Dutasteride
Avodart, Dutasteride, Jalyn (dutasteride) is a small molecule pharmaceutical. Dutasteride was first approved as Avodart on 2001-11-20. It is used to treat prostatic hyperplasia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Avodart (generic drugs available since 2010-12-21)
CombinationsJalyn (generic drugs available since 2010-12-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dutasteride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AVODART | Woodward Pharma Services | N-021319 RX | 2001-11-20 | 1 products, RLD, RS |
Dutasteride
+
Tamsulosin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JALYN | Woodward Pharma Services | N-022460 RX | 2010-06-14 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| avodart | New Drug Application | 2023-11-28 |
| dutasteride | ANDA | 2024-01-24 |
| dutasteride and tamsulosin hydrochloride | ANDA | 2023-11-15 |
| jalyn | New Drug Application | 2020-12-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| prostatic hyperplasia | EFO_0000284 | D011470 | N40 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
G: Genito urinary system and sex hormones
— G04: Urologicals
— G04C: Drugs used in benign prostatic hypertrophy
— G04CA: Alpha-adrenoreceptor antagonists, benign prostatic hypertrophy
— G04CA52: Tamsulosin and dutasteride
— G04CB: Testosterone-5-alpha reductase inhibitors for benign prostatic hypertrophy
— G04CB02: Dutasteride
HCPCS
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Clinical
Clinical Trials
134 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 | 15 | 1 | 9 | 13 | 20 | 58 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 17 | 5 | 4 | 10 | 36 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | 1 | 2 | 1 | 2 | — | 6 |
| Healthy volunteers/patients | — | — | — | 2 | 2 | 1 | 1 | — | 5 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 1 | 1 | 2 | 2 | 5 |
| Transsexualism | D014189 | — | F64.0 | — | — | 2 | 1 | — | 3 |
| Hiv | D006678 | — | O98.7 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alopecia | D000505 | HP_0002293 | L64 | 2 | 1 | 4 | — | 1 | 8 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | 1 | 1 | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | 1 | — | — | 1 |
| Drug therapy | D004358 | — | — | — | — | 1 | — | — | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Eunuchism | D005058 | EFO_0007266 | E29.1 | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 1 | 2 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | 1 | — | — | 1 | 2 |
| Contraception | D003267 | — | — | 1 | 2 | — | — | — | 2 |
| X-linked bulbo-spinal atrophy | D055534 | Orphanet_139557 | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 1 | — | — | — | 1 | 2 |
| Urologic diseases | D014570 | — | N39.9 | 2 | — | — | — | — | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | — | — | — | — | 1 |
| Premenstrual syndrome | D011293 | — | N94.3 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcohol-related disorders | D019973 | — | F10 | — | — | — | — | 2 | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | — | — | — | — | 1 | 1 |
| Suicide | D013405 | — | — | — | — | — | — | 1 | 1 |
| Urinary retention | D016055 | HP_0000016 | R33 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dutasteride |
| INN | dutasteride |
| Description | Dutasteride is an aza-steroid that is inasteride in which the tert-butyl group is replaced by a 2,5-bis(trifluoromethyl)phenyl group. A synthetic 4-azasteroid, dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5alpha-reductase, an intracellular enzyme that converts testosterone to 5alpha-dihydrotestosterone. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate gland. It has a role as an EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor and an antihyperplasia drug. It is an aza-steroid, a member of (trifluoromethyl)benzenes and a delta-lactam. It derives from a hydride of a 5alpha-androstane. |
| Classification | Small molecule |
| Drug class | steroids (androgens, anabolics); testosterone reductase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12CC[C@H]3[C@@H](CC[C@H]4NC(=O)C=C[C@]34C)[C@@H]1CC[C@@H]2C(=O)Nc1cc(C(F)(F)F)ccc1C(F)(F)F |
Identifiers
| PDB | — |
| CAS-ID | 164656-23-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200969 |
| ChEBI ID | 521033 |
| PubChem CID | 6918296 |
| DrugBank | DB01126 |
| UNII ID | O0J6XJN02I (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Dutasteride
Total medical expenditures per year (USD, in millions)
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Dutasteride
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Tamsulosin
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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9,370 adverse events reported
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