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Last update 08 May 2025

Cannabidiol

Last update 08 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(1'R,2'R)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydrobiphenyl-2,6-diol, (−)-trans-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol, (−)-trans-cannabidiol

+ [49]

Target-

Action-

Mechanism-

Therapeutic Areas

NeoplasmsNervous System DiseasesCongenital Disorders+ [8]

Active Indication

Tuberous SclerosisEpilepsies, MyoclonicLennox Gastaut Syndrome+ [32]

Inactive Indication

Acne VulgarisAcute Graft Versus Host DiseaseBenign Essential Blepharospasm+ [17]

Originator Organization

Central South UniversityApurano Pharmaceuticals GmbHDeyi Pharmaceutical Co., Ltd.

+ [1]

Active Organization

Jazz Pharmaceuticals Ireland Ltd.

University of Oxford

GW Pharmaceuticals Ltd.

+ [23]

Inactive Organization

STERO Biotechs Ltd.

Virpax Pharmaceuticals, Inc.Benuvia Therapeutics, Inc.

+ [6]

License Organization

Harmony Biosciences LLC

Sandoz Group AG

Avecho Biotechnology Ltd.

+ [13]

Drug Highest PhaseApproved

First Approval Date

United States (25 Jun 2018),

Epilepsies, MyoclonicLennox Gastaut SyndromeSeizures

RegulationRare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (Australia), Fast Track (United States)

Structure/Sequence

Molecular FormulaC21H30O2

InChIKeyQHMBSVQNZZTUGM-ZWKOTPCHSA-N

CAS Registry13956-29-1

488

Clinical Trials associated with Cannabidiol

NCT06148038

/ Not yet recruitingPhase 1IIT

A Phase 1a "Window Trial" of Cannabidiol (CBD) For Breast Cancer Primary Tumors

This is a randomized placebo controlled double blind window of opportunity trial. A maximum of 120 patients will be enrolled. Up to 60 patients with invasive breast cancer will be enrolled into cohort 1, and up to 60 patients with DCIS will be enrolled into cohort 2. Patients in each cohort will be randomized 1:1 to either CBD or placebo control using permuted block randomization with random block sizes of 2 or 4. The time window between CBD or placebo initiation and surgery will be between 5 days and 56 days.

Start Date01 Mar 2026

Sponsor / Collaborator

The Medical University of South Carolina

NCT06362889

/ Not yet recruitingPhase 1

An Exploratory Study to Evaluate the Safety and Efficacy of Microneedling With Cannabidiol (CBD) and Hempseed Oil for Treating Acne Vulgaris

This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne.

Start Date01 Dec 2025

Sponsor / Collaborator

REJUVA MEDICAL AESTHETICS, INC.

[+1]

NCT04855526

/ Not yet recruitingEarly Phase 1IIT

Effects of Marijuana on Memory-Related Neurochemistry and Neural Response

Memory deficits are one of the most consistently observed cognitive effects of marijuana use. There is evidence that some decrements attributable to the primary psychoactive ingredient, delta-9-tetrahydrocannabinol (THC), may be attenuated by cannabidiol (CBD). This study will help us learn more about the relationship between THC and CBD consumption with memory processes. A combination of MRI and neuropsychological tests (which are computer and paper/pencil tasks) will be used to measure the neurocognitive and behavioral impacts of THC and CBD use.

Start Date01 Dec 2025

Sponsor / Collaborator

Hartford Hospital

[+1]

100 Clinical Results associated with Cannabidiol

100 Translational Medicine associated with Cannabidiol

100 Patents (Medical) associated with Cannabidiol

9,603

Literatures (Medical) associated with Cannabidiol

31 Dec 2025·Drug Delivery

Exploring the effects of cannabidiol encapsulation in liposomes on their physicochemical properties and biocompatibility

Article

Author: Grava, Andra ; Jurgelane, Inga ; Dubnika, Arita ; Galkina, Dana ; Brante, Margarita ; Melnichuks, Maksims ; Egle, Karina ; Salms, Girts ; Skrinda-Melne, Marite

