A New Era for Cannabis Clinical Research: What Federal Rescheduling Could Unlock

On December 18, 2025, President Donald Trump signed an executive order directing the Attorney General to move swiftly toward rescheduling marijuana to Schedule III under the Controlled Substances Act. 

If completed through the required federal rule making steps, this shift could meaningfully reduce barriers to scientific investigation and accelerate credible, regulated cannabinoid development—creating a once-in-a-generation opening for sponsors, researchers, universities, and international innovators to enter (or expand in) the U.S. cannabis research ecosystem.

At Cannovation Clinical Research Partners (CCRP), we believe this moment can be a catalyst for better science, safer products, and faster pathways to legitimate medical adoption—if organizations move quickly and build the right clinical and regulatory strategy from day one. 

What changed: the executive order and what happens next

The executive order signed December 18, 2025 instructs the Attorney General to take steps to complete the process of moving marijuana to Schedule III as expeditiously as the law allows. 

It’s important to be clear on scope:

• Rescheduling is not federal legalization. Cannabis would remain a controlled substance at the federal level. 

• DEA rulemaking still matters. Even with an executive order, the regulatory process determines the final outcome and implementation details. 

That said, the direction of travel is what matters for R&D: fewer institutional and administrative barriers often translate into more research activity, more credible evidence, and more serious entrants.

Why Schedule III could be a breakthrough for clinical research

1) More institutions willing to participate

One of the biggest bottlenecks in cannabinoid research has been operational friction—site hesitation, compliance burden, and perceived reputational risk. A Schedule III framework can reduce “institutional reluctance,” making it easier for sophisticated research centers to say “yes” to cannabinoid studies—especially when paired with a strong regulatory and quality strategy.

2) Faster, broader study execution (especially for multi-site trials)

As barriers decline, the opportunity expands for:

• Multi-site studies with stronger statistical power

• Better-controlled investigational product handling and traceability

• More consistent clinical operations and monitoring standards

In practical terms, that means an easier path from “interesting science” to “credible evidence.”

3) Better-quality products and stronger standards

Rescheduling tends to bring greater emphasis on:

• GMP-aligned supply chains

• Characterization of APIs and impurities

• Reproducible dosing and delivery systems

• Audit-ready documentation

  
  

This is where real medical legitimacy comes from—and where many promising programs succeed or fail.

Commercial ripple effects that can accelerate R&D

Access to financing: progress, with caveats

Rescheduling can improve investor confidence and broaden financing conversations. However, large-bank participation may remain constrained until additional federal banking/legal reforms provide clearer safe harbor. 

So: expect momentum—but plan strategically, and don’t assume banking becomes frictionless overnight.

Greater international participation and new market pathways

When U.S. federal policy signals “credible medical intent,” international companies often reassess entry timing. For global innovators, the U.S. becomes less of a regulatory minefield and more of a navigable, investable path—especially for:

• Import/export planning

• U.S. development strategy alignment

• Evidence packages that support multi-country commercialization

More innovation in delivery systems and medical devices

A more workable federal framework can unlock serious investment into:

• Precise dosing formats (oral, inhalation, nasal, etc.)

• Combination products and device-enabled delivery

• Real-world evidence infrastructure and registries

  
  

Why now is the time to enter cannabis research

This isn’t just “good news for cannabis.” It’s a signal that cannabinoid science can increasingly be approached like other serious therapeutic areas—where winners are determined by:

• Correct indication selection

• Thoughtful endpoint strategy

• High-integrity quality systems

• Strong regulatory roadmaps

• Reliable supply and manufacturing

• Disciplined program execution

Organizations that move early—while the ecosystem is re-opening—can shape standards, secure the best partners, and build durable leadership positions.

How Cannovation helps you capitalize—without costly missteps

Cannovation Clinical Research Partners is a full-service research, development, and commercialization consulting firm focused on cannabinoid (and psychedelic) therapeutics and related pathways. We partner with biopharma, universities, centers of excellence, and specialized experts to accelerate programs from strategy through execution.

Where we support clients most in moments like this:

• Clinical & regulatory roadmaps (including pre-IND strategy and cross-agency considerations)

• Preclinical and clinical trial planning + execution (indications, development plans, timelines, project management)

• Material sourcing and supply chain strategy (including import/export guidance and GMP/QA/QC considerations)

• Commercialization + market entry planning aligned to evidence generation

  
  

If you’re considering entering cannabis research now, the winning move is not to “wait and see.” It’s to build a program that is regulatory-ready, quality-driven, and investable—so you can move at speed as the environment opens.

If you have an asset, formulation concept, delivery technology, or research program you want to advance in this new landscape, Cannovation can help you design the right plan and execute it with confidence.