Topsalysin

Overview

Topsalysin is being developed for the treatment of localized prostate cancer and also benign prostatic hyperplasia. Topsalysin is delivered locally to the prostate under ultrasound guidance.

Indication

Investigated for use/treatment in benign prostatic hyperplasia, cancer/tumors (unspecified), prostate cancer, prostate disorders, and solid tumors.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Intraprostatic PRX302 Injection to Treat Localised Prostate Cancer	2017/03/16	NCT03081481	Phase 2	Completed	Sophiris Bio Corp
Evaluate, Safety and Tolerability of Intraprostatic PRX302 Administration, Low to Intermediate Risk Prostate Cancer	2015/07/16	NCT02499848	Phase 2	Completed	Sophiris Bio Corp
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH	2013/10/21	NCT01966614	Phase 3	Completed	Sophiris Bio Corp
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)	2011/10/19	NCT01454349	Phase 1	Completed	Sophiris Bio Corp
Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia	2009/04/29	NCT00889707	Phase 2	Completed	Sophiris Bio Corp
An Open-Label, Multi-Center, Phase IIa Trial of PRX302 Treatment of Patients With Locally Recurrent Prostate Cancer After Primary Radiation Therapy	2008/05/29	NCT00686088	Phase 2	Completed	Sophiris Bio Corp

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

AI-Powered Research

Premium Access