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Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 22, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site details revised at 1 of 5 sitesv10
  2. Primary and study completion dates: Dec 2025 to Jun 2026v9
  3. Site details revised at 2 of 5 sitesv8
  4. Primary and study completion dates: Jun 2025 to Dec 2025v7
  5. Site details revised at 2 of 5 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Site details revised at 1 of 5 sitesv5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Dec 2024 to Dec 13, 2024
    v4
  3. Start date: Aug 2024 to Dec 2024v3
  4. Start date: Jun 2024 to Aug 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS). The study will assess PRN (as needed) dosing of up to 6 intravesical (via catheter) doses of VNX001 (study drug) to treat acute instances of moderate to severe bladder pain over a 14-day period. The main aim of the study is to tally the number of doses and assess pain before and after doses. The study will review the safety and tolerability of VNX001. Participants will need to attend up to seven (7) clinic visits (1 for screening and up to 6 visits for VNX001 dosing) or at least one (1) clinic visit (for a combined screening/dosing visit) and 5 telephone visits over the course of 14 days. Participants will also be asked complete a diary or telephone call each day of the study, in order to record bladder pain, urinary urgency, side effects, and medications taken.
Trial Details
NCT Number NCT06394830
Lead Sponsor Vaneltix Pharma, Inc.
Collaborators: Prevail Infoworks
Conditions
(from sponsor)		 Interstitial Cystitis, Bladder Pain Syndrome
Related terms Cystitis, Interstitial
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov