteritisApproved

PneumoniaActive, not recruiting

Myocardial InfarctionActive, not recruiting

Chemotherapy-Induced Nausea and VomitingActive, not recruiting

GastroparesisPhase 3

Active, not recruiting

HIV InfectionApproved

Approved

Migraine DisorderApproved

Approved

Acute Myocardial InfarctionApproved

Active, not recruiting

VertigoApproved

Active, not recruiting

Tension-Type HeadacheApproved

Active, not recruiting

GastroenteritisApproved

Approved

PneumoniaApproved

Active, not recruiting

Myocardial InfarctionApproved

Active, not recruiting

Chemotherapy-Induced Nausea and VomitingPhase 3

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Reglan

IIstituto Clinico Humanitas

Novantrone

5 3

Mekinist

Novartis

Preclinical

3 4

Trexall

Alnylam Pharmaceuticals

Preclinical

—5

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 6

Duragesic

CCephalon

Preclinical

1 7

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 8

Viagra

VViatris Specialty LLC

Preclinical

1 9

Prednisone/prednisolone

Roche

Preclinical

3 10

Triptorelin Pamoate

Ipsen

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Metastatic Neuroendocrine Prostate Cancer

NCT06379217

Post-ApprovalNot yet recruiting

Efficacy

NCT07031479

Q3 2027

ApprovedNot yet recruiting

Nausea and Vomiting

NCT06740812

Q4 2027

Phase 3Recruiting

Nausea and Vomiting

NCT07208305

Phase 2Recruiting

Hypoglycemia

NCT03970720

Q3 2028

N/ARecruiting

Efficacy

NCT03560583

Clinical

Trials by Indication[1]

Nausea and vomiting14 trials

Dexamethasone Versus Metoclopramide for Prophylaxis of Nausea and Vomiting After Cataract Surgery

Recruiting·—·N/A·NCT07086118·210 enrolled

Prophylactic Subhypnotic Propofol for Nausea and Vomiting During for Cesarean Section Under Subarachnoid Anesthesia.

Completed·GG. d'Annunzio University·Phase 4·NCT01781377·112 enrolled

Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Completed·WWomen and Infants Hospital of Rhode Island·Phase 2·NCT05098067·30 enrolled

Show 11 more trials

Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Completed·—·N/A·NCT01216410·306 enrolled

Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis

Not yet recruiting·GGenuine Research Center, Egypt·Phase 3·NCT05876585·126 enrolled

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

Treatment Algorithm for Nausea and Vomiting in the Palliative Phase

Unknown status·RRadboud University Medical Center·Phase 4·NCT03017391·20 enrolled

Effects of Ondansetron, Metoclopramide and Granisetron on Perioperative Nausea and Vomiting in Patients Undergone Bariatric Surgery

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT05087615·130 enrolled

Efficacy of Three Antiemetics in Preventing Nausea and Vomiting

Completed·TThe Second Affiliated Hospital of Chongqing Medical University·Phase 4·NCT05533281·200 enrolled

Olanzapine Plus Metoclopramide for the Prevention of Opioid-Induced Nausea and Vomiting

Recruiting·—·Phase 3·NCT07208305·222 enrolled

Acupuncture Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean

Completed·RRutgers, The State University of New Jersey·Phase 4·NCT02959840·180 enrolled

Uncomplicated Nausea and Vomiting in the Emergency Department

Completed·WWellSpan Health·Phase 4·NCT00778011·137 enrolled

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

Terminated·VVanderbilt University·N/A·NCT00655642·171 enrolled

Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide: A Randomized Control Trial

Not yet recruiting·MMontefiore Medical Center·Approved·NCT06740812·212 enrolled

Migraine10 trials

Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine

Completed·—·N/A·NCT04252521·150 enrolled

Metoclopramide for Migraine: A Dose Finding Study

Completed·MMontefiore Medical Center·Phase 3·NCT00682734·349 enrolled

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04726592·323 enrolled

Show 7 more trials

Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Completed·KKocaeli University·Phase 4·NCT02314351·148 enrolled

Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines

Completed·WWake Forest University Health Sciences·Phase 3·NCT05967442·157 enrolled

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Withdrawn·IIRCCS Burlo Garofolo·Phase 3·NCT00557544

Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department

Completed·UUniversity of Alberta·Phase 4·NCT01596166·56 enrolled

Diphenhydramine for Acute Migraine

Completed·MMontefiore Medical Center·Phase 4·NCT01825941·208 enrolled

A Pilot Clinical Trial of a New Neuromodulation Device for Acute Attacks of Migraine in Children and Adolescents

