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cannabidiol (Xalex 10)

✓ Approved

RAMM Pharma · CNR1

What is cannabidiol?

cannabidiol is a therapeutic agent developed by RAMM Pharma. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesXalex 10
CompanyRAMM Pharma
Molecular TargetCNR1, TRPV1, GPR55
RouteOral (PO)
StatusApproved

Mechanism of Action

Molecular Targets

cannabidiol acts on 3 molecular targets:

CNR1cannabinoid receptor 1 (CNR, CB1A)
TRPV1transient receptor potential cation channel subfamily V member 1 (VR1)
GPR55G protein-coupled receptor 55 (LPIR1)
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Therapeutic Indications

cannabidiol is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Nervous system disordersEpilepsy✓ Approved

Related Research Articles

PubMedFrontiers in neuroimaging2026-07-24

Functional neuroimaging of Cannabidiol in stress and anxiety: a systematic review.

Rutledge Omar O, Goyette Richard B RB, Wang Kimberly L KL, Park Madelynn S MS et al.

Cannabidiol (CBD) is a non-intoxicating phytocannabinoid primarily derived from hemp (cannabis sativa L.) that has been investigated for its potential anxiolytic effects. Prior functional neuroimaging studies suggest that CBD may affect brain regions associated with stress and anxiety. However, it remains unclear if there is a consistent pattern of modulation within these regions and if there is a correlation with behavioral or physiological measures. We conducted a systematic review examining adult human neuroimaging investigations comparing CBD with placebo under conditions related to stress or anxiety. We searched PubMed, Web of Science, EBSCO, and ProQuest for studies published before June 30, 2025. The quality of the evidence was assessed with the revised Cochrane Risk of Bias Tool for Randomized Trials (RoB 2), findings were summarized using a Synthesis Without Meta-analysis (SWiM) approach, and certainty of evidence was rated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework. A total of 12 studies with 146 participants in 7 cohorts met the eligibility criteria and were included in the synthesis. Results indicated a wide distribution of reported peaks across many cortical and subcortical regions with mixed directions of activation or perfusion, demonstrating substantial heterogeneity in the reported findings. Risk of bias assessments generally indicated either some concerns or high risk of bias, and the certainty of evidence was judged to be low to very low. Overall, there is a lack of consistent evidence showing the acute effects of CBD on the brain across various study designs. The current literature on the putative anxiolytic effects of CBD is constrained by methodological variability and limited statistical power. Future studies should employ standardized paradigms, improve reporting practices, and include more diverse and adequately powered samples to clarify the neural correlates of CBD-related effects on stress and anxiety. PROSPERO, CRD420251063369.

PubMedVeterinary world2026-07-24

Preclinical antitumor evaluation of a tetrahydrocannabinol and cannabidiol (1:6) cannabis extract in an MCF-7 xenograft model of estrogen receptor-positive breast cancer.

Meesiripan Nuntana N, Thanasitthichai Somchai S, Sangrajrang Suleeporn S, Suwanpidokkul Nuntakan N et al.

Breast cancer remains one of the leading causes of cancer-related mortality worldwide, despite advances in surgery, chemotherapy, endocrine therapy, and targeted treatments. Cannabinoids derived from Cannabis sativa, particularly tetrahydrocannabinol (THC) and cannabidiol (CBD), have demonstrated anticancer properties in several experimental models; however, in vivo evidence in estrogen receptor (ER)-positive breast cancer remains limited. This study aimed to evaluate the antitumor effects of a THC:CBD (1:6) cannabis extract in a Michigan Cancer Foundation-7 breast cancer cell line (MCF-7) xenograft mouse model of ER-positive breast cancer. Female BALB/c nude mice bearing MCF-7 xenograft tumors were randomly assigned into five groups (n = 5/group): negative control (sesame oil), positive control treated with 5-fluorouracil (5-FU; 20 mg/kg), and three treatment groups receiving oral THC:CBD (1:6) extract at doses of 2, 10, or 20 mg/kg body weight for 30 consecutive days. Tumor growth was monitored throughout the experiment. Histopathological examination and immunohistochemical analysis of proliferating cell nuclear antigen (PCNA) expression were performed to evaluate apoptosis-related morphology and tumor cell proliferation. Hematological and biochemical parameters were assessed to determine systemic safety. Cannabinoid-treated groups exhibited significant suppression of tumor growth compared with the negative control group. Tumor volume reduction was observed in all treatment groups, with the greatest reduction detected in the high-dose THC:CBD group. Histopathological evaluation revealed increased numbers of tumor cells exhibiting morphological features consistent with apoptosis in cannabinoid-treated mice. Immunohistochemical analysis demonstrated significantly lower PCNA expression scores in all THC:CBD-treated groups compared with both negative and positive controls, indicating reduced tumor cell proliferation. Hematological parameters remained within normal physiological ranges in cannabinoid-treated animals. However, elevated alanine aminotransferase and aspartate aminotransferase levels were observed in the high-dose group, suggesting potential dose-related hepatic stress. The THC:CBD (1:6) cannabis extract demonstrated significant antitumor activity in an MCF-7 xenograft model by suppressing tumor progression primarily through inhibition of tumor cell proliferation, with supportive apoptosis-related histological features. These findings provide novel in vivo evidence supporting the potential of cannabinoid-based formulations as adjunctive therapeutic approaches for ER-positive breast cancer.

