Multiple Phase 1 through Phase 3 clinical trials, sponsored primarily by federal institutes and academic centers, evaluate reserpine for indications including cardiovascular, pulmonary, and substance-related disorders, as well as traumatic brain injury. Key research encompasses Phase 3 studies on geriatric hypertension management alongside Phase 2 trials addressing refractory hypertension and cocaine dependence. Overall trial statuses range from completed to withdrawn or terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06199778 | TERMINATED | Traumatic Brain Injury |
Zeng Changhao |
2022-06-01 | |
| NCT03223272 | COMPLETED | Refractory Hypertension |
University of Alabama at Birmingham |
2015-07-23 | PHASE2 |
| NCT02684786 | WITHDRAWN | Pulmonary Artery Hypertension |
Mayo Clinic |
2016-07 | PHASE1 |
| NCT00000499 | COMPLETED | Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases |
National Heart, Lung, and Blood Institute (NHLBI) |
1980-09 | PHASE2 |
| NCT00000514 | COMPLETED | Cardiovascular Diseases; Cerebrovascular Disorders; Heart Diseases; Hypertension |
National Heart, Lung, and Blood Institute (NHLBI) |
1984-06 | PHASE3 |
| NCT00267657 | UNKNOWN | Amphetamine-Related Disorders |
National Institute on Drug Abuse (NIDA) |
2004-01 | PHASE1 |
| NCT00033033 | COMPLETED | Cocaine-Related Disorders; Substance-Related Disorders |
National Institute on Drug Abuse (NIDA) |
2001-07 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2024-03-05)
Check the
Reserpine
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.