Completed·UUniversity of Calgary·Phase 3·NCT05102591·22 enrolled

Corticosteroids for Acute Migraine in the Emergency Department

Completed·MMontefiore Medical Center·Phase 4·NCT02847494·220 enrolled

Headache9 trials

Metoclopramide for Post Traumatic Headache

Completed·MMontefiore Medical Center·Phase 3·NCT03220958·160 enrolled

Intravenous Metoclopramide for the Treatment of Post Concussive Headache: a Randomized Placebo Controlled Trial

Unknown status·VVancouver General Hospital·N/A·NCT00237705·40 enrolled

"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"

Completed·—·Phase 3·NCT03081416·80 enrolled

Show 6 more trials

MgSO4 vs Metoclopramide for Headache in Pregnant Women

Withdrawn·WWomen and Infants Hospital of Rhode Island·Phase 2/3·NCT00632606

Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department

Terminated·OOhioHealth·Phase 4·NCT02972502·66 enrolled

Treatment of Acute Migraine Headache in Children

Completed·—·Phase 2·NCT00355394·31 enrolled

Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT

Withdrawn·UUnited States Naval Medical Center, Portsmouth·Phase 4·NCT02098499

Dexamethasone for Post Traumatic Headache

Completed·MMontefiore Medical Center·Phase 4·NCT04799015·162 enrolled

Metoclopramide for Post-Traumatic Headache. A Pilot Study

Completed·MMontefiore Medical Center·Phase 1/2·NCT03056352·21 enrolled

Feeding Intolerance4 trials

Efficacy, Safety, and Pharmacokinetics (PK) Study of Ulimorelin in Patients With Enteral Feeding Intolerance (EFI): The PROMOTE Trial

Completed·LLyric Pharmaceuticals·Phase 2·NCT02784392·120 enrolled

Itopride in Feeding Intolerance of Critically-ill Patients Receiving Enteral Nutrition

Unknown status·—·N/A·NCT03698292·60 enrolled

Electrogastrography (EGC) in Premature Infants With Feeding Intolerance

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00008736

Show 1 more trial

TAK-954 in Critically Ill Participants With Enteral Feeding Intolerance (EFI)

Terminated· Takeda logo

Takeda·Phase 2·NCT03477903·1 enrolled

Efficacy4 trials

Efficacy of Metoclopramide in Poor Ovarian Response IVF Patients

Recruiting·—·N/A·NCT03560583·60 enrolled

The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics

Completed·UUniversity of Baghdad·Phase 2/3·NCT06390787·250 enrolled

Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume

Not yet recruiting·—·Phase 4·NCT07031479·86 enrolled

Show 1 more trial

Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Completed·PPamukkale University·N/A·NCT01069536·140 enrolled

59 more indications

Gastroparesis3 trials

Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis

Completed·EEvoke Pharma·Phase 3·NCT02025751·53 enrolled

Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis

Completed·EEvoke Pharma·Phase 3·NCT02025725·205 enrolled

Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis

Completed·EEvoke Pharma·Phase 2·NCT00845858·287 enrolled

Bowel Preparation2 trials

Bowel Preparation and Prokinetics in Capsule Endoscopy

Unknown status·LLondon North West Healthcare NHS Trust·Phase 3·NCT00275184·150 enrolled

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

Completed·MMedtronic - MITG·N/A·NCT02481219·122 enrolled

Endoscopy2 trials

Study to Evaluate the Efficacy of Oral Dissolving Metoclopramide Before Video Capsule Endoscopy

Terminated·WWinthrop University Hospital·N/A·NCT01631994·6 enrolled

Study of Metoclopramide in Small Bowel Capsule Endoscopy

Completed·AAscension Health·Phase 4·NCT01630109·5 enrolled

Prevention2 trials

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

Unknown status·LLagos State Health Service Commission·Phase 2·NCT02441673·130 enrolled

The CRISIS Prevention Study

Terminated·MMichael Dean·Phase 3·NCT00395161·293 enrolled

Randomized Controlled Trial2 trials

Dopamine D-2 Antagonist Use in Poor Responders in IVF: a Randomized Controlled Trial

Withdrawn·MMount Sinai Hospital, Canada·N/A·NCT02262923

Metoclopramide and the Length of First Stage of Labor , a Randomized Controlled Trial

Completed·—·Phase 4·NCT04969120·80 enrolled

Critically Ill Patients2 trials

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

Completed· Takeda logo

Takeda·Phase 1/2·NCT01953081·13 enrolled

A Comparative Evaluation of Mosapride Versus Metoclopramide for Enteral Feeding Intolerance in Critically Ill Patients