Cannabidiol (CBD) is recognized for its therapeutic properties in various conditions. However, CBD's limited water solubility and sensitivity to environmental stresses hinder its efficacy and bioavailability. Encapsulation in drug delivery systems, particularly liposomes, offers a promising solution. This study aims to prepare CBD-containing liposomes using commercially used lipids distearoyl phosphatidylcholine (DSPC) and dipalmitoyl phosphatidylcholine (DPPC), and 1,2 distearoyl-sn-glycero-3 phosphoethanolamine-N-[carbonyl-amino(polyethylene glycol)-4300] (ammonium salt) (DSPE-PEG) and to perform in vitro studies - cell viability and CBD release. Liposomes were synthesized using thin-film hydration method, and characterized by Fourier-transform infrared (FT-IR) spectroscopy, dynamic light scattering (DLS), and scanning transmission electron microscopy (STEM). DLS analysis revealed that CBD incorporation reduced liposome size by 23-53%, depending on the liposomes. Encapsulation efficiency followed the order: DPPC CBD (63%) < DSPC CBD (74%) < DSPC DPPC CBD (81%) < DSPC DSPE-PEG CBD (87%). CBD release profiles indicated that DPPC CBD liposomes released the highest CBD amount initially, while DSPC DSPE-PEG CBD exhibited sustained release, achieving 79% release over 504 h. In vitro cell viability tests showed that blank liposomes were non-cytotoxic. However, CBD-loaded liposomes significantly reduced cell viability for defined type of CBD containing liposomes. The inclusion of DSPE-PEG improved encapsulation efficiency and liposome stability, making DSPC DSPE-PEG CBD liposomes more suitable for long-term CBD release. Compared to other studies, encapsulation of CBD in liposomes enhances its bioavailability, allowing lower concentrations of CBD to be directly delivered to cells, resulting in observable changes in cell viability.

31 Dec 2025·Journal of Dermatological Treatment

The impact of cannabis use on local anesthetic dosing during hair restoration surgery: a case report, proposed mechanisms, and clinical recommendations

Review

Author: Keene, Sharon A. ; Gupta, Aditya K. ; Talukder, Mesbah

Cannabis use has increased significantly in the last decade. This article presents a case where a patient needed more local anesthetic (LA) than usual to induce effective anesthesia during hair transplant surgery. The reason cannabis users often need more LA is poorly understood. One possibility is that cannabis withdrawal effect makes patients more sensitive to pain and stress. Additionally, vasodilatory property of cannabis may speed up LA clearance from the application site. The interactions of two major cannabinoids, cannabidiol (CBD) and tetrahydrocannabinol (THC), with cannabinoid receptor type 1 (CB1), cannabinoid receptor type 2 (CB2), and transient receptor potential vanilloid 1 (TRPV1) receptors are also complex. Furthermore, CBD and THC function as cytochrome P450 enzyme inhibitors potentially impacting systemic metabolism. When planning to administer LA during hair restoration surgery in cannabis users, clinicians should obtain a detailed history of prior consumption (type of cannabis, frequency, dosage). Preoperative planning should consider the anticipated duration of surgery and calculate the maximum safe LA dose to avoid the risk of toxicity. Also, patients should be carefully monitored for vital signs during surgery. If a patient requires frequent re-injection to remain pain free, the surgeon may need to re-assess the surgical plan to avoid toxicity.

01 Dec 2025·Acta Epileptologica

The efficacy of cannabidiol for seizures reduction in pharmacoresistant epilepsy: a systematic review and meta-analysis

Review

Author: de Almeida, Natália Brito ; de Oliveira, Vinícius Gabino ; de Oliveira Santos, Bruno Fernandes ; Radmann, Guilherme Corrêa

AbstractBackgroundEpilepsy is a neurological syndrome caused by excessive neuronal discharges, with a part of the patients being pharmacoresistant to the traditional treatment. Cannabidiol, a non-psychoactive component of Cannabis Sativa, shows promise as an alternative, but further research is needed to quantify its efficacy.MethodsThis literature systematic review was made following the PRISMA protocol guidelines. The Google Scholar, Scielo, and PubMed/MEDLINE databases were included using the descriptors “Cannabidiol”, “Epilepsy”, and “Drug Resistant Epilepsy”. This research was registered in the Prospero platform with the identification (CRD42024479643).ResultsA total of 1448 results were identified from the PubMed, Virtual Health Library, and Google Scholar databases. After applying exclusion criteria, six studies met the criteria for full-text evaluation and eligibility. The compiled analysis showed that the patients who received cannabidiol experienced a 41.0875% reduction in the total number of seizures, compared to an average reduction of 18.1% in placebo groups. This represents a 127% higher response rate for patients who received the intervention.ConclusionsGiven these results, it is possible to conclude that the therapeutic response of cannabidiol is worthy of consideration in new protocols and of being added to public healthcare systems for its antiepileptic potential. However, the high efficacy rate observed in the placebo group suggests that other methods of data collection analysis may be employed.

