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Avodart

(Dutasteride)

ApprovedSmall molecule

Akero Therapeutics

Dutasteride is used to treat an enlarged prostate gland in men, helping to reduce urinary symptoms like difficulty urinating and frequent urination. It works by shrinking the prostate and is also sometimes used to treat male pattern hair loss.[2] Avodart is currently approved and in use across 20 indications[4].[1]

Avodart is one of 434 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

20

Indications

76

Total Trials

7

Active Trials

433

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaApproved

Prostate NeoplasmActive, not recruiting

ProstatitisApproved

HypogonadismApproved

Mood DisorderActive, not recruiting

Prostate CarcinomaActive, not recruiting

AlopeciaActive, not recruiting

Kennedy DiseaseApproved

Chronic ProstatitisActive, not recruiting

Benign Prostatic HyperplasiaActive, not recruiting

Prostate AdenocarcinomaApproved

Approved

Prostate NeoplasmPreclinical

Active, not recruiting

ProstatitisApproved

Approved

HypogonadismApproved

Approved

Mood DisorderPhase 1

Active, not recruiting

Prostate CarcinomaApproved

Active, not recruiting

AlopeciaPhase 2

Active, not recruiting

Kennedy DiseaseApproved

Approved

Chronic ProstatitisPhase 2/Phase 3

Active, not recruiting

Benign Prostatic HyperplasiaApproved

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Avodart

Akero Therapeutics

Novantrone

Mekinist

Trexall

Alnylam Pharmaceuticals

Viagra

VViatris Specialty LLC

Duragesic

Xylocaine

CCitius Pharmaceuticals, Inc.

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Xylocaine

MMEDRx USA, Inc.

Naropin

FFresenius Kabi Oncology Ltd.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Not yet recruiting

Outcome

NCT07417449

Q3 2027

Phase 2Recruiting

Phase II

NCT05513365

Phase 3Not yet recruiting

Androgenetic Alopecia

NCT06916793

Q4 2027

Phase 1Recruiting

Benign Prostatic Hyperplasia

NCT07065682

Q2 2028

N/ANot yet recruiting

Combination Therapy

NCT07421804

Clinical

Trials by Indication[1]

Prostate Cancer17 trials

MRI and Magnetic Resonance Spectroscopy Imaging in Patients Receiving Dutasteride for Benign Prostatic Hypertrophy and Low-Risk Prostate Cancer

Completed·UUniversity of California, San Francisco·N/A·NCT00706966·10 enrolled

Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer

Active, not recruiting·UUniversity of Chicago·N/A·NCT01342367·74 enrolled

Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia

Completed·UUnknown Sponsor·Phase 3·NCT00780754·200 enrolled

Show 14 more trials

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

Completed· GSK logo

GSK·Phase 4·NCT00470834·127 enrolled

Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT01547299·52 enrolled

Response of Patients on Surveillance for Prostate Cancer to Dutasteride

Completed·SSunnybrook Health Sciences Centre··NCT01525914·100 enrolled

Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Completed·RRoswell Park Cancer Institute·Phase 2·NCT00403000·27 enrolled

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Terminated·—·Phase 1/2·NCT00953576·11 enrolled

Dutasteride in Treating Patients With Prostate Cancer

Unknown status·UUniversity College London Hospitals·Phase 2·NCT01193855·42 enrolled

Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

Completed· GSK logo

GSK·Phase 4·NCT00363311·302 enrolled

Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer

Completed·—·Phase 2·NCT01393730·40 enrolled

Comparing 0.5 mg Dutasteride vs Placebo Daily in Men Receiving Androgen Ablation Therapy for Prostate Cancer

Completed·CCanadian Urology Research Consortium·Phase 2/3·NCT00553878·100 enrolled

Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

Terminated·UUniversity of Colorado, Denver·Phase 2·NCT00985738·16 enrolled

A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy

Withdrawn·—·Phase 2·NCT02159690

Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer

Completed·EEndeavor Health·Phase 2·NCT00668642·20 enrolled

"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

Completed· GSK logo

GSK·Phase 3·NCT00056407·8,231 enrolled

Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 3·NCT00398281·450 enrolled

Benign Prostatic Hyperplasia8 trials

Treatment of Refractory Urinary Retention Secondary to Benign Prostatic Hyperplasia (BPH) With Dual Five Alpha Reductase Inhibition Combined With an Alpha Blocker