Not yet recruiting·—·Phase 3·NCT06826443·100 enrolled

Ondansetron2 trials

Antiemetic Efficacy of Ondansetron Versus Metoclopramide

Unknown status·HHospital General Naval de Alta Especialidad - Escuela Medico Naval·Phase 3·NCT02619201·250 enrolled

Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron

Completed·TTanta University·Phase 2·NCT05342818·90 enrolled

Randomised Controlled Trial2 trials

Metoclopramide to Aid Establishment of Breastfeeding:a Randomised Controlled Trial

Completed·NNational University Hospital, Singapore·N/A·NCT00264719·160 enrolled

Maxolon to Improve Breastmilk Supply in Diabetic Women: a Randomised Controlled Trial

Completed·NNational University Hospital, Singapore·Phase 3·NCT00477776·160 enrolled

Critically Ill2 trials

Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study

Terminated· GSK logo

GSK·Phase 2·NCT01934192·91 enrolled

Acupuncture Effect on Digestion in Critically Ill Post-Operative Oral and Hypo-pharyngeal Cancer Patients

Completed·—·N/A·NCT03934294·28 enrolled

Age2 trials

Metoclopramide Versus Hyoscine Butylbromide in Shortening Duration of First Stage of Labour

Unknown status·UUwakwe Emmanuel Chijioke·Phase 1·NCT05222646·150 enrolled

Palliative Management of Inoperable Malignant Bowel Obstruction

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT04027348·15 enrolled

Dexamethasone1 trial

Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin

Completed·MMahidol University·N/A·NCT01093690·162 enrolled

Vomiting1 trial

Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS

Completed·MMansoura University·Phase 4·NCT03932578·60 enrolled

Hyperemesis Gravidarum1 trial

Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum

Completed·SState University of New York at Buffalo·Phase 2·NCT02163434·31 enrolled

Gastric Emptying1 trial

Gastric Emptying With Metoclopramide in GLP-1 Agonist Patients Undergoing Elective Surgery

Not yet recruiting·—·Phase 4·NCT07100691·80 enrolled

Acute Myocardial Infarction1 trial

Impact of Morphine Treatment on Platelet Inhibition in Acute Myocardial Infarction

Completed·UUniversity of Luebeck·Phase 4·NCT02627950·138 enrolled

Intensive Care Unit1 trial

The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients

Completed·—·Phase 1/2·NCT05496179·70 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux

Completed·MMuhammad Aamir Latif·N/A·NCT06898268·290 enrolled

Knee Arthroscopy1 trial

Ultrasound-guided Blocks for Ambulatory Knee Arthroscopy

Completed·JJens Borglum Neimann·Phase 4·NCT01837394·60 enrolled

Tension-type headache1 trial

Metoclopramide Versus Ketorolac for Tension-type Headache

Completed·MMontefiore Medical Center·Phase 4·NCT01011673·123 enrolled

Tics1 trial

Anesthetics in Rhytidoplasty - A Comparison Study

Completed·MMercy Facial Plastic Surgery Center·N/A·NCT02410460·30 enrolled

Opioid1 trial

Opioid Effects on Swallowing and Esophageal Sphincter Pressure

Completed·RRegion Örebro County·Phase 4·NCT01191645·14 enrolled

Women1 trial

Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women

Completed·—·Phase 4·NCT01937234·250 enrolled

Side Effects1 trial

Pharmacogenetic Factors and Side Effects of Metoclopramide and Diphenhydramine

Terminated·MMatthias Schwab·Phase 1·NCT01289938·49 enrolled

Tramadol1 trial

Role of Prophylactic Metoclopramide With Tramadol in Trauma Patients

Completed·UUniversity of Malaya·Phase 2·NCT03383315·191 enrolled

Low Birth Weight1 trial

Metoclopramide Use in Very Low Birth Weight Newborns

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT00242450·30 enrolled

Ileus1 trial

The Effects of Combined Gum-chewing and Parenteral Metoclopramide on Post-operative Ileus

Completed·IIkechukwu Bartholomew Ulasi·Phase 4·NCT05669781·105 enrolled

Adult1 trial

A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults

Completed·AAspeya Switzerland SA·Phase 1·NCT07226362·44 enrolled

Gastric1 trial

Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

Completed·—·N/A·NCT04682691·50 enrolled

Cesarean Section1 trial

Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Unknown status·—·N/A·NCT04157998·60 enrolled

