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GEMTESA (vibegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
Urovant Sciences and Pierre Fabre will share responsibility for Gemtesa (vibegron), clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pierre Fabre
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 05, 2022
Details:
In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA (Vibegron) was safe and well-tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2022
Details:
Interim 12-week analysis from an ongoing Phase 2a trial of an investigational novel gene therapy product URO-902 (hMaxi-K), showed clinically relevant improvement in the common symptoms of overactive bladder (OAB) compared to placebo.
Lead Product(s): Hmaxi-K
Therapeutic Area: Urology Product Name: URO-902
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2022
Details:
Post-hoc analysis indicates significant reductions in urgency episodes and micturitions in patients treated with GEMTESA vs. placebo in both types of overactive bladder (OAB).
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2022
Details:
Interim 12-week analysis from a Phase 2a trial of the potential gene therapy, URO-902, in women with overactive bladder and urge urinary incontinence will be featured in a late-breaker presentation during plenary session.
Lead Product(s): Hmaxi-K
Therapeutic Area: Urology Product Name: URO-902
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2022
Details:
The Therapeutics and Clinical Risk Management paper points out that in international phase 3 EMPOWUR trial, treatment with GEMTESA was associated with significant improvements compared with placebo.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2022
Details:
URO-902 showed a clinically meaningful and statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency episodes, and quality of life indicators compared to placebo, 12 weeks post-administration.
Lead Product(s): Hmaxi-K
Therapeutic Area: Urology Product Name: URO-902
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
New data from dedicated ambulatory blood pressure study of patients with overactive bladder (OAB) showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
The commercial launch of GEMTESA, a beta-3 (β3) adrenergic receptor agonist, was announced in April 2021. EMTESA reduces the bothersome symptoms of OAB by relaxing the detrusor bladder muscle so that the bladder can hold more urine.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2021
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