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CTRI Number  CTRI/2026/02/103145 [Registered on: 05/02/2026] Trial Registered Prospectively
Last Modified On: 18/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is the study to check the safety and efficacy of Vibegron 75 mg tablet in comparison with Mirabegron ER 25mg/50mg Tablet in Patients with Overactive Bladder 
Scientific Title of Study   A phase-III randomized open label active controlled multicenter study to evaluate the safety and efficacy of Vibegron 75 mg tablet in comparison with Mirabegron ER 25mg/50mg Tablet in Patients with Overactive Bladder (OAB) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
003/VIB/MSN/2024 V 2 0 Dated 12 JUL 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Ravinder Reddy  
Designation  Senior General Manager 
Affiliation  MSN Laboratories Private Limited 
Address  MSN Group of Companies MSN House Plot No C 24 Industrial Estate Sanathnagar Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  9912099129  
Fax  030438719  
Email  krreddy@msnlabs.com  
 
Details of Contact Person
Scientific Query  
Name  Chandu Devanpally  
Designation  Director Clinical Operations 
Affiliation  Ardent Clinical Research Services 
Address  Room No 1 Ardent Clinical Research Services Office 302 303 Level 3 West Wing Yerwada Pune

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Details of Contact Person
Public Query  
Name  Chandu Devanpally  
Designation  Director Clinical Operations 
Affiliation  Ardent Clinical Research Services 
Address  Room No 1 Ardent Clinical Research Services Office 302 303 Level 3 West Wing Yerwada Pune

Pune
MAHARASHTRA
411006
India 
Phone  9545817447  
Fax    
Email  cdevanpally@ardent-cro.com  
 
Source of Monetary or Material Support  
Ardent Clinical Research Services Nyati unitree west wing third floor office no 302 and 303 pune nagar highway yerwada pune 411006 
 
Primary Sponsor  
Name  MSN Laboratories Private Limited 
Address  Plot No C 24 Industrial Estate Sanathnagar Hyderabad 500 018 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  Not Applicable 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manidip Pal  College of Medicine and JNM Hospital  Department of Gynecology College of Medicine and JNM Hospital Kalyani Nadia West Bengal
Nadia
WEST BENGAL 		 9051678490

manideep2b@yahoo.com 
Dr Vinay Kumar  Department of Surgery, GSVM Medical College  Room no 30 Ground Floor Department of Surgery GSVM Medical College
Kanpur Nagar
UTTAR PRADESH 		 9660640989

vinaysinghkgmc99@gmail.com 
Dr Prem Mohan Jha  Gangasheel Advanced Medical research Institute  5th Floor Clinical Research Department Gangasheel Advanced Medical Research Institute C 17 Deen Dayal Puram
Bareilly
UTTAR PRADESH 		 9810400268
-
Pmjha.nephro@gmail.com 
Dr Suraj Kumar Pattanayak  Government Medical College & Govt General Hospital  Department of Surgery OPD No 03 Ground Floor Government Medical College & Govt General Hospital Srikakulam 532001
Srikakulam
ANDHRA PRADESH 		 9000268524

drskpattanayak@yahoo.com 
Dr Atul Singal  Life Care Hospital  Urology department Ground floor Lekha Nagar Mumbai Agra highway Nashik 422009
Nashik
MAHARASHTRA 		 8141156976
-
dratulsingal88@gmail.com 
Dr Sunirmal Choudhury  Medical College and Hospital Kolkata  ground Floor Department of Urology MCH 88 College street Kolkata 700073
Kolkata
WEST BENGAL 		 8961633090
-
sumir09@gmail.com 
Dr Tushar Narkhede  Omkar ENT Hospital and Research Centre  7th Floor SK Empire Near Ved Mandir Mico Circle Trimbak Road Nashik 422002
Nashik
MAHARASHTRA 		 8306830683

drtushar.narkhede85@gmail.com 
Dr Abhay Dinkarrao Mahajan  Sai Urology Hospital  Plot No.1, Vishal Nagar, Opp. Cada Office, Gajana Maharaj Mandir Road, Aurangabad
Aurangabad
MAHARASHTRA 		 9822321224

drabhaymahajan@gmail.com 
Dr Avijit Kumar  Smt Ramkali Memorial Nursing Home  OPD no 03 Ground Floor Smt Ramkali Memorial Nursing Home 117/H2/184 Kakadeo Pandu Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH 		 9918222900

