Alenura (lidocaine/heparin) / Vaneltix - LARVOL DELTA

AN ONGOING EVALUATION OF VNX001, A STABLE DOSAGE FORM OF ALKALINIZED LIDOCAINE AND HEPARIN, VERSUS ITS COMPONENTS, AND PLACEBO, IN THE TREATMENT OF BLADDER PAIN ASSOCIATED WITH IC/BPS (AUA 2025) - P2 | "The study is powered to show superiority of VNX001 over the comparators.Subjects greater than 18 years of age who had symptoms of IC/BPS and met minimum eligibility for treatment by symptom scores evaluation and a pain of at least 5 on the 11 point visual analog pain scale (0-10), and who otherwise met enrollment criteria for treatment were eligible for randomization into the study. Major exclusion criteria included the use of opiates or medical marijuana, or the recent prior use of anesthetics, or other analgesics and the presence of gross hematuria, or suspected UTI.The study has currently enrolled over 60 subjects (predominantly female) and the data was recently reviewed by the IDMC."

Clinical • Anesthesia • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Vaneltix Pharma, Inc. | Trial completion date: May 2025 ➔ Dec 2025 | Trial primary completion date: May 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Vaneltix Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Vaneltix Pharma, Inc. | Initiation date: Aug 2024 ➔ Dec 2024

Trial initiation date • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects with IC/BPS (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Vaneltix Pharma, Inc. | Trial completion date: May 2024 ➔ May 2025 | Trial primary completion date: May 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Interstitial Cystitis • Musculoskeletal Pain • Pain

Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis (clinicaltrials.gov) - P2 | N=28 | Terminated | Sponsor: Urigen | Completed ➔ Terminated; The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.

Trial termination • Gynecology • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety, Efficacy, and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Vaneltix Pharma, Inc.

New P2 trial • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Vaneltix Pharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Interstitial Cystitis • Musculoskeletal Pain • Pain

Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Vaneltix Pharma, Inc.

New P2 trial • Interstitial Cystitis • Musculoskeletal Pain • Pain

Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2; N=58; Not yet recruiting; Sponsor: Walter Reed National Military Medical Center

Clinical • New P2 trial • Anesthesia • Interstitial Cystitis • Pain

Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (clinicaltrials.gov) - P2; N=348; Recruiting; Sponsor: Urigen

New P2 trial • Biosimilar • Immunology • Inflammation • Pain

AN INNOVATIVE TREATMENT APPROACH TO HEREDITARY ALPHA-TRYPTASEMIA AND INTERSTITIAL CYSTITIS (ACAAI 2019) - "Pharmacotherapy, including omeprazole, hyoscyamine, cromolyn, methimazole, propranolol, sumatriptan, fexofenadine and oral prednisone incompletely improved her symptoms; she still had persistent abdominal cramping, dyspepsia, tachycardia, fatigue and headaches...She began bladder instillations for IC with heparin, lidocaine, sodium bicarbonate and sterile water, which improved her urinary symptoms and her headaches, abdominal cramping, fatigue, palpitations and exercise tolerance...β-tryptase is encoded by both TPSAB1 and TPSB2, while α-tryptase is only encoded by TPSAB1. Normally, α- and β-tryptase gene copies should add up to four; HAT occurs when there is an α-tryptase duplication and the summation of α-tryptase + β-tryptase is > 5."

Chronic scrotal pain: A variable symptom of interstitial cystitis/bladder pain syndrome. (PubMed, Urol Ann) - "Patients with chronic idiopathic scrotal content pain were evaluated, determined to have chronic idiopathic scrotal content pain, and were treated with either pentosan polysulfate sodium (PPS) or bladder instillations of alkalinized lidocaine and heparin. This scrotal pain may actually be referred pain from the bladder. Standard therapies for IC/BPS may be a treatment option for chronic idiopathic scrotal pain."

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