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 2A and 5-hydroxytryptamine receptor 1A.
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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 |
|---|---|---|---|---|
| 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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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
HTR2A
HTR2A
HTR1A
HTR1A
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
Protein name
5-hydroxytryptamine receptor 2A
Protein synonyms
5-HT2 receptor, 5-hydroxytryptamine (serotonin) receptor 2A, G protein-coupled, serotonin 5-HT-2A receptor, Serotonin receptor 2A
Uniprot ID
Mouse ortholog
Htr2a (15558)
5-hydroxytryptamine receptor 2A (P35363)
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 1,679 documents
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Safety
Black-box Warning
Black-box warning for: Addyi
Adverse Events
Top Adverse Reactions
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11,378 adverse events reported
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