879

News (Medical) associated with Cannabidiol

01 May 2025

·www.prnewswire.com

EPIDIOLEX Continues to Lead the Way in Cannabinoid-Based Epilepsy Treatment | DelveInsight

EPIDIOLEX has significant market potential due to the growing demand for alternative therapies and its effectiveness in treating rare seizure disorders like Lennox-Gastaut syndrome and Dravet syndrome. As awareness around the benefits of CBD in treating neurological conditions increases, EPIDIOLEX stands to benefit from expanding indications and market reach. LAS VEGAS, May 1, 2025 /PRNewswire/ -- DelveInsight's ' EPIDIOLEX Market Size, Forecast, and Market Insight Report' highlights the details around EPIDIOLEX, the first FDA-approved prescription cannabidiol (CBD) to treat seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients 1 year of age or older. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of EPIDIOLEX. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Jazz Pharmaceuticals' EPIDIOLEX (cannabidiol) Overview EPIDIOLEX (formerly known as GWP42003-P and marketed as EPIDYOLEX in Europe) is the first plant-based, prescription cannabis-derived oral medication developed by GW Pharmaceuticals. It represents a new category of antiepileptic drugs with a unique mechanism of action. The active compound, cannabidiol (CBD), is a naturally occurring cannabinoid found in the Cannabis sativa L. plant. While the exact way EPIDIOLEX works to reduce seizures in humans remains unclear, it is distinct from traditional anticonvulsants. CBD does not act through CB1 receptors or by blocking voltage-gated sodium channels, which are typical pathways for other antiepileptic drugs. Instead, CBD is thought to work by influencing multiple internal pathways, potentially producing a combined anticonvulsant effect. These include enhancing neuronal inhibition (through synaptic and extrasynaptic GABA channels), affecting intracellular calcium levels (via TRPV channels, VDAC, and GPR55), and reducing inflammation, possibly via adenosine modulation. Importantly, CBD does not directly bind to or activate the CB1 or CB2 receptors at levels relevant to its seizure-reducing effects. Ongoing research is examining other possible mechanisms such as interactions with adenosine, glycine, GABAergic systems, and serotonin receptors. EPIDIOLEX has received regulatory approval in numerous countries, including the U.S. (FDA), Europe (European Commission), Great Britain (MHRA), Australia (Therapeutic Goods Administration), Switzerland (Swissmedic), Israel (Ministry of Health), and New Zealand (Medicines and Medical Devices Safety Authority). It is formulated as an oral solution containing highly purified CBD. In the U.S., it is approved to treat seizures linked to Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC) in patients aged one year and older. In the European Union, under the name Epidyolex, it is approved as an add-on treatment with clobazam for LGS and DS in patients two years and older, and for TSC-associated seizures as well. Both the FDA and EMA have granted Orphan Drug Designation (ODD) for EPIDIOLEX/EPIDYOLEX for these conditions. EPIDIOLEX/EPIDYOLEX net product sales rose by 15% to USD 972.4 million in 2024 and by 14% to USD 275.0 million in the fourth quarter of 2024, compared to the corresponding periods in 2023. Learn more about EPIDIOLEX/EPIDYOLEX projected market size for DEE @ EPIDIOLEX Market Potential Developmental and epileptic encephalopathies (DEE) encompass a group of severe neurological conditions marked by developmental delays and persistent epilepsy. These disorders typically present early in life and are linked to significant cognitive deficits. According to DelveInsight's analysis, there were approximately 287K diagnosed prevalent cases of DEE across the 7MM in 2024. This number is projected to increase due to the rise in neurological disorders, including epilepsy, as well as environmental and maternal health factors contributing to a higher DEE prevalence throughout the forecast period (2025−2034). The US FDA has approved a range of medications for conditions like LGS, Dravet