Drugs / Scopolamine
Scopolamine
also known as
Hyoscine · scopolamine hydrobromide · DPI-386 · Hyoscine Hydrobromide · Transderm Scop · Buscopan (Hyoscine-N-butylbromide) · Hyoscine bromide · Kwells · +4 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | TRANSDERM SCOP | — | 2019-03-01 | fda.gov ↗ |
| Approved | US (FDA) | TRANSDERM SCOP | — | 1979-12-31 | fda.gov ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07423923 | Apr 2025 → Mar 2030 expected | — | University of Arizona | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT05594017 | Aug 2019 → Nov 2027 expected | amnestic disorder, epilepsy | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT06014385 | Mar → Jul 2025 | — | Yale University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04999449 | Jan 2022 → May 2025 | motion sickness | Dartmouth-Hitchcock Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03030105 | Jan → May 2017 | Alzheimer disease | Tetra Discovery Partners | Completed | No outcome recorded |
| Phase 1 | NCT02918266 | Nov 2016 → Aug 2017 | — | Takeda | Terminated | No outcome recorded |
| Phase 1 | NCT02839135 | May → Aug 2016 | motion sickness | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02811341 | Aug 2014 → Feb 2015 | — | Shandong University | Completed | No outcome recorded |
| Phase 1 | NCT01900301 | Aug 2013 → Aug 2017 | social phobia | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05852730 | Aug 2021 → Sep 2026 overdue | space motion sickness | Repurposed Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04391361 | Nov 2020 → Sep 2023 | amyotrophic lateral sclerosis | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02557087 | Sep 2015 → Mar 2016 | — | Ain Shams Maternity Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01312844 | Apr 2010 → Jul 2012 | depressive disorder | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT00369915 | Aug 2006 → Jan 2013 | bipolar depression, major depressive disorder | National Institute of Mental Health (NIMH) | Terminated | No outcome recorded |
| Phase 2 | NCT00374478 | Apr 2005 → Apr 2006 | motion sickness | Boston University | Completed | No outcome recorded |
| Phase 2 | NCT00055575 | Feb 2003 → Feb 2015 | bipolar depression, major depressive disorder | National Institute of Mental Health (NIMH) | Terminated | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02155309 | Jun 2014 → Mar 2016 | motion sickness | Repurposed Therapeutics, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT01644838 | Aug 2010 → Mar 2011 | — | Mashhad University of Medical Sciences | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05548270 | Aug → Nov 2022 | motion sickness | Repurposed Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04184115 | Jun 2019 | motion sickness | Repurposed Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03986905 | Apr → May 2019 | motion sickness | Repurposed Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03920644 | Apr → Nov 2019 | — | Naval Aeromedical Research Unit, Dayton | Unknown | No outcome recorded |
| Phase 47 trials · 1 met primary · 2 missed | ||||||
| Phase 4 | NCT03386448 | Jan → Nov 2018 | depressive disorder | The Taub Group | Completed | Met primary |
| Phase 4 | NCT03435003 | Aug 2017 → Mar 2019 | — | Stony Brook University | Completed | No outcome recorded |
| Phase 4 | NCT03131050 | Mar 2017 → Feb 2018 | major depressive disorder | Capital Medical University | Completed | Missed primary |
| Phase 4 | NCT02968082 | Nov 2016 → Oct 2017 | — | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03029650 | Nov 2016 → Apr 2017 | — | University of Iowa | Completed | No outcome recorded |
| Phase 4 | NCT02960113 | May 2016 → Sep 2021 | — | Rutgers, The State University of New Jersey | Completed | Missed primary |
