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Cannabidiol

Generic Name
Cannabidiol
Brand Names
Epidiolex, Sativex, Epidyolex
Drug Type
Small Molecule
Chemical Formula
C21H30O2
CAS Number
13956-29-1
Unique Ingredient Identifier
19GBJ60SN5

Overview

Cannabidiol, or CBD, is one of at least 85 active cannabinoids identified within the Cannabis plant. It is a major phytocannabinoid, accounting for up to 40% of the Cannabis plant's extract, that binds to a wide variety of physiological targets of the endocannabinoid system within the body. Although the exact medical implications are currently being investigated, CBD has shown promise as a therapeutic and pharmaceutical drug target. In particular, CBD has shown promise as an analgesic, anticonvulsant, muscle relaxant, anxiolytic, antipsychotic and has shown neuroprotective, anti-inflammatory, and antioxidant activity, among other currently investigated uses . CBD's exact place within medical practice is still currently hotly debated, however as the body of evidence grows and legislation changes to reflect its wide-spread use, public and medical opinion have changed significantly with regards to its usefulness in a number of medical conditions ranging from anxiety to epilepsy. From a pharmacological perspective, Cannabis' (and CBD's) diverse receptor profile explains its potential application for such a wide variety of medical conditions. Cannabis contains more than 400 different chemical compounds, of which 61 are considered cannabinoids, a class of compounds that act upon endogenous cannabinoid receptors of the body . Cannabinoid receptors are utilized endogenously by the body through the endocannabinoid system, which includes a group of lipid proteins, enzymes, and receptors that are involved in many physiological processes. Through its modulation of neurotransmitter release, the endocannabinoid system regulates cognition, pain sensation, appetite, memory, sleep, immune function, and mood among many other bodily systems. These effects are largely mediated through two members of the G-protein coupled receptor family, cannabinoid receptors 1 and 2 (CB1 and CB2). CB1 receptors are found in both the central and peripheral nervous systems, with the majority of receptors localized to the hippocampus and amygdala of the brain. Physiological effects of using cannabis make sense in the context of its receptor activity as the hippocampus and amygdala are primarily involved with regulation of memory, fear, and emotion. In contrast, CB2 receptors are mainly found peripherally in immune cells, lymphoid tissue, and peripheral nerve terminals . Tetrahydrocannabinol (THC) and cannabidiol (CBD) are two types of cannabinoids found naturally in the resin of the marijuana plant, both of which interact with the cannabinoid receptors that are found throughout the body. Although THC and CBD have been the most studied cannabinoids, there are many others identified to date including cannabinol (CBN), cannabigerol (CBG), Cannabidivarin (CBDV), and Tetrahydrocannabivarin (THCV) that can be found within the medical cannabis . While both CBD and THC are used for medicinal purposes, they have different receptor activity, function, and physiological effects. If not provided in their activated form (such as through synthetic forms of THC like Dronabinol or Nabilone), THC and CBD are obtained through conversion from their precursors, tetrahydrocannabinolic acid-A (THCA-A) and cannabidiolic acid (CBDA), through decarboxylation reactions. This can be achieved through heating, smoking, vaporization, or baking of dried unfertilized female cannabis flowers. The primary psychoactive component of Cannabis, delta 9-tetrahydrocannabinol (Δ9-THC), demonstrates its effects through weak partial agonist activity at Cannabinoid-1 (CB1R) and Cannabinoid-2 (CB2R) receptors. This activity results in the well-known effects of smoking cannabis such as increased appetite, reduced pain, and changes in emotional and cognitive processes. In contrast to THC's weak agonist activity, CBD has been shown to act as a negative allosteric modulator of the cannabinoid CB1 receptor, the most abundant G-Protein Coupled Receptor (GPCR) in the body . Allosteric regulation is achieved through the modulation of receptor activity on a functionally distinct site from the agonist or antagonist binding site which is clinically significant as direct agonists (such as THC) are limited by their psychomimetic effects such as changes to mood, memory, and anxiety. In addition to the well-known activity on CB1 and CB2 receptors, there is further evidence that CBD also activates 5-HT1A/2A/3A serotonergic and TRPV1–2 vanilloid receptors, antagonizes alpha-1 adrenergic and µ-opioid receptors, inhibits synaptosomal uptake of noradrenaline, dopamine, serotonin and gamma-aminobutyric acid (GABA), and cellular uptake of anandamide, acts on mitochondria Ca2+ stores, blocks low-voltage-activated (T-type) Ca2+ channels, stimulates activity of the inhibitory glycine-receptor, and inhibits activity of fatty amide hydrolase (FAAH) . CBD is currently available in Canada within a 1:1 formulation with tetrahydrocannbinol (THC) (as the formulation known as "nabiximols") as the brand name product Sativex. It is approved for use as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS). Sativex was also given a conditional Notice of Compliance (NOC/c) for use as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis and as adjunctive analgesic treatment for moderate to severe pain in adult patients with advanced cancer . In April 2018, a Food and Drug Administration advisory panel unanimously recommended approval of Epidiolex (cannabidiol oral solution) for the treatment of two rare forms of epilepsy - Lennox-Gastaut syndrome and Dravet syndrome, which are among the two most difficult types of epilepsy to treat . Epidiolex was granted Orphan Drug designation as well as Fast Track Approval from the FDA for further study in these hard to treat conditions. Notably, phase 3 clinical trials of Epidiolex have demonstrated clinically significant improvement in Lennox-Gastaut syndrome and Dravet syndrome . On June 25th, 2018, Epidiolex was approved by the FDA to be the first CBD-based product available on the US market.

