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 314 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.
18
Indications
77
Total Trials
8
Active Trials
313
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 18 indications
Competition
Competitive Landscape
314 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Avodart
Akero TherapeuticsApproved
Zejula
GGlaxo Dba Glaxosmithkline
Phase 3
Acetylsalicylic Acid
BayerPhase 3
Xaluritamig
AmgenPhase 3
Lhrha
Johnson & JohnsonPhase 3
Piflufolastat F 18
NovartisPhase 3
Fuzuloparib
JJiangsu HengRui Medicine Co., Ltd.
Phase 3
Trexall
Jazz PharmaceuticalsPreclinical
Jatenzo
GGrupo Espanol de Tumores Neuroendocrinos
Preclinical
Botox
VVitae Pharmaceuticals Inc., an Allergan affiliate
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer17 trials
Show 14 more trials
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Terminated·—·Phase 1/2·NCT00953576·11 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
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Completed·—·Phase 2·NCT01393730·40 enrolled
Benign Prostatic Hyperplasia9 trials
Show 6 more trials
Prostate4 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
Androgenetic Alopecia4 trials
Show 1 more trial
29 more indications
Treatment3 trials
Hypertrophy2 trials
AIN2 trials
MPA1 trial
Urinary retention1 trial
Outcome1 trial
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Not yet recruiting·—··NCT07417449·1,000 enrolled
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
Tics1 trial
Chronic Prostatitis1 trial
Role of Dutasteride in Treatment of Chronic Prostatitis
Completed·—·Phase 2/3·NCT04756206·50 enrolled
Combination Therapy1 trial
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