Venlafaxine - PharmaKB

Venlafaxine

Effexor, Venlafaxine (venlafaxine) is a small molecule pharmaceutical. Venlafaxine was first approved as Effexor on 1993-12-28. It is used to treat attention deficit disorder with hyperactivity, autistic disorder, chronic fatigue syndrome, depressive disorder, and obsessive-compulsive disorder amongst others in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter and sodium-dependent noradrenaline transporter.

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Therapeutic Areas

Therapeutic Area	MeSH
musculoskeletal diseases	D009140
nervous system diseases	D009422
signs and symptoms pathological conditions	D013568
psychological phenomena	D011579
mental disorders	D001523
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Effexor (generic drugs available since 2006-08-03)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Venlafaxine besylate

Tradename	Company	Number	Date	Products
VENLAFAXINE BESYLATE	Almatica Pharma	N-215429 RX	2022-06-29	1 products, RLD, RS

Venlafaxine hydrochloride

Tradename	Company	Number	Date	Products
VENLAFAXINE HYDROCHLORIDE	RVL Pharmaceuticals	N-022104 RX	2008-05-20	4 products, RLD
EFFEXOR XR	Upjohn	N-020699 RX	1997-10-20	3 products, RLD, RS

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Labels

FDA

EMA

No data

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
attention deficit disorder with hyperactivity	EFO_0003888	D001289	F90
autistic disorder	EFO_0003758	D001321	F84.0
chronic fatigue syndrome	EFO_0004540	D015673	G93.31
depressive disorder	EFO_1002014	D003866	F32.A
obsessive-compulsive disorder	EFO_0004242	D009771	F42
pain	EFO_0003843	D010146	R52

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Venlafaxine Besylate, Venlafaxine Besylate, Almatica
7776358	2028-05-16	DP
6717015	2023-03-27	DS, DP	U-451

ATC Codes

N: Nervous system drugs

— N06: Psychoanaleptics

— N06A: Antidepressants

— N06AX: Other antidepressants in atc

— N06AX16: Venlafaxine

HCPCS

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Clinical

Clinical Trials

257 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Major depressive disorder	D003865	EFO_0003761	F22	4	14	24	23	11	72
Depression	D003863	—	F33.9	3	11	10	27	18	65
Healthy volunteers/patients	—	—	—	14	—	1	1	1	17
Depressive disorder	D003866	EFO_1002014	F32.A	—	3	2	5	3	13
Anxiety disorders	D001008	EFO_0006788	F41.1	—	4	4	2	3	12
Treatment-resistant depressive disorder	D061218	—	—	—	—	7	1	1	9
Bipolar disorder	D001714	EFO_0000289	F30.9	—	1	1	4	1	7
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	—	—	4	3	7
Pain	D010146	EFO_0003843	R52	—	—	—	2	3	5
Anxiety	D001007	EFO_0005230	F41.1	—	—	1	2	2	5

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hot flashes	D019584	—	—	—	—	2	—	5	7
Breast neoplasms	D001943	EFO_0003869	C50	—	1	1	—	2	4
Mood disorders	D019964	EFO_0004247	F30-F39	—	—	1	—	2	3
Obsessive-compulsive disorder	D009771	EFO_0004242	F42	—	1	1	—	1	3
Mental disorders	D001523	EFO_0000677	F91.9	—	—	1	—	1	2
Cancer pain	D000072716	—	G89.3	—	1	1	—	1	2
Low back pain	D017116	HP_0003419	M54.5	—	1	1	—	1	2
Alcohol-related disorders	D019973	—	F10	—	1	1	—	1	2
Prostatic neoplasms	D011471	—	C61	—	1	1	—	—	2
Sleep initiation and maintenance disorders	D007319	—	F51.01	—	—	1	—	1	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Suicidal ideation	D059020	EFO_0004320	R45.851	—	1	—	—	1	2
Fibromyalgia	D005356	EFO_0005687	M79.1	1	1	—	—	—	1
Type 2 diabetes mellitus	D003924	EFO_0001360	E11	—	1	—	—	—	1
Prediabetic state	D011236	EFO_1001121	R73.03	—	1	—	—	—	1
Insulin resistance	D007333	HP_0000855	E88.819	—	1	—	—	—	1
Post-head injury coma	D020207	—	—	—	1	—	—	—	1
Neck pain	D019547	HP_0030833	M54.2	—	1	—	—	—	1
Cocaine-related disorders	D019970	—	F14	—	1	—	—	—	1
Marijuana abuse	D002189	EFO_0007191	F12	—	1	—	—	—	1
Laparoscopic cholecystectomy	D017081	—	—	1	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug interactions	D004347	—	—	1	—	—	—	1	2
Alzheimer disease	D000544	EFO_0000249	F03	1	—	—	—	1	2
Bariatric surgery	D050110	—	—	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug-related side effects and adverse reactions	D064420	—	T88.7	—	—	—	—	5	5
Neoplasms	D009369	—	C80	—	—	—	—	2	2
Intractable pain	D010148	—	—	—	—	—	—	1	1
Pharmacokinetics	D010599	—	—	—	—	—	—	1	1
Pregnancy	D011247	EFO_0002950	Z33.1	—	—	—	—	1	1
Inflammation	D007249	MP_0001845	—	—	—	—	—	1	1
Wounds and injuries	D014947	—	T14.8	—	—	—	—	1	1
Substance-related disorders	D019966	EFO_0003890	F13	—	—	—	—	1	1
Chronic disease	D002908	—	—	—	—	—	—	1	1
Brain injuries	D001930	—	S06.9	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Venlafaxine
INN	venlafaxine
Description	Venlafaxine is a tertiary amino compound that is N,N-dimethylethanamine substituted at position 1 by a 1-hydroxycyclohexyl and 4-methoxyphenyl group. It has a role as an antidepressant, a serotonin uptake inhibitor, an adrenergic uptake inhibitor, a dopamine uptake inhibitor, an analgesic, an environmental contaminant and a xenobiotic. It is a member of cyclohexanols, a tertiary alcohol, a tertiary amino compound and a monomethoxybenzene.
Classification	Small molecule
Drug class	antianxiety, antidepressant inhibitor of norepinephrine and dopamine re-uptake
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc(C(CN(C)C)C2(O)CCCCC2)cc1