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Drug ReportsSertraline
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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Events Timeline
5D
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2Y
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FDA approval date
EMA approval date
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Study first post date
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Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Sertraline, Zoloft (discontinued: Sertraline, Zoloft)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sertraline hydrochloride
Tradename
Company
Number
Date
Products
SERTRALINE HYDROCHLORIDEAlmatica PharmaN-215133 RX2021-10-04
2 products, RLD
ZOLOFTViatrisN-019839 RX1991-12-30
3 products, RLD, RS
ZOLOFTViatrisN-020990 RX1999-12-07
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
sertralineANDA2025-08-05
sertraline hclANDA2024-05-16
sertraline hydrochlorideANDA2025-08-08
sertraline hydrochloride tabletsANDA2009-08-20
zoloftNew Drug Application2023-08-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
panic disorderEFO_0004262D016584F41.0
post-traumatic stress disordersEFO_0001358D013313F43.1
obsessive-compulsive disorderEFO_0004242D009771F42
depressive disorderEFO_1002014D003866F32.A
feeding and eating disorders—D001068F50
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
424 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5——1—6
Panic disorderD016584EFO_0004262F41.0———134
DepressionD003863—F33.9—1—124
Major depressive disorderD003865EFO_0003761F22—1—1—2
Depressive disorderD003866EFO_1002014F32.A—1—1—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Post-traumatic stress disordersD013313EFO_0001358F43.1——1—12
Traumatic stress disordersD040921————1—12
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obsessive-compulsive disorderD009771EFO_0004242F42————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSertraline
INNsertraline
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 classselective serotonin reuptake inhibitors (SSRI)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Identifiers
PDB—
CAS-ID79617-96-2
RxCUI—
ChEMBL IDCHEMBL809
ChEBI ID9123
PubChem CID68617
DrugBankDB01104
UNII IDQUC7NX6WMB (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
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Zoloft – Viatris
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Zoloft – Pfizer
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Tabular view
Estimated US medical usage
Sertraline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 25,777 documents
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Safety
Black-box Warning
Black-box warning for: Sertraline, Sertraline hcl, Sertraline hydrochloride, Sertraline hydrochloride tablets, Zoloft
Adverse Events
Top Adverse Reactions
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70,351 adverse events reported
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