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dronabinol

Trade name: marinol

Small moleculeapproved

Approved

May 31, 1985

Dronabinol also known as (−)-trans-delta9-tetrahydrocannabinol is an active ingredient of cannabis. The drug was approved by FDA for the treatment of anorexia in patients with AIDS and chemotherapy-induced nausea and vomiting. Dronabinol exerts its action by activating CB1 and CB2 recepors which makes it a CNS active medicine. — NCATS

Clinical trial activity

126 trials · 115 clinical orgs · 10 marketing orgs

Phase 1
50
Phase 2
54
Phase 3
19
Phase 4
11

Earliest trial started Nov 2, 1999 (NCT00000737)

Timeline

1980s

  1. May 31, 1985

    Earliest FDA Approval

  2. May 31, 1985

    Alkem Labs Ltd — Marketing Organization

  3. May 31, 1985

    AbbVie — NDA Secondary Org

  4. May 31, 1985

    Alkem Labs Ltd — NDA Secondary Org

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 3 Sponsor(trial)

  3. Jun 27, 2008

    Rhodes Technologies Inc — Marketing Organization

2010s

  1. Aug 19, 2011

    Insys Therapeutics Inc — Marketing Organization

  2. Jun 20, 2014

    Akorn, Inc. — Marketing Organization

  3. Jun 20, 2014

    Hikma — Marketing Organization

  4. Jul 1, 2016

    Insys Therapeutics Inc — NDA Secondary Org

  5. Jul 1, 2016

    Benuvia — Marketing Organization

  6. Jul 1, 2016

    Benuvia — NDA Secondary Org

  7. May 18, 2018

    Lannett Company, Inc. — Marketing Organization

2020s

  1. Feb 7, 2020

    Ascent Pharmahealth — Marketing Organization

  2. Feb 7, 2020

    AbbVie — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMay 31, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCC1=CC(O)=C2[C@@H]3C=C(C)CC[C@H]3C(C)(C)OC2=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-trans-delta-9-tetrahydrocannabinol
  • 1-trans-delta-9-tetrahydrocannabinol
  • 3-pentyl-6,6,9-trimethyl-6a,7,8,10a-tetrahydro-6h-dibenzo(b,d)pyran-1-ol
  • 3-pentyl-6,6,9-trimethyl-6a,7,8,10a-tetrahydro-6h-dibenzo(b,d)pyran-1-ol
  • 6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6h-benzo[c]chromen-1-ol
  • 6,6,9-trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6h-benzo[c]chromen-1-ol
  • delta(1)-tetrahydrocannabinol
  • delta(1)-tetrahydrocannabinol
  • delta 9 tetrahydrocannabinol
  • delta 9 tetrahydrocannabinol
  • delta-9 tetrahydrocannabinol
  • delta-9 tetrahydrocannabinol
  • delta-9-tetrahydrocannabinol
  • delta-9-tetrahydrocannabinol
  • delta-9-tetrahydrocannabinol
  • delta-9-tetrahydrocannabinol
  • delta9-tetrahydrocannabinol
  • delta9-tetrahydrocannabinol
  • delta-9-thc
  • delta-9-thc
  • delta(9)-thc
  • delta(9)-thc
  • (-)-delta9-trans-tetrahydrocannabinol
  • (-)-delta9-trans-tetrahydrocannabinol
  • dronabinol
  • dronabinol
  • dronabinol
  • dronabinol
  • dronabinol
  • dronabinol
  • dronabinol
  • dronabinol
  • dronabinolum
  • dronabinolum
  • dronabinolum
  • marinol
  • marinol
  • marinol
  • marinol
  • tetrahydrocannabinol
  • tetrahydrocannabinol
  • δ9-tetrahydrocannabinol
  • δ9-tetrahydrocannabinol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07148206Phase 3Jan 31, 2026National Institute on Drug Abuse (NIDA), Yeshiva University
NCT07311330Phase 2Jan 31, 2026Beijing Inno Medicine Co., Ltd.
NCT07225777Phase 2Jan 1, 2026Medical University of South Carolina, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
NCT07309042Phase 1Dec 31, 2025Beijing Inno Medicine Co., Ltd.
NCT07231965Phase 2/Phase 3 (Phase 3)Dec 31, 2025Mayo Clinic
NCT07190885Phase 1Oct 27, 2025Beijing Inno Medicine Co., Ltd.
NCT06731894Phase 2Oct 27, 2025City of Hope National Medical Center, National Cancer Institute (NCI)
NCT07176208Phase 1Sep 22, 2025Food and Drug Administration, Spaulding Clinical Research Inc.
NCT06834997Phase 2May 1, 2025Baylor University
NCT06477952Phase 1/Phase 2 (Phase 2)Mar 3, 2025Department of Veteran Affairs, University of Illinois at Chicago
NCT06700720Phase 2Dec 16, 2024Beijing Inno Medicine Co., Ltd.
NCT06473701Phase 3Sep 30, 2024Aarhus University, Region of Southern Denmark, Region Syddanmark, University of Southern Denmark
NCT06446479Phase 2Jul 1, 2024Colorado State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Colorado, Denver
NCT06454669Phase 2Jun 15, 2024Baylor University
NCT05865470Phase 1Mar 1, 2024National Institute on Drug Abuse (NIDA), University of California, Los Angeles
NCT06175273Phase 2/Phase 3 (Phase 3)Jan 31, 2024National Center for Advancing Translational Science (NCATS), University of Kentucky
NCT06146101Phase 2/Phase 3 (Phase 3)Jan 31, 2024Incannex Healthcare Ltd
NCT05906511Early Phase 1 (Phase 1)Dec 1, 2023Department of Veteran Affairs, National Institute on Drug Abuse (NIDA), Yale University
NCT05612711Phase 2Nov 30, 2023Department of Veteran Affairs, Johns Hopkins University
NCT06048588Phase 1Oct 8, 2023Beijing Inno Medicine Co., Ltd.
Showing 20 of 126 trials
Page 1 / 7

