Recruiting

Phase 2

VNX001Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS

Sponsor:

Vaneltix Pharma, Inc.

Code:

NCT05737121

Conditions

Interstitial Cystitis

Bladder Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VNX001

Placebo

Lidocaine

Heparin

Study Details

Brief summary:

This is a Phase 2, prospective, randomized, double-blind, placebo-controlled, multi-center, single-dose, pharmacodynamic study designed to evaluate the efficacy and safety of the combination product (VNX001) versus placebo and its individual components (heparin sodium and lidocaine hydrochloride (HCl)) for the reduction of bladder pain in patients with interstitial cystitis (IC) / bladder pain syndrome (BPS), Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity.

Conditions

Interstitial Cystitis

Bladder Pain Syndrome

Study ID

NCT05737121

Start date

May 22, 2023

Status verified date

Jan, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Be able and willing to give a signed informed consent and to follow study instructions
Be male or female, ≥ 18 years of age
Have a history of IC/BPS for at least 9 months prior to the study
Have a score of ≥ 16 and ≤ 30 on the Pelvic Pain and Urgency/Frequency (PUF) questionnaire, completed at screening
Have an episode of acute bladder pain of moderate to severe intensity with a minimum score of 5 on the 11-point bladder pain NRS at time of screening and 15 minutes post void immediately prior to study drug administration.
Have previously received a therapeutic intravesicular anesthetic treatment according to medication history

Exclusion Criteria:

For females, have a positive pregnancy test at screening or be pregnant or lactating
Males who are sexually active with females and are not willing to commit to an acceptable method of birth control for the duration of the
Postmenopausal women who, if taking hormone replacement therapy, have not been stabilized on a regimen of hormone replacement therapy within 3 months of screening
Have a known hypersensitivity to heparin or lidocaine
Have used any local anesthetic by any route within 48-hours prior to study drug administration, or used a lidocaine patch or lidocaine containing topical compounds within 14 days prior to study drug administration
Have used a tricyclic antidepressant, or a gamma-aminobutyric acid (GABA) analogue (gabapentin or pregabalin), unless taking a stable dose of the medication for ≥ 3 weeks. The stable dose of gabapentin may not exceed 1,200 mg per day, and the stable dose of pregabalin may not exceed 150 mg per day
Have used any pain medication within 6 hours prior to study drug administration
Have used narcotics or medical marijuana ≤ 3 weeks prior to study entry
Have used prohibited drugs as determined by self-report, positive urine drug screen, or in the opinion of the investigator be under the influence of drugs affecting mentation precluding their ability to follow the study protocol or bias study results
Have a known abnormal laboratory test value that, in the investigator's judgement, is clinically significant.
Have a neurogenic bladder or other disorder that, in the opinion of the investigator, may cause neurogenic bladder (including Parkinson's disease, multiple sclerosis, epilepsy, myasthenia gravis, movement disorders, spinal cord damage)
Have pain or a pain disorder that, in the opinion of the investigator, would make it difficult to discriminate pelvic pain of bladder origin from the other pain
Have any of the following central nervous system (CNS) conditions that in the opinion of the investigator would impact the subject's study participation due to their ability to follow the study protocol or bias study results, severe diagnosed: major depressive disorder, bipolar disorder, schizophrenia, general anxiety disorder, attention deficit disorder, obsessive compulsive disorder, or other major central nervous system disorder
Have history of arrhythmias, conduction disturbances, or cardiac disease, or any coexisting medical condition that, in the opinion of the investigator, may be significant or interfere with study procedures or interpretation of study results
Had anesthetic bladder instillation therapy within 14 days prior to study entry
Had an in-office cystoscopy within 7 days of study drug administration
Had dilatation (hydrodistension) of bladder within 3 months of study entry
Evidence or suspected presence of cancer detected during cystoscopy 7 days prior to or at time of initial screening
Has received any investigational drug or device within 30 days prior to screening
Is currently enrolled in another investigational drug or device study
Is unwilling or unable to abide by the requirements of the study
Have an actively bleeding lesion or area in the bladder as detected by dipstick urinalysis and investigator assessment, immediately prior to randomization
Have a history of coagulopathy or taking anticoagulants.
Are taking any of the following medications, which are inducers of CYP1A2 and/or CYP3A4: Phenytoin, Carbamazepine, St. John's Wort, Phenobarbital, Rifampin
Have had any of the following:

Bacterial cystitis within 30 days as demonstrated by a positive urine culture (≥ 105 bacteria per mL)
History of pelvic irradiation or radiation cystitis
History or presence of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancer
History of benign or malignant bladder tumors
Current chemotherapy
History or presence of tuberculous cystitis
History or presence of chemical cystitis, including that due to cyclophosphamide
History or presence of urinary schistosomiasis
Bladder or ureteral calculi
Clinically significant infectious vaginitis
Currently uncontrolled genital herpes
History or presence of urethral diverticulum
Presence of bladder fistulae
History of ketamine use

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VNX001

VNX001 (lidocaine HCl \[200 mg\] and heparin sodium \[50,000 USPU\] in alkalinized buffer), administered as a single dose via intravesical instillation; n=45 (anticipated)

placebo comparator: Placebo

Alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)

experimental: Lidocaine

Lidocaine HCl (200 mg) in alkalinized buffer, administered as a single dose via intravesical instillation; n=45 (anticipated)

experimental: Heparin

Heparin sodium (50,000 USPU) in alkalinized buffer, administered as a single dose via intravesical instillation; n=15 (anticipated)

Interventions

VNX001

VNX001 (alkalinized lidocaine HCl and heparin sodium)

Placebo

Inactive placebo for VNX001

Lidocaine

Alkalinized lidocaine hydrochloride

Heparin

Alkalinized heparin sodium

Primary outcome measure

Sum of bladder pain intensity differences from baseline to 12 hours post-dose (SPID-12) [ Time Frame: 12 hours ]

Central Contacts and Locations

Central contacts

Vaneltix Pharma, Inc.

732-354-3217 info@vaneltix.com

Locations

The Clark Center for Urogynecology

Recruiting

Newport Beach, California, United States, 92663

University of California San Diego Medical Center

Recruiting

San Diego, California, United States, 92103

Prestige Medical Group

Recruiting

Tustin, California, United States, 92780

United Research Institute

Recruiting

Hialeah, Florida, United States, 33012

Florida Urology Partners

Recruiting

Tampa, Florida, United States, 33615

Georgia Urology

Recruiting

Cartersville, Georgia, United States, 30120

Southern Clinical Research Associates LLC

Recruiting

Metairie, Louisiana, United States, 70001

Bay State Clinical Trials

Recruiting

Watertown, Massachusetts, United States, 02472

Sheldon Freedman MD LTD

Recruiting

Las Vegas, Nevada, United States, 89144

Northwell Health

Recruiting

Lake Success, New York, United States, 11042

The Wake Forest Institute of Regenerative Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27101

More Information

Sponsor

Vaneltix Pharma, Inc.

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Keywords

interstitial cystitis (IC)
bladder pain syndrome (BPS)
alkalinized lidocaine
heparin
intravesical
VNX001

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vaneltix Pharma, Inc. on 2026-01-22.