Drugs / Alprazolam
Alprazolam
also known as
Xanax · Staccato alprazolam · Alp · Alprazolam XR · Alprax · Alprazolam civ · Niravam · NSC-760140 · +5 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | XANAX | — | 1990-11-06 | fda.gov ↗ |
| Approved | US (FDA) | XANAX | — | 1981-10-16 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT01747590 | Jul 2011 → Dec 2013 | drug-induced mental disorder | Mclean Hospital | Unknown | No outcome recorded |
| Phase 0 | NCT00574639 | Jul 2007 → Jun 2016 | type 1 diabetes mellitus | University of Maryland, Baltimore | Completed | No outcome recorded |
| Phase 123 trials | ||||||
| Phase 1 | NCT07020988 | Jun 2025 → Jan 2026 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT05626439 | Dec 2022 → Feb 2023 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT04970342 | Jul → Aug 2021 | — | Timothy L. Brown | Completed | No outcome recorded |
| Phase 1 | NCT04857307 | Apr 2021 → Apr 2022 | epilepsy | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT04802746 | Mar → Nov 2021 | intermittent asthma | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT04782388 | Mar → Apr 2021 | — | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 1 | NCT04658732 | Dec 2020 → Jun 2021 | — | Ehab Tarek Fahmy | Unknown | No outcome recorded |
| Phase 1 | NCT03948243 | Apr 2019 → Jul 2020 | — | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 1 | NCT03516305 | Apr → Aug 2018 | — | Engage Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03053869 | Apr 2017 → Sep 2018 | delirium | McMaster University | Completed | No outcome recorded |
| Phase 1 | NCT00810316 | Oct → Nov 2008 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00603980 | Jan 2008 → Jan 2009 | — | Nova Pneuma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00555139 | Mar 2007 → Jan 2008 | social phobia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00426608 | Oct 2006 → Jan 2007 | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01188057 | Jul → Aug 2006 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01188031 | Jun → Jul 2006 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00865761 | Sep 2005 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00865657 | Sep 2005 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00444522 | Jun → Aug 2005 | — | Alexza Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00647894 | Jan 2005 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00650299 | Aug 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00912145 | Feb 1996 | anxiety | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00913341 | Nov 1991 | anxiety | Sandoz | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06757140 | Apr 2025 → Jan 2029 expected | — | Shanna Babalonis, PhD | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04715269 | Dec 2020 → Nov 2021 | ST-elevation myocardial infarction, acute coronary syndrome, anxiety | Sohaib Ashraf | Unknown | No outcome recorded |
| Phase 1/2 | NCT03635437 | Sep 2018 → Sep 2022 | type 1 diabetes mellitus | Per-Ola Carlsson | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT03478982 | Mar 2018 → Dec 2019 | epilepsy | Engage Therapeutics, Inc. | Completed | Met primary |
| Phase 2 | NCT02351115 | Jan 2015 → Jul 2016 | epilepsy | Nova Pneuma Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00477451 | May 2007 → Apr 2008 | — | Alexza Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 2 | NCT00245609 | Jan → Oct 2006 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00004373 | Mar 1997 → Mar 2001 | panic disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05076617 | Feb 2022 → Nov 2028 expected | epilepsy syndrome | UCB Biopharma SRL | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT05077904 | Dec 2021 → Oct 2026 expected | epilepsy syndrome | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT00139854 | Aug → Nov 2004 | anxiety | UCB Pharma | Completed | No outcome recorded |
| Phase 413 trials · 2 missed | ||||||
| Phase 4 | NCT07154147 | Aug 2025 → Jan 2026 | CGF1, cataract | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT06874452 | Mar 2025 → Dec 2027 expected | cataract | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06357104 | Feb → Mar 2024 | — | Pachankis, Yang I., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT04184141 | Dec 2019 → Jun 2020 | — | Istanbul Medeniyet University | Unknown | No outcome recorded |
| Phase 4 | NCT03327506 | Nov 2018 → Dec 2021 | anxiety disorder, female reproductive system disorder | Central Hospital, Nancy, France | Unknown | No outcome recorded |
| Phase 4 | NCT03297944 | Sep 2017 → Oct 2018 | — | Marion Coe | Completed | No outcome recorded |
| Phase 4 | NCT03447353 | Jun → Oct 2016 | — | Timothy L. Brown | Completed | No outcome recorded |
