Trial Profile

Multicentre, Randomized, Open-label Study to Prove an Additional Benefit of the Full-spectrum Cannabis Extract VER-01 Over Opioids in the Treatment of Patients With Chronic Non-specific Low Back Pain

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 22 Jun 2026

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At a glance

Drugs Dronabinol (Primary) ; Buprenorphine; Fentanyl; Hydromorphone; Morphine; Naloxone; Oxycodone; Tapentadol; Tilidine; Tramadol
Indications Back pain
Focus Adverse reactions; Registrational
Acronyms ELEVATE
Sponsors Vertanical

09 Jun 2026 According to a Vertanical media release, Exilby (VER-01) has received marketing authorization in Germany for the treatment of chronic low back pain with a radicular (neuropathic) component
18 May 2026 According to a Vertanical media release, the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to VER-01 based on results from phase 3 program.
01 Oct 2025 Results presented in Vertanical media release.

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