Syndrome, and CDKL5 Deficiency Disorder, including various drug classes such as sodium channel modulators, GABA receptor modulators, calcium channel blockers, receptor blockers, and others. Some of the available anti-epileptic drugs (AEDs) include FINTEPLA, EPIDIOLEX, TOPAMAX, BANZEL, LAMICTAL, FELBATOL, ONFI, KLONOPIN, DIACOMIT, SABRIL, and more. In 2024, the total market size for DEE in the 7MM was around USD 2.3 billion, and this figure is expected to grow by 2034, driven by wider adoption of approved therapies due to label expansions and the introduction of emerging treatments. Discover more about the DEE market in detail @ Developmental and Epileptic Encephalopathy Market Report Emerging Competitors of EPIDIOLEX Some of the drugs in the pipeline include EPX-100 (Harmony Biosciences), Bexicaserin (Lundbeck), Zorevunersen (Stoke Therapeutics/Biogen), Relutrigine (Praxis Precision Medicines), and others. In August 2024, the FDA removed a partial clinical hold as the company advances toward a Phase III registrational study of zorevunersen (STK-001) in children and adolescents with Dravet syndrome. In July 2024, Longboard Pharmaceuticals announced that the FDA had granted Breakthrough Therapy designation for its investigational drug bexicaserin for the treatment of seizures associated with DEEs for patients 2 years of age or older. To know more about the number of competing drugs in development, visit @ EPIDIOLEX Alternatives Key Milestones of EPIDIOLEX In August 2024, Jazz Pharmaceuticals reported top-line results from a Phase 3 open-label, single-arm study conducted in Japan, assessing the safety and effectiveness of its cannabidiol oral solution (marketed globally as EPIDIOLEX/EPIDYOLEX) as an add-on therapy for seizures linked to Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC). While the trial did not achieve its primary efficacy goal—defined as a pre-specified percentage reduction in seizure frequency during the up-to-16-week treatment period compared to baseline in Japanese pediatric patients—numerical improvements were noted in both the primary and several secondary measures. The study did not identify any new safety concerns. In May 2021, Jazz Pharmaceuticals acquired EPIDIOLEX as part of the acquisition of GW Pharmaceuticals plc, or GW, which expanded its growing neuroscience business with a global, high-growth childhood-onset epilepsy franchise. In April 2021, EPIDYOLEX was approved for adjunctive therapy of seizures associated with TSC for patients 2 years of age and older in the EU. In July 2020, EPIDYOLEX was approved for the treatment of seizures associated with TSC in patients one year of age and older. FDA also approved the expansion of all existing indications, LGS and DS, to patients one year of age and older. In September 2019, the European Commission approved EPIDYOLEX for use as adjunctive therapy of seizures associated with LGS or DS, in conjunction with clobazam, for patients two years of age and older. In June 2018, EPIDIOLEX was approved in the US for the treatment of seizures associated with two rare and severe forms of epilepsy, LGS and DS, in patients two years of age and older. EPIDIOLEX Launch Status EPIDIOLEX was launched on November 1, 2018, in the US market after FDA approval for the treatment of seizures associated with LGS or Dravet syndrome in patients two years of age and older. EPIDYOLEX was launched in 2019 in Germany and the UK market for use as adjunctive therapy for seizures associated with LGS or Dravet syndrome, in conjunction with clobazam, for patients two years of age and older (GW Pharmaceuticals, 2019b). In 2021, EPIDYOLEX was launched in Spain. In the first quarter of 2022, the company launched EPIDYOLEX for LGS, Dravet syndrome, and TSC in Ireland, for TSC in Scotland and Wales. In the third quarter of 2022, the company launched EPIDYOLEX for TSC in Italy and Switzerland. In the fourth quarter of 2022, the company successfully completed the pricing and reimbursement process and commercial launch of EPIDYOLEX in France. Discover how EPIDIOLEX/EPIDYOLEX is shaping the DEE treatment landscape @ EPIDIOLEX CBD