| Phase 4 | NCT01546896 | Mar 2012 → Feb 2014 | anxiety disorder | Seoul National University Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT01549691 | Mar 2012 → Apr 2013 | anxiety | University Hospital, Angers | Completed | Missed primary |
| Phase 4 | NCT01546090 | Mar → Oct 2011 | — | Isfahan University of Medical Sciences | Completed | Missed primary |
| Phase 4 | NCT00662259 | Apr 2008 → Sep 2009 | generalized anxiety disorder | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT00266409 | Oct 2005 → Jun 2006 | generalized anxiety disorder, panic disorder | UCB Pharma | Completed | Mixed |
| Phase 4 | NCT00198094 | Dec 2003 → Sep 2007 | panic disorder | Indiana University | Completed | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT07275710 | Feb → Aug 2026 overdue | pain agnosia | Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi | Not yet recruiting | No outcome recorded |
| — | NCT06826417 | Jan 2024 → Sep 2026 overdue | anxiety, cataract | National Taiwan University Hospital | Recruiting | No outcome recorded |
| — | NCT06001021 | Aug → Sep 2023 | mental disorder | Sameera Shafiq | Completed | Met primary |
| — | NCT00592332 | Jun 2005 → Jun 2007 | type 1 diabetes mellitus | Vanderbilt University | Completed | No outcome recorded |
| Comparator or background therapy30 trials | ||||||
| Phase 1 | NCT05602818 Comparator | Nov 2022 → Jun 2023 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT04592536 Comparator | Oct 2020 → Nov 2021 | panic disorder | Cerevel Therapeutics, LLC | Completed | Met primary |
| Phase 1 | NCT03814733 Comparator | Nov 2018 → Mar 2019 | — | Naurex, Inc | Completed | No outcome recorded |
| Phase 1 | NCT03398083 Comparator | Dec 2017 → May 2018 | cannabis dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 1 | NCT03286218 Comparator | Sep → Nov 2017 | substance abuse | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03509285 Comparator | Mar → Nov 2017 | — | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03012334 Comparator | Jan → Jun 2017 | migraine disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01256151 Comparator | Jan → May 2011 | anxiety disorder | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01046162 Comparator | Jul 2010 | — | Viatris Inc. | Withdrawn | No outcome recorded |
| Phase 1 | NCT01161472 Comparator | Jul → Sep 2010 | — | Pfizer | Completed | Missed primary |
| Phase 1 | NCT00975481 Comparator | Oct 2009 → Feb 2010 | Alzheimer disease, Huntington disease | Pfizer | Completed | Missed primary |
| Phase 1 | NCT00580190 Comparator | Sep 2007 → Feb 2008 | — | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT00647634 Comparator | Aug 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 2 | NCT05006079 Comparator | Mar 2024 → Dec 2026 expected | opioid abuse | Wayne State University | Recruiting | No outcome recorded |
| Phase 2 | NCT03702803 Comparator | Mar 2016 → Sep 2020 | generalized anxiety disorder | Coordinación de Investigación en Salud, Mexico | Unknown | No outcome recorded |
| Phase 2 | NCT00921063 Comparator | Nov 2005 → Jul 2006 | generalized anxiety disorder | Pfizer | Completed | No outcome recorded |
| Phase 2/3 | NCT03130842 Comparator | Sep 2016 → Feb 2017 | — | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT01949038 Comparator | Sep 2011 → Oct 2012 | — | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT00356278 Comparator | Sep 2006 → Jun 2014 | post-traumatic stress disorder | Emory University | Completed | Missed primary |
| Phase 4 | NCT07777965 Comparator | Jun → Aug 2026 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT07552246 Background | Apr 2026 → Mar 2027 expected | mixed anxiety and depressive disorder | Duke Kunshan University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06097676 Comparator | Sep 2021 → Jun 2022 | substance abuse | Arbor Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01486615 Comparator | Oct 2011 → Jan 2012 | anxiety | B.P. Koirala Institute of Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT00803400 Comparator | Oct 2008 → Mar 2009 | panic disorder | University of Buenos Aires | Completed | No outcome recorded |
| Phase 4 | NCT00703885 Comparator | Jan → Aug 2008 | anxiety disorder | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT00634790 Comparator | May → Oct 2004 | panic disorder | Viatris Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00635531 Comparator | Apr → Sep 2004 | panic disorder | Viatris Inc. | Terminated | No outcome recorded |
| — | NCT03576456 Comparator | Jan 2019 → Jan 2020 | — | University Hospital Brussels | Unknown | No outcome recorded |
