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cannabidiol

Trade name: Epidiolex

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Jun 25, 2018

Cannabidiol is the major nonpsychoactive ingredient in cannabis. Cannabidiol demonstrates a range of effects that may be therapeutically useful, including anti-seizure, antioxidant, neuroprotective, anti-inflammatory, analgesic, anti-tumor, anti-psychotic, and anti-anxiety properties. Exact mechanism of action of cannabidiol is not known, but may include effects on the orphan G-protein-coupled receptor GPR55; the transient receptor potential of vanilloid type-1 channel; the 5-HT1a receptor; and the α3 glycine receptors. GW Pharmaceuticals successfully developed the world’s first prescription medicine derived from the cannabis plant, Sativex® (buccal spray containing delta-9-tetrahydrocannabinol and cannabidiol) now approved in over 29 countries outside of the United States for the treatment of spasticity due to Multiple Sclerosis. GW Pharmaceuticals is developing Epidiolex® (a liquid formulation of pure plant-derived cannabidiol) for certain rare and severe early-onset, drug-resistant epilepsy syndromes. — NCATS

Clinical trial activity

441 trials · 350 clinical orgs · 2 marketing orgs

Phase 1
145
Phase 2
241
Phase 3
73
Phase 4
19

Earliest trial started Jan 1, 2001 (NCT00129857)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Nov 14, 2013

    Orphan Drug Designation

  3. Jun 25, 2018

    GW Pharmaceuticals Ltd. — Earliest FDA Approval

  4. Jun 25, 2018

    GW Research — NDA Secondary Org

  5. Jun 25, 2018

    GW Pharmaceuticals Ltd. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJun 25, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCC1=CC(O)=C([C@@H]2C=C(C)CC[C@H]2C(C)=C)C(O)=C1
Mol. weight
314.4617 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1,1-dimethylheptyl-11-hydroxytetrahydrocannabinol
  • 1,1-dimethylheptyl-7-hydroxy-delta(6)-tetrahydrocannabinol
  • 11-hydroxy-delta-8-dmh-thc
  • 11-hydroxy-delta(8) -tetrahydrocannabinol-dimethylheptyl
  • 11-hydroxymethyl-delta(8)-tetrahydrocannabinol-dimethylheptyl
  • 11-oh-delta(8)-thc-dmh
  • (1'r,2'r)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydrobiphenyl-2,6-diol
  • (1'r,2'r)-5'-methyl-4-pentyl-2'-(prop-1-en-2-yl)-1',2',3',4'-tetrahydrobiphenyl-2,6-diol
  • 5'(1,1-dimethylheptyl)-7-hydroxyhexahydrocannabinol
  • 6h-dibenzo(b,d)pyran-9-methanol, 3-(1,1-dimethylheptyl)-6a,7,10,10a-tetrahydro-1-hydroxy-6,6-dimethyl-, (6as-trans)-
  • 7-hydroxy-delta-6-tetrahydrocannabinoldimethylheptyl
  • cannabidiol
  • cannabidiol
  • cannabidiol
  • cannabidiol
  • cannabidiol
  • (+)-cannabidiol
  • cannabinol
  • cannabinol
  • cbd
  • cbd
  • cbd
  • cbd
  • dexanabinol
  • dexanabinol
  • dexanabinol
  • dexanabinol
  • epidiolex
  • epidiolex
  • gwp42003
  • gwp42003
  • gwp42003-p
  • gwp42003-p
  • hu210
  • hu 210
  • hu-210
  • hu 211
  • hu-211
  • hu 211, (6ar-trans)-isomer
  • sinnabidol
  • sinnabidol
  • (−)-trans-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol
  • (−)-trans-2-p-mentha-1,8-dien-3-yl-5-pentylresorcinol
  • (−)-trans-cannabidiol
  • (−)-trans-cannabidiol
  • δ1(2)-trans-cannabidiol
  • δ1(2)-trans-cannabidiol
  • δ1(2)-trans-cannabidiol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07087938Phase 1/Phase 2 (Phase 2)Jul 15, 2028Washington State University
NCT06924827Phase 4Feb 2, 2026Jazz Pharmaceuticals, University of British Columbia, University of Calgary, University of Toronto
NCT07016971Phase 1Feb 1, 2026Pennsylvania State University
NCT07279558Phase 2Feb 1, 2026National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Colorado, Denver
NCT07148206Phase 3Jan 31, 2026National Institute on Drug Abuse (NIDA), Yeshiva University
NCT07148843Phase 2/Phase 3 (Phase 3)Jan 15, 2026Johns Hopkins University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NCT07298408Phase 1/Phase 2 (Phase 2)Jan 2, 2026Florida A&M University
NCT07271030N/ADec 31, 2025London Metropolitian University
NCT07233239Phase 1Dec 31, 2025Jazz Pharmaceuticals
NCT06362889Phase 1Dec 31, 2025Rejuva Medical Aesthetics
NCT07245238Phase 3Nov 5, 2025KhonKaen University
NCT07278505Phase 1/Phase 2 (Phase 2)Oct 28, 2025Icahn School of Medicine at Mount Sinai, Jazz Pharmaceuticals, National Institute of Mental Health (NIMH)
NCT06731894Phase 2Oct 27, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07167446Early Phase 1 (Phase 1)Oct 14, 2025National Cancer Institute (NCI), Temple University
NCT07199218Phase 2Oct 5, 2025Bazelet Nehushtan LtD., Hebrew University
NCT07023744Phase 2Oct 1, 2025Canadian Institutes of Health Research (CIHR), Research Manitoba, University of Manitoba
NCT07123467Phase 3Oct 1, 2025National Institute of Mental Health (NIMH), Wayne State University
NCT07186283Phase 1Sep 22, 2025NW PharmaTech Ltd
NCT07001930Phase 1Aug 25, 2025Johns Hopkins University, National Institute on Drug Abuse (NIDA), University of Minnesota
NCT06538389Phase 2Aug 15, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
Showing 20 of 441 trials
Page 1 / 23

Organizations

Research & Development (350)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GW ResearchFor profit292632010
National Institute on Drug Abuse (NIDA)Government18232013
University of California, San DiegoAcademic/Hospital151232012
Insys Therapeutics IncFor profit131032013
University of Colorado, DenverAcademic/Hospital131232016
Johns Hopkins UniversityAcademic/Hospital111132017
University of HeidelbergAcademic/Hospital101032013
Icahn School of Medicine at Mount SinaiAcademic/Hospital9432010
New York UniversityAcademic/Hospital9942018
Yale UniversityAcademic/Hospital9822009
Jazz PharmaceuticalsFor profit8342022
Mclean HospitalAcademic/Hospital8822016
Tel Aviv UniversityAcademic/Hospital8732010
University of California, Los AngelesAcademic/Hospital8742015
University of LondonAcademic/Hospital8532011
Harvard UniversityAcademic/Hospital7622019
Tetra Bio-PharmaFor profit7642017
University of CopenhagenAcademic/Hospital7632014
University of FloridaAcademic/Hospital7732015
Hurd,Yasmin, Ph.D.Academic/Hospital6622010
350 organizations
Page 1 / 18

Marketing (2)

OrganizationOrg typeRelationshipDate
GW Pharmaceuticals Ltd.For profitNDAJun 25, 2018
GW ResearchFor profitNDA2Jun 25, 2018