Dutasteride
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2001
- First approval year
- 2001
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Dutasteride
- Molecular weight
- 528.54
- Structure (SMILES)
- C[C@]12C=CC(=O)N[C@@H]1CC[C@@H]1[C@@H]2CC[C@]2(C)[C@@H](C(=O)Nc3cc(C(F)(F)F)ccc3C(F)(F)F)CC[C@@H]12
- avodart
- Avodart
- dutasteride
- Dutasteride
- dutasteride component of jalyn
- Dutasteride component of jalyn
- .ALPHA.,.ALPHA.,.ALPHA.,.ALPHA.',.ALPHA.',.ALPHA.'-HEXAFLUORO-3-OXO-4-AZA-5.ALPHA.-ANDROST-1-ENE-17.BETA.-CARBOXY-2',5'-XYLIDIDE
- (5.ALPHA.,17.BETA.)-N-(2,5-BIS(TRIFLUOROMETHYL)PHENYL)-3-OXO-4-AZAANDROST-1-ENE-17-CARBOXAMIDE
- 0 02mg dutasteride
- 0.02mg dutasteride
- 0.1mg dutasteride
- 0.5mg dutasteride
- 5 alpha 17 beta n 2 5 bis trifluoromethyl phenyl 3 oxo 4 azaandrost 1 ene 17 carboxamide
- alpha alpha alpha alpha alpha alpha hexafluoro 3 oxo 4 aza 5 alpha androst 1 ene 17 beta carboxy 2 5 xylidide
- avodart
- Avodart
- AVODART
- avolve
- Avolve
- Drug (Dutasteride) intervention first
- duastride
- Duastride
- dutasterida
- Dutasterida
- dutasteride
- Dutasteride
- Dutasteride (0.5mg)
- Dutasteride (Avodart)
- DUTASTERIDE [EP MONOGRAPH]
- dutasteride [INN]
- DUTASTERIDE [JAN]
And 38 more, listed on the interactive page.
- ATC classification codes
- G04CB02
Sources for recorded values
- CAS registry numbers
- 164656-23-9
- ChEMBL ID
- CHEMBL1200969
- InChIKey
- JWJOTENAMICLJG-QWBYCMEYSA-N
- PubChem compound IDs
- 6918296
- RxNorm IDs (RxCUI)
- 228790
- FDA ingredient codes (UNII)
- O0J6XJN02I
- Applicant
- WAYLIS THERAP
- Approval date
- 14 Jun 2010
- Application number
- NDA022460
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- Pharmacology name
- dutasteride
- Type
- Synthetic organic
- Drug name stem
- -ster-; -steride
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Mechanism
- Steroid 5-alpha-reductase inhibitor
- Action type
- Inhibitor
- Target
- Steroid 5-alpha-reductase
- Protein identifier
- P18405
- Mechanism
- Steroid 5-alpha-reductase inhibitor
- Action type
- Inhibitor
- Target
- Steroid 5-alpha-reductase
- Protein identifier
- P31213
- Mechanism
- Steroid 5-alpha-reductase inhibitor
- Action type
- Inhibitor
- Target
- Steroid 5-alpha-reductase
- Protein identifier
- Q9H8P0
Open Targets mechanisms
- Mechanism
- Steroid 5-alpha-reductase inhibitor
- Action type
- Inhibitor
- Target
- Steroid 5-alpha-reductase
- Action type
- Inhibitor
- Gene symbol
- SRD5A1
- Protein identifier
- P18405
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Inhibitor
- Gene symbol
- SRD5A2
- Protein identifier
- P31213
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Prostatic Hyperplasia
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000284
- Subject identifier
- D011470
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Prostatitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003830
- Subject identifier
- D011472
- Condition
- Alopecia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004191
- Subject identifier
- D000505
- Condition
- Aging
- Highest recorded phase
- 1
- Condition identifier
- EFO:0022597
- Subject identifier
- D000375
- Condition
- Hypogonadism
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0002146
- Subject identifier
- D007006
- Condition
- Alopecia
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004907
- Subject identifier
- D000505
- Condition
- Amyotrophic Lateral Sclerosis
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004976
- Subject identifier
- D000690
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
- Condition
- Bulbo-Spinal Atrophy, X-Linked
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0010735
- Subject identifier
- D055534
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition identifier
- EFO_0000284
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001663
- Condition identifier
- EFO_0003830
- Condition identifier
- EFO_0004191
- Condition identifier
- EFO_0008008
- Condition identifier
- EFO_0008008
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008587
- Highest recorded phase
- 3
- Condition identifier
- HP_0000016
- Condition identifier
- HP_0000027
- Highest recorded phase
- 2
- Condition identifier
- HP_0012743
- Condition identifier
- MONDO_0002046
- Condition identifier
- MONDO_0002046
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002146
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004907
- Condition identifier
- MONDO_0004907
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004976
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005159
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005339
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005362
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0008315
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0010735
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0010811
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0011438
- Condition identifier
- MONDO_0021259
And 3 more, listed on the interactive page.
