Methyldopa - PharmaKB

Methyldopa

Aldoclor, Aldoril, Methyldopa (methyldopa) is a small molecule pharmaceutical. Methyldopa was first approved as Aldoclor-150 on 1982-01-01. It is used to treat hypertension in the USA. It is known to target aromatic-L-amino-acid decarboxylase.

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EMA approval date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
cardiovascular diseases	D002318

Trade Name

FDA

EMA

Methyldopa (discontinued: Aldomet, Methyldopa)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Chlorothiazide

Methyldopa

Tradename	Company	Number	Date	Products
ALDOCLOR-150	Merck & Co	N-016016 DISCN	1982-01-01	1 products
ALDOCLOR-250	Merck & Co	N-016016 DISCN	1982-01-01	1 products

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Methyldopa

Tradename	Company	Number	Date	Products
METHYLDOPA	Chartwell Pharmaceuticals	N-018934 DISCN	1984-06-29	2 products
ALDOMET	Merck & Co	N-013400 DISCN	1982-01-01	3 products, RLD
ALDOMET	Merck & Co	N-018389 DISCN	1982-01-01	1 products

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Hydrochlorothiazide

Methyldopa

Tradename	Company	Number	Date	Products
ALDORIL 15	Merck & Co	N-013402 DISCN	1982-01-01	1 products
ALDORIL 25	Merck & Co	N-013402 DISCN	1982-01-01	1 products
ALDORIL D30	Merck & Co	N-013402 DISCN	1982-01-01	1 products
ALDORIL D50	Merck & Co	N-013402 DISCN	1982-01-01	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
methyldopa	ANDA	2025-03-28

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hypertension	EFO_0000537	D006973	I10
heart failure	EFO_0003144	D006333	I50
nephrotic syndrome	EFO_0004255	D009404	N04
edema	—	D004487	R60.9
glomerulonephritis	—	D005921	N05
liver cirrhosis	EFO_0001422	D008103	K74.0

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

C: Cardiovascular system drugs

— C02: Antihypertensives

— C02A: Antiadrenergic agents, centrally acting

— C02AB: Methyldopa, centrally acting adntiadrenergic agents

— C02AB01: Methyldopa (levorotatory)

— C02AB02: Methyldopa (racemic)

— C02L: Antihypertensives and diuretics in combination

— C02LB: Methyldopa and diuretics in combination

— C02LB01: Methyldopa (levorotatory) and diuretics

HCPCS

Code	Description
J0210	Injection, methyldopate hcl, up to 250 mg

Clinical

Clinical Trials

100 clinical trials

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Indications Phases 4

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Indications Phases 3

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Parkinson disease	D010300	EFO_0002508	G20	2	2	—	—	—	4
Central nervous system diseases	D002493	—	G96.9	—	2	—	—	—	2
Brain diseases	D001927	—	G93.40	—	2	—	—	—	2
Movement disorders	D009069	EFO_0004280	G25	—	2	—	—	—	2
Neurodegenerative diseases	D019636	EFO_0005772	G31.9	—	2	—	—	—	2
Nervous system diseases	D009422	—	G00-G99	—	1	—	—	—	1

Indications Phases 1

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Indications Without Phase

No data

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Methyldopa
INN	methyldopa
Description	Alpha-methyl-L-dopa is a derivative of L-tyrosine having a methyl group at the alpha-position and an additional hydroxy group at the 3-position on the phenyl ring. It has a role as a hapten, an antihypertensive agent, an alpha-adrenergic agonist, a peripheral nervous system drug and a sympatholytic agent. It is a L-tyrosine derivative and a non-proteinogenic L-alpha-amino acid.
Classification	Small molecule
Drug class	dopamine receptor agonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	C[C@](N)(Cc1ccc(O)c(O)c1)C(=O)O

Identifiers

PDB	—
CAS-ID	555-30-6
RxCUI	—
ChEMBL ID	CHEMBL459
ChEBI ID	61058
PubChem CID	38853
DrugBank	DB00968
UNII ID	M4R0H12F6M (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

DDC

Organism

Homo sapiens

Gene name

DDC

Gene synonyms

AADC

NCBI Gene ID

1644

Protein name

aromatic-L-amino-acid decarboxylase

Protein synonyms

DDC, DOPA decarboxylase, dopa decarboxylase (aromatic L-amino acid decarboxylase)

Uniprot ID

Q75MJ6

Mouse ortholog

Ddc (13195)

aromatic-L-amino-acid decarboxylase (O88533)

Variants

No data

Financial

Revenue by drug

€

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Estimated US medical usage

Methyldopa

Chlorothiazide

Total medical expenditures per year (USD, in millions)

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Methyldopa

Hydrochlorothiazide

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Methyldopa

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Trends

PubMed Central

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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3,522 adverse events reported

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