| Phase 4 | NCT02103166 | Apr 2014 → Apr 2018 | — | Hospital Clinic of Barcelona | Suspended | No outcome recorded Stop: Enrollment |
| Phase not applicable4 trials | ||||||
| — | NCT01613820 | Sep 2015 → Feb 2017 | major depressive disorder | Massachusetts General Hospital | Withdrawn | No outcome recorded Stop: Business |
| — | NCT01198106 | Sep 2009 → Sep 2010 | motion sickness | Medical Corps, Israel Defense Force | Unknown | No outcome recorded |
| — | NCT01060696 | Jan 2009 → Mar 2010 | female infertility | Mahidol University | Unknown | No outcome recorded |
| — | NCT01379001 | Jul 2008 → Jan 2013 | — | Hebrew SeniorLife | Completed | No outcome recorded |
| Comparator or background therapy31 trials | ||||||
| Phase 0 | NCT04366518 Comparator | Jul 2021 → Aug 2032 expected | psychotic disorder | Yale University | Recruiting | No outcome recorded |
| Phase 0 | NCT02849639 Comparator | Apr 2017 → Apr 2021 | Alzheimer disease | Daniela Moga | Completed | No outcome recorded |
| Phase 1 | NCT04314713 Comparator | Jun 2020 → Apr 2021 | organophosphate poisoning | Battelle Memorial Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03874130 Comparator | Aug 2018 → May 2020 | major depressive disorder | Repurposed Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT02033707 Background | Apr 2014 → Feb 2019 | — | Johns Hopkins University | Completed | No outcome recorded |
| Phase 1 | NCT02051335 Background | Jan → May 2014 | Alzheimer disease | AstraZeneca | Completed | Mixed |
| Phase 1 | NCT01345864 Background | May → Jul 2011 | — | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT01213355 Background | Apr → Aug 2011 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01181310 Background | Jun → Oct 2007 | dementia | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1/2 | NCT02613494 Comparator | Jan 2016 → Dec 2017 | — | Mersey Care NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT04666701 Comparator | Feb 2023 → Feb 2025 | — | EMS | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04211961 Comparator | Mar 2021 → Feb 2024 | bipolar depression | Dr. Brian Hallahan | Completed | No outcome recorded |
| Phase 2/3 | NCT04219982 Comparator | Jun 2018 → Jan 2019 | motion sickness | Repurposed Therapeutics, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT04081545 Background | Dec 2019 → Mar 2023 | substance-related disorder | Christine Oryhan | Completed | No outcome recorded |
| Phase 3 | NCT03988530 Comparator | Jun 2019 → Nov 2020 | motion sickness | Repurposed Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04272255 Comparator | Apr 2019 → Jun 2020 | motion sickness | Repurposed Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT05172739 Comparator | Oct 2021 → Nov 2025 overdue | chronic pain syndrome, non-small cell lung carcinoma, substance-related disorder | University of Crete | Recruiting | No outcome recorded |
| Phase 4 | NCT04240626 Background | Jan 2021 → Jun 2025 | morbid obesity | University of California, Davis | Completed | No outcome recorded |
| Phase 4 | NCT04894864 Comparator | Oct 2020 → Sep 2026 overdue | abdominal aortic aneurysm | University of Crete | Recruiting | No outcome recorded |
| Phase 4 | NCT03506763 Comparator | Aug 2017 → Dec 2018 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 4 | NCT03270839 Comparator | Jun 2017 → Sep 2019 | — | Medical Corps, Israel Defense Force | Completed | No outcome recorded |
| Phase 4 | NCT02009306 Background | Jan 2017 → Feb 2018 | — | Gloucestershire Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT07558226 Comparator | May 2026 → Nov 2027 expected | — | Fundacio Puigvert | Recruiting | No outcome recorded |
| — | NCT04866355 Comparator | Feb → Jun 2021 | primary dysmenorrhea | University of Alcala | Completed | No outcome recorded |
