Avodart
(Dutasteride)ApprovedSmall molecule
Akero TherapeuticsDutasteride 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 18 indications[4].[1]
Avodart is one of 326 small molecule programs targeting Benign Prostatic Hyperplasia. It is currently in Approved.
18
Indications
76
Total Trials
7
Active Trials
325
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 18 indications
Competition
Competitive Landscape
348 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Avodart
Akero TherapeuticsApproved
Cabometyx
Bristol-Myers SquibbPhase 3
Tecentriq
RochePhase 3
Ritalin
NovartisPhase 3
GM-CSF
YY-mAbs Therapeutics
Phase 3
Radium-223
BayerPhase 3
INR101
YYunhe Pharmaceutical (Tianjin) Co., Ltd
Phase 3
Antibiotic Prophylaxis
AAssistance Publique - Hôpitaux de Paris
Phase 3
Trexall
Jazz PharmaceuticalsPreclinical
Duragesic
CCephalon
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer17 trials
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
Show 14 more trials
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Completed·—·Phase 2·NCT01393730·40 enrolled
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Terminated·—·Phase 1/2·NCT00953576·11 enrolled
Benign Prostatic Hyperplasia8 trials
Testosterone4 trials
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
Prostate4 trials
Androgenetic Alopecia4 trials
Show 1 more trial
29 more indications
Treatment3 trials
Hypertrophy2 trials
AIN2 trials
MPA1 trial
PSA Progression1 trial
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
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
Combination Therapy1 trial
Urinary retention1 trial
Outcome1 trial
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Not yet recruiting·—··NCT07417449·1,000 enrolled
Tics1 trial
Chronic Prostatitis1 trial
Role of Dutasteride in Treatment of Chronic Prostatitis
Completed·—·Phase 2/3·NCT04756206·50 enrolled
Drug Interactions1 trial
Unspecified5 trials
Regulatory
FDA Approval Timeline[5]
Nov 20, 2001
AVODART
NDA NDA021319
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Avodart drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Dutasteride. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Steroid 5-Alpha-Reductase Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company