TheraRadar
Data updated: Nov 8, 2026

AVAGARD (alcohol) · SOLVENTUM

Trial Activity: Declining 4 active trials
Infectious Disease Approved 2001-06-07
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

National Institute on Alcohol Abuse and Alcoholism (NIAAA) conducting 2 trials (9%)
34 indications explored (Broad Platform)
→ alcohol drinking (5 trials)
→ alcohol use disorder (4 trials)
→ cannabis intoxication (3 trials)
1
Indication
--
Phase 3 Trials
25
Years on Market

Details

Status
Over-the-counter
First Approved
2001-06-07
Routes
TOPICAL
Dosage Forms
SOLUTION

Companies

SOLVENTUM
Active Ingredient: ALCOHOL , CHLORHEXIDINE GLUCONATE

AVAGARD Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2001 to 2017
Sep 2017 SUPPL
Label · Labeling
FDA Letter Label
Nov 2016 SUPPL
Label · Labeling
FDA Letter Label
Nov 2015 SUPPL
Label · Labeling
FDA Letter Label

What AVAGARD Treats

1 FDA approvals

Originally approved for its first indication in 2001 .

  • Other (1)
📋

Clinical Trial Registry

23 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 results posted 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
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)
NCT00731042 results posted I2MS05-010877 Ph 4 completed A Two-week Crossover Evaluation of Two Hand Antiseptic Products on Skin Condition in Healthy Human Subjects
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
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

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

AVAGARD FDA Label Details

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Data Sources

FDA Approval: NDA021074 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment