A Randomised, Double-blind, Placebo-controlled, Multi-centre Study to Investigate the Efficacy and Safety of Fedovapagon in the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia (BPH) (EQUINOC Study)

This study will investigate the efficacy and safety of fedovapagon in the treatment of nocturia in men with BPH.

Start Date01 Mar 2016

Sponsor / Collaborator

Vantia Ltd.

NCT02537288 / CompletedPhase 1

A Phase I Single Centre, Randomized, Double Blind (Except For Moxifloxacin), Placebo And Active Controlled, Four Way Cross Over Study Investigating The Effect Of Single Therapeutic And Supra Therapeutic Doses Of Fedovapagon On The QT/QTC Interval In Healthy Volunteers Using Oral Moxifloxacin To Confirm Assay Sensitivity

The purpose of this study is to assess the electrocardiogram (ECG) effects of fedovapagon dose administration relative to placebo in healthy adult male and female subjects.

Start Date01 Oct 2015

Sponsor / Collaborator

Vantia Ltd.

NCT02440841 / CompletedPhase 1

Single Center, Open-Label, Single-Sequence, Within-Subject Study In Two Cohorts Of Healthy Male Subjects Comparing Single-Dose Pharmacokinetics Of Fedovapagon Alone And In Combination With A CYP3A4 Inhibitor, Itraconazole, Or A CYP3A4 Inducer, Rifampicin

The purpose of this study is to investigate the potential for co-administration of strong inhibitors or inducers of CYP3A4 to alter the pharmacokinetics of fedovapagon.

Start Date01 May 2015

Sponsor / Collaborator

Vantia Ltd.

100 Clinical Results associated with Fedovapagon

100 Translational Medicine associated with Fedovapagon

100 Patents (Medical) associated with Fedovapagon

Literatures (Medical) associated with Fedovapagon

01 Jan 2018·European Urology FocusQ2 · MEDICINE

Lower Urinary Tract Symptoms: What’s New in Medical Treatment?

Q2 · MEDICINE

Review

Author: Michel, Martin C ; Peyronnet, Benoit ; Brucker, Benjamin M

CONTEXTPharmacological treatment is a cornerstone in the management of patients with lower urinary tract symptoms (LUTS).OBJECTIVETo review emerging evidence in the medical treatment of LUTS.EVIDENCE ACQUISITIONAn Embase/Pubmed-based literature search was conducted in December 2017, screening for randomized controlled trials (RCTs), prospective and retrospective series, animal model studies, and reviews on medical treatment of LUTS.EVIDENCE SYNTHESISThe main medical innovation in recent years in overactive bladder (OAB) has been the approval of the first β₃-adrenoceptor agonists (mirabegron) and intradetrusor onabotulinum toxin A, while several other drugs such as antiepileptics, phosphodiesterase inhibitors, or other β₃-agonists have brought promising results in phase 3 trials. Intraprostatic injections of various drugs for LUTS/benign prostatic hyperplasia have been investigated, but results of phase 3 trials are still pending, while combination therapies of phosphodiesterase type 5 inhibitors+α-blockers or finasteride have been proved as superior to single therapies in RCTs conducted in these patients. Two new formulations of desmopressin have been approved for nocturia in the USA (desmopressin nasal spray) and Europe/Canada/Australia (desmopressin orally disintegrated tablet). Fedovapagon, a vasopressin V₂ receptor agonist, has recently completed a large phase 3 trial in male patients with nocturia. Other phase 3 trials are ongoing in bladder pain syndrome (AQX 11-25, a SHIP-1 activator) and in neurogenic detrusor overactivity (mirabegron and abobotulinum toxin A).CONCLUSIONSMedical treatment of LUTS is a very active research field with recently approved drugs for nocturia (desmopressin acetate nasal spray/orally disintegrated tablet) and numerous emerging drugs currently investigated in OAB, LUTS/benign prostatic hyperplasia, nocturia, bladder pain syndrome, and neurogenic detrusor overactivity.PATIENT SUMMARYMedical treatment of lower urinary tract symptoms is a very active research field with recently approved drugs for nocturia (desmopressin acetate nasal spray/orally disintegrated tablet) and numerous emerging drugs in overactive bladder, nocturia, neurogenic detrusor overactivity, bladder pain syndrome, or benign prostatic hyperplasia.

100 Deals associated with Fedovapagon

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nocturia	Phase 3	-	Ferring BV	-
Nocturia	Phase 3	-	Vantia Ltd.	-
Prostatic Hyperplasia	Discovery	US	Vantia Ltd.	01 Mar 2016

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


2270 (AUA2013)	Not Applicable	Polyuria	-	0.5 mg fedovapagon	vznvbekqoa(ktqdemoepa) = lwfkkhofhy gkxsyngkyj (evnntmppzb )	-	01 Apr 2013
				4 mg fedovapagon	vznvbekqoa(ktqdemoepa) = vchvklabcc gkxsyngkyj (evnntmppzb )

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