avijit16@gmail.com 
Dr Rakesh B H  Subbaiah Institute of Medical Sciences  Ground Floor Department Of Urology NH 13 H H road Purle Shivamogga Karnataka 577 222
Shimoga
KARNATAKA 		 9597676399
-
raki.halappa@gmail.com 
Dr Narsing Mane  Supe Hospital  Urology department first floor Opp Adhar ashram near rungta high school gharpure ghat ashok stambh NASHIK
Nashik
MAHARASHTRA 		 9987409430
-
narsingkin@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee of Subbaiah Institute of Medical Sciences  Approved 
Ethics Committee, GSVM Medical College  Approved 
IEC College of Medicine and JNM Hospital  Submittted/Under Review 
Ikon Ethics Committee For Research On Human Subject   Approved 
Institutional Ethics Committee for Human Research  Submittted/Under Review 
Institutional Ethics Committee Gangasheel Advanced Medical Research Institute   Approved 
Institutional Ethics Committee Government General Hospital  Approved 
Muktai Hospital Institutional Ethics Committee  Approved 
Muktai Hospital Institutional Ethics Committee  Submittted/Under Review 
Smt Ramkali Memorial Nursing Home  Approved 
Supe Hospital Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N329||Bladder disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Mirabegron ER Tab 25mg  All patients who get into reference arm will receive a starting dose of Mirabegron ER Tab 25mg for 4 to 8 weeks. 
Intervention  Vibegron 75mg Tablet   All patients who get into Test arm will receive Vibegron 75mg Tablet once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Willing and able to provide written informed consent
2 Males or females greater than 18 years to less than 65 years of age
3 Patients must have a history of OAB as diagnosed by a physician for at least 3
months prior to the Screening Visit defined as urgency, with or without urge
urinary incontinence UUI usually associated with frequency and nocturia
Urodynamic evaluation is not required
4 Meets either the OAB Wet or OAB Dry criteria described below based on the
Bladder Diary returned at Baseline Visit all Complete Diary Days must be used in
determining eligibility A minimum of 4 complete diary days are required for the
diary returned at the Baseline Visit
OAB Wet Criteria
An average of ³ 8 micturition per Diary Day and
An average of ³ 1 UUI episodes per Diary Day and
If stress urinary incontinence is present the total number of UUI episodes must
be greater than the total number of stress urinary incontinence episodes from the
previous visit diary
OAB Dry Criteria
An average of ³ 8 micturition per Diary Day and
An average of ³ 3 urgency episodes per Diary Day and
An average of less than 1.0 UUI episode per Diary Day and
If stress urinary incontinence is present the total number of UUI episodes must
be greater than the total number of stress urinary incontinence episodes from the
previous visit diary
5 For females of reproductive potential: Agrees to remain abstinent or use or have
their male partner use an acceptable method of birth control each time the
patient has intercourse from the Screening Visit until completion of the Follow
up Visit
6 For females of reproductive potential who agree not to donate ova eggs until at
least 1 month after the last dose of Study Treatment
7 Is ambulatory and in good general physical and mental health as determined by
the Investigator
8 In the opinion of the Investigator, is able and willing to comply with the
requirements of the protocol including completing the questionnaires the
Bladder Diary will require ability to collect measure and record voided volume
by herself himself using a graduated urine collection and measurement container
as provided by the Sponsor if needed
 
 
ExclusionCriteria 
Details  1 Patient has a history of 24 hour urine volume greater than 3000 mL in the past 6 months or a Bladder Day measurement greater than 3000 mL during the Screening Period or after any necessary washout period
2 Has lower urinary tract pathology that could in the opinion of the Investigator be responsible for urgency frequency or incontinence including but not limited to urolithiasis interstitial cystitis prostate cancer gastrointestinal cancer tuberculosis stone disease urothelial tumour prostatitis and clinically relevant benign prostatic hypertrophy or bladder outlet obstruction as judged by the Investigator
Note Male patients with mild to moderate BPH without evidence of bladder obstruction asdetermined by the Investigator may be included as long as they have been taking a medication for the treatment of BPH for at a least 1 year prior to Screening with no change in dose of herbal medications alpha antagonist medications or other symptomatic treatments or medications within 3 months prior to Screening and no change in dose of 5 alpha reductase inhibitors within 6 months of Screening
3 Has a history of surgery to correct stress urinary incontinence pelvic organ prolapses or procedural treatments for BPH within 6 months of Screening
4 Has current history or evidence of Stage 2 or greater pelvic organ prolapse
5 Patient is currently using a pessary for the treatment of pelvic organ prolapse
6 Has a known history of elevated post void residual volume defined as greater than 150 mL
7 Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study
8 Has an active or recurrent greater than 3 episodes per year urinary tract infection by clinical symptoms or laboratory criteria greater than or equal to 5 white blood cells and or a positive urine culture defined as greater than or equal to 105 colony forming units CFU per mL in 1 specimen Patients diagnosed with a urinary tract infections at the Screening Visit may be treated and rescreened once the infection has resolved.
9 Has required for an indwelling catheter or intermittent catheterization
10 Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening
11 Has uncontrolled hyperglycemia defined as fasting blood glucose greater than 150 mg per dL or 8 point 33 mmol per L and or non fasting blood glucose greater than 200 mg per dL or 11point 1 mmol per L or if in the opinion of the Investigator is uncontrolled
12 Has evidence of diabetes insipidus
13 Is pregnant breast feeding or is planning to conceive within the projected duration of the study
14 Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer
or in situ cervical cancer
15 Has uncontrolled hypertension systolic blood pressure of greater than or equal to 180 100 mmHg or has a resting heart rate by pulse greater than 100 beats per minute
16 Has a history of cerebral vascular accident transient ischemic attack unstable angina myocardial infarction coronary artery interventions example coronary artery bypass
grafting or percutaneous coronary interventions example angioplasty stent insertion or neurovascular interventions example carotid artery stenting) within 6 months prior to the Screening Visit Patients with these conditions should be on stable medical therapy for at least 3 months prior to the Screening Visit.
17 Has a history of injury surgery or neurodegenerative diseases example multiple sclerosis Parkinsons that could affect the lower urinary tract or its nerve supply
18 Has hematuria including microscopic hematuria greater than 5 red blood cells rbcS per HPF
19 Patients with known fully evaluated benign haematuria may participate
20 Has clinically significant electrocardiogram abnormality that in the opinion of the Investigator exposes the patient to risk by participating in the study
21 Has a known history of liver disease Has alanine aminotransferase or aspartate aminotransferase greater than 2 point 0 times the upper limit of normal or bilirubin total
Bilirubin greater than 1 point 5 X ULN or greater than 2 point 0 X ULN if secondary to Gilbert
syndrome or pattern consistent with Gilbert syndrome
22 Has clinically significant laboratory abnormality from the Screening Visit results that remains unresolved after repeat testing or that could confound the results of the
study or indicate that it is not in the best interest of the patient to participate
23 Has an estimated glomerular filtration rate eGFR less than 30
mL per min per 1 point 73 m2
24 Use of any prohibited medications as detailed in Prohibited Medication and Non Drug therapies suitable washout periods from these medications are also described therein
25 Has an allergy intolerance or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the Vibegron and or the Mirabegron ER 25mg per 50mg Tablet formulation
26 Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent
27 Has a history of significant drug or alcohol abuse dependence within a year prior to informed consent as assessed by the investigator
28 Has coronary or neurovascular interventions planned during the duration of the study
29 Has a history or current evidence of any condition therapy lab abnormality or other circumstance that might in the opinion of the Investigator confound the results of the study interfere with the patients ability to comply with study procedures or make participation in the study not in the patients best interest
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Change in average number of micturition per 24 hours in all OAB patients
2 change in average number of urge urinary incontinence episodes per 24 hours in OAB Patients
 		 1 baseline to week 12
2 Baseline to week 12 
 