PubMedACS omega2026-07-24

Cannabis Sativa L. Hemp Hurd Biochar: Influence of Pyrolysis Conditions on Carbonization and Residual Volatile Organic Compounds.

Patterson Gabriel D GD, Olajide Samuel S, Hafez Islam I, Karman Andrew A et al.

Cannabis sativa L. (hemp) is increasingly recognized not only as an agricultural commodity for textile fibers and cannabidiol (CBD) products but also as a platform for domestic innovation in biobased materials. Hemp hurd (HH), the woody inner core of the hemp stalk, is a fibrous, carbon-rich (∼50 wt %) lignocellulosic biomass with potential for conversion into value-added biochar. Herein, HH-derived biochar was investigated with emphasis on how pyrolysis conditions influence yield, carbonization, structure, and residual volatile organic compounds (VOCs). The effects of temperature (250-650 °C), residence time (15-60 min), particle size (1.0-12.7 mm), and sample mass (5.0-20.0 g) were evaluated. HH biochar structure was characterized by Raman spectroscopy, while residual VOCs associated with a representative high-loading condition were analyzed using headspace solid-phase microextraction coupled with gas chromatography-mass spectrometry (HS-SPME/GC-MS). Within the resolution of the data set, reduced particle size and temperatures ≥550 °C were associated with enhanced carbonization and greater structural ordering, while increased biomass loading at fixed reactor volume led to elevated apparent biochar yields consistent with partial retention of condensable species. Biochar produced at ≥550 °C exhibited low H/C ratios (∼0.20) and aromatic carbon structures indicative of extensive carbonization. These results guide rational optimization and scale-up of HH-derived biochar production.

PubMedDrug delivery2026-07-23

Development and in vivo pharmacokinetic evaluation of a phospholipid complex self-nanoemulsifying drug delivery system (PLC-SNEDDS) for enhanced oral bioavailability of cannabidiol.

Muta Thabata T, Mukhopadhyay Songhita S, Noll Benjamin B, Song Yunmei Y et al.

Cannabidiol (CBD) exhibits poor oral bioavailability (approximately 6%) due to low solubility and excessive first-pass metabolism, limiting its therapeutic potential. This study introduces a novel phospholipid complex self-nanoemulsifying drug delivery system (CBD-PLC-SNEDDS) to enhance CBD delivery. CBD-PLC was integrated into an optimized SNEDDS via Design of Experiments (DoE), yielding nanoemulsions with 118.9 ± 0.77 nm particle size, 0.258 PDI, and -21.9 mV zeta potential. Physicochemical characterization (DSC, FTIR) confirmed amorphization and physical encapsulation without chemical alteration. In vitro dissolution showed 100% CBD release within 1 h for CBD-PLC-SNEDDS vs. 8 h for CBD-SNEDDS. Stability studies (ICH guidelines) retained 94.73% ± 0.62% CBD at 25 °C/60% RH and 80.21% ± 0.61% at 40 °C/75% RH after 4 months with preservatives. In vivo pharmacokinetics in Sprague-Dawley rats (n = 9, 20 mg/kg oral; 4 mg/kg IV) demonstrated that CBD-PLC-SNEDDS significantly enhanced systemic exposure, achieving a calculated absolute bioavailability (F) of 92%, compared to 47% for the oleic acid control. The formulation yielded a 5-fold higher C max (593 ± 246 vs 118 ± 63 ng/mL) doubled AUC0-∞ (88 vs. 45 h·kg·ng/mL/mg), faster T max (2 ± 0.3 vs. 7.4 ± 2.3 h), and extended T 1/2 (3.7 ± 0.9 vs. 1.9 ± 0.6 h) versus control. CBD-PLC alone yielded only 39%. IVIVC modelling via Wagner-Nelson deconvolution established a strong correlation (R2 > 0.7) between in vitro dissolution and in vivo absorption, validating the system's predictive performance. This synergistic PLC-SNEDDS platform outperforms prior systems, offering a scalable template for lipophilic drugs and paving the way for clinical CBD therapeutics.

