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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.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2023
Details:
KYORIN will grant Sumitomo Pharma the exclusive rights to develop, manufacture, and commercialize the therapeutic agent for OAB called Vibegron in in Taiwan and Other Asian Countries, and Sumitomo Pharma will develop, manufacture, and commercialize the Compound.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitomo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 06, 2023
Details:
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:
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:
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:
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
Details:
Based on this agreement, Eisai will acquire exclusive development and marketing rights from Kyorin for the agent in the said four countries, and will be responsible for submitting a New Drug Application for the agent.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Gemtesa
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 31, 2021
Details:
Vibegron is a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), 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 February 23, 2021
Details:
Vibegron was very well tolerated in the study and did not lead to any worsening of IBS symptoms. Key secondary endpoint of Global Improvement Scale (GIS) showed numerical differences in favor of vibegron versus placebo, however data was not statistically significant.
Lead Product(s): Vibegron
Therapeutic Area: Gastroenterology Product Name: Gemtesa
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
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 responder efficacy endpoints.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: KRP114V
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
The merger may enable Urovant's team to fully concentrate on the important task of preparing for its potential commercial launch of vibegron, the first new branded prescription drug for the treatment of OAB in nearly a decade.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: RVT-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitovant Biopharma
Deal Size: $584.0 million Upfront Cash: Undisclosed
Deal Type: Merger November 12, 2020
Details:
Under the terms of the agreement, Sunovion will deploy its multi-specialty sales force to bring vibegron to primary care physicians (PCP). In support of this effort, Sunovion will provide sales and marketing activities targeting the PCP segment through March 31, 2026.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: RVT-901
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Urovant Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 07, 2020
Details:
The exclusive three-year distribution agreement with aims to support the commercialization of vibegron, an investigational agent for the treatment of overactive bladder.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sumitovant Biopharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration June 19, 2020
Details:
Urovant Sciences a family company of Sumitovant announced the publication of the safety and efficacy results of URO-902 in female patients with overactive bladder from two Phase 1 trials.
Lead Product(s): Vibegron,Tolterodine Tartrate
Therapeutic Area: Urology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 21, 2020
Details:
52-week post hoc analysis shows Vibegron patients had statistically significant, sustained reduction in UUI and total incontinence episodes compared to active control.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
The double-blind, placebo-controlled 12-week trial, in patients with OAB, studied vibegron 75 mg once-daily compared to placebo and included an active control.
Lead Product(s): Vibegron
Therapeutic Area: Urology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2020
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