Clinical Trials

Isradipine has been evaluated across multiple clinical trials ranging from Early Phase 1 to Phase 3, sponsored primarily by academic medical centers. These studies focused on neurodegenerative, psychiatric, and substance use disorders—specifically Parkinson's disease, nicotine and opioid dependence, bipolar disorder, and schizophrenia—as well as secondary hypertension. Trial recruitment statuses are predominantly completed, alongside a small number of terminated or unknown entries.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03083353 COMPLETED
Nicotine Dependence; Smoking, Cigarette; Smoking Cessation; Smoking Behaviors; Smoking Reduction; Craving
Jasper A. Smits
 2020-01-22 EARLY_PHASE1
NCT01007994 COMPLETED
Hypertension Secondary to Kidney Transplant
Northwell Health
 2009-11 PHASE2; PHASE3
NCT02168842 COMPLETED
Parkinson Disease
University of Rochester
 2014-11 PHASE3
NCT01658150 COMPLETED
Schizophrenia; Schizoaffective Disorder
Icahn School of Medicine at Mount Sinai
 2012-09
NCT01895270 COMPLETED
Opioid Dependence
University of Arkansas
 2013-10 PHASE1; PHASE2
NCT02136823 UNKNOWN
Chronic Spinal Cord Injury
Shirley Ryan AbilityLab
 2009-06
NCT01784666 TERMINATED
Bipolar Disorder
Massachusetts General Hospital
 2013-02 PHASE2
NCT00909545 COMPLETED
Parkinson Disease
Northwestern University
 2009-07 PHASE2
NCT00593463 COMPLETED
Drug Dependence
University of Arkansas
 2006-09 PHASE1
NCT00753636 COMPLETED
Parkinson's Disease
Northwestern University
 2008-04 PHASE2
NCT00753636 Completed
Parkinson''s Disease
Northwestern University|Northwestern Memorial Hospital
 2008-04 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-06-15)

Check the Isradipine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isradipine selectively binds to L-type voltage-gated calcium channels to block transmembrane calcium influx, thereby preventing intracellular calcium overload in vascular and neuronal cells. This channel inhibition promotes smooth muscle relaxation and neuroprotection, which provides therapeutic efficacy in controlling hypertension and addressing neurodegenerative conditions such as Parkinson's disease.

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>).

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Note: Technical data last updated: Sep 1, 2026.