metoclopramide

Trade name: reglan

Small moleculeapproved

Approved

Feb 7, 1979

Metoclopramide is a dopamine D2 antagonist that is used as an antiemetic. Metoclopramide inhibits gastric smooth muscle relaxation produced by dopamine, therefore increasing cholinergic response of the gastrointestinal smooth muscle. It accelerates intestinal transit and gastric emptying by preventing relaxation of gastric body and increasing the phasic activity of antrum. Simultaneously, this action is accompanied by relaxation of the upper small intestine, resulting in an improved coordination between the body and antrum of the stomach and the upper small intestine. Metoclopramide also decreases reflux into the esophagus by increasing the resting pressure of the lower esophageal sphincter and improves acid clearance from the esophagus by increasing amplitude of esophageal peristaltic contractions. Metoclopramide's dopamine antagonist action raises the threshold of activity in the chemoreceptor trigger zone and decreases the input from afferent visceral nerves. Studies have also shown that high doses of metoclopramide can antagonize 5-hydroxytryptamine (5-HT) receptors in the peripheral nervous system in animals. Metoclopramide is used for the treatment of gastroesophageal reflux disease (GERD). It is also used in treating nausea and vomiting, and to increase gastric emptying. — NCATS

Clinical trial activity

160 trials · 170 clinical orgs · 49 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started May 1, 1996 (NCT00003213)

Timeline

1970s

Feb 7, 1979
Earliest FDA Approval
Feb 7, 1979
West-Ward Pharmaceutical — NDA Secondary Org
Feb 7, 1979
Hikma — Marketing Organization
Feb 7, 1979
Hikma — NDA Secondary Org

1980s

Dec 30, 1980
Ani Pharmaceuticals — First NDA Organization
Dec 30, 1980
Ani Pharmaceuticals — NDA Secondary Org
Dec 30, 1980
Ani Pharmaceuticals — NDA Organization
Mar 25, 1983
AH Robins — NDA Secondary Org
Oct 17, 1985
Strides Pharma Science — Marketing Organization
Oct 17, 1985
Par Pharmaceuticals — Marketing Organization
Oct 28, 1985
Quantum Pharmaceutical — Marketing Organization
Jan 22, 1986
Watson Pharmaceuticals — Marketing Organization
Jan 24, 1986
Lyphomed, Inc. — Marketing Organization
Feb 2, 1987
Schering — Marketing Organization
Feb 2, 1987
Schering-Plough — Marketing Organization
Feb 10, 1987
Mutual Pharmaceutical — Marketing Organization
Mar 2, 1987
Smith & Nephew — Marketing Organization
Jun 26, 1987
Superpharm — Marketing Organization
Feb 3, 1988
Impax Laboratories — Marketing Organization
Aug 18, 1988
Actavis — Marketing Organization
Aug 26, 1988
Norbrook — Marketing Organization
Nov 7, 1988
Hospira — Marketing Organization
Dec 5, 1988
Roxane Laboratories — Marketing Organization
Dec 5, 1988
Boehringer Ingelheim — Marketing Organization
May 25, 1989
Morton Grove Pharmaceuticals — Marketing Organization

1990s

Jan 30, 1990
Fosun — Marketing Organization
May 9, 1991
Clonmel Hlthcare — Marketing Organization
May 28, 1991
Pharmaceutical Associates — Marketing Organization
Nov 27, 1991
Teva — Marketing Organization
Oct 27, 1992
Chartwell Pharmaceuticals — Marketing Organization
Oct 27, 1992
Lannett Company, Inc. — Marketing Organization
Apr 28, 1993
Sun Pharmaceuticals — Marketing Organization
Jun 25, 1993
Ani Pharmaceuticals — Marketing Organization
Jan 1, 1996
Earliest Phase 1 Sponsor(trial)
Jan 1, 1996
Earliest Phase 3 Sponsor(trial)
Oct 31, 1997
Xttrium Laboratories — Marketing Organization
Oct 31, 1997
Wockhardt — Marketing Organization

2000s

Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
Jan 26, 2001
VistaPharm, Inc. — Marketing Organization
Jun 10, 2005
Meda Pharmaceuticals — NDA Secondary Org
Aug 28, 2006
Vintage — Marketing Organization
Nov 30, 2007
Northstar Healthcare — Marketing Organization
Jun 12, 2008
IPCA Laboratories Ltd. — Marketing Organization
Sep 4, 2009
Salix — NDA Secondary Org

2010s

Apr 19, 2013
Fresenius — Marketing Organization
Dec 20, 2013
Emcure — Marketing Organization
Dec 20, 2013
Avet Lifesciences — Marketing Organization
Aug 15, 2014
Novel Anti-Infective Technologies, LLC — Marketing Organization

