Exilby® - The first cannabis medicine for back pain

What is Exilby® (VER-01)?

Exilby® is the trade name of the active ingredient candidate VER-01, a cannabinoid-based medicine developed by the Munich biopharmaceutical company Vertanical for the treatment of chronic low back pain (CLBP). The preparation received market authorization in 2026 as the first cannabis-based finished medicinal product in Europe for this indication. Unlike medical cannabis flowers or individually prepared cannabis extracts, Exilby® is a standardized, industrially manufactured medicine with a defined composition, fixed dosage, and extensive clinical testing.

What is Exilby® made of?

VER-01 is an oral solution based on a standardized full-spectrum cannabis extract from a specially developed Cannabis sativa strain (DKJ127 L.). In addition to the main active ingredient Δ9-tetrahydrocannabinol (THC), the preparation contains other cannabinoids and bioactive plant compounds, including:

• Cannabigerol (CBG)
• β-Caryophyllene
• α-Bisabolol

other cannabinoids and terpenes.

This combination is intended to influence various mechanisms of pain processing and thereby not only reduce pain but also improve accompanying symptoms such as sleep disturbances and limitations in quality of life.

For which patients was Exilby® developed?

The approval is aimed at adult patients with chronic nonspecific low back pain for whom non-opioid analgesics have not provided sufficient relief or cannot be used due to intolerance or contraindications. Chronic low back pain is one of the most common causes of disability and work incapacity worldwide. Many affected individuals also suffer from sleep problems, depressive moods, and significantly reduced quality of life.

Why is Exilby® a milestone?

The significance of Exilby® lies in the fact that, for the first time, a cannabis-based medicine has successfully completed full clinical development with Phase III studies and obtained European market authorization for chronic back pain. Until now, cannabinoids in Europe have mainly been used as medical cannabis or magistral preparations.

Furthermore, Vertanical positions Exilby® as a non-opioid alternative. In clinical studies, VER-01 demonstrated not only significant pain relief but also benefits in sleep quality and physical function. Additionally, no signs of dependence or withdrawal symptoms were observed. Exilby® (VER-01) is a standardized, prescription cannabis medicine for the treatment of chronic low back pain. It combines THC with other cannabinoids and terpenes in a defined formulation and is the first cannabis-based finished medicinal product in Europe to receive market authorization for this indication.

This development could mark a turning point in evidence-based cannabinoid therapy for chronic pain.

For which condition was Exilby approved?

Exilby® (VER-01) has been approved for the treatment of chronic low back pain (CLBP). This refers to pain in the lumbar spine area that lasts for at least twelve weeks and is often associated with significant mobility restrictions, sleep disturbances, and reduced quality of life.

The approval is specifically aimed at adult patients for whom previous non-opioid treatments have not provided sufficient pain relief. Chronic low back pain is one of the most common causes of disability and work incapacity worldwide, affecting several hundred million people.

What is chronic low back pain?

Chronic low back pain refers to pain in the lower back that persists over a longer period and no longer serves as an acute warning signal. Often, there are no clearly treatable structural causes. The condition develops into an independent chronic pain syndrome, which is often accompanied by additional complaints:

Common accompanying symptoms

• Sleep disorders
• Limited mobility
• Reduced physical performance
• Depressive moods
• Neuropathic pain components

These accompanying symptoms were also a focus of the clinical development program for VER-01.

Why is the approval remarkable?

The approval of Exilby® is particularly significant because it is the first cannabinoid-based medicine approved in Europe specifically for chronic low back pain. The decision is based on several Phase III studies involving more than 1,000 patients, in which VER-01 demonstrated significant pain relief as well as improvements in sleep quality and physical function.

Furthermore, the drug was developed as a non-opioid treatment option. In the ELEVATE study, VER-01 even showed better pain reduction and tolerability than the opioid therapies examined.

Why is the approval considered a historic milestone?

The approval of Exilby® (VER-01) is considered a historic milestone because it is the first cannabinoid-based medicine in Europe to receive regular market authorization for the treatment of chronic low back pain. Unlike medical cannabis or individually prepared cannabis formulations, Exilby® was tested in extensive Phase III clinical trials and evaluated according to the same scientific standards as other prescription drugs.

Furthermore, the approval opens up a new, non-opioid treatment option for patients with chronic back pain. It could pave the way for further cannabinoid-based medicines and sustainably strengthen the role of cannabinoids in evidence-based pain therapy.