| — | NCT02625181 Background | Jul 2016 → Nov 2017 | — | Vanderbilt University | Completed | No outcome recorded |
| — | NCT03357393 Background | Apr 2016 → May 2017 | — | Lena Nilsson | Completed | No outcome recorded |
| — | NCT02725398 Comparator | Dec 2013 → Dec 2016 | — | Xijing Hospital of Digestive Diseases | Unknown | No outcome recorded |
| — | NCT02410460 Background | Sep 2013 → Jun 2014 | — | Mercy Facial Plastic Surgery Center | Completed | No outcome recorded |
| — | NCT00659737 Comparator | Apr 2008 → Mar 2010 | — | Drexel University College of Medicine | Completed | No outcome recorded |
| — | NCT00717054 Comparator | Feb 2008 → Mar 2010 | — | Drexel University | Completed | No outcome recorded |
| — | NCT02273895 Comparator | Apr → Oct 2004 | — | Mentis Cura | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-10-03 | Perrigo Company | Perrigo Announces the Relaunch of the AB Rated Generic Version of Transderm Scop® 1.5 MG perrigo.com ↗ |
| 2017-07-31 | Perrigo Company | Perrigo Announces The Launch Of The AB Rated Generic Version Of Transderm Scop® 1.5 mg perrigo.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | scopolamine | “Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design...” NCT03029650 ↗51“Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.” NCT03506763 ↗ “The primary specific aim is to evaluate the use of intranasal scopolamine gel (DPI-386) in operational field settings.” NCT05852730 ↗ “Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )” NCT03270839 ↗ “between 0.2 mg scopolamine administered as the DPI-386 Nasal Gel and Placebo Nasal Gel” NCT05548270 ↗ “-4mg dexamethasone, 1mg haloperidol, scopolamine patch” NCT04081545 ↗ “DPI 386 nasal gel (intranasal scopolamine gel)” NCT04184115 ↗ “Scopolamine (patients high risk PONV) iv” NCT07558226 ↗ “Other: alcohol, scopolamine, nicotine” NCT02033707 ↗ |
| Known as | Buscopan (Hyoscine-N-butylbromide) | “Buscopan (Hyoscine-N-butylbromide)” NCT01060696 ↗ |
| Known as | DPI-386 | “The primary specific aim is to evaluate the use of intranasal scopolamine gel (DPI-386) in operational field settings.” NCT05852730 ↗1“DPI-386 nasal gel (intranasal scopolamine gel)” NCT03920644 ↗ |
| Known as | Hyoscine | “Ketamine 1-1.5mg/kg, Hyoscine 10mg, Cisatracurium 0.2mg/kg” NCT04894864 ↗6“Propofol, Ketamine, Hyoscine, Cisatracurium” NCT05172739 ↗ |
| Known as | Hyoscine bromide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02103166 ↗ |
| Known as | Hyoscine Hydrobromide | “Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )” NCT03270839 ↗1“* Hyoscine hydrobromide” NCT02009306 ↗ |
| Known as | Kwells | “Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )” NCT03270839 ↗ |
| Known as | scopolamine HBr | “Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr as the active ingredient” NCT04219982 ↗ |
| Known as | scopolamine hydrobromide | “Each of the subjects will receive a single intravenous dose of 0.4 mg scopolamine hydrobromide and will wear the Transderm Scop® patch (1.5 mg) for 3 days in a crossover design...” NCT03029650 ↗2“observed rapid reductions in depression severity following the administration of the antimuscarinic drug scopolamine hydrobromide (4 microg/kg intravenously) compared with...” PMID 17015814 ↗ Oct 2006 |
| Known as | Scopolamine Hydrobromide Trihydrate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04314713 ↗ |
| Known as | TDS | “FDA approved Transderm Scop® (TDS).” NCT04219982 ↗ |
| Known as | Transderm Scop | “Scopolamine Transdermal Patch [Transderm Scop]” NCT03920644 ↗ |
| Known as | Transdermal Scopolamine | “Drug: Transdermal Scopolamine” NCT04272255 ↗ |
| Action | Inhibit | “the cholinergic antagonist, scopolamine” NCT00055575 ↗ |
| Route | Intranasal | “Scopolamine Nasal Spray” NCT00055575 ↗ |