2020s

Jun 19, 2020
Evoke Pharma — Marketing Organization
Jun 19, 2020
Evoke Pharma — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Serotonin 4 (5-HT4) receptorAGONIST
HTR4 agonist
- 5-hydroxytryptamine receptor 4 (HTR4) ↗
Dopamine D2 receptorANTAGONIST
DRD2 antagonist
- D(2) dopamine receptor (DRD2) ↗
Serotonin 3a (5-HT3a) receptorANTAGONIST
HTR3A antagonist
- 5-hydroxytryptamine receptor 3A (HTR3A) ↗

Approval history

approvedPriority reviewFeb 7, 1979

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CC)CCNC(=O)c1cc(Cl)c(N)cc1OC

Mol. weight: 299.8 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Achiral Molecule
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral, Topical
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Yes

Black box warning

Sources

Also known as

2-methoxy-4-amino-5-chloro-n,n-(dimethylaminoethyl)benzamide
2-methoxy-4-amino-5-chloro-n,n-(dimethylaminoethyl)benzamide
2-methoxy-5-chloroprocainamide
2-methoxy-5-chloroprocainamide
4-amino-5-bromo-n-[2-(diethylamino)ethyl]-2-methoxybenzamide
4-amino-5-bromo-n-[2-(diethylamino)ethyl]-2-methoxybenzamide
4-amino-5-chloro-2-methoxy-n-(β-diethylaminoethyl)benzamide
4-amino-5-chloro-2-methoxy-n-(β-diethylaminoethyl)benzamide
4-amino-5-chloro-n-(2-(diethylamino)ethyl)-o-anisamide
4-amino-5-chloro-n-(2-(diethylamino)ethyl)-o-anisamide
ahr-3070-c
ahr-3070-c
ahr-3070-c
bromoprid
bromoprid
bromoprid
bromoprida
bromoprida
bromopride
bromopride
bromopride
bromopride
bromopride
bromopride
bromopride
bromopride
bromopride dihydrochloride
bromopride hydrochloride
bromopridum
bromopridum
clopra
clopra
clopra-yellow
clopra-yellow
emepride
gastrese l.a.
gastrobid continus
gastroflux
gastromax
gastromax
maxolon
maxolon
maxolon sr
metaclopramide
metaclopramide
metaclopramide
metclopramide
methochlopramide
metochlopramide
metoclomex
metoclopramida
metoclopramida
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide
metoclopramide hcl
metoclopramide hcl
metoclopramide hcl
metoclopramide hydrochloride
metoclopramide hydrochloride
metoclopramide hydrochloride hydrate
metoclopramide hydrochloride hydrate
metoclopramide hydrochloride hydrate
metoclopramide intensol
metoclopramide intensol
metoclopramide monohydrochloride
metoclopramidum
metoclopramidum
metox
metox
metozolv odt
metozolv odt
metramid
metramid
mygdalon
mygdalon
n-(diethylaminoethyl)-2-methoxy-4-amino-5-bromobenzamide
parmid
parmid
primperan
primperan
reglan
reglan
reglan
reglan
reglan odt
reglan odt
viaben

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07147114	Phase 4	Oct 31, 2025	Gachon University
NCT07208305	Phase 3	Sep 30, 2025	Qinghai University
NCT07100691	Phase 4	Aug 31, 2025	Mater Misericordiae University Hospital
NCT07031479	Phase 4	Jul 1, 2025	Chulalongkorn University
NCT06740812	Phase 2/Phase 3 (Phase 3)	Jun 30, 2025	Yeshiva University
NCT07226362	Phase 1	Jun 9, 2025	Aspeya Switzerland SA
NCT07086118	N/A	May 1, 2025	Alexandria University
NCT06826443	Phase 3	Feb 28, 2025	Ain Shams University
NCT06793267	Phase 3	Feb 15, 2025	Assiut University
NCT06810531	Phase 4	Feb 5, 2025	Suez Canal University
NCT06584006	Phase 2	Sep 1, 2024	Xiamen University
NCT06379217	Phase 1	Jul 29, 2024	Novartis
NCT06898268	N/A	Jul 1, 2024	RESnTEC, Institute of Research
NCT06390787	Phase 2/Phase 3 (Phase 3)	Jan 30, 2024	University of Baghdad
NCT05983354	N/A	Jan 1, 2024	Health Sciences North Research Institute
NCT05957081	Phase 1	Nov 28, 2023	Merck, Novotech, PharmAbcine
NCT06167837	Phase 4	Oct 1, 2023	Chulalongkorn University
NCT05953012	Phase 1	Jul 20, 2023	C&R Research, Inc., PharmAbcine, Seoul National University
NCT05876585	Phase 3	Jun 30, 2023	Beni Suef University, Fayoum University, Genuine Research Center, Egypt
NCT05746377	Phase 4	May 20, 2023	Mercy Health System, Wisconsin