- Event
- breast cancer
- Reports
- 26
- Reporting signal score
- 23.7746
- Event
- breast cancer male
- Reports
- 9
- Reporting signal score
- 37.2469
- Event
- breast enlargement
- Reports
- 15
- Reporting signal score
- 46.2667
- Event
- breast pain
- Reports
- 25
- Reporting signal score
- 58.1692
- Event
- breast tenderness
- Reports
- 21
- Reporting signal score
- 58.19
- Event
- bundle branch block left
- Reports
- 13
- Reporting signal score
- 24.1982
- Event
- cardiac failure
- Reports
- 35
- Reporting signal score
- 24.3003
- Event
- conjunctivitis allergic
- Reports
- 12
- Reporting signal score
- 39.4257
- Event
- dark circles under eyes
- Reports
- 7
- Reporting signal score
- 23.3562
- Event
- diarrhoea
- Reports
- 12
- Reporting signal score
- 37.781
- Event
- dihydrotestosterone increased
- Reports
- 5
- Reporting signal score
- 31.226
- Event
- disorganised speech
- Reports
- 10
- Reporting signal score
- 31.6787
- Event
- drug dispensed to wrong patient
- Reports
- 17
- Reporting signal score
- 72.1551
- Event
- dust allergy
- Reports
- 10
- Reporting signal score
- 42.2154
- Event
- dysuria
- Reports
- 24
- Reporting signal score
- 24.1006
- Event
- erectile dysfunction
- Reports
- 44
- Reporting signal score
- 86.2088
- Event
- foveal degeneration
- Reports
- 6
- Reporting signal score
- 38.5659
- Event
- gamma-glutamyltransferase increased
- Reports
- 29
- Reporting signal score
- 29.5105
- Event
- gynaecomastia
- Reports
- 58
- Reporting signal score
- 171.403
- Event
- hepatic function abnormal
- Reports
- 32
- Reporting signal score
- 28.884
- Event
- ischaemic cardiomyopathy
- Reports
- 12
- Reporting signal score
- 26.4235
- Event
- libido decreased
- Reports
- 14
- Reporting signal score
- 24.0227
- Event
- mite allergy
- Reports
- 10
- Reporting signal score
- 48.7624
- Event
- mycotic allergy
- Reports
- 10
- Reporting signal score
- 43.2073
- Event
- nausea
- Reports
- 25
- Reporting signal score
- 30.7773
And 12 more, listed on the interactive page.
- NCT00056407
- NCT00298155
- NCT00363311
- NCT00470834
- NCT00558363
- NCT00062790
- NCT00090103
- NCT00368979
- NCT00375765
- NCT00421421
- NCT00431626
- NCT00527605
- NCT00690950
- NCT00827814
- NCT00880672
- NCT00939120
- NCT01254071
- NCT01294592
- NCT01471678
- NCT01495026
- NCT01577693
- NCT01657851
- NCT01673490
- NCT01777269
- NCT01942551
And 40 more, listed on the interactive page.
- Dose
- 0.5mg
- Route
- Oral
- How often
- Once daily
- Swallow capsule whole
- Take after the same meal each day
- Hydrogen bond acceptors
- 2
- Hydrogen bond donors
- 2
- Polar surface area
- 58.2
- Calculated partition coefficient (ALogP)
- 6.58
- Calculated partition coefficient (XLogP)
- 5.4
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 2
- Rotatable bonds
- 2
- Heavy atoms
- 37
- Molecular formula
- C27H30F6N2O2
- Monoisotopic mass
- 528.22114718
- Natural product
- No
- 25000-011
- 31722-131
- 42806-549
- 59651-021
- 59651-063
- 64380-763
- 65162-750
- 68382-640
- 71205-039
- 71205-278
- 72865-140
- 80725-809
- 84091-100
- 50090-4010
- 50090-7305
- 50090-7852
- 63629-1222
- 63629-1223
- 63629-8207
- 68071-3732
- 68071-3757
- 68071-3857
- 68071-4821
- 70771-1356
- 72162-1296
- Recorded assays
- 234
- Active assays
- 13
- Confirmatory
- Summary
- 5-alpha Reductase Inhibitors
Oral bioavailability
- Median
- 60
- Mean
- 60
- Minimum
- 60
- Maximum
- 60
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (184)
- "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
- 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
- A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol
- A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade
- A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers
- A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
- A Bioequivalence Study of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) Versus Advil Dual Action Caplets (125 mg/250 mg) and Bioavailability Assessment of Advil Dual Action Liquid Filled Capsules (125 mg/250 mg) and Advil Liqui-Gels (200 mg) in Healthy Adult Subjects
- A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions
- A Clinical Study of Curcuvail® in Patients With Non-alcoholic Fatty Liver Disease
- A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500mg in Healthy Male Volunteers
- A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers
- A Clinical Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.5/1000 mg in Healthy Male Volunteers
- A Clinical Study to Observe the Effectiveness and Safety of IBI310, Bevacizumab Combined With Sintilimab in the Treatment of Advanced Hepatocellular Carcinoma
- A Clinical Trial Comparing Laser TURP With and Without Dutasteride.
- A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
- A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
- A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
- A Phase I/Ⅱ Human Study of HY0001a for Injection in Adult Participants With Advanced Solid Tumors
- A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes
- A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy
Approved for (3)
- Benign prostatic hyperplasia
- Prostate adenocarcinoma
- Prostate carcinoma
In development for (8)
- Alopecia Phase 3
- Amyotrophic lateral sclerosis Phase 2
- Androgenetic alopecia Phase 3
- COVID-19 Phase 2
- Hypogonadism Phase 3
- Kennedy disease Phase 2
- Prostate cancer Phase 3
- Prostatitis Phase 2