Organizations

Research & Development (115)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute on Drug Abuse (NIDA)Government22342001
Yale UniversityAcademic/Hospital131312007
Columbia UniversityAcademic/Hospital8532001
Beijing Inno Medicine Co., Ltd.For profit6622022
Department of Veteran AffairsGovernment6332008
SolvayFor profit6332001
University of ChicagoAcademic/Hospital6532010
BionoricaFor profit4222007
Johns Hopkins UniversityAcademic/Hospital4312009
GW Pharmaceuticals Ltd.For profit3232002
Harvard UniversityAcademic/Hospital3232001
Humboldt UniversityAcademic/Hospital3322020
Mayo ClinicAcademic/Hospital3322009
Radboud UniversityAcademic/Hospital3322011
University of Illinois at ChicagoAcademic/Hospital3222012
University of VermontAcademic/Hospital3022008
Wayne State UniversityAcademic/Hospital3332014
Baylor UniversityAcademic/Hospital2212024
Brain & Behavior Research FoundationAcademic/Hospital2022005
Dartmouth UniversityAcademic/Hospital2212009
115 organizations
Page 1 / 6

Marketing (16)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2May 31, 1985
AbbVieFor profitMKTGFeb 7, 2020
Akorn, Inc.For profitSYNJun 20, 2014
Akorn, Inc.For profitMKTGJun 20, 2014
Alkem Labs LtdFor profitMKTGMay 31, 1985
Alkem Labs LtdFor profitNDA2May 31, 1985
Ascent PharmahealthFor profitMKTGFeb 7, 2020
BenuviaFor profitMKTGJul 1, 2016
BenuviaFor profitSYNJul 1, 2016
BenuviaFor profitNDA2Jul 1, 2016
HikmaFor profitMKTGJun 20, 2014
Insys Therapeutics IncFor profitNDA2Jul 1, 2016
Insys Therapeutics IncFor profitMKTGAug 19, 2011
Lannett Company, Inc.For profitMKTGMay 18, 2018
Rhodes Technologies IncFor profitMKTGJun 27, 2008
Unimed PharmaceuticalsFor profitNDA—