Showing 20 of 160 trials

Page 1 / 8

Organizations

Research & Development (170)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Yeshiva University	Academic/Hospital	12	12	3	2006
Ain Shams University	Academic/Hospital	4	4	4	2013
Merck	For profit	4	1	3	2001
Vanderbilt University	Academic/Hospital	4	4	3	1996
Assiut University	Academic/Hospital	3	3	3	2019
Brown University	Academic/Hospital	3	3	2	2008
Cairo University	Academic/Hospital	3	3	3	2021
Chulalongkorn University	Academic/Hospital	3	3	1	2021
Evoke Pharma	For profit	3	3	2	2009
Dalhousie University	Academic/Hospital	2	1	2	2008
Duke University	Academic/Hospital	2	2	2	2008
Future University in Egypt	Academic/Hospital	2	0	2	2018
GlaxoSmithKline	For profit	2	1	2	2001
Millennium Pharmaceuticals	For profit	2	2	2	2017
National Institutes of Health (NIH)	Government	2	0	1	2007
National University of Singapore	Academic/Hospital	2	2	2	2006
Pamukkale University	Academic/Hospital	2	2	2	2007
PharmAbcine	For profit	2	2	1	2023
State University of New York, Buffalo	Academic/Hospital	2	2	2	2014
Tanta University	Academic/Hospital	2	2	2	2022

170 organizations

Page 1 / 9

Marketing (57)

Organization	Org type	Relationship	Date
AH Robins	For profit	NDA2	Mar 25, 1983
Actavis	For profit	MKTG	Aug 18, 1988
Ani Pharmaceuticals	For profit	NDA2	Dec 30, 1980
Ani Pharmaceuticals	For profit	NDA	Dec 30, 1980
Ani Pharmaceuticals	For profit	MKTG	Jun 25, 1993
Athenex, Inc.	For profit	MKTG	—
Avet Lifesciences	For profit	MKTG	Dec 20, 2013
Bedford Pharmaceuticals	For profit	MKTG	—
Boehringer Ingelheim	For profit	MKTG	Dec 5, 1988
Chartwell Pharmaceuticals	For profit	MKTG	Oct 27, 1992
Chartwell Pharmaceuticals	For profit	SYN	Jan 30, 1990
Clonmel Hlthcare	For profit	MKTG	May 9, 1991
Emcure	For profit	MKTG	Dec 20, 2013
Evoke Pharma	For profit	MKTG	Jun 19, 2020
Evoke Pharma	For profit	NDA2	Jun 19, 2020
Fosun	For profit	MKTG	Jan 30, 1990
Fresenius	For profit	MKTG	Apr 19, 2013
Halsey	For profit	MKTG	—
Hikma	For profit	SYN	Feb 7, 1979
Hikma	For profit	MKTG	Feb 7, 1979
Hikma	For profit	NDA2	Feb 7, 1979
Hospira	For profit	MKTG	Nov 7, 1988
IPCA Laboratories Ltd.	For profit	MKTG	Jun 12, 2008
Impax Laboratories	For profit	MKTG	Feb 3, 1988
Interpharm	For profit	MKTG	—
King Pharmaceuticals	For profit	MKTG	—
Lannett Company, Inc.	For profit	MKTG	Oct 27, 1992
Lyphomed, Inc.	For profit	MKTG	Jan 24, 1986
Meda Pharmaceuticals	For profit	NDA2	Jun 10, 2005
Morton Grove Pharmaceuticals	For profit	MKTG	May 25, 1989
Mutual Pharmaceutical	For profit	MKTG	Feb 10, 1987
Norbrook	For profit	MKTG	Aug 26, 1988
Northstar Healthcare	Academic/Hospital	MKTG	Nov 30, 2007
Novel Anti-Infective Technologies, LLC	For profit	MKTG	Aug 15, 2014
Paco	For profit	MKTG	—
Par Pharmaceuticals	For profit	SYN	Sep 16, 1986
Par Pharmaceuticals	For profit	MKTG	Oct 17, 1985
Pharmaceutical Associates	For profit	MKTG	May 28, 1991
Quantum Pharmaceutical	For profit	MKTG	Oct 28, 1985
Roxane Laboratories	For profit	MKTG	Dec 5, 1988
Salix	For profit	NDA2	Sep 4, 2009
Sandoz	For profit	MKTG	—
Schering	For profit	MKTG	Feb 2, 1987
Schering-Plough	For profit	MKTG	Feb 2, 1987
Smith & Nephew	For profit	MKTG	Mar 2, 1987
Strides Pharma Science	For profit	MKTG	Oct 17, 1985
Sun Pharmaceuticals	For profit	MKTG	Apr 28, 1993
Superpharm	For profit	MKTG	Jun 26, 1987
Teva	For profit	SYN	Jul 29, 1985
Teva	For profit	MKTG	Nov 27, 1991
Upsher-Smith Laboratories	For profit	MKTG	—
Vintage	For profit	MKTG	Aug 28, 2006
VistaPharm, Inc.	For profit	MKTG	Jan 26, 2001
Watson Pharmaceuticals	For profit	MKTG	Jan 22, 1986
West-Ward Pharmaceutical	For profit	NDA2	Feb 7, 1979
Wockhardt	For profit	MKTG	Oct 31, 1997
Xttrium Laboratories	For profit	MKTG	Oct 31, 1997