Clinical Trials
Numerous clinical trials evaluate interventions across diverse therapeutic areas, including neuropsychiatric conditions (bipolar I disorder, major depressive disorder, migraine), metastatic colorectal cancer, bronchial asthma, and sarcopenia. Spanning Early Phase 1 through Phase 4, these studies encompass completed, actively recruiting, terminated, and withdrawn protocols. Research sponsors include pharmaceutical companies—such as AstraZeneca, Abbott, and Dr. Reddy's Laboratories—alongside academic and clinical institutions, including the National Cancer Institute, Naples and the Mario Negri Institute for Pharmacological Research.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07017010 | RECRUITING | Reading Difficulties |
Ohio State University |
2025-09-12 | |
| NCT06714357 | RECRUITING | Colorectal Cancer Metastatic |
National Cancer Institute, Naples |
2025-03-12 | PHASE2 |
| NCT07572500 | WITHDRAWN | Hypoxia; OSA; Obesity |
Stanford University |
2025-11 | |
| NCT07023068 | ENROLLING_BY_INVITATION | Lung Cancers |
Peking Union Medical College Hospital |
2024-09-28 | EARLY_PHASE1 |
| NCT05757765 | NOT_YET_RECRUITING | Sarcopenia |
Zuyderland Medisch Centrum |
2023-02-27 | |
| NCT03689114 | COMPLETED | Epilepsies, Partial |
Mario Negri Institute for Pharmacological Research |
2021-05-10 | PHASE4 |
| NCT04088240 | TERMINATED | Elevated Triglycerides; Cardiovascular Risk Factor |
University of Arizona |
2019-09-04 | |
| NCT06533891 | WITHDRAWN | Insulin Resistance |
University of Arizona |
2020-02-01 | |
| NCT04796207 | COMPLETED | Traumatic Brain Injury (TBI); Chronic Traumatic Encephalopathy (CTE) |
University of Arizona |
2019-05-28 | |
| NCT03694314 | COMPLETED | Disturbances in Initiating and Maintaining Sleep; Behavior Problem |
University of Pennsylvania |
2018-05-15 | |
| NCT02446652 | WITHDRAWN | Cervical Cancer |
National Institute of Cancerología |
2015-01-01 | PHASE3 |
| NCT02893852 | COMPLETED | Motor Skills Disorders; Attention Deficit and Disruptive Behavior Disorders |
Federal University of Minas Gerais |
2016-05-12 | |
| NCT01898676 | UNKNOWN | Epilepsy |
Vince & Associates Clinical Research, Inc. |
2013-07 | PHASE1 |
| NCT01333631 | UNKNOWN | Pancreatic Cancer |
Soroka University Medical Center |
2011-06 | PHASE2 |
| NCT01750541 | COMPLETED | Psychomotor Agitation |
Shahid Beheshti University of Medical Sciences |
2012-12 | PHASE3 |
| NCT00581009 | COMPLETED | Major Depressive Disorder; Bipolar Disorder |
University of California, Irvine |
2001-05-30 | PHASE1; PHASE2 |
| NCT01132183 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2007-02 | PHASE1 |
| NCT01055938 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2006-12 | PHASE1 |
| NCT01056627 | COMPLETED | Healthy |
Dr. Reddy's Laboratories Limited |
2006-12 | PHASE1 |
| NCT00312455 | COMPLETED | Substance-related Disorders |
National Institute on Drug Abuse (NIDA) |
2004-07 | PHASE2 |
| NCT00107731 | COMPLETED | Bipolar I Disorder |
AstraZeneca |
2004-04 | PHASE3 |
| NCT00114686 | COMPLETED | Bipolar I Disorder; Alcohol Dependence |
AstraZeneca |
2006-01 | PHASE3 |
| NCT00153270 | COMPLETED | Bronchial Asthma |
Centre of Chinese Medicine, Georgia |
2000-09 | PHASE4 |
| NCT00195741 | COMPLETED | Migraine |
Abbott |
2003-05 | PHASE3 |
| NCT00081380 | COMPLETED | Bipolar Disorder |
AstraZeneca |
2004-03 | PHASE3 |
| NCT00000629 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00309686 | COMPLETED | Affective Psychosis, Bipolar; Bipolar Disorder; Mania |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2006-04 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-12-08)
Compliance for Clinical Use
Mechanism and Biochemical Profile
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>).