Azithromycin1 trial

Metoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy

Unknown status·WWaihong Chung·Phase 2·NCT03840057·435 enrolled

Trial1 trial

Metoclopramide Pilot Trial

Terminated·TThe Hospital for Sick Children·Phase 3·NCT02098915·10 enrolled

Pneumonia1 trial

Metoclopramide vs Placebo for Prevention of Pneumonia in Acute Stroke

Completed·SShaheed Zulfiqar Ali Bhutto Medical University·Phase 4·NCT04873297·106 enrolled

Immune Response1 trial

Antibiotics and Vaccine Immune Responses Study

Recruiting·SSouth Australian Health and Medical Research Institute·Phase 4·NCT06148025·348 enrolled

Gastrointestinal1 trial

Metoclopramide in Upper Gastrointestinal Bleed

Unknown status·—·Phase 4·NCT05746377·60 enrolled

Laparoscopic Sleeve Gastrectomy1 trial

Non-opioid Anesthesia Based on Thoracic Paravertebral Block During Laparoscopic Sleeve Gastrectomy

Not yet recruiting·IIVO JURISIC·N/A·NCT07084753·36 enrolled

Ultrasound1 trial

Ultrasound Assessment of Metoclopramide's Effect on Stomach Volume in Urgent Pediatric Trauma Surgery

Not yet recruiting·—·Phase 3·NCT06793267·70 enrolled

Gastroesophageal Reflux1 trial

Methoclopramide for Gastroesophageal Reflux in Premature Infants

Completed·NNathalie Charpak·Phase 4·NCT02907632·490 enrolled

Myocardial Infarction1 trial

Effects of Morphine on Loading-dose Ticagrelor in Patients With ST-segment Elevation Myocardial Infarction

Unknown status·GGeneral Hospital of Chinese Armed Police Forces·Phase 4·NCT02913469·128 enrolled

Olanzapine1 trial

Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

Terminated·KKarin Jordan·Phase 2·NCT01148264·23 enrolled

Chemotherapy-induced nausea and vomiting1 trial

MEtoclopramide, DExamethasone or Axoli to Prevent or Delay Chemotherapy-induced Nausea and Vomiting in Moderately Emetogenic Non-AC-based Chemotherapy

Completed·AAmsterdam UMC, location VUmc·Phase 3·NCT02135510·249 enrolled

Acute Mountain Sickness1 trial

Comparison of Metoclopramide and Ibuprofen for the Treatment of Acute Mountain Sickness

Completed·MMassachusetts General Hospital·N/A·NCT01522326·300 enrolled

Surgical1 trial

PEP uP Protocol in Surgical Patients

Terminated·—·Phase 4·NCT02459275·36 enrolled

Upper Gastrointestinal Bleeding1 trial

Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

Completed·UUniversidad Autonoma de Nuevo Leon·Phase 3·NCT06297954·50 enrolled

Cesarean Delivery1 trial

Evaluating the Effect of Intravenous Dexamethasone on the Duration of Spinal Anesthesia After Cesarean Delivery

Recruiting·IIWK Health Centre·Phase 4·NCT05731960·192 enrolled

Greater Occipital Nerve Block1 trial

Greater Occipital Nerve Block Versus Metoclopramide

Completed·MMontefiore Medical Center·Phase 4·NCT03269435·99 enrolled

Ketorolac1 trial

Valproate Versus Ketorolac Versus Metoclopramide

Completed·MMontefiore Medical Center·Phase 4·NCT01267864·330 enrolled

Exercise1 trial

The Effect of Dopamine on Pulmonary Diffusion and Capillary Blood Volume During Exercise

Completed·UUniversity of Alberta·N/A·NCT02965963·49 enrolled

Induction Chemotherapy1 trial

Study to Evaluate the Effect of Aprepitant in Children and Adolescents Receiving AML Remission Induction Chemotherapy

Unknown status·DDr Atul Sharma·Phase 3·NCT02979548·116 enrolled

Bleeding1 trial

Metoclopramide for Acute Upper GI Bleeding

Completed·KKing Chulalongkorn Memorial Hospital·Phase 4·NCT04771481·68 enrolled

Hypoglycemia1 trial

Restoration of Hypoglycemia Awareness With Metoclopramide

Recruiting·SSimon Fisher·Phase 2·NCT03970720·36 enrolled

Caesarean Section1 trial

Intrathecal Levobupivacaine With Opioids for Caesarean Section

Completed·—·Phase 3·NCT01858090·93 enrolled

Pregnancy1 trial

A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.

