methyldopa

Trade name: aldomet

Small moleculeapproved

Approved

Dec 20, 1962

Methyldopate hydrochloride [levo-3-(3,4-dihydroxyphenyl)-2-methylalanine, ethyl ester hydrochloride] is the ethyl ester of methyldopa, supplied as the hydrochloride salt with a molecular weight of 275.73. Methyldopate hydrochloride is more soluble and stable in solution than methyldopa and is the preferred form for intravenous use. Methyldopate hydrochloride is an alpha adrenergic agonist that has both central and peripheral nervous system effects. Its primary clinical use is as an antihypertensive agent. — NCATS

Clinical trial activity

19 trials · 30 clinical orgs · 31 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Dec 1, 1996 (NCT00748059)

Timeline

1960s

Dec 20, 1962
Merck — Earliest FDA Approval
Dec 20, 1962
Merck — NDA Organization
Dec 20, 1962
Merck — NDA Secondary Org

1980s

Jun 29, 1984
Fosun — NDA Secondary Org
Jun 29, 1984
Chartwell Pharmaceuticals — Marketing Organization
Jun 29, 1984
Chartwell Pharmaceuticals — NDA Secondary Org
Apr 18, 1985
Mylan — Marketing Organization
Apr 18, 1985
Rising Pharmaceuticals — Marketing Organization
Oct 15, 1985
Accord Research — Marketing Organization
Feb 20, 1986
Heritage Pharma — Marketing Organization
Apr 15, 1986
Parke-Davis — Marketing Organization
Apr 15, 1986
Warner Lambert — Marketing Organization
Jun 3, 1986
Abraxis — Marketing Organization
Jun 6, 1986
Watson Pharmaceuticals — Marketing Organization
Jul 1, 1986
Baxalta — Marketing Organization
Jul 1, 1986
Baxter — Marketing Organization
Oct 9, 1986
Sun Pharmaceuticals — Marketing Organization
Dec 16, 1986
Duramed Research — Marketing Organization
Jan 2, 1987
Par Pharmaceuticals — Marketing Organization
Jan 2, 1987
Strides Pharma Science — Marketing Organization
Jun 15, 1987
Hospira — Marketing Organization
Dec 2, 1987
Sankyo — Marketing Organization
Dec 2, 1987
Lutipold — Marketing Organization
Dec 22, 1987
Marsam Pharmaceuticals — Marketing Organization
Apr 8, 1988
Teva — Marketing Organization
Jul 7, 1988
Pliva — Marketing Organization
Jun 2, 1989
DAVA Pharmaceuticals — Marketing Organization

1990s

Jan 1, 1996
Earliest Phase 1 Sponsor(trial)

2000s

Jan 1, 2004
Earliest Phase 3 Sponsor(trial)

2010s

Jan 1, 2011
Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Adrenergic receptor alpha-2AGONIST
Adrenergic receptor alpha-2 agonist

Combination products

aldoclor
with chlorothiazide
aldoril
with hydrochlorothiazide

Approval history

approvedPriority reviewDec 20, 1962

Chemistry & pharmacology

Loading structure…

SMILES

CCOC(=O)[C@@](C)(N)Cc1ccc(O)c(O)c1

Mol. weight: 239.27 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Discontinued

Oral

Parenteral

Yes

Topical

Sources

Also known as

2-amino-3-(3,4-dihydroxy-phenyl)-2- methyl-propionic acid(catechol metabolite)
2-amino-3-(3,4-dihydroxy-phenyl)-2- methyl-propionic acid(catechol metabolite)
3-hydroxy-alpha-methyl-l-tyrosine
3-hydroxy-alpha-methyl-l-tyrosine
aldochlor
aldomet
aldomet
aldomet
aldomine
alpha medopa
alpha medopa
(-)-alpha-methyl-3,4-dihydroxyphenylalanine
alphamethyldopa
alphamethyldopa
alphamethyldopa
alpha methyldopa
alpha methyldopa
alpha-methyldopa
alpha-methyldopa
alpha-methyldopa
alpha-methyl dopa
alpha-methyl dopa
alpha-methyldopa ethyl ester
alpha-methyl-l-dopa
alpha-methyl-l-dopa
amd
amd
anhydrous methyldopa
anhydrous methyldopa
dopamet
dopamet
l-alpha-methyldopa
l-alpha-methyldopa
lederdopa
lederdopa
lederdopa
l-methyl dopa
l-methyl dopa
medomet
medomet
metalpha 250
metalpha 500
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyldopa
methyl dopa
methyl dopa
methyldopa anhydrous
methyldopa anhydrous
methyldopa (levorotatory)
methyldopa (levorotatory)
methyldopa (racemic)
methyldopa (racemic)
methyldopate
methyldopate
methyldopate
methyldopate
methyldopate
methyldopate hcl
methyldopate hcl
methyldopate hcl
methyldopate hydrochloride
methyldopate hydrochloride
methyldopate hydrochloride
methyldopate hydrochloride
methyl-l-dopa ethyl ester
metyldopa
mk-351
mk-351
(s)-(-)-alpha-methyldopa
(s)-(-)-alpha-methyldopa
α-methyl dopa
α-methyl dopa
α-methyl-l-dopa
α-methyl-l-dopa

