Xanax

(Alprazolam)

ApprovedSmall molecule

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Alprazolam is used to treat anxiety disorders and panic disorder by helping calm excessive worry and fear. It can also be used short-term to relieve anxiety symptoms.[2] Xanax is currently approved and in use across 12 indications[4].[1]

Xanax is one of 298 small molecule programs targeting Migraine Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

297

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Migraine DisorderApproved

Dental PhobiaApproved

Panic DisorderActive, not recruiting

Drug DependenceApproved

CataractRecruiting

AnxietyUnknown status

SeizureApproved

Essential TremorActive, not recruiting

Generalized Anxiety DisorderCompleted

InteractionRecruiting

Migraine DisorderApproved

Approved

Dental PhobiaApproved

Approved

Panic DisorderApproved

Active, not recruiting

Drug DependenceApproved

Approved

CataractApproved

Recruiting

AnxietyApproved

Unknown status

SeizureApproved

Approved

Essential TremorPreclinical

Active, not recruiting

Generalized Anxiety DisorderApproved

Completed

InteractionPhase 2

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

64 competitors in Type 1 Diabetes Mellitus

#DrugCompanyPhaseTrials

Xanax

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

75 2

Actos

Takeda

Approved

2 3

Diamox

Ozempic

Brethine

Estrace

Rocaltrol

Neoral

Opzelura

Calciferol

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Drug Abuse

NCT05006079

Recruiting

Essential Tremor

NCT06293638

Q2 2029

Phase 1/2Recruiting

Interaction

NCT06757140

Clinical

Trials by Indication[1]

LAM11 trials

To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 1 mg

Completed· Novartis logo

Novartis·Phase 1·NCT00913341·30 enrolled

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1·NCT00878865·18 enrolled

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1·NCT00878514·18 enrolled

Show 8 more trials

Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects

Terminated· Pfizer logo

Pfizer·Phase 1·NCT00580190·47 enrolled

Fasting Study of Alprazolam Extended-Release Tablets 3 mg to Xanax XR® Tablets 3 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00647634·21 enrolled

Fasting Study of Alprazolam Extended-Release Tablets 1 mg to Xanax XR Tablets 1 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00647894·24 enrolled

Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation

Withdrawn·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00877955

To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg

Completed· Novartis logo

Novartis·Phase 1·NCT00912145·26 enrolled

A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT01322867·30 enrolled

Staccato Alprazolam Abuse Liability

Completed·AAlexza Pharmaceuticals, Inc.·Phase 1·NCT00603980·31 enrolled

Fed Study of Alprazolam Extended-release Tablets 3 mg to Xanax XR® Tablets 3 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650299·21 enrolled

Fasting Conditions7 trials

A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

Withdrawn·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01046162

A Relative Bioavailability Study of Alprazolam 3 mg Extended Release Tablets Under Non-fasting Conditions

Completed·AActavis Inc.·Phase 1·NCT00865657·40 enrolled

Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Non-fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00830024·36 enrolled

Show 4 more trials

A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Non-Fasting Conditions

Completed·AActavis Inc.·Phase 1·NCT01188057·40 enrolled

A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions

Completed·AActavis Inc.·Phase 1·NCT01188031·40 enrolled

A Relative Bioavailability Study of Alprazolam 3 mg ER Tablets Under Fasting Conditions

Completed·AActavis Inc.·Phase 1·NCT00865761·40 enrolled

Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00829426·32 enrolled

Anxiety5 trials

Efficacy and Safety Study of a IMSS Developed Phytopharmaceutical for the Treatment of Anxiety.

Unknown status·CCoordinación de Investigación en Salud, Mexico·Phase 2·NCT03702803·122 enrolled

Trial of Pregabalin, Alprazolam, and Placebo in Subjects With Anxiety Prior to Dental Procedure

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT00245609·90 enrolled

Preoperative Use of Alprazolam and Hydroxyzine in Anxiety

Unknown status·IIstanbul Medeniyet University·Phase 4·NCT04184141·90 enrolled

Show 2 more trials

A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety

Completed· UCB logo

UCB·Phase 3·NCT00139854

Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00004373·80 enrolled

Premedication4 trials

Reassessment of Premedication in Surgery

Completed·UUniversity Hospital, Angers·Phase 4·NCT01549691·455 enrolled

Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone

Completed·—·Phase 4·NCT01486615·80 enrolled

Sedative Premedication in Coronary Angiography

Unknown status·UUniversitair Ziekenhuis Brussel·N/A·NCT03576456·264 enrolled

Show 1 more trial

Preoperative Hypnosis Versus Premedication in Gynecological Surgery

Unknown status·—·Phase 4·NCT03327506·128 enrolled

Panic Disorder4 trials

Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

Completed·UUniversity of Buenos Aires·Phase 4·NCT00803400·150 enrolled

A Study to Assess the Long-term Use of Alprazolam Extended Release (XL) in the Treatment of Adolescents With Panic Disorder