EPIDIOLEX Market Dynamics EPIDIOLEX, the first FDA-approved cannabidiol (CBD)-based medication for the treatment of rare forms of epilepsy, has had a significant impact on the pharmaceutical market since its approval in 2018. The drug is primarily used to treat seizures associated with Dravet syndrome and Lennox-Gastaut syndrome, two rare and severe forms of epilepsy. The market dynamic for EPIDIOLEX is shaped by several factors, including increasing awareness of its therapeutic potential, the expanding medical cannabis industry, and the growing demand for alternative treatments to traditional anti-epileptic drugs. One of the main drivers of the EPIDIOLEX market is the rising acceptance of CBD-based therapies. As medical cannabis becomes more mainstream and research into its medicinal properties continues to grow, patients and healthcare providers are increasingly turning to EPIDIOLEX as a treatment option. The growing body of clinical evidence supporting its effectiveness and safety has reinforced this trend. Additionally, as the stigma around cannabis-derived medications continues to fade, it opens up more opportunities for EPIDIOLEX in both pediatric and adult patient populations. However, the market for EPIDIOLEX is not without its challenges. High treatment costs and insurance coverage issues can limit accessibility for some patients, especially in markets outside the United States. Despite its clinical efficacy, the price point for EPIDIOLEX remains a point of contention, as it may not be affordable for all families, especially when compared to other conventional anti-epileptic drugs. Furthermore, competition from other cannabinoid-based therapies, as well as new developments in the broader epilepsy drug market, could impact the drug's market share over time. Looking ahead, the market dynamics for EPIDIOLEX will likely continue to evolve as the global regulatory landscape changes and new clinical trials further establish its benefits in other neurological conditions. With increasing research into CBD's potential applications, there may be opportunities for EPIDIOLEX to expand its indications, providing a solid foundation for its continued growth. However, market growth will also depend on the ability to address pricing concerns, improve insurance coverage, and navigate potential competitive pressures from both traditional and emerging therapies. Dive deeper to get more insight into EPIDIOLEX/EPIDYOLEX's strengths & weaknesses relative to competitors @ EPIDIOLEX Market Drug Report Table of Contents Related Reports Developmental and Epileptic Encephalopathies Market Developmental and Epileptic Encephalopathies Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key DEE companies, including vid Therapeutics, Stoke Therapeutics, Biogen, Harmony Biosciences, Lundbeck (Longboard Pharmaceuticals), Praxis Precision Medicines, SK Life Science, Cerecin Neurosciences, Encoded Therapeutics, Praxis Precision Medicines, among others. Developmental and Epileptic Encephalopathies Pipeline Developmental and Epileptic Encephalopathies Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key DEE companies, including Denovo Biopharma, Cantex Pharmaceuticals, CNS Pharmaceuticals, CANbridge Pharmaceuticals, Vaximm, Inovio Pharmaceuticals, Mustang Bio, Bullfrog AI Holdings, Cantex, Chimeric Therapeutics, Philogen, Boehringer Ingelheim, Photonamic GmbH, Berg Pharma, Beyond Bio, Genenta Science, Polaris Pharmaceuticals, Telix Pharmaceuticals, Shanghai Simnova Biotechnology, NEONC Technologies, among others. Dravet Syndrome Market Dravet Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Dravet syndrome companies including Biocodex, GW Pharmaceuticals, Zogenix, Ovid Therapeutics, PTC Therapeutics, among others. Lennox-Gastaut Syndrome Market Lennox-Gastaut Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Lennox-Gastaut syndrome companies, including GlaxoSmithKline, Meda Pharmaceuticals, Roche, Lundbeck, Greenwich Biosciences, Janssen Pharmaceuticals, Eisai, Zogenix, Takeda, Ovid Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3AcquisitionBreakthrough TherapyOrphan Drug

