Midodrine - PharmaKB

Midodrine

Midodrine, Orvaten (midodrine) is a small molecule pharmaceutical. Midodrine was first approved as Proamatine on 1996-09-06. It is used to treat orthostatic hypotension and urinary incontinence in the USA.

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Events Timeline

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Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

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Completion date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422
urogenital diseases	D000091642
cardiovascular diseases	D002318
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Midodrine, Orvaten (discontinued: Midodrine, Proamatine)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Midodrine hydrochloride

Tradename	Company	Number	Date	Products
PROAMATINE	Takeda	N-019815 DISCN	1996-09-06	3 products, RLD

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FDA

EMA

Brand Name	Status	Last Update
midodrine hydrochloride	ANDA	2024-12-26
midodrine hcl	ANDA	2024-05-21
midodrine hydrochloride	ANDA	2024-12-17
proamatine	New Drug Application	2010-05-26

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
orthostatic hypotension	—	D007024	I95.1
urinary incontinence	HP_0000020	D014549	R32

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

C: Cardiovascular system drugs

— C01: Cardiac therapy drugs

— C01C: Cardiac stimulants excl. cardiac glycosides

— C01CA: Adrenergic and dopaminergic cardiac stimulants

— C01CA17: Midodrine

HCPCS

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Clinical

Clinical Trials

92 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypotension	D007022	EFO_0005251	I95	6	9	5	11	8	34
Orthostatic hypotension	D007024	—	I95.1	5	5	2	9	3	22
Fibrosis	D005355	—	—	—	4	2	1	12	17
Liver cirrhosis	D008103	EFO_0001422	K74.0	—	4	2	1	11	16
Ascites	D001201	HP_0001541	R18	—	2	3	1	9	13
Syndrome	D013577	—	—	1	2	1	2	3	8
Hepatorenal syndrome	D006530	—	K76.7	—	4	2	1	2	7
Shock	D012769	—	R57.1	—	1	2	4	—	7
Renal insufficiency	D051437	HP_0000083	N19	—	3	—	2	—	5
Septic shock	D012772	—	A48.3	—	—	2	3	—	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Spinal cord injuries	D013119	EFO_1001919	—	—	4	2	—	1	6
Orthostatic intolerance	D054971	—	—	1	1	1	—	3	5
Blood pressure	D001794	EFO_0004325	—	1	2	1	—	—	3
Liver diseases	D008107	HP_0002910	K70-K77	—	1	1	—	2	3
Autonomic dysreflexia	D020211	EFO_1001762	G90.4	—	2	1	—	—	2
Cerebrovascular circulation	D002560	—	—	—	2	1	—	—	2
Heart failure	D006333	HP_0001635	I50	1	2	1	—	—	2
Recurrence	D012008	—	—	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pure autonomic failure	D054970	—	—	5	1	—	—	1	6
Shy-drager syndrome	D012791	EFO_1001050	—	4	1	—	—	1	5
Multiple system atrophy	D019578	—	—	4	1	—	—	1	5
Acute kidney injury	D058186	HP_0001919	N17	—	1	—	—	3	4
Tachycardia	D013610	HP_0001649	R00.0	1	1	—	—	3	4
Ischemic stroke	D000083242	—	—	—	1	—	—	2	3
Stroke	D020521	EFO_0000712	I63.9	—	1	—	—	2	3
Wounds and injuries	D014947	—	T14.8	—	1	—	—	2	3
Hypertension	D006973	EFO_0000537	I10	—	1	—	—	—	1
Ischemia	D007511	EFO_0000556	—	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Parkinson disease	D010300	EFO_0002508	G20	2	—	—	—	1	3
Healthy volunteers/patients	—	—	—	3	—	—	—	—	3
Hepatopulmonary syndrome	D020065	EFO_1001346	K76.81	1	—	—	—	—	1
Toxemia	D014115	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
End stage liver disease	D058625	EFO_1001311	K72.1	—	—	—	—	3	3
Postural orthostatic tachycardia syndrome	D054972	—	G90.A	—	—	—	—	3	3
Liver failure	D017093	HP_0001399	K72.9	—	—	—	—	2	2
Acute-on-chronic liver failure	D065290	—	—	—	—	—	—	2	2
Parkinsonian disorders	D020734	HP_0001300	G20.C	—	—	—	—	1	1
Hydrothorax	D006876	—	J94.8	—	—	—	—	1	1
Only child	D009863	—	—	—	—	—	—	1	1
Spinal anesthesia	D000775	—	—	—	—	—	—	1	1
Portal hypertension	D006975	EFO_0000666	K76.6	—	—	—	—	1	1
Autonomic nervous system diseases	D001342	EFO_0009532	G90	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Midodrine
INN	midodrine
Description	Midodrine is an aromatic ether that is 1,4-dimethoxybenzene which is substituted at position 2 by a 2-(glycylamino)-1-hydroxyethyl group. A direct-acting sympathomimetic with selective alpha-adrenergic agonist activity, it is used (generally as its hydrochloride salt) as a peripheral vasoconstrictor in the treatment of certain hypotensive states. The main active moiety is its major metabolite, deglymidodrine. It has a role as a prodrug, an alpha-adrenergic agonist, a sympathomimetic agent and a vasoconstrictor agent. It is a secondary alcohol, an amino acid amide and an aromatic ether. It is functionally related to a glycinamide and a deglymidodrine. It is a conjugate base of a midodrine(1+).
Classification	Small molecule
Drug class	sympathomimetics
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc(OC)c(C(O)CNC(=O)CN)c1