Multiple clinical trials evaluating dopamine hydrochloride are currently documented in healthy volunteers and individuals with depression. Encompassing Phase 1 research as well as studies with unassigned phases, these non-recruiting trials are supported by industry sponsors such as AbbVie and academic institutions like University College London. These investigations focus on evaluating dopamine receptor occupancy in the brain and exploring underlying mechanisms in psychiatric health.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06387732 | Not yet recruiting | Depression |
University College London|King''s College London|Queen Mary University of London|University of Dublin Trinity College |
2024-06 | Not Applicable |
| NCT06300580 | Not yet recruiting | Healthy Volunteers |
AbbVie |
2024-05-03 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Check the
Dopamine HCl
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.