> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/dutasteride-306d3291-8d9c-4df3-9ccc-cd0d00c59c92
> Record changed: 2026-10-13

# Dutasteride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

First approval year

2001

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

## Development status

**First approval year**

2001

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**Drug name**

Dutasteride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**Molecular weight**

528.54

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

### Brand names (6)

- avodart
- Avodart
- dutasteride
- Dutasteride
- dutasteride component of jalyn
- Dutasteride component of jalyn

### Other names (63)

- .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.

## Identifiers

**ATC classification codes**

- G04CB02

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**CAS registry numbers**

- 164656-23-9

**ChEMBL ID**

CHEMBL1200969

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**InChIKey**

JWJOTENAMICLJG-QWBYCMEYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200969)

**PubChem compound IDs**

- 6918296

**RxNorm IDs (RxCUI)**

- 228790

**FDA ingredient codes (UNII)**

- O0J6XJN02I

## Regulatory information

### United States

**Applicant**

WAYLIS THERAP

**Approval date**

14 Jun 2010

**Application number**

NDA022460

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

dutasteride

**Type**

Synthetic organic

**Drug name stem**

\-ster-; -steride

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (3)

- **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

### DrugCentral mechanisms (2)

- **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

### Investigated indications (12)

- **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

### Open Targets indications (28)

- **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.

### Reported adverse events (37)

- **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.

### Trial references (65)

- NCT00056407  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00056407)
- NCT00298155  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00298155)
- NCT00363311  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00363311)
- NCT00470834  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00470834)
- NCT00558363  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00558363)
- NCT00062790  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00062790)
- NCT00090103  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00090103)
- NCT00368979  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00368979)
- NCT00375765  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00375765)
- NCT00421421  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00421421)
- NCT00431626  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00431626)
- NCT00527605  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00527605)
- NCT00690950  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00690950)
- NCT00827814  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00827814)
- NCT00880672  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00880672)
- NCT00939120  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00939120)
- NCT01254071  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01254071)
- NCT01294592  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01294592)
- NCT01471678  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01471678)
- NCT01495026  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01495026)
- NCT01577693  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01577693)
- NCT01657851  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01657851)
- NCT01673490  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01673490)
- NCT01777269  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01777269)
- NCT01942551  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01942551)

And 40 more, listed on the interactive page.

## Dosing

**Dose**

0.5mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (2)

- Swallow capsule whole
- Take after the same meal each day

## Chemical properties

**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

## National Drug Codes

- 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

## Evidence counts

**Recorded assays**

234

**Active assays**

13

### Active assay types (2)

- Confirmatory
- Summary

## Pharmacologic actions

- 5-alpha Reductase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D058891.html)

## Biological measurements

### Observed measurements

#### 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](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md)
- [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md)

### In development for (8)

- [Alopecia](https://trialight.com/data/condition/alopecia-bb72324d-7d2e-5ac9-962f-2cdc0cf3ca73.md) Phase 3
- [Amyotrophic lateral sclerosis](https://trialight.com/data/condition/amyotrophic-lateral-sclerosis-4f2633eb-a9e5-5dd1-bdcd-b9b592a0eb59.md) Phase 2
- [Androgenetic alopecia](https://trialight.com/data/condition/androgenetic-alopecia-8971c9fa-6fd1-50f4-96d4-6f14f6edcec4.md) Phase 3
- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 2
- Hypogonadism Phase 3
- Kennedy disease Phase 2
- [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Phase 3
- Prostatitis Phase 2

### Other linked conditions (2)

- [Alcohol abuse](https://trialight.com/data/condition/alcohol-abuse-de2eaa0d-f882-51b6-befd-e62533fe8ee1.md)
- [Prostate neoplasm](https://trialight.com/data/condition/prostate-neoplasm-28a8a0a9-1d2f-5539-80c9-7eb822c444fc.md)

### Targets (3)

- [SRD5A1](https://trialight.com/data/target/srd5a1-05c22107-0f3b-54ef-86d2-0212faac6d02.md) Steroid 5-alpha-reductase inhibitor
- [SRD5A2](https://trialight.com/data/target/srd5a2-6094932b-07bd-507e-80fe-6205004a84e6.md) Steroid 5-alpha-reductase inhibitor
- [SRD5A3](https://trialight.com/data/target/srd5a3-8798a5ea-9f31-5f8f-98d1-5852efcce00c.md) Steroid 5-alpha-reductase inhibitor

---

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