TheraRadar
Data updated: May 26, 2026

DEHYDRATED ALCOHOL

Cardiovascular Approved 2025-06-23

Dehydrated alcohol helps patients with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. It is used to improve exercise capacity by inducing a controlled cardiac septal infarction. This procedure helps reduce the thickness of the heart's septum in adults suffering from this condition.

Source: FDA Label • ROYAL PHARMS

How DEHYDRATED ALCOHOL Works

This drug works as a tissue toxin that produces a localized myocardial infarction when injected into a specific septal vessel via an intra-arterial catheter. This process causes the thickened heart septum to thin, which helps alleviate the obstruction.

3
Indications
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-06-23
Patent Cliff
2032

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Routes
INTRAVENOUS, INTRA-ARTERIAL
Dosage Forms
SOLUTION

DEHYDRATED ALCOHOL Approval History

2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2025 to 2025
Oct 2025 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
Jul 2025 ORIGINAL
Update
Jun 2025 ORIGINAL
Update

What DEHYDRATED ALCOHOL Treats

1 indications

DEHYDRATED ALCOHOL is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertrophic Obstructive Cardiomyopathy
Source: FDA Label

DEHYDRATED ALCOHOL Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DEHYDRATED ALCOHOL

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ABLYSINOL
DEHYDRATED ALCOHOL
1 shared
BPI LABS
Shared indications:
Hypertrophic Obstructive Cardiomyopathy
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Clinical Trial Registry

24 trials
Trial Sponsor ID Phase Status Title
NCT00713492 080178 08-AA-0178 Ph 1 completed Computer-Assisted Self-Administration of Ethanol
NCT04300751 results posted 55176 R01DA016718 Ph 1 completed The Behavioral Effects of Opioids and Alcohol
NCT04931095 IRB00290015 1R01DA052295-01 Ph 1 completed The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment
NCT06293040 IRB00434441 R01DA052295 Ph 1 recruiting Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
NCT06703437 STUDY-22-00221 Ph 1 active not recruiting Long Acting Neuraxial Peri-prostatic Block in Cancer
NCT00295334 results posted 250505 Ph 2 completed Moderate Alcohol Intake Among Patients With Type 2 Diabetes
NCT06712602 90580 R01AA030774 Ph 1 recruiting PT150 Drug for Use in Alcohol Use Disorder
NCT03503773 results posted CR0014 Ph 2 completed The TARGET BP OFF-MED Trial
NCT03575403 BED[IN]:36 results posted 44796 R01AA026255 Ph 1 completed Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate)
NCT04003402 8062-CL-2001 Ph 1 completed A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
NCT05389930 2022003195 R01AA029711 Ph 2 recruiting Cannabis' Impact on Alcohol Consumption
NCT03699540 results posted 43636 R21DA045101-02 Ph 1 completed Marijuana Effects on Simulated Driving Performance
NCT06524609 EGCG-TIPN Ph 1, Ph 2 recruiting EGCG for the Prevention and Treatment of TIPN
NCT02910414 TARGET BP I CR0002 Ph 3 active not recruiting TARGET BP I Clinical Trial
NCT05273658 192048 Ph 1, Ph 2 withdrawn Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests
NCT00559819 ALCDrive MMoric111207 Ph 3 completed Validation of Driving Simulator to Blood Alcohol Concentration Standards for Impaired Driving
NCT03416348 OP150030 (Aim 1&2) OP150030 Ph 1 completed Hyperhidrosis, Developing a Treatment Approach Aims 1 & 2
NCT03361384 14-068 R01AA022301 Ph 1 completed Alcohol and Implicit Process in Sexual Risk Behavior in MSM
NCT03483636 E2006-A001-009 Ph 1 completed Study of Lemborexant-Alcohol Interaction in Healthy Subjects
NCT02046200 results posted IVM UL1TR000124 Ph 1, Ph 2 completed Development of Ivermectin for Alcohol Use Disorders
NCT01779024 results posted 130043 13-AA-0043 Ph 2 completed Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers
NCT02488889 VAR 23FT-0102 Ph 4 withdrawn Effects of Varenicline in Heavy Drinking Smokers
NCT02294266 IMIMFTCL/MEF/2 Ph 1 completed Mephedrone and Alcohol Interactions in Humans
NCT00879047 R01AA018001 Ph 1 completed Interaction of Alcohol and Highly Active Antiretroviral Therapy (HAART) in HIV/AIDS and HIV/AIDS With Hepatitis C Virus (HCV) Co-Infection
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

DEHYDRATED ALCOHOL FDA Label Details

Indications & Usage

FDA Label (PDF)

DEHYDRATED ALCOHOL is indicated for the treatment of Hypertrophic Obstructive Cardiomyopathy.

DEHYDRATED ALCOHOL Patents & Exclusivity

Exclusivity: Oct 2032

Exclusivity

ODE-521 Until Oct 2032
Source: FDA Orange Book

Looking for the branded version?

ABLYSINOL

Full clinical data, patents, trials, and competitive landscape for dehydrated alcohol.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.