There is nothing sexy about the next big thing in weed. Vertanical, the Munich-based pharmaceutical company, is developing a cannabinoid-based extract to treat chronic pain it hopes will soon become an approved medicine, first in the European Union and eventually in the United States. The drug, currently called Ver-01, is not for stoners—each dose is low enough to avoid getting most patients high, the company says, but it packs enough low levels of cannabinoids (including THC) to relieve pain. And if it is approved, it won’t be found at a cannabis dispensary either. Instead, Clemens Fischer, the 50-year-old medical doctor who is the founder of Vertanical, hopes it will become the first cannabis-based painkiller prescribed by physicians and covered by insurance.
“I usually end up with the boring things no one wants to do,” says Fischer, who stopped practicing medicine decades ago to get an MBA from Harvard. A serial pharmaceutical and supplement entrepreneur, Fischer, who was born in Weilheim, Germany, runs a mini-empire through the Futrue Group, a Munich-based holding company with a collection of about 20 drug and R&D companies. Over the last two decades, he has built and sold a series of companies in the over-the-counter drug and supplement space, ranging from sleep aids to treatments for irritable bowel syndrome, amassing a $1 billion fortune.
Although Ver-01 is cannabis-based, Fischer has no interest in selling marijuana, which he says is a “shiny” object to be avoided. The $32 billion (2024 sales) cannabis industry in the U.S., which spans 40 states, is plagued with banking and financial challenges due to pot still being illegal at the federal level. The industry is still waiting, rather impatiently, for President Donald Trump to announce his decision whether to reschedule marijuana from its current status as a Schedule I drug alongside heroin and LSD to a less restrictive category. None of that matters for Fischer. He prefers the boring, arduous and expensive path of getting a new drug approved by the European Medicines Agency and hopefully, eventually the U.S. Food and Drug Administration.
So far, Fischer has invested more than $250 million of his own money in Vertanical, which he founded in 2017, with his business partner Madlena Hohlefelder. With a cannabis cultivation site and pharmaceutical manufacturing plant in Denmark, Vertanical has successfully passed Phase III, the last clinical trial hurdle, in Germany and is currently awaiting marketing approval. So far, the data from the clinical trials is promising: Ver-01 was found to be more effective than opioid painkillers with fewer side effects, including no evidence for addiction. The company is expecting a decision from the German and Austrian authorities later this year or early next year, which would allow the company to start selling its medicine. (Vertanical will then apply for broader authorization across the EU.) It hopes to launch Phase III trials in the U.S. in 2026.
“We believe that we will be the first non-opiate chronic pain treatment worldwide,” says Fischer.
The quest for non-opioid pain relievers is hot. After pharmaceutical drugs such as OxyContin fueled the opioid epidemic in the U.S., medical professionals have been searching for a better option—an effective pain reliever without the risks of addiction or overdose. Journavx, a non-opioid drug that dampens the pain signals sent to the brain, was approved by the FDA for acute pain in January 2025. Vertex, the drug’s manufacturer, reported $13 million in sales for the first six months on the market. Yet with 125 million opioid prescriptions written in the U.S. in 2023, according to the Centers for Disease Control and Prevention, a market worth about $20 billion in annual sales, according to Precedence Research, there is a lot of opportunity for alternatives. And as opioid overdoses claimed the lives of more than 80,000 people in the U.S. last year, it is an urgent problem that needs solutions. Earlier this week, the FDA announced its plan to accelerate the approval of non-opioid drugs for chronic pain.
Fischer hopes that Vertanical can bring its cannabis-based drug to market, replace a portion of those opioid sales, and cash in on the multibillion-dollar chronic pain sector.
“If you have a drug which shows it is more efficacious and has less side effects, you can get a significant share of this market,” says Fischer. “I don't want to do any projections, but the market is huge, and there is it's not a single replacement for opioids in the world.”
Dr. Jonathann Kuo, a New York-based pain management specialist, says cannabis-based compounds are promising contenders for opioid alternatives, but they will never fully replace them. “The holy grail is to have a substance that provides pain relief without physical dependency,” says Kuo, who is not involved with Vertanical or its clinical studies. “It’s not a pipe dream; cannabis can make headway in this.”
Vertanical is not alone in its quest to transform marijuana into an FDA-approved medicine. The Stanley Brothers, known for popularizing CBD with their groundbreaking company Charlotte’s Web a decade ago, are currently developing a hemp-derived drug to treat several symptoms associated with autism. The botanical tincture of CBD and THC, extracted from a patented strain of Charlotte’s Web hemp plants, passed FDA Phase I trials and was cleared to enter Phase II to study the drug’s efficacy and side effects earlier this year. (Typically, only 33% of drugs make it through Phase II trials.)
As with the Stanley’s drug, Vertanical’s Ver-01 is also following the FDA’s botanical drug pathway, meaning it is wholly derived from the plant and not a synthetic single molecule drug, like most pharmaceuticals on the market. If Vertanical gets the green light to start its Phase III trial in the U.S., it will enter the most challenging part of the process which monitors adverse reactions and efficacy in a bigger patient population. More than 70% of candidates fail in Phase III.
Botanical drugs can often be more difficult to get approval than single molecule drugs due to the sheer number of active compounds in plants. Ver-01, for instance, contains more than 100 compounds. Currently, there are only four FDA-approved botanical drugs, including sinecatechins, a topical cream for genital warts made from green tea leaves and marketed as Veregen.
Getting a new drug through clinical trials and approved by the FDA is a herculean task that requires very deep pockets. On average, it costs $880 million to get a completely new medication through the FDA approval process. That number can easily surpass $1 billion if there are any issues with trials or data. The whole process can often take a decade—Vertanical has been at it for seven years—and companies are battling a 90% overall failure rate. Sebastian Hach, Vertanical’s chief commercial officer, says the company has already spent around $130 million on EU clinical trials and several hundred million dollars in total to develop its drug.
It is not, however, an impossible task to transform marijuana’s active compounds into medicine. In 1985, the FDA approved Marinol, a synthetic form of THC called dronabinol, for cancer and AIDS patients. Marinol’s sales are estimated at around $250 million annually. The current cannabis-derived blockbuster is Epidiolex, a CBD tincture that has been FDA approved for children and adults with Lennox-Gastaut syndrome, Dravet syndrome and other rare epilepsy seizure disorders. With a small patient population hovering around 100,000 people globally, Epidiolex, owned by Ireland-based Jazz Pharmaceuticals, has managed to reach $970 million in sales last year and is tracking to surpass $1 billion in sales this year, analysts say. Hach says Ver-01, if approved, will attain blockbuster status. “Within the first two years [on the market], we're expecting to hit revenue of more than $2 billion,” he says. “It's a tremendous market opportunity.”
There are also plenty of failures along the way that serve as cautionary tales for entrepreneurs like Fischer. Jazz, for instance, also owns a mouth spray that contains THC and CBD, a drug called nabiximols that is marketed as Sativex. It was first approved to ease muscle spasticity for people with multiple sclerosis in Canada in 2005 and has since been approved in more than 20 other countries globally. But nabiximols has not been able to clear the FDA approval process in the US. In 2022, nabiximols failed its Phase III clinical trial after spending nearly $20 million over 5 years.
After quitting his job as a doctor in 2001, Fischer went to work for Novartis. He left after a few years to start a series of companies, focusing on probiotics, supplements and OTC drugs. In 2016, he sold his company Naturwohl Pharma, a Munich-based company known for its dietary supplement brand Yokebe, to French OTC purveyor Perrigo for $150 million. The biggest company in his portfolio currently is SYNFormulas, which sells an over-the-counter probiotic named Kijimea, which treats irritable bowel syndrome. SYNFormulas, Forbes estimates, generated about $100 million in revenue with a 30% profit margin in 2024. Last month, Fischer took PharmaSGP, another of his companies that sells OTC remedies including Baldriparan, a valerian root sleep aid, that was listed on the Frankfurt exchange, private in a $446 million deal.
In 2017, he was reading news about the burgeoning cannabis industry in the U.S. and something caught his attention: medical marijuana patients were using weed products to treat chronic pain. He took a trip to California and Nevada and met with more than a dozen companies to do research and find out the best growing methods and looked for strains that could be effective in pain management. Back in Europe, Fischer ordered 500 marijuana seeds and transformed a Denmark greenhouse built to grow roses into a 215,000 square foot pot nursery and got to work phenohunting, a term marijuana breeders use to find the best cultivar for a specific purpose, whether that is to get someone stoned or medicated. Fischer landed on a strain he calls DKJ-127, which is high in THC, CBD and another cannabinoid called CGN, best known as a sleep aid. Fischer has received patents in the U.S. and around the world for this strain and its specific use to treat chronic pain, and he believes Vertanical will become his most successful venture.
Sarah Gaus, a 39-year-old German native who has chronic lower back pain after herniating two discs, participated in one of Vertanical’s clinical trials in 2023. She took Ver-01 for 12 months and says it worked better than opioids she had taken during a previous round of treatment. There was one downside: for the first week or so after taking the tincture in the morning, she was unable to work for about an hour while the effects took hold.
“I experienced a kind of high; it made me very tired and impaired my concentration, and narrowed my field of vision,” says Gaus. She says that Ver-01 was “not a godsend” but effective. She did not experience any withdrawal symptoms after she stopped taking the medication.
Though Fischer is convinced he will be successful with the new medication, he is not a pothead and remains afraid of smoking weed, which he believes is bad for you. “I'm a control freak,” he says. “I can't handle the effect. I'm very scared that something's going to happen.”
Yet, Fischer says, if his drug is approved, patients should not fear Ver-01, a big difference when compared to opioid medications. “With our drug, even if you swallow the whole bottle, you will not die from any side effects,” he says, “but you might feel knocked out.”