How does VER-01 work in chronic back pain?

VER-01 works through the body's own endocannabinoid system, which is involved in regulating pain, inflammation, and sleep. The cannabinoids contained influence pain signals in the central and peripheral nervous systems and can thereby reduce pain intensity. At the same time, VER-01 showed positive effects on sleep quality and physical function in patients with chronic lower back pain in clinical studies. 

Which studies demonstrate the efficacy?

The efficacy of Exilby® (VER-01) is primarily supported by two approval-relevant Phase III studies:

VER-CLBP-001: Comparison with Placebo

The international Phase III study VER-CLBP-001 investigated more than 800 patients with chronic lower back pain. After 12 weeks, patients treated with VER-01 achieved significantly greater pain reduction than those on placebo. Additionally, sleep quality, physical function, and quality of life improved. The positive effects were maintained during long-term observation.

ELEVATE Study: Comparison with Opioids

In the Phase III ELEVATE study, VER-01 was directly compared to an opioid therapy. VER-01 showed stronger pain relief, better sleep quality, and significantly better gastrointestinal tolerability. In particular, constipation occurred much less frequently than with opioids.

This makes VER-01 one of the best-studied cannabinoid-based medicines for chronic pain, with an evidence base that meets the requirements of European drug approval.

How does VER-01 compare to opioids?

In the Phase III ELEVATE study, VER-01 demonstrated greater pain reduction than the opioid therapy tested. At the same time, patients reported better sleep quality and fewer side effects, especially significantly less constipation. Thus, VER-01 represents a promising non-opioid treatment option for patients with chronic lower back pain.

What benefits does the new therapy offer patients?

Exilby® (VER-01) offers patients with chronic lower back pain a new, non-opioid treatment option. In clinical studies, the therapy led to significant pain relief as well as improvements in sleep quality, physical function, and quality of life. At the same time, VER-01 showed a favorable tolerability profile and caused fewer typical side effects than opioids, particularly fewer gastrointestinal complaints. Additionally, no signs of physical dependence or relevant withdrawal symptoms were observed in the studies.

What side effects were observed?

In the Phase III study, VER-01 showed an overall good safety profile. Most side effects were mild to moderate and occurred mainly during the initial dose adjustment. The most common were dizziness, nausea, fatigue, dry mouth, and drowsiness. Serious side effects did not occur more frequently than with placebo. Furthermore, researchers found no evidence of abuse, dependence, or withdrawal symptoms after stopping therapy. These results indicate an overall good long-term tolerability of VER-01 in patients with chronic lower back pain.

What does the approval mean for cannabis medicine in Europe?

The approval of Exilby® (VER-01) marks a turning point for cannabis medicine in Europe. For the first time, a cannabinoid-based medicinal product has been approved based on large Phase III studies according to the same scientific and regulatory standards as other prescription drugs.

This shifts the focus from medical cannabis as an individual therapy option to evidence-based cannabis medicines with proven efficacy, safety, and standardized dosing. The approval could also pave the way for further cannabinoid-based drugs in areas such as neuropathic pain, osteoarthritis, or other chronic pain conditions and further strengthen the acceptance of cannabinoid therapy in modern medicine.

What does the approval mean for our market for the medical device CANNEFF?

The key message is: A European medicinal product approval strengthens the credibility of the entire cannabinoid sector.

Until now, cannabis was often viewed in many medical circles as a therapy with limited evidence. With Exilby®, there is now for the first time an approval based on large Phase III studies. This increases the acceptance of cannabinoids among:

• Doctors
• Pharmacists
• Health insurance companies
• Authorities
• Patients

Other cannabinoid-based products like CANNEFF also generally benefit from this.

A patient with vaginal dryness, vaginal atrophy, cervicitis, or hemorrhoidal complaints will not have to choose between Exilby® and CANNEFF. The indications do not overlap.

Indirect opportunities for CANNEFF

From a marketing perspective, the approval could even be helpful.

• Cannabis is increasingly perceived as a serious medical substance class.
• Doctors are more frequently engaging with the endocannabinoid system.
• The scientific discussion around cannabinoids is increasing.
• The media report much more positively about cannabinoid-based therapies.

This lowers the barrier for doctors to also engage with local CBD-based medical products.

The approval simultaneously sets a new evidence standard.

