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Drug ReportsMetoclopramide
Metoclopramide
Gimoti, Metoclopramide, Reglan (metoclopramide) is a small molecule pharmaceutical. Metoclopramide was first approved as Reglan on 1982-01-01. It is used to treat gastroesophageal reflux, gastroparesis, and postoperative nausea and vomiting in the USA. The pharmaceutical is active against 5-hydroxytryptamine receptor 4 and D(2) dopamine receptor.
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5D
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Gimoti, Reglan (generic drugs available since 1985-07-29, discontinued: Clopra, Clopra-yellow, Maxolon, Metozolv)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Metoclopramide hydrochloride
Tradename
Company
Number
Date
Products
REGLANANI PharmaceuticalsN-017854 RX1982-01-01
2 products, RLD, RS
GIMOTIEvoke PharmaN-209388 RX2020-06-19
1 products, RLD, RS
Show 4 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
gimotiNew Drug Application2021-01-07
metoclopramideANDA2024-09-16
metoclopramide hydrochlorideANDA2024-01-31
reglanNew Drug Application2020-06-19
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Metoclopramide Hydrochloride, Gimoti, Evoke Pharma Inc
83342812030-05-16DPU-2843
110203612029-12-22U-2843
116281502029-12-22DPU-2843
118132312029-12-22DPU-2843
ATC Codes
A: Alimentary tract and metabolism drugs
— A03: Drugs for functional gastrointestinal disorders
— A03F: Propulsives
— A03FA: Propulsives
— A03FA01: Metoclopramide
HCPCS
Code
Description
J2765
Injection, metoclopramide hcl, up to 10 mg
Clinical
Clinical Trials
200 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
VomitingD014839HP_0002013R11.1—31115937
Migraine disordersD008881EFO_0003821G43—3814630
NauseaD009325HP_0002018R11.0—1513928
HeadacheD006261HP_0002315R511666925
Postoperative nausea and vomitingD020250EFO_0004888———25613
Gastrointestinal hemorrhageD006471HP_0002239K92.2112318
HemorrhageD006470MP_0001914R581123—7
Critical illnessD016638——13—137
NeoplasmsD009369—C80112216
EmergenciesD004630————2226
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GastroparesisD018589EFO_1000948K31.84—42—28
Headache disordersD020773EFO_0009550G44——1—12
Breast feedingD001942————1—12
Myeloid leukemia acuteD015470—C92.0——1——1
SialorrheaD012798HP_0002307K11.7——1——1
Hiv infectionsD015658EFO_0000764B20——1——1
DyspepsiaD004415EFO_0008533K30——1——1
GastroschisisD020139EFO_1000949Q79.3——1——1
SepsisD018805HP_0100806A41.9——1——1
AnemiaD000740HP_0001903D64.9——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———31———3
Hyperemesis gravidarumD006939EFO_1000971O21—2——13
LymphomaD008223—C85.911——12
Intestinal obstructionD007415—K56.6012———2
Colonic neoplasmsD003110—C1811——12
SyndromeD013577———2———2
Diabetes mellitusD003920HP_0000819E08-E13—2———2
Enteral nutritionD004750———2———2
Ovarian neoplasmsD010051EFO_0003893C5611———1
Fallopian tube neoplasmsD005185——11———1
Show 14 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I951———23
Inborn errors metabolismD008661——1————1
Autonomic nervous system diseasesD001342EFO_0009532G901————1
Orthostatic hypotensionD007024—I95.11————1
Nervous system diseasesD009422—G00-G991————1
Primary dysautonomiasD054969——1————1
Orthostatic intoleranceD054971——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obstetric labor complicationsD007744——————22
Non-hodgkin lymphomaD008228—C85.9————11
RhytidoplastyD015361——————11
Knee osteoarthritisD020370EFO_0004616M17————11
ArthritisD001168HP_0001369M05-M14————11
DeliriumD003693—R41.0————11
Insulin resistanceD007333HP_0000855—————11
Labor painD048949——————11
Sudden death cardiacD016757EFO_0004278—————11
DeathD003643PATO_0001422—————11
Show 31 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMetoclopramide
INNmetoclopramide
Description
Metoclopramide is a member of the class of benzamides resulting from the formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with the primary amino group of N,N-diethylethane-1,2-diamine. It has a role as an antiemetic, a dopaminergic antagonist, a gastrointestinal drug, a xenobiotic and an environmental contaminant. It is a tertiary amino compound, a substituted aniline, a member of benzamides and a member of monochlorobenzenes. It is a conjugate base of a metoclopramide(1+).
Classification
Small molecule
Drug classD2 receptor antagonist; 5-HT3 receptor antagonist; 5-HT4 receptor agonist; Prolactin releaser
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC
Identifiers
PDB—
CAS-ID364-62-5
RxCUI—
ChEMBL IDCHEMBL86
ChEBI ID107736
PubChem CID4168
DrugBankDB01233
UNII IDL4YEB44I46 (ChemIDplus, GSRS)
Target
Agency Approved
HTR4
HTR4
DRD2
DRD2
Organism
Homo sapiens
Gene name
HTR4
Gene synonyms
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 4
Protein synonyms
5-hydroxytryptamine (serotonin) receptor 4, G protein-coupled, cardiac 5-HT4 receptor, Serotonin receptor 4
Uniprot ID
Mouse ortholog
Htr4 (15562)
5-hydroxytryptamine receptor 4 (Q9R2A4)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Metoclopramide
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,486 documents
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Safety
Black-box Warning
Black-box warning for: Gimoti, Metoclopramide, Metoclopramide hydrochloride, Reglan
Adverse Events
Top Adverse Reactions
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32,737 adverse events reported
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