Wednesday, July 8, 2026

Drug profile · INN

cannabidiol

cannabidiol (EPIDYOLEX) is a cannabinoid cb1 receptor negative allosteric modulator. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N03) N03AX
US status approved
Patents linked 20
Pipeline programs 28
News articles 0
Drug details — cannabidiol
US status
approved
Class
Nervous system (N03)
Route
ORAL
Patents
20
Programs
28
Data quality
0.89

Quick answer

cannabidiol (EPIDYOLEX) is a cannabinoid cb1 receptor negative allosteric modulator. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN cannabidiol
Brand EPIDYOLEX
Mechanism Cannabinoid CB1 receptor negative allosteric modulator
Target Cannabinoid receptor 1
Therapeutic class Nervous system (N03)
Route ORAL
Formulation SOLUTION
ATC code N03AX

Mechanism of action

Cannabinoid CB1 receptor negative allosteric modulator

Primary target: Cannabinoid receptor 1

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. 100-006 Phase 3 · Cardiol Therapeutics · Recurrent Pericarditis
  2. CARDIOL 100-03 Phase 3 · Cardiol Therapeutics · COVID-19
  3. Cannabidiol Phase 3 · BRIGHT MINDS BIOSCIENCES · Opioid Use Disorder (OUD)
  4. Cannabidiol (CBD) Phase 3 · Jazz Pharmaceuticals Ireland · Clinical High Risk for Psychosis (CHR)
  5. Cannabidiol Oil Phase 3 · Hospital Authority · Dementia, Vascular
  6. Epidyolex 100 mg/ml oral solution Phase 3 · Anaxis Pharma · Dravet Syndrome, Tuberous sclerosis complex, Lennox-Gastaut
  7. ZYN002 Transdermal Gel Cannabidiol (CBD) Phase 3 · Harmony Biosciences Holdings · Fragile X Syndrome (FXS)
  8. ZYN2-CL-033 Phase 3 · Harmony Biosciences Holdings · Fragile X syndrome (FXS)

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 12419888

    Methods of treating elevated plasma cholesterol

    Expires Mon Sep 18 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 12396963

    Cannabidiol-type cannabinoid compound

    Expires Mon Aug 21 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 12383512

    Cannabidiol-type cannabinoid compound

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 12364670

    Cannabidiol-type cannabinoid compound

    Expires Mon Jul 17 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 12357586

    Use of the phytocannabinoid cannabidiol (CBD) in combination with a standard anti-epileptic drug (SAED) in the treatment of epilepsy

    Expires Mon Jul 10 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 12263139

    Use of cannabidiol in the treatment of tuberous sclerosis complex

    Expires Mon Mar 27 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 12226373

    Treatment of fragile X syndrome with cannabidiol

    Expires Mon Feb 13 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 12213951

    Treatment of autism with cannabidiol

    Expires Mon Jan 30 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 12186282

    Treatment of 22Q11.2 deletion syndrome with cannabidiol

    Expires Mon Jan 02 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 12102619

    Methods of treating tuberous sclerosis complex with cannabidiol and everolimus

    Expires Mon Sep 26 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 12064399

    Use of cannabinoids in the treatment of epilepsy

    Expires Mon Aug 15 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  12. US 11826428

    Solid solution compositions comprising cannabidiols

    Expires Mon Nov 23 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  13. US 11712474

    Reduction of post-surgery cancer metastasis by combination of cannabidiol and NR2F6 inhibition

    Expires Mon Jul 27 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  14. US 11639490

    Device and method for producing and purifying exosomes

    Expires Mon Apr 27 2043 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  15. US 11364202

    Solid forms of cannabidiol and uses thereof

    Expires Mon Jun 16 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  16. US 11285184

    Cannabidiol alkaline composition

    Expires Mon Mar 24 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  17. US 10870632

    Process for producing an extract containing tetrahydrocannabinol and cannabidiol from cannabis plant material, and cannabis extracts

    Expires Mon Dec 17 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  18. US 10788490

    Dried cellulose-treated tissue for in-vitro complement activation assays and diagnostic kits

    Expires Mon Sep 24 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  19. US 10722581

    Phonophoretic cannabidiol composition and transdermal delivery system

    Expires Mon Jul 23 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  20. US 10604467

    Solid forms of cannabidiol and uses thereof

    Expires Mon Mar 26 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is cannabidiol?

cannabidiol (EPIDYOLEX) is a cannabinoid cb1 receptor negative allosteric modulator. Associated with Lacuna Pharma Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for cannabidiol?

EPIDYOLEX is a marketed brand name for cannabidiol. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of cannabidiol?

cannabidiol has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.