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00635076·3 enrolled

A Study To Assess the Safety of Extended Release Alprazolam for the Treatment of Adolescents With Panic Disorder or Anxiety With Panic Attacks

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00634790·49 enrolled

Show 1 more trial

A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic Disorder

Terminated·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00635531·16 enrolled

31 more indications

Abuse Potential3 trials

A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03286218·96 enrolled

A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

Completed· Pfizer logo

Pfizer·Phase 1·NCT00975481·36 enrolled

An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users

Completed·AArbor Pharmaceuticals, Inc.·Phase 4·NCT06097676·86 enrolled

Oral3 trials

Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00810316·24 enrolled

Bioequivalence of Alprazolam Sublingual vs Oral Tablets

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT00860119·23 enrolled

A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants

Completed· UCB logo

UCB·Phase 1·NCT05626439·21 enrolled

Trial3 trials

Bioequivalence Trial of Alprazolam 2 mg Tablets

Completed· GSK logo

GSK·Phase 1·NCT01745575·26 enrolled

Bioequivalence Trial of Alprazolam 0.5 mg Tablets

Completed· GSK logo

GSK·Phase 1·NCT01745562·28 enrolled

Bioequivalence Trial of Alprazolam 0.25 mg Tablets

Completed· GSK logo

GSK·Phase 1·NCT01853956·28 enrolled

Driving2 trials

Assessment of Effect of Rapastinel on Driving Performance

Completed· AbbVie logo

AbbVie·Phase 1·NCT03814733·107 enrolled

The Effects of Lasmiditan on Simulated Driving Performance - Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03012334·90 enrolled

Imaging2 trials

Spectroscopic Imaging at 4T: A Drug Challenge Study

Terminated·MMclean Hospital·N/A·NCT01577706·7 enrolled

Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T

Unknown status·MMclean Hospital·Phase 1·NCT01747590·12 enrolled

Tics2 trials

Study to Assess the Safety, Tolerability, And Pharmacokinetics of Staccato Alprazolam in Healthy Japanese, Chinese, and Caucasian Participants

Completed· UCB logo

UCB·Phase 1·NCT04782388·30 enrolled

Pharmacokinetics Of Alprazolam Sublingual Tablet Versus Conventional Tablet

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01256151·28 enrolled

Generalized Anxiety Disorder2 trials

Drug Treatment Validation of Functional Magnetic Resonance Imaging in Generalized Anxiety Disorder

Completed·UUniversity of California, San Diego·Phase 4·NCT00662259·32 enrolled

A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder

Completed· Pfizer logo

Pfizer·Phase 2·NCT00921063·222 enrolled

Hypoglycemia2 trials

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Completed·VVanderbilt University·N/A·NCT00592332·56 enrolled

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT00574639·14 enrolled

Virtual Reality1 trial

D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD

Completed·EEmory University·Phase 2/3·NCT00356278·156 enrolled

Drug Abuse1 trial

Opioid/Benzodiazepine Polydrug Abuse: Aim 3

Recruiting·WWayne State University·Phase 2·NCT05006079·24 enrolled

Anxiety Disorder1 trial

Effects of Buspar on Depressive Symptom Improvement and Neuroprotection in Patients With Anxiety Disorder

Withdrawn·SSeoul National University Hospital·Phase 4·NCT01546896

Lip1 trial

Detoxification From the Lipid Tract

Completed·PPachankis, Yang I., M.D.·Phase 4·NCT06357104·1 enrolled

Interaction1 trial

Opioid Drug Interaction Study

Recruiting·SShanna Babalonis, PhD·Phase 1/2·NCT06757140·25 enrolled

Essential Tremor1 trial

Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor

Recruiting·TThe Cleveland Clinic··NCT06293638·55 enrolled

CBD1 trial

Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT03398083·42 enrolled

Acute Coronary Syndrome1 trial

Role of Alprazolam in the Management of Acute Coronary Syndrome

Unknown status·SSohaib Ashraf·Phase 1/2·NCT04715269·48 enrolled

ESS1 trial

Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block

Completed·IIsfahan University of Medical Sciences·Phase 4·NCT01546090·60 enrolled