28 Apr 2025

·www.businesswire.com

Qualthera Health Corporation Launches Qualthera Pharmaceuticals Ltd. Co., a New R&D Subsidiary Focused on Drug Repurposing and Innovative Delivery

DALLAS--(BUSINESS WIRE)--Qualthera Health Corporation, dedicated to building a nationwide network of quality, patient-centered compounding pharmacies, has announced the official launch of Qualthera Pharmaceuticals Ltd. Co., a research-driven subsidiary dedicated to drug repurposing and innovative delivery systems. This expansion marks a significant step forward in accelerating pharmaceutical innovation, leveraging real-world patient insights to develop new therapies with streamlined development. This expansion marks a significant step forward in accelerating pharmaceutical innovation, leveraging real-world patient insights to develop new therapies with streamlined development. “With Qualthera Pharmaceuticals, we are redefining how underutilized compounds can be developed, repurposed and delivered,” said Donald Prentiss, CEO of Qualthera Health Corporation. “Our work doesn’t start in a lab—it starts with real patients and real prescribing challenges. This ensures every compound we explore is grounded in clinical relevance and tangible patient need.” Revolutionizing Drug Repurposing Unlike traditional pharmaceutical R&D, Qualthera Pharmaceuticals focuses on identifying new therapeutic uses for active pharmaceutical ingredients (APIs) that are already approved and off-patent. By repurposing compounds with known pharmacology and safety profiles, the company aims to bring innovative therapies to market more efficiently, taking advantage of existing regulatory pathways and leveraging established safety data. “In the past, drug repurposing relied heavily on academic research or abandoned R&D programs,” said Prentiss. “At Qualthera Pharmaceuticals, we take a different approach. We analyze real-world prescribing trends, patient access challenges, and therapeutic gaps, then assess compound viability and delivery innovation. It’s repurposing with intent, not just exploration.” Flagship Product: The Biodegradable CBD Implant Leading Qualthera Pharmaceuticals’ portfolio is its patent-pending biodegradable CBD implant, designed to provide consistent, long-term therapeutic exposure to cannabidiol (CBD). This innovative technology addresses limitations in traditional CBD formats, including inconsistent absorption, which may lead to unpredictable therapeutic outcomes. “We’re not just repurposing CBD—we’re re-engineering how it’s delivered,” added Prentiss. “By creating a long-acting implant, we aim to unlock its potential for treating chronic pain and neurodegenerative disorders such as Alzheimer’s and Parkinson’s, where steady exposure is critical, and treatment options remain limited.” Qualthera Pharmaceuticals intends to pursue FDA approval for its CBD implant, which could become the first implantable formulation of CBD and only the second FDA-approved CBD drug in the U.S. The company is also evaluating three additional drug candidates targeting ALS, weight loss, and opioid use disorder, reinforcing its commitment to tackling high-need, scalable therapeutic opportunities. A Bold New Chapter for Qualthera The launch of Qualthera Pharmaceuticals Ltd. Co. represents the next evolution of Qualthera Health Corporation, expanding from personalized compounding into scalable pharmaceutical development. “Our guiding principle has always been ‘quality therapy for life’—from individual patients to broader populations,” said Prentiss. “This subsidiary allows us to build a pipeline of transformative therapies, all informed by real-world medical challenges and science-driven solutions.” For more information about Qualthera, visit Qualthera.com. About Qualthera Health Corporation Qualthera is a provider of quality-focused compounding pharmacy services. Founded by CEO, Donald Prentiss, the company is dedicated to delivering accessible, high-quality medications nationwide, a commitment reflected in the name “Qualthera”—a blend of “Quality” and “Therapy.” With a focus on patient-centered care, they are building a trusted network of compounding pharmacies that prioritize excellence in personalized therapy. Learn more about Qualthera at www.qualthera.com. About Qualthera Pharmaceuticals Qualthera Pharmaceuticals Ltd. Co. is a research-driven subsidiary of Qualthera Health Corporation, dedicated to drug repurposing and innovative delivery systems. Established to accelerate meaningful pharmaceutical innovation, Qualthera Pharmaceuticals identifies new therapeutic uses for active pharmaceutical ingredients (APIs) that are already approved and off-patent. As its flagship product, Qualthera Pharmaceuticals intends to pursue FDA approval for its patent-pending biodegradable CBD implant, designed to provide consistent, long-term therapeutic exposure to cannabidiol (CBD) for chronic pain and neurodegenerative disorders. In addition, the company is evaluating three additional drug candidates targeting ALS, weight loss, and opioid use disorder, reinforcing its commitment to tackling high-need, scalable therapeutic opportunities. By applying real-world patient insights, systematic compound assessment, and innovative drug delivery science, Qualthera Pharmaceuticals bridges the gap between personalized care and scalable pharmaceutical development, fulfilling its mission to deliver quality therapy for life. Learn more about Qualthera Pharmaceuticals at www.qualtheratx.com.

