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Flibanserin
Addyi (flibanserin) is a small molecule pharmaceutical. Flibanserin was first approved as Addyi on 2015-08-18. The pharmaceutical is active against 5-hydroxytryptamine receptor 1A and 5-hydroxytryptamine receptor 2A.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Addyi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Flibanserin
Tradename
Company
Number
Date
Products
ADDYISprout PharmaceuticalsN-022526 RX2015-08-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
addyiNew Drug Application2019-10-10
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Flibanserin, Addyi, Sprout Pharms
71511032028-05-09U-1734
82274712023-05-09U-1734
ATC Codes
G: Genito urinary system and sex hormones
G02: Other gynecologicals in atc
G02C: Other gynecologicals in atc
G02CX: Other gynecologicals in atc
G02CX02: Flibanserin
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic hyperplasiaD011470EFO_0000284N402273115
AlopeciaD000505HP_0002293L64535112
Prostatic neoplasmsD011471C613137
Sleep apnea syndromesD012891EFO_0003877G47.311
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PolycythemiaD011086EFO_0005804D75.111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients10111
Retinal diseasesD012164HP_0000479H35.9233
HypogonadismD007006E23.0112
Wounds and injuriesD014947T14.811
Spinal cord injuriesD013119EFO_100191911
Endocrine system diseasesD004700EFO_0001379E34.911
Gonadal disordersD00605811
Central nervous system diseasesD002493HP_0002011G96.911
Nervous system diseasesD009422G00-G9911
Spinal cord diseasesD013118HP_0002196G95.911
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD00326711
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD00023011
Urologic diseasesD014570N39.911
Lower urinary tract symptomsD059411EFO_000800811
Prostatic diseasesD011469N42.911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLIBANSERIN
INNflibanserin
Description
Flibanserin is an N-alkylpiperazine that is 1-[2-(1,3-dihydro-2-oxobenzimidazol-1-yl)ethyl]piperazine in which the remaining amino proton is replaced by a 3-(trifluoromethyl)phenyl group. A multifunctional serotonin agonist and antagonist which is used for the treatment of pre-menopausal women with hypoactive sexual desire disorder. It has a role as a serotonergic agonist, a serotonergic antagonist and an antidepressant. It is a member of benzimidazoles, a N-arylpiperazine, a N-alkylpiperazine and an organofluorine compound.
Classification
Small molecule
Drug classserotonin 5-HT2 receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1
Identifiers
PDB
CAS-ID167933-07-5
RxCUI1665509
ChEMBL IDCHEMBL231068
ChEBI ID
PubChem CID6918248
DrugBankDB04908
UNII ID37JK4STR6Z (ChemIDplus, GSRS)
Target
Agency Approved
HTR1A
HTR1A
HTR2A
HTR2A
Organism
Homo sapiens
Gene name
HTR1A
Gene synonyms
ADRB2RL1, ADRBRL1
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 1A
Protein synonyms
5-HT1a receptor, 5-hydroxytryptamine (serotonin) receptor 1A, G protein-coupled, G-21, guanine nucleotide-binding regulatory protein-coupled receptor, Serotonin receptor 1A
Uniprot ID
Mouse ortholog
Htr1a (15550)
5-hydroxytryptamine receptor 1A (Q8BGS4)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,692 documents
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Safety
Black-box Warning
Black-box warning for: Addyi
Adverse Events
Top Adverse Reactions
Mock data
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11,273 adverse events reported
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