CLINICAL TRIALS PROFILE FOR GEMTESA

All Clinical Trials for GEMTESA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05067478 ↗	Composur: Study to Understand the Performance of Vibegron in Participants With Overactive Bladder (OAB)	Not yet recruiting	Urovant Sciences GmbH	Phase 4	2021-10-01	This study will evaluate the treatment satisfaction, discontinuation, reasons for discontinuation, quality of life, healthcare resource utilization, and safety with Vibegron for the treatment of OAB in the context of real-world clinical practice.
NCT06417177 ↗	Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia	RECRUITING	University of Missouri-Columbia	EARLY_PHASE1	2024-06-03	The purpose of this study is to examine hypoxic vasodilation and the role of beta-adrenergic receptors in younger premenopausal, perimenopausal, and older postmenopausal women.
NCT06987383 ↗	Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2026-08-01	This 12-week randomized, double-blind, placebo-controlled trial will test the hypothesis that Vibegron (brand name GEMTESA) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function in middle-aged and older adults with obesity.

Clinical Trial Conditions for GEMTESA

Condition Name

Condition Name for GEMTESA
Intervention	Trials
Menopause	1
Obesity	1
Overactive Bladder	1
Vasodilation	1

Condition MeSH

Condition MeSH for GEMTESA
Intervention	Trials
Obesity	1
Hypoxia	1
Aneurysm	1
Urinary Bladder, Overactive	1

Clinical Trial Locations for GEMTESA

Trials by Country

Trials by Country for GEMTESA
Location	Trials
United States	21

Trials by US State

Trials by US State for GEMTESA
Location	Trials
North Carolina	1
Missouri	1
Wisconsin	1
Virginia	1
Texas	1

Clinical Trial Progress for GEMTESA

Clinical Trial Phase

Clinical Trial Phase for GEMTESA
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	1
EARLY_PHASE1	1

Clinical Trial Status

Clinical Trial Status for GEMTESA
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	1
RECRUITING	1
Not yet recruiting	1

Clinical Trial Sponsors for GEMTESA

Sponsor Name

Sponsor Name for GEMTESA
Sponsor	Trials
University of Missouri-Columbia	1
Wake Forest University Health Sciences	1
Urovant Sciences GmbH	1

Sponsor Type

Sponsor Type for GEMTESA
Sponsor	Trials
OTHER	2
Industry	1

GEMTESA (vibegron) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is GEMTESA and what assets drive its clinical and commercial profile?

GEMTESA is vibegron, an oral, once-daily beta-3 adrenergic receptor agonist indicated for overactive bladder (OAB), including urgent urinary incontinence, urgency, and frequency.

What is the current clinical-trials status for vibegron (GEMTESA)?

Insufficient information is available in the provided prompt to compile a complete, accurate, source-cited clinical-trials update (by trial ID, phase, enrollment, endpoints, and timelines).

Where does GEMTESA compete in the OAB market landscape?

GEMTESA’s therapeutic category places it in direct competition with established OAB agents, including:

• Antimuscarinics (focus on bladder muscarinic receptor blockade; tolerability issues such as dry mouth, constipation)
• Other beta-3 agonists (class competition)
• Combination and later-line positioning typically guided by symptom response and tolerability

Market competition is shaped by:

• Differentiation on tolerability (beta-3 pathway vs muscarinic)
• Adherence due to once-daily oral dosing
• Reimbursement and formulary placement, typically tied to payer preference and comparative endpoints in label-relevant populations

What does the available information support on market size and dynamics?

Insufficient information is available in the provided prompt to deliver a complete, accurate, source-cited market analysis (category size, share, pricing, channel mix, and segment-level projections for the relevant geography and time horizon).

What can be projected for GEMTESA revenue and volume growth?

Insufficient information is available in the provided prompt to create a complete, accurate, source-cited projection model (assumptions, estimated addressable population, penetration ramp, price realization, and competitive erosion).

Key Takeaways

• GEMTESA is vibegron, an oral beta-3 adrenergic receptor agonist for OAB symptoms.
• The prompt does not contain enough source data to produce a complete, accurate clinical-trials update or a hard, cited market analysis and revenue projection.

FAQs

1. What is GEMTESA’s active ingredient?
   GEMTESA contains vibegron.

2. What is GEMTESA used to treat?
   It treats overactive bladder symptoms, including urgency, frequency, and urgent urinary incontinence.

3. What drug class is vibegron?
   Vibegron is a beta-3 adrenergic receptor agonist.

4. Is GEMTESA dosed once daily?
   GEMTESA is positioned as once-daily oral therapy.

5. Can you provide a clinical-trials update and market projections from the provided prompt?
   No. The prompt does not include the necessary cited trial and market data to produce those deliverables.

---

References

[1] None provided in the prompt.