Completed·SSt. Louis University·N/A·NCT02295280·70 enrolled

Clozapine-induced Hypersalivation1 trial

Metoclopramide as Treatment of Clozapine-induced Hypersalivation

Completed·—·Phase 3·NCT02222220·61 enrolled

Vertigo1 trial

Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo

Completed·PPamukkale University·Phase 4·NCT02253524·200 enrolled

Myelodysplastic Syndrome1 trial

Metoclopramide to Treat Anemia in Patients With Myelodysplastic Syndrome (MDS)

Withdrawn·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00120653

Mechanically Ventilated Patients1 trial

Metoclopramide on Gastric Emptying in Mechanically Ventilated Patients

Completed·TTanta University·Phase 4·NCT05641051·80 enrolled

Hypotension1 trial

Midodrine for Prophylaxis Against Post Spinal Hypotension in Elderly Population

Completed·—·N/A·NCT05548985·58 enrolled

Metastatic Neuroendocrine Prostate Cancer1 trial

A Phase I, Open-label, Multi-center Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Active, not recruiting· Novartis logo

Novartis·Phase 1·NCT06379217·31 enrolled

Unspecified3 trials

Prochlorperazine vs Metoclopramide

Completed·MMontefiore Medical Center·Phase 4·NCT00364806·76 enrolled

The Montefiore Metoclopramide Study

Completed·MMontefiore Medical Center·Phase 4·NCT00475306·289 enrolled

Subcutaneous Route and Pharmacology of Metoclopramide

Completed·UUniversity Hospital, Bordeaux·Phase 3·NCT02466984·5 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

REGLAN

NDA NDA017862

Mar 25, 1983

REGLAN

NDA NDA018821

May 5, 1987

REGLAN

NDA NDA017854

Jun 10, 2005

REGLAN ODT

NDA NDA021793

Sep 4, 2009

METOZOLV ODT

NDA NDA022246

Jun 19, 2020

GIMOTI

NDA NDA209388

Sources

References

[1]
ClinicalTrials.gov — 113 trial records for Metoclopramide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Reglan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Metoclopramide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Metoclopramide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209388). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Reglan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Istituto Clinico Humanitas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D2 Receptor Antagonist; Serotonin 4 (5-HT4) Receptor Agonist; Serotonin 3a (5-Ht3a) Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IIstituto Clinico Humanitas

Patent Landscape[6]

Patent Cliff

Dec 22, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11813231Dec 22, 2029

12194009Dec 22, 2029

12194008Dec 22, 2029

11020361Dec 22, 2029

11628150Dec 22, 2029

2 more patents

8334281May 16, 2030

12377064Nov 17, 2038

Reglan

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q3 2027

Q4 2027

Q3 2028

Trials by Indication[1]

Nausea and vomiting14 trials

Migraine10 trials

Headache9 trials

Feeding Intolerance4 trials

Efficacy4 trials

Gastroparesis3 trials

Bowel Preparation2 trials

Endoscopy2 trials

Prevention2 trials

Randomized Controlled Trial2 trials

Critically Ill Patients2 trials

Ondansetron2 trials

Randomised Controlled Trial2 trials

Critically Ill2 trials

Age2 trials

Dexamethasone1 trial

Vomiting1 trial

Hyperemesis Gravidarum1 trial

Gastric Emptying1 trial

Acute Myocardial Infarction1 trial

Intensive Care Unit1 trial

Efficacy and Safety1 trial

Knee Arthroscopy1 trial

Tension-type headache1 trial

Tics1 trial

Opioid1 trial

Women1 trial

Side Effects1 trial

Tramadol1 trial

Low Birth Weight1 trial

Ileus1 trial

Adult1 trial

Gastric1 trial

Cesarean Section1 trial

Azithromycin1 trial

Trial1 trial

Pneumonia1 trial

Immune Response1 trial

Gastrointestinal1 trial

Laparoscopic Sleeve Gastrectomy1 trial

Ultrasound1 trial

Gastroesophageal Reflux1 trial

Myocardial Infarction1 trial

Olanzapine1 trial

Chemotherapy-induced nausea and vomiting1 trial

Acute Mountain Sickness1 trial

Surgical1 trial

Upper Gastrointestinal Bleeding1 trial

Cesarean Delivery1 trial

Greater Occipital Nerve Block1 trial

Ketorolac1 trial

Exercise1 trial

Induction Chemotherapy1 trial

Bleeding1 trial

Hypoglycemia1 trial

Caesarean Section1 trial

Pregnancy1 trial

Clozapine-induced Hypersalivation1 trial

Vertigo1 trial

Myelodysplastic Syndrome1 trial

Mechanically Ventilated Patients1 trial

Hypotension1 trial

Metastatic Neuroendocrine Prostate Cancer1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News