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Drug

Ethanol

Regulatory activity · FDA
Emerging researchLate-stage developmentRising momentum
Also known as 1-Hydroxyethane, ALCOHOL, ALCOHOL,ETHYL, Alcohol (ethyl)+20 more

1-Hydroxyethane, ALCOHOL, ALCOHOL,ETHYL, Alcohol (ethyl), Alcohol etílico, Alcohol, Dehydrated, Alcool éthylique, Alkohol, Avagard, DEHYDRATED ALCOHOL, Dehydrated ethanol, EtOH - Ethanol, Ethyl Alcohol, Ethyl Alcohol Topical, Grain alcohol, Hydroxyethane, Methylcarbinol, Spiritus vini, etanol, Äthanol, Äthylalkohol, éthanol, Alcohol anhydrous, anhydrous ethanol.

RxNorm448ChEMBLCHEMBL545ATCD08AX08ATCV03AB16ATCV03AZ01UNII3K9958V90M
24
Research papers
25
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Acute Effects of Alcohol on PET Imaging of Phosphodiesterase-4B (PDE4B)

Clinical trial2026-07-07Results expected Q1 2028 · ClinicalTrials.gov

A Double-blind, Placebo-controlled, Phase I Study of the Pharmacokinetic and Pharmacodynamic Interaction of Oral AFA-281 With Alcohol in Healthy Volunteers

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Nicotinic Receptor Genetic Variation and Alcohol Reward

Clinical trial2026-06-30Results expected Q4 2026 · ClinicalTrials.gov

A Novel Drug Combination for Alcohol-Use Disorders: A Human Laboratory Study

Clinical trial2026-06-09Results posted · ClinicalTrials.gov

A Multicenter, Prospective, Randomized Controlled Trial of Combined Pulsed-Field and Radiofrequency-Modified Linear Ablation Versus Pulsed-Field Ablation Alone for Long-Standing Persistent Atrial Fibrillation

Clinical trial2026-06-08Results expected Q4 2028 · ClinicalTrials.gov

Influence of Orexin Antagonism on Motivation for Alcohol

Clinical trial2026-06-08Results expected Q1 2027 · ClinicalTrials.gov

Role of Metal Ion Transporter ZIP8 in Alcohol Related Behaviors

Clinical trial2026-06-01Results expected Q4 2027 · ClinicalTrials.gov

Recall (Class II): ETHANOL

Regulatory2026-05-22FDA

Chronic alcohol-induced brain states limit propagation of direct cortical stimulation.

Research2025-10-10Scientific reports

Central amygdala astrocyte plasticity underlies GABAergic dysregulation in ethanol dependence.

Research2025-04-08Translational psychiatry

Astrocyte Extracellular Matrix Modulates Neuronal Dendritic Development.

Research2025-04-07Glia

The glucagon-like peptide-1 and other endocrine responses to alcohol ingestion in women with versus without metabolic surgery.

Research2024-10-01Addiction biology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ethanol
Aliases & brands
1-HydroxyethaneALCOHOLALCOHOL,ETHYLAlcohol (ethyl)Alcohol etílicoAlcohol, DehydratedAlcool éthyliqueAlkoholAvagardDEHYDRATED ALCOHOLDehydrated ethanolEtOH - EthanolEthyl AlcoholEthyl Alcohol TopicalGrain alcoholHydroxyethaneMethylcarbinolSpiritus vinietanolÄthanolÄthylalkoholéthanolAlcohol anhydrousanhydrous ethanol
RxNorm CUI
448
ChEMBL ID
CHEMBL545
ATC codes
D08AX08V03AB16V03AZ01
UNII
3K9958V90M
Regulatory jurisdictions
fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2026-05-22RecallSafety
Recall (Class II): ETHANOL
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

121 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
121
registered trials across all phases
LATEST COMPLETION 2025
25
Active studies
21
Recruiting
46
Late-stage (III+)
76
Completed
20
Discontinued
PHASE DISTRIBUTIONn = 121
Early Phase 114Phase 140Phase 1 / 26Phase 215Phase 2 / 32Phase 39Phase 47Phase N / A28

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous Ultrasound Guided Treatment of Benign Thyroid Cyst

Unknown statusPH IVAssiut Universityn=302025

Endoscopic Ultrasound-Guided Coeliac Plexus Neurolysis for Cancer Pain: Chemical Versus Radiofrequency Ablation

Unknown statusPH IVThe University of Hong Kongn=542025

Effect of Ethanol Intoxication on the Anti-hypoglycemic Action of Glucagon

CompletedPH IVMassachusetts General Hospitaln=262017

Functional Imaging of Tremor Circuits and Mechanisms of Treatment Response

CompletedPH IVUniversity of California, San Diegon=562017

Effects of Varenicline in Heavy Drinking Smokers

WithdrawnPH IVUniversity of California, Los Angeles2016

Recent completions

Trials that read out recently, adding to the completed evidence base.

The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment

CompletedPH IJohns Hopkins Universityn=602025

Interactions of Alcohol and Opioids: Pharmacodynamic Effects

CompletedPH ISharon Walshn=112024

Estradiol Effects on Behavioral and Reward Sensitivity to Alcohol Across the Menstrual Cycle

CompletedN/AMark Fillmoren=1002024

A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications

CompletedPH IIAblative Solutions, Inc.n=3502024

Computer-Assisted Self-Administration of Ethanol (CASE) in Humans

CompletedPH INational Institute on Alcohol Abuse and Alcoholism (NIAAA)n=2292023

Social Effects of Alcohol

CompletedPH IUniversity of Chicagon=372023

Research activity

24 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132025
Major research themes8
Alcoholism5Ethanol5Alcohol Drinking3Astrocytes3Diabetes Mellitus, Type 23Neuronal Plasticity3Behavior, Addictive2Basal Ganglia1
Journals, researchers & institutions
Top journals
  • Alcoholism, clinical and experimental research2
  • Scientific reports2
  • Translational psychiatry2
  • Addiction biology1
  • Annals of hepatology1
  • Annual review of pharmacology and toxicology1
Leading researchers
  • Boissoneault J2
  • Cortez-Pinto H2
  • Fink-Jensen A2
  • Klausen MK2
  • Loomba R2
  • Lovinger DM2
  • Stennett B2
  • Thomsen M2
Leading institutions
free-text, unnormalised
  • University of Copenhagen3
  • Clínica Universitária de Gastrenterologia2
  • Department of Clinical and Health Psychology2
  • Indiana University School of Medicine2
  • Laboratory for Integrative Neuroscience2
  • Laboratory of Neuropsychiatry2

Related diseases

4 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Semaglutide

Studied across 9 of the same disease areas as Ethanol in the shared literature.

9 shared diseases2 shared papers
Insulin

Studied across 8 of the same disease areas as Ethanol in the shared literature.

8 shared diseases1 shared paper
Tirzepatide

Studied across 6 of the same disease areas as Ethanol in the shared literature.

6 shared diseases1 shared paper
Triglycerides

Studied across 5 of the same disease areas as Ethanol in the shared literature.

5 shared diseases1 shared paper
gamma-Aminobutyric Acid

Studied across 3 of the same disease areas as Ethanol in the shared literature.

3 shared diseases1 shared paper
Ghrelin

Studied across 2 of the same disease areas as Ethanol in the shared literature.

2 shared diseases1 shared paper
Glycerides

Frequently co-studied with Ethanol in the research literature.

1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.