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Why Schedule III cannabis could be a win for Big Pharma

By Drug Discovery Trends Editor | December 12, 2025

In door grow hemp. Cannabis at the beginning of flowering. Legal Marijuana cultivation in the home. Green background of leaves. Young cannabis plant. Medicinal indica with CBD.

[Adobe Stock]

Fifty years of restricted research may be coming to an end. Reports that President Trump plans to direct cannabis rescheduling would finally open federally-funded clinical trials for cannabinoid therapeutics, and force the industry to answer questions it’s long avoided.

Pharma companies like Jazz (Epidiolex) and AbbVie already have cannabinoid programs. This could accelerate M&A or partnerships.

Schedule III is not the finish line

Rescheduling cannabis to Schedule III would mark a major shift in federal drug policy, but policy experts caution that it stops well short of comprehensive reform.

“Rescheduling alone will not untangle the web of barriers facing cannabis consumers and the industry that serves them,” said Betty Aldworth, co-executive director of MAPS and chair of the Marijuana Policy Project. “It will not resolve the dangers of cash-only operations, eliminate risks embedded in housing, immigration, workplace drug testing, or family law, or establish the regulatory clarity needed for insurance coverage when patients choose cannabis over pharmaceuticals.”

Aldworth argues that while rescheduling acknowledges medical utility and reduces research barriers, it leaves intact many of the structural constraints that shape real-world access and patient outcomes.

“Cannabis regulation is not a fringe experiment,” she said. “It is a $38 billion economic engine operating under state-legal frameworks across much of the country. Policy must catch up to political reality.”

Rescheduling could also redraw the competitive map by making FDA-style drug development the clearest federal pathway. Big pharma has already demonstrated there is a playbook for cannabinoids when the molecule, dosing, and endpoints fit FDA norms. Jazz Pharmaceuticals completed its acquisition of GW Pharmaceuticals in 2021, inheriting Epidiolex and the infrastructure behind one of the most successful cannabinoid drug development efforts to date. That template could accelerate partnerships, licensing deals, and acquisitions around purified, standardized cannabinoids that can survive Phase II and Phase III trials, not necessarily around plant-scale cultivation.

Moving from Schedule I to Schedule III lowers practical barriers that have made U.S. clinical work slow, expensive, and hard to standardize. It also clarifies what “success” looks like federally: controlled substances in Schedule III can be lawfully dispensed by prescription, but any marijuana-derived product would still have to comply with the Food, Drug, and Cosmetic Act and clear FDA requirements before it could be legally marketed. As Adam Stettner, CEO of FundCanna, put it in a statement circulating among industry advocates: “It also unlocks long-blocked research pathways, enabling rigorous clinical studies, standardized formulations, and a new era of product innovation.”

That new era would come with a harder test of claims the industry has marketed for years. The risk-benefit picture is genuinely messy, especially on mental health. Federal health agencies and major reviews have flagged links between heavy use and psychosis risk, concerns about adolescent exposure, and the reality of cannabis use disorder, even as they also note therapeutic promise in narrower lanes. On the “clean evidence” side, Epidiolex remains the clearest FDA-level example: a purified cannabidiol product indicated for seizures associated with Lennox-Gastaut syndrome, Dravet syndrome or tuberous sclerosis complex.

The shift would also land on top of a national patchwork. Recreational cannabis is legal in 24 states, and medical marijuana is legal in more than 40 states plus Washington, D.C., depending on how states’ “medical” programs are defined. Public opinion is broadly permissive even as it has cooled from recent highs. Gallup’s annual Crime poll (conducted Oct. 1 to 16, 2025) found 64% of U.S. adults say marijuana use should be legal, down from the 68% to 70% range Gallup recorded from 2020 to 2024.


Filed Under: Drug Discovery
Tagged With: AbbVie cannabinoid program, cannabinoid clinical trials, cannabinoid therapeutics, cannabis rescheduling, DEA rescheduling, DOJ cannabis, Epidiolex, FDA cannabinoid drugs, GW Pharmaceuticals, Jazz Pharmaceuticals, marijuana rescheduling, pharmaceutical cannabinoids, Phase II trials, Phase III trials, prescription cannabinoids, Schedule III cannabis, standardized cannabinoid formulations
 

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