Vensica Medical has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (IND) application, allowing the company to initiate a Phase II clinical trial for its ViXe programme, a needle-free therapeutic approach for treating Overactive Bladder (OAB).

The upcoming study will evaluate the company’s proprietary Vibe platform, an ultrasound-based drug delivery system, in combination with Xeomin. The approach aims to deliver botulinum toxin directly into the bladder wall without the need for injections, addressing a key limitation of current treatment methods.

Overactive bladder is estimated to affect around 33 million adults in the United States and is marked by symptoms such as urinary urgency, frequent urination and incontinence. While botulinum toxin injections are widely used as a second-line treatment, their invasive nature often restricts patient adoption. Vensica’s ViXe programme is designed to overcome this barrier by offering a non-invasive alternative.

The Phase II trial is expected to enroll approximately 210 patients across multiple sites in the United States and Europe. The study will assess both the safety and efficacy of the Vibe-enabled delivery of botulinum toxin type A, with patient enrollment anticipated to begin in the third quarter of 2026.

According to company leadership, the IND clearance validates the scientific rationale behind the ViXe programme and represents a significant milestone in its clinical development. The company believes that a needle-free delivery system could expand access to treatment for a broader patient population.

The Vibe platform has been engineered to address biological barriers that have historically limited the delivery of large-molecule drugs without needles. Vensica aims to generate clinical data that demonstrates the effectiveness and patient benefits of this technology.

The IND clearance also triggers a development milestone payment from the company’s strategic partners, supporting the execution of the Phase II trial. Vensica is backed by investors and partners including Merz Pharma, Laborie and Israel Biotech Fund.

Vensica Medical continues to focus on advancing needle-free therapeutic delivery solutions for urologic diseases through its proprietary ultrasound-based platform, with the ViXe programme as its lead clinical initiative.