Secondary Outcome  
Outcome  TimePoints 
1 Change in average number of urgency episodes need to urinate immediately over 24 hours in all OAB patients
2 Percent of OAB Wet patients with at least a 75% reduction
3 Percent of OAB Wet patients with a 100% reduction from
4 Percent of all OAB patients with at least a 50% reduction
5 change in average number of total incontinence episodes over 24 hours in OAB Wet patients
6 Change in Coping Score from the Overactive Bladder Questionnaire Long Form OAB-q 1week recall in all OAB patients
7 Change in average volume voided per micturition in all OAB patients
8 assessing the improvement in Overactive Bladder Symptoms Score
 		 1 from Baseline to Week 12
2 from baseline in UUI episodes per 24 hours at Week 12
3 baseline in UUI episodes per 24 hours at Week 12
4 from baseline in urgency episodes need to urinate
immediately per 24 hours a Week 12
5 from Baseline to Week 12
6 from Baseline to Week 12
7 from Baseline to Week 12
8 from Baseline to Week 12
 
 
Target Sample Size   Total Sample Size="222"
Sample Size from India="222" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
A Phase III, randomized, open label, active controlled, multicenter study to evaluate the safety and efficacy of Vibegron 75 mg tablet, in comparison with reference product Mirabegron ER 25mg/50mg Tablet in Patients with Overactive Bladder (OAB). Approximately 222 men and women with overactive bladder will be enrolled at 8 to 10 study sites. At Baseline, patients who meet all eligibility criteria are randomized 1:1 ratio to receive either vibegron 75 mg, or Mirabegron ER 25mg/50mg Tablet in an open- label fashion. Between the Baseline and Week 12 Visits, patients will attend Visits at Week 2, week 4 and week 8.
This study consists of a Screening Period (2 weeks), a randomized Treatment Period (12 weeks), and a Safety Follow-up Period (2 weeks). Patients will have a Follow-up Visit approximately 14 days after the patient’s last dose of Study Treatment (i.e., at Week 14 for patients who complete the Week 12 Visit, or approximately 2 weeks after withdrawal for patients who discontinue the study early). Additionally, Unscheduled Visit(s) may be arranged for patients with study-related safety concerns as needed.Patients will be screened based on Demographics, Physical examination including vital signs (heart rate, blood pressure, body temperature, respiratory rate), past medical history, medication history, haematology, biochemistry, serology, Serum pregnancy test, Urine analysis, 12-lead ECG. On Day 0, the eligible patients will be randomized to receive one of the treatments arms tests drugs or active comparator group which will be administered for 12 weeks. End of study assessment will be performed at week 14. As per the Investigator’s opinion if there is a need to change the line of treatment for the patient then the patient will be withdrawn from the study and managed as per treating physician’s discretion. If any time during the study, the investigator performs any laboratory test as per his/her discretion the data will be captured in the source data. Adverse events (serious, non-serious, unexpected, expected, related, not related) will be monitored throughout the study period. The study will last approximately 12 weeks. The follow-up period will last for 14 days after the patient’s last dose under the study treatment (i.e. at week 12).
 
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