Completed·—·N/A·NCT00680680·20 enrolled

Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia

Completed·DDongkook Pharmaceutical Co., Ltd.·Phase 3·NCT04947631·667 enrolled

A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

Unknown status·UUrologic Consultants of Southeastern PA·Phase 4·NCT00690950·50 enrolled

Show 5 more trials

Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer

Completed· GSK logo

GSK·Phase 4·NCT00375765·40 enrolled

Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

Completed· GSK logo

GSK·Phase 3·NCT00527605·253 enrolled

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

Completed· GSK logo

GSK·Phase 3·NCT02058368·607 enrolled

Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia

Recruiting·UUniversitas Diponegoro·Phase 1·NCT07065682·84 enrolled

Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

Completed· GSK logo

GSK·Phase 3·NCT00368979·378 enrolled

Prostate4 trials

Effect of Dutasteride on HIF-1alpha and VEGF in the Prostate

Completed·SSeoul National University Hospital·Phase 4·NCT00880672·40 enrolled

PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue

Completed·UUniversity of Washington·Phase 2/3·NCT00490555·32 enrolled

Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies

Completed·UUniversity of Illinois at Chicago··NCT01594502·139 enrolled

Show 1 more trial

Dutasteride for Improving Peri-Operative and Long-Term Outcomes of Photoselective Vaporization of the Prostate (DOP)

Unknown status·UUrology of Virginia·N/A·NCT00274417·60 enrolled

Testosterone4 trials

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Completed· GSK logo

GSK·Phase 4·NCT00062790·50 enrolled

Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement

Completed·TThe Miriam Hospital·Phase 4·NCT00752869·24 enrolled

The Role of 5-alpha Reductase in Mediating Testosterone Actions

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 4·NCT00493987·184 enrolled

Show 1 more trial

Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

Completed·UUniversity of Washington·Phase 2·NCT00161421·18 enrolled

Androgenetic Alopecia4 trials

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

Completed· GSK logo

GSK·Phase 3·NCT02014584·117 enrolled

A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

Completed· GSK logo

GSK·Phase 3·NCT00441116·153 enrolled

A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia

Completed· GSK logo

GSK·Phase 3·NCT01831791·120 enrolled

Show 1 more trial

A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

Not yet recruiting· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 3·NCT06916793·288 enrolled

29 more indications

Treatment3 trials

Pharmacogenetics of Alcohol: Treatment Implications

Completed·UUConn Health·N/A·NCT00734656·94 enrolled

Dutasteride Treatment for the Reduction of Heavy Drinking in Men

Completed·UUConn Health·Phase 4·NCT01758523·189 enrolled

Dutasteride Treatment for Reducing Heavy Drinking in AUD: Predictors of Efficacy

Completed·UUConn Health·Phase 2/3·NCT04098302·180 enrolled

Alopecia2 trials

AVODART® Alopecia Post-marketing Surveillance (PMS)

Completed· GSK logo

GSK··NCT01004809·712 enrolled

Clinical Trial of Safety and Efficacy of Daily Application of Topical Dutasteride in Men With Androgenic Alopecia.

Completed·FFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal·Phase 2·NCT05599243·45 enrolled

Trial2 trials

Economic Analyses of the REDUCE Trial

Completed· GSK logo

GSK··NCT01337258·1 enrolled

EAT-DUTA AndroCoV Trial

Completed·CCorpometria Institute·Phase 2/3·NCT04729491·138 enrolled

Hypertrophy2 trials

Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction

Completed·SSamsung Medical Center·Phase 4·NCT00827814·36 enrolled

Dutasteride After Failure of Finasteride In the Management of Symptomatic Prostatic Enlargement/Hypertrophy (BPE/H)

Completed·NNorth Florida/South Georgia Veterans Health System·N/A·NCT00382356·20 enrolled

AIN2 trials

A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia

Completed· GSK logo

GSK·Phase 1·NCT01495026·63 enrolled

Bioequivalence - Duodart Against Avodart & Omnic

Completed· GSK logo

GSK·Phase 1·NCT01657851·35 enrolled

Single Dose1 trial

Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects

Completed·UUConn Health·N/A·NCT00802321·40 enrolled

Mood Disorder1 trial

Dutasteride to Treat Women With Menstrually Related Mood Disorders

Completed·NNational Institute of Mental Health (NIMH)·Phase 1·NCT00082043·34 enrolled

