Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vibegron · 3 trials · 2 indications
Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over a week (4 to 10 days) during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.
| Arm | Type | Description |
|---|---|---|
| Part 1: placebo | PLACEBO_COMPARATOR | Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 3 mg | EXPERIMENTAL | Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 15 mg | EXPERIMENTAL | Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 50 mg | EXPERIMENTAL | Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 100 mg | EXPERIMENTAL | Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks. |
| Part 1: tolterodine ER 4 mg | ACTIVE_COMPARATOR | Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks. |
| Part 1: vibegron 50 mg + tolterodine ER 4 mg/vibegron 50 mg | EXPERIMENTAL | Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning. |
| Part 2: placebo | PLACEBO_COMPARATOR | Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks. |
| Part 2: vibegron 100 mg | EXPERIMENTAL | Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks. |
| Part 2: tolterodine ER 4 mg | ACTIVE_COMPARATOR | Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks. |
| Part 2: vibegron 100 mg + tolterodine ER 4 mg | EXPERIMENTAL | Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks. |
| Extension Study: vibegron 50 mg | EXPERIMENTAL | Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks. |
| Extension Study: vibegron 100 mg | EXPERIMENTAL | Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks. |
| Extension Study: tolterodine ER 4 mg | EXPERIMENTAL | Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks. |
| Extension Study: vibegron 100 mg + tolterodine ER 4 mg | EXPERIMENTAL | Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks. |
| Participants With Moderate Hepatic Insufficiency | EXPERIMENTAL | Participants with moderate hepatic insufficiency will receive a single oral dose of vibegron 100 mg. |
| Healthy Matched Control Participants | EXPERIMENTAL | Participants who are healthy will receive a single oral dose of vibegron 100 mg. |
| Participants With Mild Hepatic Insufficiency | EXPERIMENTAL | Participants with mild hepatic insufficiency will receive a single oral dose of vibegron 100 mg. |
| Participants With Severe Renal Insufficiency | EXPERIMENTAL | Participants will receive a single oral dose of vibegron 100 mg on Day 1. |
| Participants With Moderate Renal Insufficiency | EXPERIMENTAL | Participants will receive a single oral dose of vibegron 100 mg on Day 1. |
| Participants With Mild Renal Insufficiency | EXPERIMENTAL | Participants will receive a single oral dose of vibegron 100 mg on Day 1. |
| Name | Type | Description |
|---|---|---|
| Vibegron | DRUG | Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning. |
| Tolterodine ER | DRUG | Participants received one tolterodine ER 4 mg capsule, taken orally once a day. |
| Placebo matching vibegron | DRUG | Participants received placebo matching vibegron tablets, taken orally each morning. |
| Placebo matching tolterodine ER | DRUG | Participants received placebo matching tolterodine ER capsule, taken orally each morning. |
| Vibegron 100 mg | DRUG | Vibegron tablets, orally, on Day 1 |
Inclusion Criteria: * If participant is of reproductive potential, must agree to remain abstinent or use (or have his/her partner use) 2 acceptable methods of birth control within the projected duration of the study * Clinical history of OAB for at least 3 months and meets either the OAB wet or OAB...
Vibegron is an investigational small molecule being developed for the treatment of overactive bladder (OAB), a condition characterized by urinary urgency, frequency, and urge incontinence. It is also studied in patients with renal or hepatic insufficiency who have overactive bladder. Vibegron is not yet approved and remains in clinical development.
Vibegron is a small molecule that acts as a beta-3 adrenergic receptor agonist. By stimulating this receptor, it is designed to relax the detrusor muscle of the bladder during the storage phase, thereby increasing bladder capacity and reducing symptoms of overactive bladder. This mechanism is being evaluated in clinical trials.
Vibegron is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and efficacy of Vibegron for the treatment of overactive bladder.
Vibegron is currently in Phase 1 clinical development. While a Phase 2 study has been completed, the most advanced ongoing development stage is Phase 1, with trials evaluating the drug's pharmacokinetics in special populations. Vibegron is investigational and has not received FDA approval.
Vibegron has been studied in three completed clinical trials. NCT01314872 was a Phase 2 efficacy and safety study in 1,395 participants with overactive bladder. NCT01628042 and NCT01737684 were Phase 1 pharmacokinetic studies in participants with renal insufficiency and hepatic insufficiency, respectively, enrolling 32 and 16 participants.
Yes, Vibegron is also known as MK-4618. Clinical trial titles and protocols refer to the drug by both names, such as in the study of MK-4618 in participants with overactive bladder. This alternative name is used interchangeably in research documentation.