Sumitomo Pharma’s Vibegron Supplemental NDA Accepted By FDA
Details : Gemtesa (vibegron) is a beta-3 adrenergic receptor agonist for treating male overactive bladder (OAB) with benign prostatic hyperplasia.
Brand Name : Gemtesa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 13, 2024
Lead Product(s) : Dutasteride,Tadalafil
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Will Dongkook Pharm Present New Combo Therapy for BPH?
Details : DKF-313 is a combination of dutasteride (5α-reductase inhibitor) and tadalafil (PDE5 inhibitor). It is being evaluated in phase 3 clinical trials for the treatment of benign prostatic hyperplasia.
Brand Name : DKF-313
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 26, 2023
Lead Product(s) : Dutasteride,Tadalafil
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Gemtesa (vibegron) is a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under investigation for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia.
Brand Name : Gemtesa
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 11, 2023
Lead Product(s) : Fexapotide triflutate
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Nymox Announces NYMOZARFEX Marketing Application is Accepted For Review
Details : Nymozarfex (fexapotide triflutate) causes selective apoptosis in the glandular portions of the prostate. It is currently being investigated for benign prostate enlargement (BPH).
Brand Name : Nymozarfex
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 15, 2023
Lead Product(s) : Fexapotide triflutate
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fexapotide triflutate
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
NYMOX Announces New Marketing Submission for NYMOZARFEX for BPH
Details : Nymozarfex (fexapotide triflutate) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. Fexapotide has led to significant long-term improvements and has shown an excellent safety profile.
Brand Name : Nymozarfex
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 05, 2022
Lead Product(s) : Fexapotide triflutate
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Botulinum toxin type A
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Dysport® is an injectable form of a botulinum neurotoxin type A (BoNT-A) product, which has previously shown clinically meaningful benefit in the symptomatic treatment of focal spasticity and cervical dystonia.
Brand Name : Dysport
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 09, 2022
Lead Product(s) : Botulinum toxin type A
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fexapotide triflutate
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
NYMOX Announces Submission of New Drug Application (NDA) to the FDA for Fexapotide Triflutate
Details : NX-1207 (fexapotide triflutate), is a protein injectable for benign prostatic hyperplasia and for low grade localized prostate cancer, a new molecular entity which safely targets prostate glandular cells that have proliferated in BPH.
Brand Name : NX-1207
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 03, 2022
Lead Product(s) : Fexapotide triflutate
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : IncobotulinumtoxinA
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Merz Therapeutics
Deal Size : $19.0 million
Deal Type : Partnership
Merz Strengthens Partnership With Start-up Vensica and Invests up to $3 million
Details : This investment follows the strategic license and collaboration agreement signed in 2021 to utilize Merz’s botulinum neurotoxin A (XEOMIN®) for the innovative ultrasound-assisted delivery catheter of Vensica.
Brand Name : Xeomin
Molecule Type : Large molecule
Upfront Cash : Undisclosed
February 07, 2022
Lead Product(s) : IncobotulinumtoxinA
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Merz Therapeutics
Deal Size : $19.0 million
Deal Type : Partnership
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The NDA and sNDA were based on findings from a Phase 3 pivotal study that evaluated the efficacy, safety, tolerability and pharmacokinetics of mirabegron in children and adolescents with NDO and using clean intermittent catheterization.
Brand Name : Myrbetriq
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 06, 2021
Lead Product(s) : Mirabegron
Therapeutic Area : Urology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Results from the 40-week EMPOWUR extension to the 12-week EMPOWUR trial shows that 75 mg of vibegron was well tolerated over the total exposure of 52 weeks with numerically greater improvements from baseline, compared to tolterodine across QoL and respon...
Brand Name : KRP114V
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 19, 2020
LOOKING FOR A SUPPLIER?