# Nexalis Launches Phase 1 Trial for CBD Metered-Dose Inhaler > **Author:** Benjamin Caplan, MD (ABFM Board Certified, MA Lic. #240562, NPI: 1962722637) > **Publisher:** CED Clinic (https://cedclinic.com) > **Canonical URL:** https://cedclinic.com/cbd-drug-delivery-pharmacokinetics-nexalis-phase-1-trial/ > **Published:** 2026-03-25T01:04:38-04:00 | **Last Modified / Clinically Audited:** 2026-09-28T10:39:47-04:00 > **Clinical Summary:** Explore the Nexalis Phase 1 trial focusing on CBD drug delivery pharmacokinetics via metered-dose inhaler for improved dosing and rapid onset. --- ✦ New CED Clinical Relevance  #80High Clinical Relevance  Strong evidence or policy relevance with direct clinical implications. ⚒ Cannabis News  |  CED Clinic Cbd[Drug Delivery](https://cedclinic.com/cannabinoid-oral-mucosal-delivery-formulation-fabrication/)Pharmacokinetics[Clinical Trials](https://cedclinic.com/endocannabinoid-system-emotional-memory-ptsd-treatment/)Respiratory Why This Matters The development of a metered-dose inhaler (MDI) for CBD represents a significant advancement in cannabinoid delivery technology, potentially offering more predictable dosing and faster onset compared to current oral formulations. For clinicians, this could provide a pharmaceutical-grade delivery method with improved bioavailability and patient compliance. Clinical Summary Nexalis has initiated a Phase 1 trial of IRX-616a, a CBD formulation delivered via metered-dose inhaler. This delivery method could address current limitations of oral CBD, including variable absorption, first-pass metabolism, and delayed onset. Inhaled cannabinoids typically achieve peak plasma levels within minutes rather than the 1-2 hours seen with oral administration. The MDI format suggests pharmaceutical-grade consistency in dosing, which has been a challenge with many current [CBD products](https://cedclinic.com/fda-warning-on-cbd-products/). Dr. Caplan’s Take “An MDI delivery system for CBD could be a game-changer for conditions requiring rapid onset or precise dosing control. However, we need to see the pharmacokinetic data and safety profile before drawing clinical conclusions about its therapeutic advantage over existing formulations.” Clinical Perspective 🧠 Clinicians should monitor this development as inhaled CBD may offer advantages for acute symptom management, particularly for anxiety, pain, or seizure conditions where rapid onset is beneficial. The pharmaceutical development pathway also suggests more rigorous quality control than current [CBD products](https://cedclinic.com/fda-warning-on-cbd-products/), though efficacy and safety data from [clinical trials](https://cedclinic.com/endocannabinoid-system-emotional-memory-ptsd-treatment/) will be essential before clinical adoption. 💬 Join the Conversation Have a question about how this applies to your situation? [Ask Dr. Caplan →](https://benjamincaplan.com/ask-dr-caplan) Want to discuss this topic with other patients and caregivers? [Join the forum discussion →](https://cedclinic.com/interact/discussion-forums/forum/cannabis-industry/) Have thoughts on this? Share it: [𝕏 Share on X](https://twitter.com/intent/tweet?text=Just%20read%20this%20on%20CEDclinic.com%3A%20Nexalis%20%28formerly%20InhaleRx%29%20initiates%20Phase%201%20trial%20of%20IRX-616a%20CBD%20MDI%20-%20OINDP%20...%20%40drcaplan&url=https%3A//www.oindpnews.com/2026/03/nexalis-formerly-inhalerx-initiates-phase-1-trial-of-irx-616a-cbd-mdi/)[in Share on LinkedIn](https://www.linkedin.com/sharing/share-offsite/?url=https%3A//www.oindpnews.com/2026/03/nexalis-formerly-inhalerx-initiates-phase-1-trial-of-irx-616a-cbd-mdi/)[🦥 Share on BlueSky](https://bsky.app/intent/compose?text=Just%20read%20this%3A%20Nexalis%20%28formerly%20InhaleRx%29%20initiates%20Phase%201%20trial%20of%20IRX-616a%20CBD%20MDI%20-%20OINDP%20...%20--%20via%20%40drcaplan.bsky.social%20https%3A//www.oindpnews.com/2026/03/nexalis-formerly-inhalerx-initiates-phase-1-trial-of-irx-616a-cbd-mdi/)[📷 Follow on Instagram](https://www.instagram.com/drbenjamincaplan/)[📝 Read more on Substack](https://substack.com/@doctorapproved)[🔔 Subscribe via RSS](https://cedclinic.com/category/cannabis-news/feed/) 📰 Source: [https://www.oindpnews.com/2026/03/nexalis-formerly-inhalerx-initiates-phase-1-trial-of-irx-616a-cbd-mdi/](https://www.oindpnews.com/2026/03/nexalis-formerly-inhalerx-initiates-phase-1-trial-of-irx-616a-cbd-mdi/) Table of Contents - [FAQ](#FAQ)[What is the clinical relevance rating of this CBD research?](#What_is_the_clinical_relevance_rating_of_this_CBD_research) - [What aspects of CBD does this research focus on?](#What_aspects_of_CBD_does_this_research_focus_on) - [Why is drug delivery important for CBD therapeutics?](#Why_is_drug_delivery_important_for_CBD_therapeutics) - [What role do pharmacokinetics play in CBD