Duavee, Conbriza(bazedoxifene)
Conbriza, Duavee, Duavive (bazedoxifene) is a small molecule pharmaceutical. Bazedoxifene was first approved as Conbriza on 2009-04-17. It is used to treat menopause in the USA. It has been approved in Europe to treat postmenopausal osteoporosis and postmenopause. The pharmaceutical is active against estrogen receptor beta and estrogen receptor.
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Commercial
Trade Name
FDA
EMA
Combinations
Duavee
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bazedoxifene acetate
+
Estrogens
+
conjugated
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUAVEE | WYETH PHARMS | N-022247 RX | 2013-10-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| duavee | New Drug Application | 2022-12-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| menopause | EFO_0003922 | D008593 | N95 |
Agency Specific
FDA
EMA
No data
ATC Codes
G: Genito urinary system and sex hormones
— G03: Sex hormones and modulators of the genital system
— G03C: Estrogens, sex hormones and modulators of the genital system
— G03CC: Estrogens, combinations with other drugs
— G03CC07: Conjugated estrogens and bazedoxifene
— G03X: Other sex hormones and modulators of the genital system in atc
— G03XC: Selective estrogen receptor modulators
— G03XC02: Bazedoxifene
HCPCS
No data
Clinical
Clinical Trials
44 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 1 | — | 1 | 1 | 3 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | 1 | — | 2 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | 1 | — | 1 |
| Psychotic disorders | D011618 | F20.81 | — | — | — | 1 | — | 1 | |
| Depression | D003863 | F33.9 | — | — | — | 1 | — | 1 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | 1 | — | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 2 | — | 6 | — | 2 | 10 |
| Postmenopause | D017698 | 4 | — | 2 | — | 1 | 7 | ||
| Menopause | D008593 | EFO_0003922 | N95 | 3 | 1 | 1 | — | — | 5 |
| Endometrial hyperplasia | D004714 | N85.0 | — | — | 2 | — | — | 2 | |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | 1 | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | — | — | 1 | |
| Hot flashes | D019584 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 5 |
| Risk reduction behavior | D040242 | — | 1 | — | — | — | 1 | ||
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | — | — | — | 1 | |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | — | — | — | 1 | |
| Ductal carcinoma breast | D018270 | — | 1 | — | — | — | 1 | ||
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Sleep | D012890 | GO_0030431 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | BAZEDOXIFENE |
| INN | bazedoxifene |
| Description | Bazedoxifene is a phenylindole. |
| Classification | Small molecule |
| Drug class | antiestrogens of the clomifene and tamoxifen groups |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | Cc1c(-c2ccc(O)cc2)n(Cc2ccc(OCCN3CCCCCC3)cc2)c2ccc(O)cc12 |
Identifiers
| PDB | 4XI3 |
| CAS-ID | 198481-32-2 |
| RxCUI | 1441386 |
| ChEMBL ID | CHEMBL46740 |
| ChEBI ID | — |
| PubChem CID | 154257 |
| DrugBank | DB06401 |
| UNII ID | Q16TT9C5BK (ChemIDplus, GSRS) |
Target
Agency Approved
ESR2
ESR2
ESR1
ESR1
Organism
Homo sapiens
Gene name
ESR2
Gene synonyms
ESTRB, NR3A2
NCBI Gene ID
Protein name
estrogen receptor beta
Protein synonyms
estrogen receptor beta 2, estrogen receptor beta 4, Nuclear receptor subfamily 3 group A member 2, oestrogen receptor beta
Uniprot ID
Mouse ortholog
Esr2 (13983)
estrogen receptor beta (O08537)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Duavee
Adverse Events
Top Adverse Reactions
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6,198 adverse events reported
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