Dantrium

(Dantrolene)

Phase 3Small molecule

AAultman Health Foundation

Dantrium is one of 10 small molecule programs targeting Myopathy. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MyopathyNot yet recruiting

MyopathyPhase 3

Not yet recruiting

Competition

Competitive Landscape

12 competitors in Myopathy

#DrugCompanyPhaseTrials

Viagra

VViatris Specialty LLC

Approved

1 2

Zocor

OOrganon and Co

Approved

1 3

Deltasone

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

1 4

Mesnex

BBaxter Healthcare Corporation

Approved

—5

Acetadote

AArbor Pharmaceuticals, Inc.

Approved

—6

Cytoxan

BBaxter Healthcare Corporation

Approved

—7

Dantrium

AAultman Health Foundation

Phase 3

1 8

Salbutamol

GSK

Preclinical

1 9

Coenzyme Q10

MMclean Hospital

Preclinical

1 10

Thioctic Acid

MMEDA Pharma GmbH & Co. KG

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2029

PreclinicalRecruiting

Multiple Sclerosis

NCT03109288

Q1 2030

Phase 2/3Not yet recruiting

Myopathy

NCT06966843

Clinical

Trials by Indication[1]

Subarachnoid Hemorrhage2 trials

Safety Study of Dantrolene in Subarachnoid Hemorrhage

Completed·UUniversity of Massachusetts, Worcester·Phase 1/2·NCT01024972·31 enrolled

Safety Study of Dantrolene to Treat Cerebral Vasospasm After Subarachnoid Hemorrhage

Completed·UUniversity of Massachusetts, Worcester·Phase 1/2·NCT00964548·10 enrolled

Hemorrhage1 trial

Dantrolene for Treatment of Hyperthermia in Subarachnoidal Hemorrhage (SAH)

Terminated·MMedical University of Vienna·Phase 2/3·NCT00796900·34 enrolled

Analgesia1 trial

The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery

Completed·—·Phase 2·NCT03762109·90 enrolled

Myopathy1 trial

Dantrolene in Statin-induced Myopathy

Not yet recruiting·TTanta University·Phase 2/3·NCT06966843·23 enrolled

Shivering1 trial

Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01950520·47 enrolled

1 more indication

Multiple Sclerosis1 trial

Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT03109288·250 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

DANTRIUM

NDA NDA017443

Jan 1, 1982

DANTRIUM

NDA NDA018264

Jul 22, 2014

RYANODEX

NDA NDA205579

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Dantrolene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dantrolene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dantrolene. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205579). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Aultman Health Foundation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAultman Health Foundation

Dantrium

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2029

Q1 2030

Trials by Indication[1]

Subarachnoid Hemorrhage2 trials

Hemorrhage1 trial

Analgesia1 trial

Myopathy1 trial

Shivering1 trial

Multiple Sclerosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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