PubMedThe Journal of organic chemistry2026-07-23

Unveiling the Origin of Regioselectivity in Iron(III)-Promoted Friedel-Crafts Synthesis of Cannabinoids: Theoretical Studies and Synthetic Applications.

El Hllafi Mohamed M, Cheng-Sánchez Iván I, Fuentes-Pino Irama I, Sánchez-Ruiz Antonio A et al.

Phytocannabinoids, particularly cannabidiol (CBD), are important targets in pharmaceutical and industrial development due to their promising biological properties. However, access to CBD and related cannabinoids remains limited by their low abundance and variable composition in plant sources, whereas chemical synthesis of CBD is often hampered by the poor regioselectivity and modest yields associated with conventional Friedel-Crafts approaches. We recently disclosed an FeCl3·6H2O-catalyzed reaction that enables diastereoselective and highly regioselective preparation of (-)-CBD under mild and scalable conditions. Here, we report experimental and computational mechanistic studies that provide insight into the origin of this regioselectivity and support the involvement of a catalytically relevant iron(III)-olivetol complex, which reacts regioselectively with the carbocation generated from the terpenic unit. We also define the scope and limitations of the method and demonstrate its synthetic utility through the efficient formal synthesis of bioactive cannabinoid derivatives, including HU-210 and ajulemic acid.

PubMedEpilepsy & behavior : E&B2026-07-23

Epilepsy of infancy with migrating focal seizures: A scoping review of clinical features, diagnostic testing including genetics, long-term outcomes, mortality, and current and emerging therapeutic strategies.

Samanta Debopam D

Epilepsy of infancy with migrating focal seizures (EIMFS) is among the most severe developmental and epileptic encephalopathies (DEEs), marked by intractable multifocal seizures migrating across both hemispheres, profound developmental arrest, and high early mortality. Advances in next-generation sequencing have revealed a heterogeneous genetic architecture dominated by KCNT1 gain-of-function variants across more than 30 implicated genes, creating opportunities for precision therapeutics. To systematically map published evidence on the clinical, electrophysiological, neuroimaging, genetic, and therapeutic landscape of EIMFS, and to delineate critical knowledge gaps and future research priorities. A scoping review was conducted following the Arksey and O'Malley framework, searching PubMed, Ovid MEDLINE, Embase, Cochrane Library/CENTRAL, and ClinicalTrials.gov. Of 643 articles screened, 89 met inclusion criteria. Beyond confirmation of the canonical electroclinical phenotype, several gaps emerged: neonatal versus post-neonatal onset stratification by genetic etiology remains largely uncharacterized; genotype-specific EEG biomarkers are lacking except for a single small KCNT1 study; and the clinical significance of atypical EEG features-including burst suppression and hypsarrhythmia-is undefined. Neuroimaging literature documents progressive cerebral atrophy and myelination abnormalities without quantitative volumetry, diffusion tractography markers, or attribution to seizure burden, medication effects, or underlying etiology. Genetic diagnostic yield was 70-80%, with KCNT1 accounting for 30-50% of solved cases; however, genotype-outcome stratification is limited. Seizures were broadly refractory; potassium bromide, ketogenic diet, cannabidiol, and quinidine (in KCNT1-confirmed cases) showed partial efficacy. Emerging precision approaches include sodium channel blockers for SCN2A gain-of-function variants, novel small molecules, fluoxetine, antisense oligonucleotides, and divalent siRNA targeting KCNT1. Systemic-to-pulmonary collateral circulation causing severe cardiopulmonary complications was reported across multiple cases, yet no consensus screening protocol exists. EIMFS remains one of the most refractory epilepsy syndromes of infancy. Precision genetic diagnosis is essential to guide targeted therapy. International collaborative registries, standardized outcome measures, genotype-stratified biomarker studies, and rapid point-of-care genomic testing are urgently needed to advance evidence-based care for this highly vulnerable population.

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