Drug1 trial

A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users

Completed·SSK Life Science, Inc.·Phase 1·NCT03509285·53 enrolled

Dietary Supplements1 trial

Licorice Botanical Dietary Supplements - Metabolism and Safety in Women

Completed·UUniversity of Illinois at Chicago·Phase 1·NCT03948243·19 enrolled

Elderly1 trial

A Study to Assess the Cognitive Effects of Fesoterodine in Elderly Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01161472·20 enrolled

Anxiolytic Effect1 trial

Sedative-Anxiolytic Effects on Simulated Driving Performance

Completed·MMarion Coe·Phase 4·NCT03297944·15 enrolled

Carbon Dioxide1 trial

A Trial of the Effect of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subjects

Completed·CCerevel Therapeutics, LLC·Phase 1·NCT04592536·56 enrolled

Treatment1 trial

Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes

Completed·PPer-Ola Carlsson·Phase 1/2·NCT03635437·35 enrolled

Sedation1 trial

Alprazolam as Conscious Sedation for Upper Gastrointestinal Endoscopy

Completed·IIsfahan University of Medical Sciences·Phase 2/3·NCT01949038·220 enrolled

Upper Gastrointestinal Endoscopy1 trial

Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy

Completed·IIsfahan University of Medical Sciences·Phase 2/3·NCT03130842·136 enrolled

Asthma1 trial

A Study to Assess the Pulmonary Safety of Staccato Alprazolam in Healthy Study Participants and in Study Participants With Mild Asthma

Completed· UCB logo

UCB·Phase 1·NCT04802746·78 enrolled

Social Anxiety Disorder1 trial

A Study To Compare The Putative Anxiolytic Effect Of 2 New Drugs In Subjects With Social Anxiety Disorder

Completed· GSK logo

GSK·Phase 1·NCT00555139·35 enrolled

ART1 trial

To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.

Completed· GSK logo

GSK·Phase 1·NCT00426608·20 enrolled

Epilepsy1 trial

A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

Completed· UCB logo

UCB·Phase 1·NCT04857307·14 enrolled

Cataract1 trial

Oral vs IV Sedation for Cataract Surgery in Older Adults

Recruiting·UUniversity of California, San Francisco·Phase 4·NCT07154147·20 enrolled

Unspecified3 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

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

Completed· Takeda logo

Takeda·Phase 1·NCT05602818·100 enrolled

A Phase 4, Randomized, Double-Blind, Placebo and Active-Controlled, Single-Dose, Four-Way Crossover Study Evaluating the Abuse Potential of Two Doses of Gabapentin Taken Orally in Healthy, Non-Drug-Dependent Participants With Sedative Drug Use Experience

Completed· Viatris logo

Viatris·Approved·NCT07777965·44 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

XANAX

NDA NDA018276

Jan 17, 2003

XANAX XR

NDA NDA021434

Jan 19, 2005

NIRAVAM

NDA NDA021726

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for Alprazolam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Xanax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alprazolam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alprazolam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021726). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer's Upjohn has merged with Mylan to form Viatris Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor; Anion Channel Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Xanax

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2029

Trials by Indication[1]

LAM11 trials

Fasting Conditions7 trials

Anxiety5 trials

Premedication4 trials

Panic Disorder4 trials

Abuse Potential3 trials

Oral3 trials

Trial3 trials

Driving2 trials

Imaging2 trials

Tics2 trials

Generalized Anxiety Disorder2 trials

Hypoglycemia2 trials

Virtual Reality1 trial

Drug Abuse1 trial

Anxiety Disorder1 trial

Lip1 trial

Interaction1 trial

Essential Tremor1 trial

CBD1 trial

Acute Coronary Syndrome1 trial

ESS1 trial

Drug1 trial

Dietary Supplements1 trial

Elderly1 trial

Anxiolytic Effect1 trial

Carbon Dioxide1 trial

Treatment1 trial

Sedation1 trial

Upper Gastrointestinal Endoscopy1 trial

Asthma1 trial

Social Anxiety Disorder1 trial

ART1 trial

Epilepsy1 trial

Cataract1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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