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TC-3 mixed with Botox · 1 trial · 2 indications
Change from baseline in Visual Analog Scale (VAS) score for bladder pain measured at week 12 post BTX+TC-3 instillation.
| Arm | Type | Description |
|---|---|---|
| TC-3 Gel with Botox | EXPERIMENTAL | open label observational study |
| Name | Type | Description |
|---|---|---|
| TC-3 Gel mixed with Botox (BTX) | DEVICE | TC-3 gel mixed with Botox (BTX). Single intravesical instillations of 40 ml of TC-3 mixed with 200 units of preconstitued BTX, using catheter |
Inclusion Criteria: 1. Subject diagnosed with Interstitial Cystitis/PBS. 2. Subject has signed Informed Consent Form and is willing and able to abide by the protocol. 3. Subject has IC Symptom index (of IC Symptom and Problem Questionnaire) score of 12-20 points. 4. Subject has IC Problem index (of...
TC-3 mixed with Botox is an investigational intravesical gel being studied for the treatment of interstitial cystitis, a chronic bladder condition. It is administered as an instillation directly into the bladder. The combination is designed to deliver botulinum toxin within a gel formulation for local therapeutic effect.
TC-3 mixed with Botox is being developed by UroGen Pharma Ltd., a biopharmaceutical company focused on urological treatments. UroGen Pharma Ltd. trades on the NASDAQ under the ticker symbol URGN.
TC-3 mixed with Botox is in Phase 1 clinical development. It has completed a Phase 1 trial, and the drug remains investigational, meaning it has not been approved by regulatory authorities. Further clinical studies would be required to assess its safety and efficacy.
TC-3 mixed with Botox has one completed clinical trial, registered as NCT01997983, titled "Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients." This Phase 1 study enrolled 15 participants with interstitial cystitis in Israel.
TC-3 mixed with Botox combines botulinum toxin with a gel formulation for intravesical instillation. The botulinum toxin is intended to act locally within the bladder, potentially reducing pain and urinary symptoms associated with interstitial cystitis. The gel is designed to facilitate delivery and retention of the toxin in the bladder.
TC-3 mixed with Botox is not the same as Botox alone. It is a combination product that mixes botulinum toxin with a proprietary gel called TC-3, designed for intravesical delivery. This formulation is being studied specifically for interstitial cystitis, whereas Botox alone is used for various other indications.