When an approved cannabis medicine can refer to phase III data with over 800 patients, professionals will increasingly ask:

• What evidence exists for other cannabinoid-based products?
• Which studies are available?
• Which clinical endpoints were investigated?

For CANNEFF®, it will therefore become even more important to actively communicate the existing studies on CBD and hyaluronic acid and to clearly position itself as an evidence-based medical product. For CANNEFF®, the approval of Exilby® is more of a market validation than a threat. It confirms that cannabinoid-based therapies can make their way into evidence-based medicine. Since Exilby® and CANNEFF® serve different indications, mechanisms of action, and regulatory categories, there is hardly any direct competition. In the long term, the increasing acceptance of cannabinoids is even likely to help increase interest in products like CANNEFF® with CBD and hyaluronic acid.

What does the approval mean for the flower market in Germany?

The approval of Exilby® is likely to change the market for cannabis flowers in Germany in the long term, but not to displace it. Rather, a clear distinction between approved cannabis medicines and prescribed cannabis flowers is emerging for the first time.

So far, cannabis flowers have often been used despite the lack of approval for many indications and only limited clinical evidence. Exilby® now offers doctors a standardized alternative with fixed dosing, reproducible quality, and approval based on large phase III studies. For chronic lower back pain, this could lead some doctors to prefer Exilby® over cannabis flowers in the future.

At the same time, cannabis flowers will continue to play an important role. They cover numerous other areas of application, allow for individual dosing, and are especially used in patients who do not respond sufficiently to standardized finished medicinal products.

In the long term, however, the approval of Exilby® could increase pressure on the flower market. Health insurers, doctors, and authorities will increasingly ask why cannabis flowers should be prescribed for a particular indication when an approved drug with proven efficacy is available.

The approval of Exilby® is likely not the end of the flower market but the beginning of stronger segmentation. For indications with approved cannabis medicines, flowers could lose market share. However, for many other areas of application, they will continue to be an important therapy option. Manufacturers who also pursue the path through clinical studies and regular drug approvals in the future are likely to benefit especially.

What other indications does Vertanical plan?

After the approval of Exilby® (VER-01) for chronic low back pain, Vertanical is already working on expanding the scope of use. The current focus is primarily on two other chronic pain conditions:

• Osteoarthritis (OA)
• Painful diabetic peripheral neuropathy (PDPN)

Both indications are already in the company's development pipeline and are to be investigated in further clinical studies.

The selection of these diseases is obvious: Both osteoarthritis and diabetic neuropathic pain are among the most common causes of chronic pain and are often associated with a high need for long-term, well-tolerated therapy options. If the efficacy of VER-01 is also confirmed in these indications, the preparation could develop into a more broadly applicable non-opioid pain therapy.

In the long term, Vertanical pursues the strategy of establishing VER-01 as a platform therapy for various chronic pain syndromes.

Sources:

Karst, M., Meissner, W., Sator, S., Keßler, J., Schoder, V., & Häuser, W. (2025). Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nature medicine, 31(12), 4189–4196. https://doi.org/10.1038/s41591-025-03977-0

https://www.prnewswire.com/news-releases/vertanical-receives-first-european-marketing-authorization-for-exilby-as-a-first-in-class-non-opioid-treatment-for-chronic-low-back-pain--pivotal-us-phase-3-trial-underway-302794524.html

Student, V., Repa, V., Vrbkova, J., & Vacek, J. (2026). Cannabidiol-hyaluronic acid combination delivered rectally for attenuating abacterial prostatitis symptoms: Single-arm open-label pilot clinical trial. Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia, 170(1), 47–52. https://doi.org/10.5507/bp.2026.002

Schmiedhofer, P., Vogel, F. D., Koniuszewski, F., & Ernst, M. (2022). Cys-loop receptors on cannabinoids: All high?. Frontiers in physiology, 13, 1044575. https://doi.org/10.3389/fphys.2022.1044575

Meissner, W., Argoff, C., Sator, S., Schoder, V., & Karst, M. (2025). VER-01 Shows Enhanced Gastrointestinal Tolerability, Superior Pain Relief, and Improved Sleep Quality Compared to Opioids in Treating Chronic Low Back Pain: A Randomized Phase 3 Clinical Trial. Pain and therapy, 14(6), 1765–1782. https://doi.org/10.1007/s40122-025-00773-z