Dutasteride
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Also known as AvodartAvolveDuastrideDutasteridaDutasteride component of jalynGG-745GI 198745GI-198745NSC-740477NSC-759880SID144205752DutasterideÊDutasterideÂ
Summary
Dutasteride (CHEMBL1200969) is an approved small-molecule EC 1.3.1.22 [3-oxo-5α-steroid 4-dehydrogenase (NADP+)] inhibitor (ATC G04CB02); indicated across 12 conditions including prostate carcinoma and benign prostatic hyperplasia.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- ATC class: G04CB02
- Indications: 12 conditions
- Clinical trials: 89
- Chemistry: 528.5 Da · C27H30F6N2O2
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1200969 |
| Name | Dutasteride |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 6918296 |
| ChEBI | CHEBI:521033 |
| ATC | G04CB02 |
| Molecular formula | C27H30F6N2O2 |
| Molecular weight | 528.5 |
| InChIKey | JWJOTENAMICLJG-QWBYCMEYSA-N |
SMILES: C[C@]12CC[C@H]3[C@H]([C@@H]1CC[C@@H]2C(=O)NC4=C(C=CC(=C4)C(F)(F)F)C(F)(F)F)CC[C@@H]5[C@@]3(C=CC(=O)N5)C
IUPAC name: (1S,3aS,3bS,5aR,9aR,9bS,11aS)-N-[2,5-bis(trifluoromethyl)phenyl]-9a,11a-dimethyl-7-oxo-1,2,3,3a,3b,4,5,5a,6,9b,10,11-dodecahydroindeno[5,4-f]quinoline-1-carboxamide
ChEBI definition: 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 5α-reductase, an intracellular enzyme that converts testosterone to 5α-dihydrotestosterone. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate gland.
Pharmacological roles (ChEBI): EC 1.3.1.22 [3-oxo-5α-steroid 4-dehydrogenase (NADP+)] inhibitor, antihyperplasia drug.
Also known as: Avodart, Avolve, Duastride, Dutasterida, Dutasteride, Dutasteride component of jalyn, GG-745, GI 198745, GI-198745, NSC-740477, NSC-759880, dutasteride
Patent coverage: 3,067 distinct patent families (11,156 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 11,154 (100%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
Broader ChEMBL bioactivity targets: 4 (assay-derived). Sample: 3-oxo-5-alpha-steroid 4-dehydrogenase 1, Keap1/Nrf2, Glycine receptor subunit alpha-1, Bile salt export pump.
Bioactivity
ChEMBL activities: 3 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):
| Target | pChembl | Type | Value | Unit | Activity ID |
|---|---|---|---|---|---|
| SRD5A1 | 8.4 | IC50 | 4 | nM | CHEMBL_ACT_19113986 |
| GLRA1 | 6.48 | EC50 | 330 | nM | CHEMBL_ACT_15241386 |
| KEAP1 | 5.55 | IC50 | 2810 | nM | CHEMBL_ACT_24992834 |
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
12 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| prostate carcinoma | 4 | MONDO:0005159 | EFO:0001663 |
| benign prostatic hyperplasia | 4 | MONDO:0010811 | EFO:0000284 |
| prostate adenocarcinoma | 4 | MONDO:0005082 | EFO:0000673 |
| androgenetic alopecia | 3 | MONDO:0005339 | EFO:0004191 |
| hypogonadism | 3 | MONDO:0002146 | MONDO:0002146 |
| alopecia | 3 | MONDO:0004907 | MONDO:0004907 |
| prostatitis | 2 | MONDO:0005280 | EFO:0003830 |
| severe acute respiratory syndrome | 2 | MONDO:0005091 | MONDO:0100096 |
| amyotrophic lateral sclerosis | 2 | MONDO:0004976 | MONDO:0004976 |
| Kennedy disease | 2 | MONDO:0010735 | MONDO:0010735 |
2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 89.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 19 |
| Not specified | 18 |
| PHASE4 | 16 |
| PHASE1 | 15 |
| PHASE3 | 13 |
| PHASE2/PHASE3 | 5 |
| PHASE1/PHASE2 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00062790 | PHASE4 | COMPLETED | Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels |
| NCT00194675 | PHASE4 | COMPLETED | TRADE-Testosterone Replacement and Dutasteride Effectiveness |
| NCT00363311 | PHASE4 | COMPLETED | Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men |
| NCT00375765 | PHASE4 | COMPLETED | Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer |
| NCT00421421 | PHASE4 | TERMINATED | Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter |
| NCT00470834 | PHASE4 | COMPLETED | Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy |
| NCT00493987 | PHASE4 | COMPLETED | The Role of 5-alpha Reductase in Mediating Testosterone Actions |
| NCT00690950 | PHASE4 | UNKNOWN | A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart |
| NCT00752869 | PHASE4 | COMPLETED | Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement |
| NCT00805701 | PHASE4 | COMPLETED | Study Assessing The Efficacy And Safety Of Avodart (Dutasteride) At Improving Urinary Symptoms In Men With Prostate Cancer Who Are Undergoing Seed Implantation |
| NCT00827814 | PHASE4 | COMPLETED | Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction |
| NCT00880672 | PHASE4 | COMPLETED | Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate |
| NCT00939120 | PHASE4 | COMPLETED | Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS) |
| NCT01262287 | PHASE4 | COMPLETED | Dutasteride for the Reduction of Alcohol Use in Male Drinkers |
| NCT01673490 | PHASE4 | TERMINATED | Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia |
| NCT01758523 | PHASE4 | COMPLETED | Dutasteride Treatment for the Reduction of Heavy Drinking in Men |
| NCT06916793 | PHASE3 | NOT_YET_RECRUITING | A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia |
| NCT00056407 | PHASE3 | COMPLETED | REDUCE - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk |
| NCT00070733 | PHASE3 | UNKNOWN | The Effect of 5-Alpha Reductase on Testosterone in Men |
| NCT00368979 | PHASE3 | COMPLETED | Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects |
| NCT00398281 | PHASE3 | COMPLETED | Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer |
| NCT00431626 | PHASE3 | TERMINATED | A Clinical Trial Comparing Laser TURP With and Without Dutasteride. |
| NCT00490555 | PHASE2/PHASE3 | COMPLETED | PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue |
| NCT00553878 | PHASE2/PHASE3 | COMPLETED | Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer |
| NCT00780754 | PHASE3 | COMPLETED | Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia |
| NCT01231607 | PHASE3 | COMPLETED | Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia |
| NCT01831791 | PHASE3 | COMPLETED | A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia |
| NCT02014584 | PHASE3 | COMPLETED | Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia |
| NCT02058368 | PHASE3 | COMPLETED | Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia |
| NCT04098302 | PHASE2/PHASE3 | COMPLETED | Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy |
| NCT04545450 | PHASE3 | COMPLETED | Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen |
| NCT04729491 | PHASE2/PHASE3 | COMPLETED | EAT-DUTA AndroCoV Trial |
| NCT04756206 | PHASE2/PHASE3 | COMPLETED | Role of Dutasteride in Treatment of Chronic Prostatitis |
| NCT04947631 | PHASE3 | COMPLETED | Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia |
| NCT05513365 | PHASE2 | RECRUITING | Phase II Dutasteride in Combination With CAB vs CAB in SDC |
| NCT07420517 | PHASE2 | RECRUITING | Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer |
| NCT00161421 | PHASE2 | COMPLETED | Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone |
| NCT00298155 | PHASE2 | COMPLETED | Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer |
| NCT00303446 | PHASE2 | COMPLETED | Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA) |
| NCT00398580 | PHASE2 | COMPLETED | 28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).