DUTASTERIDE

Post-LOE

dutasteride

Ascentage Pharma

ANDAORALCAPSULE

Approved

Oct 2016

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Mechanism of Action

5-alpha Reductase Inhibitors

Pharmacologic Class:

5-alpha Reductase Inhibitor

Indications (6)

symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: (1 symptomatic BPH in men with an enlarged prostate symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: improve symptoms reduce the risk of acute urinary retention (AUR)reduce the risk of the need for BPH-related surgery prostate cancer

Clinical Trials (5)

NCT02578953Phase 1Completed

Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects

Started Sep 2015

36 enrolled

Prostatic Hyperplasia

NCT02509104Phase 1Completed

Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects

Started Jul 2015

56 enrolled

Prostatic Hyperplasia

NCT02184585Phase 1Completed

Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States

Started Jul 2014

84 enrolled

Prostatic Hyperplasia

NCT02014584Phase 3Completed

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

Started Jul 2014

117 enrolled

Alopecia

NCT02052713Phase 1Completed

Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State

Started Feb 2014

78 enrolled