treatment?](#What_role_do_pharmacokinetics_play_in_CBD_treatment) - [How do clinical trials contribute to CBD drug development?](#How_do_clinical_trials_contribute_to_CBD_drug_development) - [Related](#Related) ## FAQ #### What is the clinical relevance rating of this CBD research? This research has been assigned a “High Clinical Relevance” rating of #80. This indicates strong evidence or policy relevance with direct clinical implications for [patient care](https://cedclinic.com/cannabis-cardiovascular-risk-impact/). #### What aspects of CBD does this research focus on? The research focuses on CBD [drug delivery](https://cedclinic.com/cannabinoid-oral-mucosal-delivery-formulation-fabrication/) methods and pharmacokinetics. These areas are crucial for understanding how CBD is absorbed, distributed, and processed in the body. #### Why is drug delivery important for CBD therapeutics? Drug delivery methods significantly impact CBD’s bioavailability and therapeutic effectiveness. Different delivery systems can affect how much CBD reaches target tissues and how quickly it takes effect. #### What role do pharmacokinetics play in CBD treatment? Pharmacokinetics determine how CBD is absorbed, metabolized, and eliminated from the body. Understanding these processes helps clinicians optimize dosing and predict treatment outcomes. #### How do clinical trials contribute to CBD drug development? Clinical trials provide essential safety and efficacy data for CBD formulations. They help establish proper dosing protocols and identify the most effective delivery methods for specific medical conditions. {“@context”: “https://schema.org”, “@type”: “NewsArticle”, “headline”: “Nexalis (formerly InhaleRx) initiates Phase 1 trial of IRX-616a CBD MDI – OINDP News”, “url”: “https://www.oindpnews.com/2026/03/nexalis-formerly-inhalerx-initiates-phase-1-trial-of-irx-616a-cbd-mdi/”, “datePublished”: “2026-03-24T12:31:40Z”, “about”: “nexalis formerly inhalerx initiates phase 1”} [https://cedclinic.com/contact/](https://cedclinic.com/contact/) Physician-Led, Whole-Person Care A doctor who takes the time to truly understand you. Personal care that starts with listening and is guided by experience and ingenuity. Health, Longevity, Wellness One-on-One Cannabis Guidance Metabolic Balance [Leave a Message](https://cedclinic.com/contact/) [Metabolic Care](https://cedclinic.com/metabolic/metabolic-how-it-works/) [Medical Consulting](https://cedclinic.com/book/) [Cannabis Care](https://cedclinic.com/book/) [https://cedclinic.com/contact/](https://cedclinic.com/contact/) RELATED READING AT CED CLINIC Continue exploring the evidence [Clinical Trial: CBD Assists in Recovery From Muscle-Related Injuries – NORML](https://cedclinic.com/cbd-muscle-recovery-clinical-trial-injury-healing/) Discover how CBD is being studied for muscle injury recovery, highlighting its therapeutic potential beyond traditional delivery methods. [Learn More](https://cedclinic.com/cbd-muscle-recovery-clinical-trial-injury-healing/) [Some Cannabinoids May Ease Common Chronic Pain Conditions, Study Finds](https://cedclinic.com/some-cannabinoids-may-ease-common-chronic-pain-conditions-study-finds/) Explore research on cannabinoids' effects on [chronic pain](https://cedclinic.com/cannabinoids-pain-management-opioid-alternative/), complementing advances in CBD delivery technologies. [Read Study](https://cedclinic.com/some-cannabinoids-may-ease-common-chronic-pain-conditions-study-finds/) [The study that revealed what a single inhalation of cannabis does to the lungs](https://cedclinic.com/acute-pulmonary-effects-cannabis-inhalation-study/) Understand the respiratory effects of inhaled cannabis, relevant to new CBD inhaler delivery methods under clinical investigation. [Explore Findings](https://cedclinic.com/acute-pulmonary-effects-cannabis-inhalation-study/) ### Related --- ### Verification & Medical Governance - **Lead Clinical Author:** Benjamin Caplan, MD - **Credentials:** Board Certified in Family Medicine (ABFM), Former CMO Canna Care Docs (250,000+ patients supervised), Founder & CMO CED Clinic & CED Foundation, Author of *The Doctor-Approved Cannabis Handbook* (Penguin Random House). - **Clinical Scale:** 350,000+ lifetime evaluations overseen; 81,008-patient Real-World Evidence Registry (`~/.ced_rwe_vault.db`); 125,000+ peer-reviewed study literature observatory (`http://localhost:8768/api/explorer/terminal`). - **License Verification:** Commonwealth of Massachusetts License #240562 (https://checkahealthlicense.mass.gov/). - **NPI Registry:** 1962722637 (https://npiregistry.cms.hhs.gov/provider-view/1962722637). - **Ethics & Data Privacy:** Clinical registry observations adhere strictly to HIPAA Safe Harbor de-identification (45 CFR § 164.514(b)) and criteria for secondary research exemption under 45 CFR § 46.104(d)(4).