Urovant Sciences and Sunovion Pharmaceuticals launch primary care co-promotion of GEMTESA® (vibegron) for patients with overactive bladder

IRVINE, CA & BASEL, Switzerland & MARLBOROUGH, Mass .– (COMMERCIAL THREAD) – Urovant Sciences, Inc. and Sunovion Pharmaceuticals Inc. today announced the launch of co-promotion activities for GEMTESA® (vibegron) 75 mg tablets extend promotion to general practitioners through the deployment of Sunovion’s multi-specialty sales force. The collaboration is covered by a five-year US co-promotion agreement between the two companies concluded in October 2020.

The commercial launch of GEMTESA, a beta-3 (β3) adrenergic receptor agonist, was announced in April 2021. In December 2020, the treatment received approval from the United States Food and Drug Administration for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence (UUI), urgency and urinary frequency.

Urovant and Sunovion have also put in place an exclusive three-year agreement signed in June 2020 for services related to wholesale and retail distribution, contractual operations and certain account management activities for GEMTESA. Urovant and Sunovion are indirect wholly owned subsidiaries of Sumitomo Dainippon Pharma Co., Ltd.

“The launch of this co-promotion agreement will accelerate the launch of GEMTESA in the primary care community in the United States,” said Walt Johnston, executive vice president, commercial, at Urovant. “Primary care physicians play a key role in identifying and treating patients with overactive bladder. This collaboration between Urovant and Sunovion highlights the strategic advantage of our affiliation with the Sumitomo Dainippon Pharma group of companies. ”

“Co-promotion efforts will leverage Sunovion’s extensive business capabilities and expertise in primary care,” said Thomas Gibbs, senior vice president and chief commercial officer of Sunovion. “In partnership with Urovant, we aim to provide this treatment option to the more than the estimated 30 million Americans who suffer from symptoms of OAB.”

GEMTESA reduces bothersome symptoms of overactive bladder by relaxing the bladder detrusor muscle so that the bladder can hold more urine. GEMTESA was approved by the United States Food and Drug Administration in December 2020 and is the first and only β3 agonist with emergency data and no blood pressure warnings on its label. In clinical studies, GEMTESA was shown to significantly reduce the three key symptoms of overactive bladder compared to placebo at week 12, and there is no known association with cognitive decline for the class of beta-3 agonists.1

To learn more about GEMTESA, please visit GEMTESA.com.

About overactive bladder

OAB is a clinical condition that occurs when the muscle in the bladder involuntarily contracts. Symptoms may include urgent urination (a sudden urge to urinate that is difficult to control), urge incontinence (involuntary loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours) and nocturia (waking up more than twice in the night to urinate).2

About 30 million Americans suffer from bothersome symptoms of overactive bladder, which can significantly interfere with a patient’s daily activities.2.3


GEMTESA is a prescription medicine for adults used to treat the following symptoms of a condition called overactive bladder:

  • urge urinary incontinence: a strong need to urinate with accidents of leakage or wetting

  • urgency: the need to urinate right away

  • frequency: urinate often

It is not known if GEMTESA is safe and effective in children.


Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.

Before taking GEMTESA tell your doctor about all your health problems, including if you have liver problems; have kidney problems; you have trouble emptying your bladder or you have a weak urine stream are taking medicines containing digoxin; are pregnant or plan to become pregnant (it is not known whether GEMTESA will harm your unborn baby; talk to your doctor if you are pregnant or plan to become pregnant); if you are breast-feeding or planning to breast-feed (it is not known whether GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you are taking GEMTESA).

Tell your doctor about all the medicines you are taking, including prescription and over-the-counter drugs, vitamins, and herbal supplements. Know the medications you are taking. Keep a list to show your doctor and pharmacist when you are given a new medicine.

What are the possible side effects of GEMTESA?

GEMTESA can cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your chances of not being able to empty your bladder, especially if you have a bladder obstruction or if you are taking other medicines for the treatment of overactive bladder. Tell your doctor immediately if you cannot empty your bladder.

The most common side effects of GEMTESA include headache, urinary tract infections, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infections. These are not all the possible side effects of GEMTESA. For more information, consult your doctor or pharmacist.

Call your doctor for medical advice on side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Please click here for complete product information for GEMTESA.

About Urovant Sciences

Urovant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies for urological conditions. The Company’s flagship product, GEMTESA® (vibegron), is a small molecule beta-3 agonist administered once daily (75 mg) orally approved by the US FDA in December 2020 for the treatment of patients adults with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia (OAB + BPH). The company’s second product candidate, URO-902, is a new gene therapy under development for patients with overactive bladder who have failed oral pharmacological treatment. Urovant Sciences, a subsidiary of Sumitovant Biopharma Ltd., intends to develop new treatments for other urological diseases. Learn more about us on www.urovant.com.

About Sunovion Pharmaceuticals

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious illnesses. Sunovion’s vision is to lead the way towards a healthier world. The company’s innovative spirit is driven by the belief that scientific excellence combined with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has forged new paths to life-transforming treatments that reflect continued investments in research and development and an unwavering commitment to supporting people with psychiatric disorders, neurological and respiratory. Based in Marlborough, Massachusetts, Sunovion is an indirect wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are direct wholly owned subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the company’s websites : www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitovant Biopharma Ltd.

Sumitovant is a global biopharmaceutical company with offices in New York and London. Sumitovant is a 100% subsidiary of Sumitomo Dainippon Pharma. Sumitovant is the majority shareholder of Myovant Sciences and owns 100% of Urovant Sciences, Enzyvant Therapeutics, Spirovant Sciences and Altavant Sciences. Sumitovant’s promising pipeline includes early to late-stage investigational drugs in a range of disease areas targeting high unmet need. For more information on Sumitovant, please visit https://www.sumitovant.com.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is among the top 10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets including Japan, United States, China and European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the fields of Psychiatry and Neurology, Oncology and Regenerative Medicine / Cell Therapy, which have been designated as priority therapeutic areas. Sumitomo Dainippon Pharma is the result of the merger in 2005 between Dainippon Pharmaceutical Co., Ltd. and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available on its website at https://www.ds-pharma.com.

  1. Welk, B., & McArthur, E. (2020). Increased risk of dementia in patients with overactive bladder treated with an anticholinergic drug compared to a beta-3 agonist: a population-based cohort study. BJU International, 126 (1), 183-190. https://doi.org/10.1111/bju.15040

  2. Reynolds, WS, Fowke, J., & Dmochowski, R. (2016). The burden of overactive bladder on American public health. Current reports on bladder dysfunction, 11 (1), 8-13. https://doi.org/10.1007/s11884-016-0344-9

  3. Coyne, KS, Sexton, CC, Vats, V., Thompson, C., Kopp, ZS & Milsom, I. (2011). National community prevalence of overactive bladder in the United States stratified by sex and age. Urology, 77 (5), 1081-1087. https://doi.org/10.1016/j.urology.2010.08.039