Interaction1 trial

Safety and Pharmacokinetic Interaction Study of Tadalafil and Dutasteride

Completed·DDongkook Pharmaceutical Co., Ltd.·Phase 1·NCT01942551·47 enrolled

Drug Interactions1 trial

A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects

Completed·YYuyu Pharma, Inc.·Phase 1·NCT02839122·28 enrolled

MPA1 trial

Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects

Completed· GSK logo

GSK·Phase 1·NCT01577693·35 enrolled

PSA Progression1 trial

Biomarker Study of in Men With PSA Progression on Abi for CR or CS PC (Bio-STAMP)

Withdrawn·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT05705700

Steroid1 trial

Metabolic Effects of Steroids in Obese Men

Unknown status·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·N/A·NCT00983554·57 enrolled

ART1 trial

AVODART(Dutasteride) Post-marketing Surveillance(PMS)

Completed· GSK logo

GSK··NCT01299571·3,977 enrolled

Alcohol Use1 trial

Dutasteride for the Reduction of Alcohol Use in Male Drinkers

Completed·UUConn Health·Phase 4·NCT01262287·47 enrolled

Effectiveness1 trial

TRADE-Testosterone Replacement and Dutasteride Effectiveness

Completed·UUniversity of Washington·Phase 4·NCT00194675·53 enrolled

Oral1 trial

Oral Androgens in Man-4: (Short Title: Oral T-4)

Completed·UUniversity of Washington·Phase 1/2·NCT00399165·20 enrolled

Growth1 trial

Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men

Completed·MMayo Clinic·Phase 1·NCT00309855·80 enrolled

Clinical Trial1 trial

A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

Terminated·NNorthwestern University·Phase 3·NCT00431626·4 enrolled

mCRPC1 trial

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

Terminated·PPellficure Pharmaceuticals, Inc·Phase 1·NCT04677855·7 enrolled

Bladder Cancer1 trial

Dutasteride in Patients With Low-grade Non-muscle Invasive Bladder Cancer

Not yet recruiting·PPaul Toren·Phase 2·NCT07420517·95 enrolled

Tics1 trial

Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

Completed·YYuyu Pharma, Inc.·Phase 1·NCT03240939·36 enrolled

Phase II1 trial

Phase II Dutasteride in Combination With CAB vs CAB in SDC

Recruiting·RRadboud University Medical Center·Phase 2·NCT05513365·26 enrolled

Chronic Prostatitis1 trial

Role of Dutasteride in Treatment of Chronic Prostatitis

Completed·—·Phase 2/3·NCT04756206·50 enrolled

Combination Therapy1 trial

Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)

Not yet recruiting·—·N/A·NCT07421804·50 enrolled

Urinary retention1 trial

Effects Of Dutasteride On Risk Reduction Of Acute Urinary Retention Relapse Following Trial Without Catheter

Terminated· GSK logo

GSK·Phase 4·NCT00421421·276 enrolled

Outcome1 trial

Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP

Not yet recruiting·—··NCT07417449·1,000 enrolled

Drug1 trial

Drug Use Investigation for AVOLVE(BPH)

Completed· GSK logo

GSK··NCT01376284·1,000 enrolled

Atrophy1 trial

Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00303446·57 enrolled

Unspecified5 trials

ITT4 Intratesticular Hormonal Milieu in Man (ITT4)

Completed·UUniversity of Washington·Phase 1/2·NCT01215292·46 enrolled

ITT-5 Mechanisms of Spermatogenesis in Man

Withdrawn·UUniversity of Washington·Phase 2·NCT02147964

ARI103094-Follow-Up Study for REDUCE Study Subjects

Completed· GSK logo

GSK··NCT00883909·2,795 enrolled

Show 2 more trials

Bioavailability of Two Combination Products of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) in Asian Males.

Completed· GSK logo

GSK·Phase 1·NCT01471678·27 enrolled

Finasteride, Dutasteride and Insulin Action

Unknown status·UUniversity of Birmingham·Phase 2·NCT01923090·12 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 20, 2001

AVODART

NDA NDA021319

Sources

References

[1]
ClinicalTrials.gov — 76 trial records for Dutasteride. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Avodart drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dutasteride compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dutasteride. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021319). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Akero Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Steroid 5-Alpha-Reductase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Akero Therapeutics

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