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
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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 |
|---|---|---|---|---|
| ADDYI | Sprout Pharmaceuticals | N-022526 RX | 2015-08-18 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| addyi | New Drug Application | 2019-10-10 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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 hyperplasia | D011470 | EFO_0000284 | N40 | 2 | 2 | 7 | 3 | 1 | 15 |
| Alopecia | D000505 | HP_0002293 | L64 | 5 | 3 | 5 | 1 | — | 12 |
| Prostatic neoplasms | D011471 | C61 | — | 3 | — | 1 | 3 | 7 | |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycythemia | D011086 | EFO_0005804 | D75.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 10 | 1 | — | — | — | 11 | ||
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 2 | 3 | — | — | — | 3 |
| Hypogonadism | D007006 | E23.0 | 1 | 1 | — | — | — | 2 | |
| Wounds and injuries | D014947 | T14.8 | — | 1 | — | — | — | 1 | |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | — | — | — | 1 | |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 1 | — | — | — | 1 |
| Gonadal disorders | D006058 | — | 1 | — | — | — | 1 | ||
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | — | 1 | — | — | — | 1 |
| Nervous system diseases | D009422 | G00-G99 | — | 1 | — | — | — | 1 | |
| Spinal cord diseases | D013118 | HP_0002196 | G95.9 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Contraception | D003267 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | FLIBANSERIN |
| INN | flibanserin |
| 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 class | serotonin 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-ID | 167933-07-5 |
| RxCUI | 1665509 |
| ChEMBL ID | CHEMBL231068 |
| ChEBI ID | — |
| PubChem CID | 6918248 |
| DrugBank | DB04908 |
| UNII ID | 37JK4STR6Z (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:
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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
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11,273 adverse events reported
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