Drugs / Buspirone
Buspirone
also known as
Buspirone Hydrochloride · BuSpar · BCI-024 · APD405 · Buspirona · Buspirone HCl · Gen-buspirone · MJ 9022-1 · +2 more
Small molecule targets HTR1A via activation
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | BUSPAR | — | 1996-04-22 – 2001-07-19 | fda.gov ↗ |
| Approved | US (FDA) | BUSPAR | — | 1986-09-29 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04105114 | Sep 2019 → Aug 2025 overdue | spinal cord injury | University of Louisville | Active not recruiting | No outcome recorded |
| Phase 0 | NCT02363478 | Dec 2014 → Sep 2015 | systemic sclerosis | Laiko General Hospital, Athens | Completed | Mixed |
| Phase 16 trials | ||||||
| Phase 1 | NCT02589340 | Jan 2016 → Feb 2021 | Parkinson disease, movement disorder | Oregon Health and Science University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00270959 | Jun 2006 → Sep 2010 | post-traumatic stress disorder | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT00840606 | Dec 2001 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00840398 | Dec 2001 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00652730 | Jul → Sep 1998 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00653419 | Jun → Sep 1998 | — | Par Pharmaceutical, Inc. | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT05377619 | Jan → Mar 2022 | dyspepsia | Universidade de Passo Fundo | Completed | No outcome recorded |
| Phase 1/2 | NCT02313194 | Jul 2013 → Jun 2026 overdue | quadriplegia, spinal cord injury | University of California, Los Angeles | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT01699828 | Oct 2012 → Jun 2014 | nicotine dependence | Centre for Addiction and Mental Health | Completed | No outcome recorded |
| Phase 1/2 | NCT00166621 | Mar 2004 → Aug 2005 | autism | Chugani, Diane C. | Completed | No outcome recorded |
| Phase 216 trials · 1 missed | ||||||
| Phase 2 | NCT03432065 | Dec 2024 → Aug 2025 | anxiety, autism spectrum disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05511909 | Mar 2023 → Jan 2027 expected | anxiety, opiate dependence, substance withdrawal syndrome | University of Maryland, Baltimore | Recruiting | No outcome recorded |
| Phase 2 | NCT05357547 | May 2022 → Apr 2023 | atypical depressive disorder | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT04458324 | Dec 2020 → Jul 2026 overdue | spinal cord injury | Spaulding Rehabilitation Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02803749 | Oct 2016 → Jan 2019 | Parkinson disease, anxiety | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT02101203 | Jul 2013 → Aug 2014 | hypoactive sexual desire disorder | Emotional Brain NY Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02132832 | Jun 2013 → Mar 2016 | cannabis dependence | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT01743235 | Jul 2012 → Jun 2013 | hypoactive sexual desire disorder | Emotional Brain NY Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01496612 | Nov 2011 → Apr 2016 | anxiety disorder, depressive disorder, focal epilepsy | National Institute of Neurological Disorders and Stroke (NINDS) | Terminated | No outcome recorded |
| Phase 2 | NCT01267292 | Mar 2011 → Dec 2015 | cocaine dependence | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT00895830 | May → Nov 2009 | — | Acacia Pharma Ltd | Completed | Missed primary |
| Phase 2 | NCT00731653 | Jul → Dec 2008 | major depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00705003 | May → Dec 2008 | major depressive disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00174226 | Nov 2004 → Jan 2006 | attention deficit-hyperactivity disorder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT00360191 | Apr 2004 → Dec 2007 | cannabis dependence | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT00149617 | Apr 2004 → Dec 2007 | cannabis dependence, mood disorder | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2/32 trials · 2 missed | ||||||
| Phase 2/3 | NCT00873509 | May 2009 → Jan 2015 | autism | Chugani, Diane C. | Completed | Missed primary |
| Phase 2/3 | NCT00053846 | Nov 2002 → Nov 2010 | cancer of unknown primary site | University of Rochester | Completed | Missed primary |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT05430217 | Jan → May 2022 | dysautonomia | Valenta Pharm JSC | Completed | No outcome recorded |
| Phase 3 | NCT02617017 | Jun 2016 → Mar 2023 | Parkinson disease | Assistance Publique - Hôpitaux de Paris | Completed | 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 | NCT00746954 | Sep 2008 → Sep 2011 | central sleep apnea syndrome, heart failure | VA Office of Research and Development | Terminated | Missed primary Stop: Enrollment |
| Phase 414 trials · 1 missed | ||||||
| Phase 4 | NCT06321341 | Jan 2024 → Dec 2026 expected | dysautonomia | Valenta Pharm JSC | Recruiting | No outcome recorded |
| Phase 4 | NCT04807517 | Aug 2021 → Sep 2023 | Williams syndrome, anxiety | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05629325 | Jul 2021 → Sep 2024 overdue | esophageal disorder | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04400266 | Aug 2020 → Jul 2028 expected | depressive disorder, traumatic brain injury | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT03538431 | Oct 2018 → Dec 2019 | autism spectrum disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03444831 | Mar 2016 → Mar 2017 | dyspepsia | Isfahan University of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02483598 | Jun 2015 → Jun 2018 | — | North Dakota State University | Terminated | No outcome recorded |
| Phase 4 | NCT02273154 | Aug 2014 → Dec 2015 | major depressive disorder | Si Tianmei | Unknown | No outcome recorded |
| Phase 4 | NCT01821690 | May 2013 → Sep 2025 | traumatic brain injury | Indiana University | Completed | Missed primary |
| Phase 4 | NCT01546896 | Mar 2012 → Feb 2014 | anxiety disorder | Seoul National University Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT00875836 | Sep 2009 → Jun 2014 | cannabis dependence | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 4 | NCT00334360 | Sep 2004 → Aug 2007 | — | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00326235 | Jan 2002 → Jul 2004 | heroin dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 4 | NCT00021528 | Jul 2001 → Sep 2006 | major depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT03954483 | Oct 2023 → Oct 2026 expected | anxiety disorder | University of Manitoba | Recruiting | No outcome recorded |
