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dantrolene

Trade name: dantrium

Small moleculeapprovedCOVID-19

Approved

Jan 15, 1974

Dantrolene is a drug which was approved by FDA for the treatment of chronic spasticity and malignant hyperthermia (a rare life-threatening clinical syndrome). Dantrolene effect was shown both in vivo and in vitro and proved to be mediated by interaction with Ryanodine receptor 1. The drug has a potential for hepatotoxicity and should be used as indicated in the label. — NCATS

Clinical trial activity

16 trials · 13 clinical orgs · 11 marketing orgs

Phase 1
6
Phase 2
10
Phase 3
4
Phase 4
0

Earliest trial started Feb 1, 2007 (NCT00797953)

Timeline

1970s

  1. Jan 15, 1974

    Par Pharmaceuticals — Earliest FDA Approval

  2. Jan 15, 1974

    Endo Pharmaceuticals — Marketing Organization

  3. Jan 15, 1974

    Par Pharmaceuticals — NDA Secondary Org

  4. Jan 15, 1974

    Par Pharmaceuticals — NDA Organization

  5. Jan 15, 1974

    PH HEALTH — Marketing Organization

2000s

  1. Mar 1, 2005

    Impax Laboratories — Marketing Organization

  2. Oct 24, 2005

    Elite Laboratories, Inc — Marketing Organization

  3. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

  4. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

  5. Jul 24, 2007

    US WorldMeds — Marketing Organization

2010s

  1. Jan 1, 2012

    Earliest Phase 3 Sponsor(trial)

  2. Jul 22, 2014

    Eagle Pharmaceuticals, Inc. — NDA Secondary Org

  3. Feb 18, 2016

    Eugia Pharma — Marketing Organization

  4. Feb 18, 2016

    Mylan — Marketing Organization

  5. Feb 18, 2016

    Auromedics Pharma — Marketing Organization

  6. Jun 19, 2017

    Hikma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJan 15, 1974

Chemistry & pharmacology

Loading structure…

SMILES

O=C1CN(/N=C/c2ccc(-c3ccc([N+](=O)[O-])cc3)o2)C(=O)N1
Mol. weight
314.26 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • dantamacrin
  • dantamacrin
  • dantrium
  • dantrium
  • dantrium
  • dantrium
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene
  • dantrolene sodium
  • dantrolene sodium
  • dantrolene sodium
  • dantrolene sodium
  • dantrolene sodium
  • dantrolene sodium salt
  • dantroleno
  • dantroleno
  • dantrolenum
  • dantrolenum
  • f-368
  • f-368
  • f-368
  • f-440
  • f-440
  • t89
  • t89

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06966843Phase 2/Phase 3 (Phase 3)Oct 31, 2027Tanta University
NCT04285190N/AFeb 26, 2020Tasly Pharmaceuticals, Inc.
NCT04134845Early Phase 1 (Phase 1)Oct 7, 2019Vanderbilt University
NCT03762109Phase 2Jul 1, 2019Harvard University
NCT03600376Phase 3Aug 19, 2018Eagle Pharmaceuticals, Inc.
NCT03621410Phase 2Jun 1, 2018Tasly Pharmaceuticals, Inc., University of California, San Francisco
NCT03189433Phase 2Jul 1, 2017Eagle Pharmaceuticals, Inc.
NCT02829268Phase 1/Phase 2 (Phase 2)Jan 1, 2017Washington University in St. Louis
NCT02513095Phase 2Sep 1, 2015Eagle Pharmaceuticals, Inc., IQVIA
NCT01679028Phase 1Aug 1, 2012Parexel, Tasly Pharmaceuticals, Inc.
NCT01659580Phase 3Aug 1, 2012Tasly Pharmaceuticals, Inc.
NCT01473888Phase 1Jan 1, 2011Tasly Pharmaceuticals, Inc.
NCT01024972Phase 1/Phase 2 (Phase 2)Oct 1, 2009American Heart Association, University of Massachusetts
NCT00796900Phase 2/Phase 3 (Phase 3)May 1, 2008Medical University of Vienna, University of Vienna
NCT00964548Phase 1/Phase 2 (Phase 2)Jul 1, 2007Harvard University, University of Massachusetts
NCT00797953Phase 2Feb 1, 2007Tasly Pharmaceuticals, Inc.
Showing 16 of 16 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Tasly Pharmaceuticals, Inc.For profit6542007
Eagle Pharmaceuticals, Inc.For profit3322015
Harvard UniversityAcademic/Hospital2112007
University of MassachusettsAcademic/Hospital2212007
American Heart AssociationAcademic/Hospital1012009
IQVIAFor profit1012015
Medical University of ViennaAcademic/Hospital1012008
ParexelFor profit1012012
Tanta UniversityAcademic/Hospital1112027
University of California, San FranciscoAcademic/Hospital1112018
University of ViennaAcademic/Hospital1112008
Vanderbilt UniversityAcademic/Hospital1112019
Washington University in St. LouisAcademic/Hospital1112017
13 organizations
Page 1 / 1

Marketing (14)

OrganizationOrg typeRelationshipDate
Auromedics PharmaFor profitMKTGFeb 18, 2016
Eagle Pharmaceuticals, Inc.For profitNDA2Jul 22, 2014
Elite Laboratories, IncFor profitMKTGOct 24, 2005
Endo PharmaceuticalsFor profitMKTGJan 15, 1974
Eugia PharmaFor profitMKTGFeb 18, 2016
HikmaFor profitMKTGJun 19, 2017
HikmaFor profitSYNJun 19, 2017
Impax LaboratoriesFor profitMKTGMar 1, 2005
MylanFor profitMKTGFeb 18, 2016
PH HEALTHFor profitMKTGJan 15, 1974
Par PharmaceuticalsFor profitNDA2Jan 15, 1974
Par PharmaceuticalsFor profitNDAJan 15, 1974
US WorldMedsFor profitMKTGJul 24, 2007
US WorldMedsFor profitSYNJul 24, 2007