Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS

ClinicalTrials.gov ID: NCT05737121

Public ClinicalTrials.gov record NCT05737121. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 20, 2026, 11:56 PM EDT

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Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of VNX001 Compared to Placebo, and the Individual Components of Lidocaine, and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity; The Engage 2024 Study

Study identification

NCT ID: NCT05737121
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Vaneltix Pharma, Inc.; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Interventions

Heparin Drug
Lidocaine Drug
Placebo Drug
VNX001 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 21, 2023
Primary completion: May 31, 2026
Completion: May 31, 2026
Last update posted: Jan 21, 2026

2023 – 2026

United States locations

U.S. sites: 14
U.S. states: 8
U.S. cities: 13

Facility	City	State	ZIP	Site status
IC Study LLC	Escondido	California	92025	Suspended
University of California Los Angeles Center for Women's Pelvic Health	Los Angeles	California	90095	Completed
The Clark Center for Urogynecology	Newport Beach	California	92663	Recruiting
The Continence Center Medical Group, Inc dba Southern California Continence Center	Newport Beach	California	92663	Completed
University of California San Diego Medical Center	San Diego	California	92103	Recruiting
Prestige Medical Group	Tustin	California	92780	Recruiting
United Research Institute	Hialeah	Florida	33012	Recruiting
Florida Urology Partners	Tampa	Florida	33615	Recruiting
Georgia Urology	Cartersville	Georgia	30120	Recruiting
Southern Clinical Research Associates LLC	Metairie	Louisiana	70001	Recruiting
Bay State Clinical Trials	Watertown	Massachusetts	02472	Recruiting
Sheldon Freedman MD LTD	Las Vegas	Nevada	89144	Recruiting
Northwell Health	Lake Success	New York	11042	Recruiting
The Wake Forest Institute of Regenerative Medicine	Winston-Salem	North Carolina	27101	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05737121, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 21, 2026 · Synced May 20, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05737121 live on ClinicalTrials.gov.

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