Indication

When used in combination with delta-9-tetrahydrocannabinol as the product Sativex, cannabidiol was given a standard marketing authorization (ie. a Notice of Compliance (NOC)) by Health Canada for the following indications: 1) as adjunctive treatment for symptomatic relief of spasticity in adult patients with multiple sclerosis (MS) who have not responded adequately to other therapy and who demonstrate meaningful improvement during an initial trial of therapy ; Due to the need for confirmatory studies to verify the clinical benefit coupled with the promising nature of the clinical evidence, Sativex was also given a Notice of Compliance with Conditions (NOC/c) by Health Canada for the following indications: 1) as adjunctive treatment for the symptomatic relief of neuropathic pain in adult patients with multiple sclerosis; 2) as adjunctive analgesic treatment in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain .

Associated Conditions

  • Multiple Sclerosis
  • Seizures
  • Severe Pain
  • Moderate Pain

Research Report

Published: Jul 21, 2025

A Comprehensive Monograph on Cannabidiol (DB09061): From Molecular Profile to Clinical and Regulatory Landscape

I. Compound Identification and Physicochemical Properties

Cannabidiol (CBD) is a naturally occurring phytocannabinoid compound isolated from plants of the Cannabis genus. Unlike its well-known isomer, tetrahydrocannabinol (THC), cannabidiol is devoid of the characteristic psychotropic effects associated with cannabis.[1] Over the past several decades, it has transitioned from a botanical curiosity to a subject of intense scientific investigation and, ultimately, an approved pharmaceutical agent for specific medical conditions. Its unique pharmacological profile and complex legal status have positioned it at the intersection of medicine, public policy, and wellness industries. This monograph provides a comprehensive overview of cannabidiol, synthesizing data on its chemical properties, pharmacological mechanisms, clinical applications, safety profile, and regulatory landscape.

1.1. Nomenclature and Identifiers

The compound is universally known as Cannabidiol, often abbreviated as CBD. For scientific, clinical, and regulatory purposes, it is identified by a series of standardized codes and names that ensure unambiguous reference across different domains.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/17
Phase 2
Not yet recruiting
2025/06/03
Phase 1
Not yet recruiting
2025/04/23
Phase 3
Recruiting
2025/04/16
Phase 1
Recruiting
2025/04/11
Phase 4
Not yet recruiting
Elizabeth Donner
2025/03/17
Not Applicable
Not yet recruiting
2025/03/03
Phase 1
Recruiting
Tiamat Australia Pty Ltd
2025/02/21
Phase 2
Recruiting
2025/01/22
Phase 3
Not yet recruiting
2024/12/13
Phase 2
Recruiting
City of Hope Medical Center

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Jazz Pharmaceuticals, Inc.
70127-100
ORAL
100 mg in 1 mL
1/1/2023

EMA Drug Approvals

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
MediPharm Labs 10:15 THC:CBD
364776
Medicine
A
5/6/2021
DEMECAN 22:01 FLORESTURA
357695
Medicine
A
3/25/2021
Medleaf Pure CBD Oil
347391
Medicine
A
11/5/2020
MediPharm Labs Extract 25:25 THC:CBD
378013
Medicine
A
11/16/2021
Cann Group Balance THC10:CBD15
364414
Medicine
A
5/4/2021
Nanadol
390626
Medicine
A
6/17/2022
Superseed T26
470649
Medicine
A
11/27/2024
Mystery Mountain T24
470646
Medicine
A
11/27/2024
Cybis 10:25
403392
Cymra Life Sciences Ltd
Medicine
A
1/24/2023
CBD100, 50 mL
396299
Medicine
A
9/23/2022

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
EPIDIOLEX
02543079
Solution - Oral
100 MG / ML
3/28/2024

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
EPIDYOLEX 100 MG/ML SOLUCION ORAL
1191389001
SOLUCIÓN ORAL
Diagnóstico Hospitalario
Commercialized
SATIVEX 2,7 MG/2,5 MG SOLUCION PARA PULVERIZACION BUCAL
72544
SOLUCIÓN PARA PULVERIZACIÓN BUCAL
Diagnóstico Hospitalario. Psicótropos
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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