Multiple clinical trials investigate CTB-associated regimens across diverse therapeutic areas, encompassing solid pediatric malignancies, neurological and psychiatric disorders, and viral infections like SARS-CoV-2. Spanning Phase 1 through Phase 4 alongside unclassified studies, these trials cover recruiting, completed, and not yet recruiting statuses. Major academic and clinical institutions—such as Memorial Sloan Kettering Cancer Center and the University of Pennsylvania—serve as primary sponsoring bodies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07292636 | NOT_YET_RECRUITING | CLASS II DIVISION 1 MALOCCLUSION; Class II Malocclusion; Growth; Overjet; Class II Buccal Segment Relationship; Class II Growth Modification; Distalization; Oral Health-Related Quality of Life |
Aslam Alkadhimi |
2026-03 | |
| NCT05433181 | Not yet recruiting | SARS-CoV-2 |
University of Pennsylvania |
2025-02 | Phase 1|Phase 2 |
| NCT06593054 | COMPLETED | Healthy |
Pfizer |
2024-07-29 | PHASE1 |
| NCT06344559 | Not yet recruiting | Healthy |
Rutgers The State University of New Jersey |
2024-05-01 | Not Applicable |
| NCT06347055 | Not yet recruiting | Nicotine Dependence |
University of Missouri-Columbia |
2024-04-15 | Not Applicable |
| NCT06301334 | Not yet recruiting | Pain Mangement of Thoracotomy |
Sohag University |
2024-03-01 | Not Applicable |
| NCT05646732 | Recruiting | Post Traumatic Stress Disorder|PTSD |
Allyson Rosen|National Institute of Mental Health (NIMH)|Palo Alto Veterans Institute for Research |
2023-08-02 | Not Applicable |
| NCT05554237 | COMPLETED | Healthy |
Pfizer |
2022-10-07 | PHASE1 |
| NCT05983211 | Recruiting | Amyotrophic Lateral Sclerosis |
Sunnybrook Health Sciences Centre |
2023-06-01 | Not Applicable |
| NCT05418413 | COMPLETED | Class II Malocclusion |
Damascus University |
2021-12-28 | |
| NCT01492673 | COMPLETED | Neuroblastoma; Sarcoma |
Memorial Sloan Kettering Cancer Center |
2011-12 | PHASE2 |
| NCT02300480 | UNKNOWN | Post-operative Pain; Gallstone Disease |
First Affiliated Hospital of Chongqing Medical University |
2014-12 | PHASE4 |
| NCT00820144 | COMPLETED | Infection |
Centre Hospitalier Universitaire de Nice |
2006-04 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2025-12-18)
Check the
CTB
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.