| — | NCT04478526 | Apr 2020 → May 2021 | generalized anxiety disorder | Dr. Nazanin Alavi | Completed | No outcome recorded |
| — | NCT02674412 | Feb 2016 → Apr 2017 | dyskinesia of esophagus | The Cleveland Clinic | Completed | No outcome recorded |
| — | NCT02186366 | Sep 2014 → Oct 2015 | anxiety disorder | Sun Qing | Unknown | No outcome recorded |
| — | NCT01850355 | Jul 2013 → Dec 2024 | anxiety, autism spectrum disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| — | NCT01639157 | Sep 2012 → Dec 2014 | substance-related disorder | William Stoops | Completed | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 0 | NCT06906224 Comparator | May 2022 → Nov 2023 | schizophrenia | Chuanfu Song | Completed | No outcome recorded |
| Phase 1 | NCT04052776 Comparator | Sep 2020 → Oct 2023 | spinal cord injury | Centre Hospitalier Universitaire Vaudois | Completed | No outcome recorded |
| Phase 1 | NCT03521960 Comparator | May 2018 → Jun 2020 | chronic pain syndrome, substance dependence, substance withdrawal syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT01347541 Background | Jan → Nov 2011 | post-traumatic stress disorder | University of Washington | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01484184 Comparator | Jul 2013 → Aug 2015 | spinal cord injury | Nordic Life Science Pipeline Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05041322 Comparator | Nov 2020 → Nov 2024 | spinal cord injury | Spaulding Rehabilitation Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03587142 Comparator | Aug 2019 → Apr 2022 | gastroparesis | Johns Hopkins Bloomberg School of Public Health | Completed | No outcome recorded |
| Phase 2 | NCT02458469 Comparator | May 2015 → Apr 2019 | sleep apnea syndrome, spinal cord injury | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 2 | NCT01641159 Comparator | Aug 2012 → Jun 2013 | cocaine dependence | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT01395953 Comparator | Nov 2011 → Jul 2013 | autism spectrum disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT06243614 Comparator | Jul 2023 → Jun 2026 overdue | generalized anxiety disorder | Beijing Union Pharmaceutical Factory Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT01833312 Background | Jul 2013 → Jul 2018 | ischemic stroke | University of Erlangen-Nürnberg Medical School | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00178971 Comparator | Jan 2003 → Oct 2004 | schizoaffective disorder, schizophrenia | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT07439042 Comparator | Sep 2026 → Feb 2029 expected | anxiety, autism spectrum disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04118387 Comparator | Jan 2021 → Dec 2026 expected | central sleep apnea syndrome | VA Office of Research and Development | Recruiting | No outcome recorded |
| — | NCT04352686 Comparator | Feb → Sep 2012 | gastroesophageal reflux disease | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2002-02-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Buspirone Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg and 15 mg. |
| 2001-08-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval of Buspirone HCI Tablets, 15mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded tentative approval for Buspirone HCL Tablets, 15 mg. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2002-02-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approval of Buspirone Tablets tevapharm.com ↗ |
| 2001-08-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Buspirone HCI Tablets, 15mg tevapharm.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 71 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Buspirone | “If the patient has been deemed unresponsive to both an SSRI and an SNRI/pregabalin, the patient will commence the secondary medication arm. The two classes of medications...” NCT04478526 ↗64“Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline;...” NCT00270959 ↗ “Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline,...” NCT01347541 ↗ “Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks.” NCT00705003 ↗ “Buspirone” NCT06321341 ↗ |
| Known as | APD405 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00895830 ↗ |
| Known as | BCI-024 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00705003 ↗ |
| Known as | BuSpar | “The purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called...” NCT02458469 ↗3“Buspirone (Buspar) has shown initial efficacy in reducing symptoms of opioid withdrawal in animal studies and in human patients undergoing a methadone taper.” NCT03521960 ↗ “BuSpar/Buspirone is a serotonin 5HT1A agonist and used as an anxiolytic in humans.” NCT05041322 ↗ “BUSPAR® 30 mg Tablet” NCT00840606 ↗ |
| Known as | Buspirona | ChEMBL registry synonym — accepted as the source's own label CHEMBL49 ↗ |
| Known as | Buspirone HCl | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00652730 ↗ |
| Known as | Buspirone Hydrochloride | “Buspirone Hydrochloride 30 mg Tablet” NCT00840606 ↗5“Buspirone Hydrochloride 30 mg Tablet” NCT00840398 ↗ “BuSpar, Buspirone Hydrochloride” NCT05041322 ↗ “Drug: buspirone hydrochloride” NCT00053846 ↗ |
| Known as | Gen-buspirone | ChEMBL registry synonym — accepted as the source's own label CHEMBL49 ↗ |
| Known as | MJ 9022-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL49 ↗ |
| Known as | NSC-751138 | ChEMBL registry synonym — accepted as the source's own label CHEMBL49 ↗ |
| Known as | NSC-759571 | ChEMBL registry synonym — accepted as the source's own label CHEMBL49 ↗ |
| Action | Activate | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL49 ↗1“5-HT1A agonist” NCT00178971 ↗ |
| Modality | Small molecule | — CHEMBL49 ↗ |
| Route | Oral | “patients receive oral buspirone” NCT00053846 ↗ |
| Target | HTR1A | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL49 ↗ |