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

Brand Name	Status	Last Update
sertraline hydrochloride	ANDA	2023-06-16
zoloft	New Drug Application	2021-10-29

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

268 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	3	13	18	28	20	76
Major depressive disorder	D003865	EFO_0003761	F22	5	13	8	12	8	43
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	1	5	7	12	3	26
Healthy volunteers/patients	—			13	—	—	2	2	17
Anxiety disorders	D001008	EFO_0006788	F41.1	—	2	2	5	4	13
Obsessive-compulsive disorder	D009771	EFO_0004242	F42	—	2	2	4	3	10
Alcoholism	D000437	EFO_0003829	F10.1	1	6	—	3	—	10
Depressive disorder	D003866	EFO_1002014	F32.A	—	1	2	1	5	9
Bipolar disorder	D001714	EFO_0000289	F30.9	1	2	4	1	2	9
Panic disorder	D016584	EFO_0004262	F41.0	—	1	1	4	3	8

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Treatment-resistant depressive disorder	D061218			—	1	7	—	1	9
Schizophrenia	D012559	EFO_0000692	F20	—	—	1	—	2	3
Mood disorders	D019964	EFO_0004247	F30-F39	—	1	2	—	—	2
Cardiovascular diseases	D002318	EFO_0000319	I98	—	—	1	—	1	2
Traumatic brain injuries	D000070642		S06	—	1	1	—	1	2
Neoplasms	D009369		C80	—	—	1	—	1	2
Heart failure	D006333	EFO_0003144	I50	—	1	1	—	1	2
Intellectual disability	D008607		F73	—	1	1	—	—	2
Stereotyped behavior	D013239	HP_0000733		—	1	1	—	—	2
Heart diseases	D006331	EFO_0003777	I51.9	—	—	2	—	—	2

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Substance-related disorders	D019966	EFO_0003890	F13	—	2	—	—	1	3
Autism spectrum disorder	D000067877		F84.0	—	2	—	—	—	2
Parkinson disease	D010300	EFO_0002508	G20	1	1	—	—	1	2
Acute coronary syndrome	D054058	EFO_0005672		2	1	—	—	—	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
Coccidioidomycosis	D003047	EFO_0007211	B38	—	1	—	—	—	1
Fragile x syndrome	D005600		Q99.2	—	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		G10	1	—	—	—	—	1
Myeloid leukemia acute	D015470		C92.0	1	—	—	—	—	1
Myelodysplastic syndromes	D009190		D46	1	—	—	—	—	1
Obesity	D009765	EFO_0001073	E66.9	1	—	—	—	—	1
Machiavellianism	D008257			1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cognitive dysfunction	D060825		G31.84	—	—	—	—	3	3
Separation anxiety	D001010	EFO_1001916		—	—	—	—	2	2
Hot flashes	D019584			—	—	—	—	2	2
Psychotic disorders	D011618		F20.81	—	—	—	—	2	2
Pharmacokinetics	D010599			—	—	—	—	1	1
Inflammation	D007249			—	—	—	—	1	1
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	—	—	—	—	1	1
Interstitial lung diseases	D017563	EFO_0004244	J84.89	—	—	—	—	1	1
Wounds and injuries	D014947		T14.8	—	—	—	—	1	1
Pain	D010146	EFO_0003843	R52	—	—	—	—	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

Identifiers

PDB	6F6N
CAS-ID	79617-96-2
RxCUI	36437
ChEMBL ID	CHEMBL809
ChEBI ID	9123
PubChem CID	68617
DrugBank	DB01104
UNII ID	QUC7NX6WMB (ChemIDplus, GSRS)

Target

Agency Approved

SLC6A4

Organism

Homo sapiens

Gene name

SLC6A4

Gene synonyms

HTT, SERT

NCBI Gene ID

6532

Protein name

sodium-dependent serotonin transporter

Protein synonyms

5-hydroxytryptamine (serotonin) transporter, 5HT transporter, 5HTT, Na+/Cl- dependent serotonin transporter, serotonin transporter 1, solute carrier family 6 (neurotransmitter transporter), member 4, solute carrier family 6 (neurotransmitter transporter, serotonin), member 4, Solute carrier family 6 member 4

Uniprot ID

Q5EE02

Mouse ortholog

Slc6a4 (15567)

sodium-dependent serotonin transporter (Q60857)

Alternate

No data

Variants

Clinical Variant

Identifier	Target mutation	Effect	Evaluation	Status
VCV000638805	CYP2C19, Gly91Arg	drug response	2019-06-17	P
VCV000638804	CYP2C19, His78Tyr	drug response	2019-06-17	P
VCV000638803	CYP2C19, Arg73Cys	drug response	2019-06-17	P
VCV000638802	CYP2C19, Arg442Cys	drug response	2019-06-17	P
VCV000638801	CYP2C19, Ser51Gly	drug response	2019-06-17	P
VCV000638800	CYP2C19, Asp256Asn	drug response	2019-06-17	P
VCV000638799	CYP2C19, Ile19Leu	drug response	2019-06-17	P
VCV000638798	CYP2C19, Lys399=, Arg335Gln	drug response	2019-06-17	P
VCV000638797	CYP2C19, Pro227=	drug response	2019-06-17	P
VCV000638796	CYP2C19, Arg410Cys	drug response	2019-06-17	P

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Financial

Zoloft - Viatris

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Zoloft - Pfizer

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Trends

PubMed Central

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Additional graphs summarizing 20,689 documents

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Safety

Black-box Warning

Black-box warning for: Sertraline hydrochloride, Zoloft

Adverse Events

Top Adverse Reactions

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9,110 adverse events reported

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MATERIALS

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