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT06618521	N/A	Apr 30, 2024	Cairo University
NCT05888896	N/A	Jun 9, 2023	Cairo University
NCT04835233	Phase 4	Mar 1, 2021	Federal University of Paraiba, FMUSP
NCT04625595	Phase 1	Nov 6, 2020	Immunomolecular Therapeutics, Inc., WCCT Global
NCT03396484	Phase 2	Mar 31, 2018	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Type 1 Diabetes TrialNet
NCT03210025	Phase 1	Sep 20, 2017	Bright Future Pharmaceuticals Factory, Chinese University of Hong Kong
NCT02531490	Phase 4	Dec 1, 2015	Maastricht University
NCT01912677	Phase 4	Apr 1, 2015	Bill and Melinda Gates Foundation, Daga Memorial Women's Hospital, Nagpur, India, Government Medical College, Nagpur, Gynuity Health Projects, University of British Columbia
NCT01911494	N/A	Sep 1, 2013	Aga Khan University, Bill and Melinda Gates Foundation, Government of Mozambique, Jawaharlal Nehru Medical College, Olabisi Onabanjo University, University of British Columbia
NCT01883804	N/A	Jun 1, 2013	Juvenile Diabetes Research Foundation, University of Colorado, University of Colorado, Denver
NCT01500590	Phase 4	Nov 1, 2011	Government of Hong Kong
NCT01674127	Phase 2	Aug 1, 2011	Isfahan University
NCT01361425	Phase 4	May 1, 2011	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Instituto de Medicina Integral Professor Fernando Figueira
NCT00580619	Phase 1	Apr 1, 2007	Vanderbilt University
NCT00117546	Phase 4	Sep 1, 2005	Radboud University
NCT00329511	N/A	Sep 1, 2004	University of California, Irvine
NCT00194974	Phase 1/Phase 2 (Phase 2)	Jul 1, 2004	Cornell University
NCT00581477	Phase 3	Jan 1, 2004	Vanderbilt University
NCT00748059	Phase 1	Dec 1, 1996	Vanderbilt University

Showing 19 of 19 trials

Page 1 / 1

Organizations

Research & Development (30)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Vanderbilt University	Academic/Hospital	3	3	2	1996
Bill and Melinda Gates Foundation	Academic/Hospital	2	0	2	2013
Cairo University	Academic/Hospital	2	2	1	2023
University of British Columbia	Academic/Hospital	2	1	2	2013
Aga Khan University	Academic/Hospital	1	0	1	2013
Bright Future Pharmaceuticals Factory	For profit	1	1	1	2017
Chinese University of Hong Kong	Academic/Hospital	1	0	1	2017
Conselho Nacional de Desenvolvimento Científico e Tecnológico	Government	1	0	1	2011
Cornell University	Academic/Hospital	1	1	1	2004
Daga Memorial Women's Hospital, Nagpur, India	Academic/Hospital	1	0	1	2015
Federal University of Paraiba	Academic/Hospital	1	1	1	2021
FMUSP	Academic/Hospital	1	0	1	2021
Government Medical College, Nagpur	Academic/Hospital	1	0	1	2015
Government of Hong Kong	Government	1	1	1	2011
Government of Mozambique	Government	1	0	1	2013
Gynuity Health Projects	Academic/Hospital	1	1	1	2015
Immunomolecular Therapeutics, Inc.	For profit	1	1	1	2020
Instituto de Medicina Integral Professor Fernando Figueira	Academic/Hospital	1	1	1	2011
Isfahan University	Academic/Hospital	1	1	1	2011
Jawaharlal Nehru Medical College	Academic/Hospital	1	0	1	2013

30 organizations

Page 1 / 2

Marketing (35)

Organization	Org type	Relationship	Date
Abraxis	For profit	MKTG	Jun 3, 1986
Accord Research	For profit	MKTG	Oct 15, 1985
Athenex, Inc.	For profit	MKTG	—
Baxalta	For profit	MKTG	Jul 1, 1986
Baxter	For profit	MKTG	Jul 1, 1986
Chartwell Pharmaceuticals	For profit	MKTG	Jun 29, 1984
Chartwell Pharmaceuticals	For profit	NDA2	Jun 29, 1984
DAVA Pharmaceuticals	For profit	MKTG	Jun 2, 1989
Duramed Research	For profit	MKTG	Dec 16, 1986
Fosun	For profit	NDA2	Jun 29, 1984
Halsey	For profit	MKTG	—
Heritage Pharma	For profit	MKTG	Feb 20, 1986
Hospira	For profit	MKTG	Jun 15, 1987
Lutipold	For profit	MKTG	Dec 2, 1987
Marsam Pharmaceuticals	For profit	MKTG	Dec 22, 1987
Merck	For profit	NDA	Dec 20, 1962
Merck	For profit	NDA2	Dec 20, 1962
Mylan	For profit	MKTG	Apr 18, 1985
Par Pharmaceuticals	For profit	MKTG	Jan 2, 1987
Parke-Davis	For profit	MKTG	Apr 15, 1986
Pliva	For profit	MKTG	Jul 7, 1988
Puracap Pharmaceutical	For profit	MKTG	—
Rising Pharmaceuticals	For profit	MKTG	Jan 23, 1986
Rising Pharmaceuticals	For profit	MKTG	Apr 18, 1985
Roxane Laboratories	For profit	MKTG	—
Sandoz	For profit	MKTG	—
Sankyo	For profit	MKTG	Dec 2, 1987
Smith & Nephew	For profit	MKTG	—
Strides Pharma Science	For profit	MKTG	Jan 2, 1987
Sun Pharmaceuticals	For profit	MKTG	Oct 9, 1986
Superpharm	For profit	MKTG	—
Teva	For profit	MKTG	Apr 8, 1988
Teva	For profit	MKTG	Nov 22, 1991
Warner Lambert	For profit	MKTG	Apr 15, 1986
Watson Pharmaceuticals	For profit	MKTG	Jun 6, 1986