| — | NCT01577706 Comparator | Jun → Dec 2013 | — | Mclean Hospital | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2022-02-15 | AbbVie | Results Cerevel Therapeutics Announces Positive Topline Results for Darigabat in Phase 1 Clinical Trial in Acute Anxiety abbvie.com ↗
The alprazolam 1 mg twice-daily dose demonstrated a 1.6 point (p=0.286) placebo-adjusted improvement on the PSL-IV total score. |
| 2010-06-18 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Xanax® Tablets sunpharma.com ↗
Sun Pharma announced that USFD A has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Xanax ®, alprazolam tablets. |
| 2007-05-29 | Impax Laboratories, LLC | Regulatory IMPAX Receives Final FDA Approval for Generic Xanax(R) XR Extended Release Tablets amneal.com ↗
the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application (ANDA) for generic versions of Xanax(R) XR, (Alprazolam) 0.5 mg, 1 mg, 2 mg and 3 mg Extended-release Tablets. |
| 2007-03-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Alprazolam ER Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) for Alprazolam Extended Release Tablets, 0.5 mg, 1 mg, 2 mg and 3 mg. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-02-15 | AbbVie | Cerevel Therapeutics Announces Positive Topline Results for Darigabat in Phase 1 Clinical Trial in Acute Anxiety abbvie.com ↗ |
| 2010-06-18 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA approval for generic Xanax® Tablets sunpharma.com ↗ |
| 2007-05-29 | Impax Laboratories, LLC | IMPAX Receives Final FDA Approval for Generic Xanax(R) XR Extended Release Tablets amneal.com ↗ |
| 2007-03-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Alprazolam ER Tablets tevapharm.com ↗ |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 89 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alprazolam | “Selective Serotonin Reuptake Inhibitor (Escitalopram, 5-10 mg in pregnancy and Sertraline, 12.5-25 mg in postpartum) and/or Benzodiazepine (Alprazolam, 0.25-0.5 mg) will be...” NCT06001021 ↗79“Administer Toludesvenlafaxine (40-80 mg daily) or imported Sertraline (50-200 mg daily), supplemented with Lorazepam (0.4-0.8 mg) or Alprazolam (0.4-0.8 mg) as needed for sleep support.” NCT07552246 ↗ “Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem” NCT02033707 ↗ |
| Known as | Alp | “Combat veterans with PTSD underwent 6 weeks of VR exposure therapy combined with either d-cycloserine (DCS), alprazolam (ALP), or placebo (PBO).” PMID 27183343 ↗ May 20161“Group 2: Ibuprofen 400 mg (Abbott Brufen) + Alprazolam 0.5 mg (Hilton Pharma Alp)” NCT07275710 ↗ |
| Known as | Alprax | “Premedication with 0.5 mg alprazolam (Alprax) tablet orally 1-2 hr prior to anesthesia” NCT01486615 ↗ |
| Known as | Alprazolam civ | ChEMBL registry synonym — accepted as the source's own label CHEMBL661 ↗ |
| Known as | Alprazolam XR | “Drug: Alprazolam XR” NCT00810316 ↗1“Drug: alprazolam XR” NCT00635531 ↗ |
| Known as | Niravam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00266409 ↗ |
| Known as | NSC-760140 | ChEMBL registry synonym — accepted as the source's own label CHEMBL661 ↗ |
| Known as | Staccato alprazolam | “A randomized phase 2b efficacy study in patients with seizure episodes with a predictable pattern using Staccato® alprazolam for rapid seizure termination.” PMID 36268811 ↗ Dec 20222“Study participants will receive single dose of Staccato alprazolam by inhalation at pre-specified time points.” NCT05626439 ↗ “Participants will receive Staccato alprazolam during the Treatment Period.” NCT05076617 ↗ |
| Known as | StaccatoTM Alprazolam | “Safety, Tolerability, and Pharmacokinetics of a Single Dose of StaccatoTM Alprazolam for Inhalation in Normal, Healthy Volunteers” NCT00444522 ↗ |
| Known as | STAP | “Staccato alprazolam (STAP) is a hand-held device that can provide rapid systemic delivery of alprazolam via pulmonary inhalation.” PMID 41747804 ↗ Feb 2026 |
| Known as | U 31,889 | ChEMBL registry synonym — accepted as the source's own label CHEMBL661 ↗ |
| Known as | Xanax | “Alprazolam group (n=15): patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer).” NCT04658732 ↗7“Alprazolam (Xanax), gel-capsule, 1mg, single-dose, 1-day” NCT01577706 ↗ “Alprazolam Tablets, 2 mg, Xanax (The Upjohn Company)” NCT00912145 ↗ “Xanax, Valium, Ativan” NCT03053869 ↗ “Alprazolam (Xanax)” NCT07777965 ↗ “Alprazolam (Xanax)” NCT06874452 ↗ |
| Known as | Xanax 0.25 | “Alprazolam capsules 0.25 mg are hard gelatine capsules containing 1 tablet of commercial alprazolam (Xanax 0.25).” NCT00555139 ↗ |
| Known as | Xanax XR | “Xanax XR” NCT00635531 ↗ |
| Action | Activate | “GABA A activation with alprazolam during day 1 euglycemia” PMID 25901095 ↗ Apr 2015 |
| Modality | Small molecule | “the benzodiazepine alprazolam” NCT00004373 ↗ |
| Route | Oral | “Alprazolam orally disintegrating tablets” NCT00139854 ↗ |