22 Apr 2025

·tnfpharma.com

TNF Pharmaceuticals and Renova Health Utilize AI to Accelerate Drug Development

Machine learning technology used to identify patients for studies of muscle mass preservation during GLP-1 treatment BALTIMORE–(BUSINESS WIRE)– TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health announce the application of AI and machine learning technologies to identify high-risk patient groups that may benefit the most from interventions that preserve lean muscle mass during GLP-1 treatment for diabetes, weight loss, and chronic weight management. In keeping with FDA’s recent draft Guidance on using Artificial Intelligence, the TNF-Renova partnership is analyzing data from 30,000 patients to identify high-risk patients. TNF plans to use these data to optimize appropriate patient recruitment, accelerating isomyosamine drug development. “Our collaboration partner, Renova Health has used its AI and machine learning technology platform to analyze and identify optimal patient pools and study sites, enabling a swift and efficient progression of our study series over the coming months,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. “This technology has allowed us to look at the constellation of underlying conditions, symptoms, acute events, and medications being taken across thousands of patients to identify specific patient subsets for which isomyosamine treatment may be most beneficial.” Renova Health’s proprietary AI and machine learning technology—including a cutting-edge natural language processing (NLP) and large language model (LLM) platform—offers key benefits to TNF Pharmaceuticals including the ability to quickly review thousands of patient records to identify a target population that may benefit from isomyosamine. This target population consists of patients who have underlying chronic diseases, such as diabetes, COPD, chronic kidney disease, or sarcopenia/frailty, have suffered an acute medical event associated with inflammation (such as a fall or bone fracture), and are taking GLP-1 medications. “We are thrilled to collaborate with TNF Pharmaceuticals to advance precision medicine through our cutting-edge NLP, LLM, and AI platform,” said David Jacobs, CEO of Renova Health. “Our technology transcends traditional big data analytics by creating highly specific patient personas, identifying optimal cohorts for isomyosamine based on underlying conditions, acute events, and medication profiles. Furthermore, our platform uncovers the nuanced impact of individual physician practices—such as varying diagnosis codes for GLP-1 prescriptions, like BMI versus diabetes—which can significantly influence cohort selection and study outcomes. This unparalleled precision enables TNF Pharmaceuticals to target patients who stand to benefit most, accelerating study timelines and enhancing therapeutic impact.” About Renova Health Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health’s success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit www.renovahealth.care. About Isomyosamine Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases. About TNF Pharmaceuticals, Inc. TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com. Cautionary Statement Regarding Forward-Looking Statements This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s goals and expectations related to TNF-Renova partnership. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20250422412441/en/ Investor Contact: Robert Schatz (646) 421-9523 rschatz@tnfpharma.com www.tnfpharma.com Source: TNF Pharmaceuticals, Inc.

