Sertraline - PharmaKB

Sertraline

Sertraline, Zoloft (sertraline) is a small molecule pharmaceutical. Sertraline was first approved as Zoloft on 1991-12-30. It is used to treat depressive disorder, feeding and eating disorders, obsessive-compulsive disorder, panic disorder, and post-traumatic stress disorders in the USA. The pharmaceutical is active against sodium-dependent serotonin transporter.

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Therapeutic Areas

Therapeutic Area	MeSH
mental disorders	D001523

Trade Name

FDA

EMA

Zoloft (generic drugs available since 2006-06-30)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Sertraline hydrochloride

Tradename	Company	Number	Date	Products
SERTRALINE HYDROCHLORIDE	Almatica Pharma	N-215133 RX	2021-10-04	2 products, RLD, RS
ZOLOFT	Viatris	N-019839 RX	1991-12-30	3 products, RLD, RS
ZOLOFT	Viatris	N-020990 RX	1999-12-07	1 products, RLD, RS

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Labels

FDA

EMA

No data

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
depressive disorder	EFO_1002014	D003866	F32.A
feeding and eating disorders	—	D001068	F50
obsessive-compulsive disorder	EFO_0004242	D009771	F42
panic disorder	EFO_0004262	D016584	F41.0
post-traumatic stress disorders	EFO_0001358	D013313	F43.1

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

N: Nervous system drugs

— N06: Psychoanaleptics

— N06A: Antidepressants

— N06AB: Selective serotonin reuptake inhibitors

— N06AB06: Sertraline

HCPCS

No data

Clinical

Clinical Trials

402 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Depression	D003863	—	F33.9	5	19	20	32	38	106
Major depressive disorder	D003865	EFO_0003761	F22	7	20	18	22	22	86
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	4	5	8	13	5	33
Anxiety disorders	D001008	EFO_0006788	F41.1	1	3	2	5	7	18
Obsessive-compulsive disorder	D009771	EFO_0004242	F42	—	2	3	7	7	18
Healthy volunteers/patients	—	—	—	14	—	—	2	2	18
Depressive disorder	D003866	EFO_1002014	F32.A	1	2	2	2	6	13
Treatment-resistant depressive disorder	D061218	—	—	—	1	7	1	1	10
Bipolar disorder	D001714	EFO_0000289	F30.9	1	2	4	2	2	10
Alcoholism	D000437	EFO_0003829	F10.1	1	6	—	3	—	10

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Heart failure	D006333	HP_0001635	I50	—	1	1	—	3	4
Separation anxiety	D001010	EFO_1001916	—	—	1	1	—	2	4
Sleep initiation and maintenance disorders	D007319	—	F51.01	—	1	2	—	1	3
Mood disorders	D019964	EFO_0004247	F30-F39	—	1	2	—	1	3
Schizophrenia	D012559	EFO_0000692	F20	—	—	1	—	2	3
Cardiovascular diseases	D002318	HP_0001626	—	—	1	1	—	1	3
Heart diseases	D006331	EFO_0003777	I51.9	—	1	2	—	—	3
Neoplasms	D009369	—	C80	—	—	1	—	2	3
Low back pain	D017116	HP_0003419	M54.5	—	1	1	—	1	2
Obesity	D009765	EFO_0001073	E66.9	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
Autism spectrum disorder	D000067877	HP_0000729	F84.0	—	3	—	—	—	3
Substance-related disorders	D019966	EFO_0003890	F13	—	2	—	—	1	3
Acute coronary syndrome	D054058	EFO_0005672	—	2	1	—	—	1	3
Parkinson disease	D010300	EFO_0002508	G20	1	1	—	—	1	2
Fragile x syndrome	D005600	—	Q99.2	—	2	—	—	—	2
Cocaine-related disorders	D019970	—	F14	—	2	—	—	—	2
Glioblastoma	D005909	EFO_0000515	—	1	1	—	—	—	1
Tachycardia	D013610	HP_0001649	R00.0	1	1	—	—	—	1
Orthostatic intolerance	D054971	—	—	1	1	—	—	—	1
Prediabetic state	D011236	EFO_1001121	R73.03	—	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Huntington disease	D006816	Orphanet_399	G10	1	—	—	—	—	1
Myeloid leukemia acute	D015470	—	C92.0	1	—	—	—	—	1
Myelodysplastic syndromes	D009190	—	D46	1	—	—	—	—	1
Machiavellianism	D008257	—	—	1	—	—	—	—	1
Respiratory insufficiency	D012131	HP_0002093	J96.9	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	—	—	—	—	4	4
Taste disorders	D013651	—	—	—	—	—	—	3	3
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	—	—	—	3	3
Psychotic disorders	D011618	—	F20.81	—	—	—	—	3	3
Suicidal ideation	D059020	EFO_0004320	R45.851	—	—	—	—	2	2
Hypoglycemia	D007003	HP_0001943	E16.2	—	—	—	—	2	2
Hot flashes	D019584	—	—	—	—	—	—	2	2
Hemorrhage	D006470	MP_0001914	R58	—	—	—	—	1	1
Covid-19	D000086382	—	U07.1	—	—	—	—	1	1
Menorrhagia	D008595	EFO_0003945	N92.0	—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Sertraline
INN	sertraline
Description	Sertraline is a member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder. It has a role as an antidepressant and a serotonin uptake inhibitor. It is a member of tetralins, a secondary amino compound and a dichlorobenzene. It is a conjugate base of a sertraline(1+). It derives from a hydride of a tetralin.
Classification	Small molecule
Drug class	selective serotonin reuptake inhibitors (SSRI)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21