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Drug

Alprazolam

Approved · FDA
Emerging researchLate-stage development

Also known as Niravam, Xanax, 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-a)(1,4)benzodiazepine.

RxNorm596ChEMBLCHEMBL661UNIIYU55MQ3IZY
2
Research papers
4
Active clinical trials
1
Regulatory events
Latest activity
beta

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

Approval: ALPRAZOLAM (ANDA213204)

Regulatory2026-07-13FDA

Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects

Clinical trial2026-05-14Results expected Q1 2029 · ClinicalTrials.gov

Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia. An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction.

Clinical trial2026-04-24Results expected Q4 2027 · ClinicalTrials.gov

Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia

Clinical trial2026-04-23Results expected Q3 2026 · ClinicalTrials.gov

Abuse Liability Study of Staccato® Alprazolam for Inhalation in Subjects With Histories of Sedative Abuse

Clinical trial2026-04-22Results posted · ClinicalTrials.gov

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

Clinical trial2026-01-19Completed · ClinicalTrials.gov

Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies - Study 3

Clinical trial2025-12-30Results expected Q4 2026 · ClinicalTrials.gov

A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience

Clinical trial2024-12-09Results posted · ClinicalTrials.gov

A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience

Clinical trial2024-08-12Results posted · ClinicalTrials.gov

Detoxification From the Lipid Tract by Cocktail Design

Clinical trial2024-03-20Completed · ClinicalTrials.gov

Time to response in generalized anxiety disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone.

Research2006-12-01Psychiatry (Edgmont (Pa. : Township))

Time to response in panic disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone.

Research2006-12-01Psychiatry (Edgmont (Pa. : Township))

Profile

Identifiers & mechanism

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

Canonical name
Alprazolam
Aliases & brands
NiravamXanax8-Chloro-1-methyl-6-phenyl-4H-s-triazolo(4,3-a)(1,4)benzodiazepine
RxNorm CUI
596
ChEMBL ID
CHEMBL661
UNII
YU55MQ3IZY
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.

Earliest approval
2026-07-13
Latest approval
2026-07-13
Authorities
FDA
Total events
1
fdaU.S. Food and Drug Administration· 1 event
2026-07-13Approval
Approval: ALPRAZOLAM (ANDA213204)
Evidence ↗

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

Clinical trials

61 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
61
registered trials across all phases
LATEST COMPLETION 2026
4
Active studies
4
Recruiting
23
Late-stage (III+)
46
Completed
11
Discontinued
PHASE DISTRIBUTIONn = 61
Early Phase 12Phase 129Phase 1 / 23Phase 24Phase 2 / 32Phase 31Phase 416Phase N / A4

Late-stage studies

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

Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia. An Extension Test of Whether to Use Oral Anti-anxiety Drugs (Alprazolam) When Patients Choose Second Eye Cataract Surgery After Unblinding, and Analyze Their Anxiety, Satisfaction and Pain Satisfaction.

RecruitingPH IVNational Taiwan University Hospitaln=2502027

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

CompletedPH IVUniversity of California, San Franciscon=202026

Detoxification From the Lipid Tract by Cocktail Design

CompletedPH IVPachankis, Yang I., M.D.n=12024

A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience

CompletedPH IVArbor Pharmaceuticals, Inc.n=862022

Efficacity of Hypnosis Versus Premedication for the Management of Perioperative Anxiety in Gynecological Surgery

Unknown statusPH IVCentral Hospital, Nancy, Francen=1282021

Recent completions

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

Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

CompletedPH IVUniversity of California, San Franciscon=202026

Detoxification From the Lipid Tract by Cocktail Design

CompletedPH IVPachankis, Yang I., M.D.n=12024

A Phase 1, Randomized, Double-Blind, Double-Dummy, Active- and Placebo-Controlled, 5-Way Crossover Study Evaluating the Abuse Potential of Soticlestat (TAK-935) in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System Depressant Experience

CompletedPH ITakedan=1002023

An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Evaluate The Relative Bioavailability of Staccato Alprazolam Compared to Oral Alprazolam in Healthy Study Participants

CompletedPH IUCB Biopharma SRLn=212023

A Phase I/II, 3-Arm, Open Label, Single Centre Study to Investigate the Safety and Effect of Oral GABA Therapy on Beta-Cell Regeneration in Type 1-diabetes Patients

CompletedPH I/IIPer-Ola Carlssonn=352022

A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experience

CompletedPH IVArbor Pharmaceuticals, Inc.n=862022

Research activity

2 papers

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

Journals, researchers & institutions
Top journals
  • Psychiatry (Edgmont (Pa. : Township))2
Leading researchers
  • Harper JM2
  • Katzelnick DJ2
  • McCrary KE2
  • Dewester JN1
  • Jefferson JW1
  • Rapaport MH1
  • Saidi J1
  • Skarky SB1
Leading institutions
free-text, unnormalised
  • Cedars-Sinai Medical Center1
  • Inc. and is Clinical Professor of Psychiatry1
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.