100 Deals associated with Cannabidiol

External Link

KEGG	Wiki	ATC	Drug Bank
D10915	Cannabidiol	N03AX24	DB09061

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Tuberous Sclerosis	United States	Jazz Pharmaceuticals UK Ltd.	31 Jul 2020
Epilepsies, Myoclonic	United States	Jazz Pharmaceuticals UK Ltd.	25 Jun 2018
Lennox Gastaut Syndrome	United States	Jazz Pharmaceuticals UK Ltd.	25 Jun 2018
Seizures	United States	Jazz Pharmaceuticals UK Ltd.	25 Jun 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Spasms, Infantile	Phase 3	Poland	Jazz Pharmaceuticals Plc	24 Apr 2017
Spasms, Infantile	Phase 3	United States	Jazz Pharmaceuticals Plc	24 Apr 2017
Epilepsies, Myoclonic	Phase 3	Japan	Jazz Pharmaceuticals Plc	-
Fragile X Syndrome	Phase 3	-	Harmony Biosciences LLC	-
Lennox Gastaut Syndrome	Phase 3	Japan	Jazz Pharmaceuticals Plc	-
Seizures	Phase 3	Japan	Jazz Pharmaceuticals Plc	-
Tuberous Sclerosis	Phase 3	Japan	Jazz Pharmaceuticals Plc	-
Rett Syndrome	Preclinical	Spain	Jazz Pharmaceuticals Plc	29 Jul 2019
Spasms, Infantile	Preclinical	United States	Jazz Pharmaceuticals Plc	24 Apr 2017
Spasms, Infantile	Preclinical	Poland	Jazz Pharmaceuticals Plc	24 Apr 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03802799 (ZYN2-CL-017, Company_Website) Manual	Phase 2/3	Fragile X Syndrome	240	ZYN002	smftqcjucy(oyneloheef) = achieved clinically meaningful improvement of at least 9 points on the ABC-CFXS Irritability scores at two consecutive visits. ycbyfdygvp (jmunrxpmgq ) View more	Positive	08 Apr 2025
				Placebo
NCT03467113 (P9-9.010, AAN2025)	Phase 1	Epilepsies, Myoclonic \| Lennox Gastaut Syndrome	9	Fenfluramine	xejpqwgjxj(vurumweous) = qvfxmlnces akaeflzzyh (obzfzrgbcd, 4 - hours post to dose) View more	Positive	07 Apr 2025
				Cannabidiol	xejpqwgjxj(vurumweous) = cqxatlqjcs akaeflzzyh (obzfzrgbcd, 2 - hours post to dose) View more
NCT04527003 (CTgov)	Phase 3	Endometriosis \| Pelvic Pain	12	Placebo+Norethindrone Acetate (Group A - Placebo)	abhrzfisoc(oyrlhprszg) = vzoorpnata spcbjnrxed (ajmvuzmcwg, pcvhkbxnzr - jtneemxvza) View more	-	04 Apr 2025
				Norethindrone Acetate+Cannabidiol (CBD) Extract (Group B - Low Dose CBD)	abhrzfisoc(oyrlhprszg) = fvmgkkrzpt spcbjnrxed (ajmvuzmcwg, ifjbgnbqjs - lfgyfihxzy) View more
NCT04745026 (CTgov)	Phase 2	Autism Spectrum Disorder	103	Placebo	tkuwbdbpwk(lrpdnaeekb) = mafigknlca drezrryrlu (mkjehssmho, jdmghccosi - eiepelfaiv) View more	-	30 Mar 2025
NCT06074172 (CTgov)	Phase 2	-	57	Placebo (Placebo (Administered During Visits 1 or 2))	agsodspqqd(wqmrorlrdm) = ccivhbqzny pjlwbmzmwe (mygumcjkqe, ihdsfvftub - kpsusiwdhr) View more	-	24 Mar 2025
				Cannabidiol (Cannabidiol (Administered During Visits 1 or 2))	agsodspqqd(wqmrorlrdm) = dpygmtsyjo pjlwbmzmwe (mygumcjkqe, dmlgwjyoeq - brkkkwwvuh) View more
NCT04428203 (CTgov)	Phase 1	Recurrent Prostate Carcinoma \| Non-metastatic prostate cancer \| Adenocarcinoma of prostate	21	Epidiolex Oral Liquid Product (Dose Escalation: Epidiolex 600 mg)	orzgyvlhhs(raitfnptsa) = jjgqsrxboq uwlmjjdnme (nwdrlgyexh, ebwmwlxtus - tkhhfsfrck) View more	-	05 Mar 2025
				Epidiolex Oral Liquid Product (Dose Escalation: Epidiolex 800 mg)	orzgyvlhhs(raitfnptsa) = wzhkyqpztj uwlmjjdnme (nwdrlgyexh, zullssaadm - pbhmvpwjtp)
NCT05288283 (CTgov)	Phase 3	Seizures \| Epilepsies, Myoclonic	3	GWP42003-P (GWP42003-P)	ympwplsxtg(mkzzuyyevm) = lkqyqwkklp uumaemdvtc (wqyskwdnsx, fsphvgrkeq - guxmzxosmr) View more	-	03 Feb 2025
				Placebo (Placebo)	ympwplsxtg(mkzzuyyevm) = bdmvfcspnp uumaemdvtc (wqyskwdnsx, twrlzuwjdb - voxdvvvoqa) View more
NCT04482244 (Pubmed) Manual	Phase 2	Anxiety Disorders	50	cannabidiol	keclxoqbzd(ozfocfbxsv) = mwkvajnjez ndgmitkvmi (xnwpajdnuz, 15.4) Not Met View more	Negative	02 Dec 2024
				Placebo	keclxoqbzd(ozfocfbxsv) = ocyzbtibgv ndgmitkvmi (xnwpajdnuz, 10.9) Not Met View more
NCT04760613 (CTgov)	Phase 1/2	Pain Disorder \| Radicular Pain \| Intervertebral Disc Disease	14	cannabidiol (Cannabidiol (CBD))	jfargdduux(ovkkhapdhm) = sjmecpgcep lxyogspdor (papdtohokv, bqlzocmriq - wcgkikohry) View more	-	19 Sep 2024
				Placebo (Placebo (PCB))	jfargdduux(ovkkhapdhm) = sxdniaoawx lxyogspdor (papdtohokv, gykudiytsl - sgqaltvxdc) View more
NCT04286594 (CTgov)	Phase 2	Anxiety Disorders	15	CBD	mtbmmeocbp(gyxrytloch) = ougtrodydl iyesswztzt (wtebahoypg, pahjazousm - qohnjqcvtk) View more	-	27 Aug 2024

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