Clinical Trials

Scopolamine has been evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4, encompassing completed, recruiting, and terminated studies. Sponsored by academic medical centers, research institutes, and pharmaceutical entities including Takeda and Merck Sharp & Dohme LLC, these investigations assess novel formulations, alternative delivery methods, safety, and pharmacokinetics. Primary indications evaluated include post-operative nausea and vomiting, motion sickness, major depressive disorder, postoperative pain management, and cognitive impairment associated with Alzheimer's disease or dementia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04366518 RECRUITING
Hallucinations, Auditory; Psychosis
Yale University
 2021-07-15 EARLY_PHASE1
NCT07423923 ENROLLING_BY_INVITATION
Scopolamine or Placebo; Schema to Organize Memory or no Schema
University of Arizona
 2025-04-01 EARLY_PHASE1
NCT05594017 RECRUITING
Epilepsy; Seizures; Cognitive Impairment, Mild; Memory Disorders; Memory Loss
University of Texas Southwestern Medical Center
 2019-08-01 EARLY_PHASE1
NCT05852730 RECRUITING
Motion Sickness, Space; Motion Simulation; Parabolic Flight
Repurposed Therapeutics, Inc.
 2021-08-10 PHASE2
NCT04240626 ACTIVE_NOT_RECRUITING
Obesity, Morbid; Surgery; Bariatric Surgery Candidate
University of California, Davis
 2021-01-20 PHASE4
NCT03616067 TERMINATED
Cerebral Palsy
Hospices Civils de Lyon
 2022-04-27 PHASE3
NCT06014385 WITHDRAWN
Muscarinic Receptor Occupancy
Yale University
 2025-03 PHASE1
NCT04999449 COMPLETED
Scopolamine; Motion Sickness
Dartmouth-Hitchcock Medical Center
 2022-01-24 PHASE1
NCT04666701 WITHDRAWN
Acute Pain
EMS
 2023-02 PHASE2
NCT05719467 RECRUITING
Labor Complication; Induced; Birth; Pregnancy Related
Oslo University Hospital
 2023-01-03 PHASE3
NCT05886660 UNKNOWN
Motion Sickness, Space; Motion Sickness; Sea Sickness
Repurposed Therapeutics, Inc.
 2022-01-21 PHASE2
NCT04211961 COMPLETED
Bipolar Disorder Depression
Dr. Brian Hallahan
 2021-03-23 PHASE2
NCT05759481 Recruiting
Post-operative Nausea and Vomiting
Milton S. Hershey Medical Center
 2024-02-01 Phase 2
NCT04391361 UNKNOWN
Amyotrophic Lateral Sclerosis; Respiratory Function; Scopolamine
Ruijin Hospital
 2020-11-01 PHASE2
NCT04999449 Recruiting
Scopolamine|Motion Sickness
Dartmouth-Hitchcock Medical Center
 2022-01-24 Phase 1
NCT02960113 COMPLETED
Nausea; Vomiting; Satisfaction
Rutgers, The State University of New Jersey
 2016-05 PHASE4
NCT03961165 COMPLETED
Labor (Obstetrics)--Complications; Labor; Prolonged, First Stage
Oslo University Hospital
 2019-05-25 PHASE3
NCT02849639 COMPLETED
Alzheimer's Disease; Dementia
Daniela Moga
 2017-04-04 EARLY_PHASE1
NCT04314713 TERMINATED
Medical Countermeasures; Organophosphate Poisoning
Battelle Memorial Institute
 2020-06-02 PHASE1
NCT03988530 COMPLETED
Motion Sickness
Repurposed Therapeutics, Inc.
 2019-06-07 PHASE3
NCT04314713 Terminated
Scopolamine Causing Adverse Effects in Therapeutic Use
Battelle Memorial Institute
 2020-06-02 Phase 1
NCT04272255 UNKNOWN
Motion Sickness
Repurposed Therapeutics, Inc.
 2019-04-22 PHASE3
NCT03874130 UNKNOWN
Major Depressive Disorder (MDD)
Repurposed Therapeutics, Inc.
 2018-08-01 PHASE1
NCT03920644 UNKNOWN
Prevention of Nausea Associated With Motion Sickness; Treatment of Nausea Associated With Motion Sickness
Naval Aeromedical Research Unit, Dayton
 2019-04 PHASE3
NCT03698695 COMPLETED
Cognitive Impairment; Alzheimer Disease
Theranexus
 2018-09-27 PHASE1
NCT03986905 COMPLETED
Motion Sickness
Repurposed Therapeutics, Inc.
