FDA green lights trial of needle-free drug delivery system for overactive bladder

The FDA has cleared an investigational new drug (IND) application for a phase 2 study evaluating ViXe, an investigational product that combines an ultrasound-based, needle-free drug delivery system (Vibe) with incobotulinumtoxinA (Xeomin) for adults with overactive bladder (OAB), according to an announcement from Vensica Medical.¹

If successful, the approach could offer an alternative to intravesical injections of botulinum toxin, which are guideline-supported for patients with OAB refractory to behavioral and pharmacologic therapy but may be underused due to the invasive nature of the procedure.²

“FDA clearance of this IND is an important milestone for Vensica and validates the clinical rationale behind the ViXe program,” Avner Geva, CEO of Vensica Medical, said in the company news release.¹ “Botulinum toxin is a proven therapy for OAB, but needle-based delivery remains a barrier for many patients. We believe ViXe has the potential to expand access to a much broader population.”

The planned multicenter phase 2 study is expected to enroll approximately 210 patients across the United States and Europe, with enrollment anticipated to begin in the third quarter of 2026. The company said the trial will assess the safety and efficacy of ultrasound-enabled delivery of botulinum toxin type A into the bladder wall without needles.

Platform and drug background

Vensica’s Vibe platform uses focused ultrasound technology to generate cavitation and facilitate localized drug penetration directly into the bladder wall, according to the company.³ The pharmacologic component, incobotulinumtoxinA, is an FDA-approved botulinum toxin type A product currently indicated in the US for several neurologic and movement disorders, including cervical dystonia and blepharospasm.⁴

“The Vibe platform was specifically engineered to overcome biological barriers that have historically limited needle-free delivery of large-molecule drugs,” Avi Eftel, cofounder and chief technology officer of Vensica Medical, said in the news release.¹ “We look forward to executing this study and generating data to further demonstrate the clinical value of our approach.”

Why this matters clinically

OnabotulinumtoxinA is an established second-line therapy for patients who have an inadequate response to or intolerable adverse effects from pharmacotherapy or behavioral therapy,² but office-based cystoscopic injection can be a barrier for some patients. A needle-free method that reliably deposits toxin directly into the bladder wall could potentially broaden acceptance of chemodenervation therapy.

“This IND clearance represents a key milestone in Vensica’s development and highlights the potential of the ViXe program,” Ken Berlin, executive chairman at Vensica Medical, said in the news release.¹ “A needle-free approach to botulinum toxin delivery could meaningfully expand patient access and create significant value for patients, partners, and investors.”

REFERENCES

1. Vensica Medical receives FDA IND clearance to initiate phase 2 study of ViXe, its needle-free Xeomin delivery system for overactive bladder. News release. Vensica Medical. April 28, 2026. Accessed April 28, 2026. https://www.businesswire.com/news/home/20260414145279/en/Vensica-Medical-Receives-FDA-IND-Clearance-to-Initiate-Phase-2-Study-of-ViXe-Its-Needle-Free-Xeomin-Delivery-System-for-Overactive-Bladder

2. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. 2024;212(1):11-20. doi:10.1097/JU.0000000000003985

3. Vensica Medical. Accessed April 28, 2026. https://vensica.com/#treatments

4. Xeomin. Prescribing information. Merz Pharmaceuticals; 2023. Accessed April 28, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125360s097lbl.pdf