ABLYSINOL (dehydrated alcohol)
Ablysinol is a dehydrated alcohol injection used for adults with symptomatic hypertrophic obstructive cardiomyopathy. It helps patients who are not candidates for surgical myectomy by improving their ability to exercise. This medication acts as an ablative agent to create a controlled area of tissue death within the heart's septum.
How ABLYSINOL Works
This drug works by acting as a tissue toxin when injected through a catheter into a specific septal vessel. This process produces a controlled myocardial infarction, which causes the thickened heart septum to thin.
Details
- Status
- Prescription
- First Approved
- 2018-06-21
- Routes
- INTRA-ARTERIAL
- Dosage Forms
- SOLUTION
ABLYSINOL Approval History
What ABLYSINOL Treats
1 indicationsABLYSINOL is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertrophic Obstructive Cardiomyopathy
ABLYSINOL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06703437 | STUDY-22-00221 | Ph 1 | active not recruiting | Long Acting Neuraxial Peri-prostatic Block in Cancer |
| NCT02910414 TARGET BP I | CR0002 | Ph 3 | active not recruiting | TARGET BP I Clinical Trial |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ABLYSINOL FDA Label Details
Indications & Usage
FDA Label (PDF)ABLYSINOL is indicated for the treatment of Hypertrophic Obstructive Cardiomyopathy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.