 2019-04-26 PHASE3
NCT03435003 COMPLETED
Post-operative Nausea and Vomiting; Laparoscopic Sleeve Gastrectomy
Stony Brook University
 2017-08-28 PHASE4
NCT03386448 COMPLETED
Depression
The Taub Group
 2018-01-01 PHASE4
NCT03874130 Unknown status
Major Depressive Disorder (MDD)
Repurposed Therapeutics Inc.
 2018-08-01 Phase 1
NCT03131050 COMPLETED
Major Depressive Disorder
Capital Medical University
 2017-03-15 PHASE4
NCT03294109 Completed
Pain Postoperative|Analgesics Opioid|Analgesics Non-Narcotic|Physiological Effects of Drugs|Peripheral Nervous System Agents|Patient Satisfaction|Return to Work|Activity Sexual
University of California Los Angeles
 2018-01-01 Phase 4
NCT02625181 COMPLETED
Postoperative Nausea and Vomiting
Vanderbilt University
 2016-07
NCT02968082 UNKNOWN
Patients
Seoul National University Hospital
 2016-11 PHASE4
NCT02918266 TERMINATED
Healthy Volunteers
Takeda
 2016-11-21 PHASE1
NCT01900301 COMPLETED
Social Anxiety Disorder
University of California, Los Angeles
 2013-08 PHASE1
NCT03357393 COMPLETED
Sedation, Bronchoscopy
Lena Nilsson
 2016-04-04
NCT03030105 COMPLETED
Alzheimer Disease
Tetra Discovery Partners
 2017-01 PHASE1
NCT03029650 COMPLETED
Healthy
University of Iowa
 2016-11 PHASE4
NCT01613820 WITHDRAWN
Major Depressive Disorder
Massachusetts General Hospital
 2015-09
NCT02725398 UNKNOWN
Gastrointestinal Imaging With pCLE
Xijing Hospital of Digestive Diseases
 2013-12
NCT02839135 COMPLETED
Motion Sickness
GlaxoSmithKline
 2016-05-13 PHASE1
NCT02155309 TERMINATED
Motion Sickness
Repurposed Therapeutics, Inc.
 2014-06 PHASE2; PHASE3
NCT00055575 TERMINATED
Mood Disorders; Healthy; Unipolar Depression; Bipolar Depression
National Institute of Mental Health (NIMH)
 2003-02-27 PHASE2
NCT02811341 COMPLETED
Using Copolamine Butylbromide in Probe-based Confocal Laser Endomicroscopy for Gastroendoscopy Examination
Shandong University
 2014-08 PHASE1
NCT02410460 COMPLETED
Rhytidoplasty
Mercy Facial Plastic Surgery Center
 2013-09
NCT02051335 COMPLETED
Memory Impairment; Alzheimer's Disease
AstraZeneca
 2014-01 PHASE1
NCT00369915 TERMINATED
Unipolar Depression; Bipolar Depression
National Institute of Mental Health (NIMH)
 2006-08 PHASE2
NCT01379001 COMPLETED
Cholinergic Function
Hebrew SeniorLife
 2008-07
NCT01312844 TERMINATED
Depression
Massachusetts General Hospital
 2010-04 PHASE2
NCT01213355 COMPLETED
Healthy
Pfizer
 2011-04 PHASE1
NCT01345864 TERMINATED
Healthy
Pfizer
 2011-05 PHASE1
NCT01198106 UNKNOWN
Simulator Sickness
Medical Corps, Israel Defense Force
 2009-09
NCT01044342 COMPLETED
Cognition
AstraZeneca
 2009-12 PHASE1
NCT00659737 COMPLETED
Nausea; Vomiting
Drexel University College of Medicine
 2008-04
NCT00717054 COMPLETED
Nausea; Vomiting
Drexel University
 2008-02
NCT00740324 COMPLETED
Healthy
Nihon Pharmaceutical Co., Ltd
 2008-08 PHASE3
NCT01181310 COMPLETED
Dementia
Merck Sharp & Dohme LLC
 2007-06 PHASE1
NCT02273895 COMPLETED
AD
Mentis Cura
 2004-04
NCT00389259 WITHDRAWN
Neurotoxicity Syndromes
Assaf-Harofeh Medical Center
 2007-10
NCT00374478 COMPLETED
Motion Sickness
Boston University
 2005-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-06-05)

Check the Scopolamine (LSM-4015) HBr product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Scopolamine acts as a competitive antagonist at muscarinic acetylcholine receptors, specifically targeting M1 receptors to block downstream cholinergic signaling. By inhibiting parasympathetic neurotransmission, scopolamine blunts central vestibular and emetic signaling, providing clinical utility in mitigating motion sickness, post-operative nausea and vomiting, and depressive disorders.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.