Gemtesa

(Vibegron)

Phase 3Small molecule

Sumitomo Pharma America, Inc.

Gemtesa is one of 134 small molecule programs targeting Benign Prostatic Hyperplasia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

133

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Benign Prostatic HyperplasiaActive, not recruiting

Irritable Bowel SyndromeActive, not recruiting

WomenNot yet recruiting

Overactive BladderActive, not recruiting

Renal InsufficiencyActive, not recruiting

Benign Prostatic HyperplasiaPhase 3

Active, not recruiting

Irritable Bowel SyndromePhase 2

Active, not recruiting

WomenPhase 1

Not yet recruiting

Overactive BladderPreclinical

Active, not recruiting

Renal InsufficiencyPhase 1

Active, not recruiting

Competition

Competitive Landscape

185 competitors in Irritable Bowel Syndrome

#DrugCompanyPhaseTrials

Lialda

Takeda

Phase 3

2 2

Xifaxan

SSalix

Phase 3

10 3

Zofran

Novartis

Phase 3

1 4

Amitiza

SSucampo Pharma Americas, LLC

Phase 3

5 5

Gemtesa

Sumitomo Pharma America, Inc.

Phase 3

1 6

Circadin

NNeurim Pharmaceuticals Ltd.

Phase 3

1 7

Zarontin

PParkedale

Phase 3

1 8

Mesalazine

Ferring

Phase 3

4 9

Saccharomyces Boulardii

BBiocodex

Phase 3

3 10

Trulance

SSalix

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2/3Recruiting

Pediatric

NCT05491525

Q3 2028

Phase 3Not yet recruiting

Aging

NCT06987383

Q2 2029

Phase 1Not yet recruiting

Women

NCT07674680

Clinical

Trials by Indication[1]

Overactive Bladder6 trials

A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT01500382·4 enrolled

A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)

Completed·UUrovant Sciences GmbH·Phase 3·NCT03492281·1,530 enrolled

An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).

Completed·UUrovant Sciences GmbH·Phase 3·NCT03583372·506 enrolled

Show 3 more trials

Role of Combination Therapy in Women With Refractory Overactive Bladder

Withdrawn·UUniversity of Alabama at Birmingham·N/A·NCT06438861

A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01314872·1,395 enrolled

Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)

Completed·UUrovant Sciences GmbH··NCT05067478·403 enrolled

Benign Prostatic Hyperplasia2 trials

Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia

Completed·UUrovant Sciences GmbH·Phase 3·NCT04103450·276 enrolled

Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Completed·UUrovant Sciences GmbH·Phase 3·NCT03902080·1,105 enrolled

Pediatric1 trial

A Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC

Recruiting·UUrovant Sciences GmbH·Phase 2/3·NCT05491525·85 enrolled

Irritable Bowel Syndrome1 trial

Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome

Completed·UUrovant Sciences GmbH·Phase 2·NCT03806127·222 enrolled

Renal insufficiency1 trial

A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01628042·32 enrolled

3 more indications

Hepatic Insufficiency1 trial

A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01737684·16 enrolled

Aging1 trial

Vibegron for ENergy Thinking and Resilience in Aging

Not yet recruiting·WWake Forest University Health Sciences·Phase 3·NCT06987383·40 enrolled

Women1 trial

Beta3-adrenergic Receptors and Cardiovascular Function in Aging Women

Not yet recruiting·UUniversity of Missouri-Columbia·Phase 1·NCT07674680·60 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 23, 2020

GEMTESA

NDA NDA213006

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Vibegron. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vibegron compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Vibegron. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213006). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gemtesa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sumitomo Pharma America, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Sumitomo Pharma America, Inc.

Patent Landscape[5]

Patent Cliff

Apr 2, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8653260Apr 2, 2029

12180219Mar 12, 2034

8247415Dec 23, 2034

12102638Mar 22, 2040

12357636Jul 6, 2042

Gemtesa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q3 2028

Q2 2029

Trials by Indication[1]

Overactive Bladder6 trials

Benign Prostatic Hyperplasia2 trials

Pediatric1 trial

Irritable Bowel Syndrome1 trial

Renal insufficiency1 trial

Hepatic Insufficiency1 trial

Aging1 trial

Women1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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