Dutasteride
Avodart, 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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| avodart | New Drug Application | 2022-12-15 |
| dutasteride | ANDA | 2023-05-19 |
| 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
No data
Clinical
Clinical Trials
38 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Orthostatic hypotension | D007024 | I95.1 | 2 | 3 | 6 | 4 | 1 | 15 | |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | 5 | 2 | 4 | 1 | 13 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | 1 | — | 1 | — | 3 |
| Spinal cord injuries | D013119 | EFO_1001919 | 1 | — | — | 1 | — | 2 | |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 1 | — | 1 |
| Parkinsonian disorders | D020734 | HP_0001300 | — | — | — | 1 | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postural orthostatic tachycardia syndrome | D054972 | G90.A | 1 | 2 | — | — | — | 2 | |
| Neurologic gait disorders | D020233 | R26.1 | 1 | 1 | — | — | — | 1 | |
| Hereditary sensory and autonomic neuropathies | D009477 | — | 1 | — | — | — | 1 | ||
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | — | — | — | 1 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | — | 1 |
| Progressive supranuclear palsy | D013494 | EFO_0002512 | G23.1 | — | 1 | — | — | — | 1 |
| Vasovagal syncope | D019462 | R55 | — | 1 | — | — | — | 1 | |
| Syncope | D013575 | HP_0001279 | G90.01 | — | 1 | — | — | — | 1 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | 1 | — | — | — | 1 |
| Menkes kinky hair syndrome | D007706 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Retinal diseases | D012164 | HP_0000479 | H35.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Shy-drager syndrome | D012791 | EFO_1001050 | — | — | — | — | 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 | 228790 |
| ChEMBL ID | CHEMBL1200969 |
| ChEBI ID | 521033 |
| PubChem CID | 6918296 |
| DrugBank | DB01126 |
| UNII ID | O0J6XJN02I (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18,996 adverse events reported
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