Clinical Trials

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 Overall trial statuses range from completed to withdrawn or terminated.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NCT02684786 WITHDRAWN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.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Reserpine selectively inhibits vesicular monoamine transporter 2 (VMAT2), preventing the sequestration of dopamine, norepinephrine, and serotonin into presynaptic vesicles and leading to their metabolic degradation by monoamine oxidase. This depletion of central and peripheral monoamine neurotransmitters reduces vascular tone and dampens neuronal signaling, underlying its clinical relevance in managing hypertension and substance dependence.

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.