CLINICAL TRIALS PROFILE FOR ISRADIPINE

All Clinical Trials for ISRADIPINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00593463 ↗	Drug Discrimination in Methadone-Maintained Humans Study 1	Completed	University of Arkansas	Phase 1	2006-09-01	This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.
NCT00753636 ↗	Parkinson's Disease Isradipine Safety Study	Completed	Northwestern Memorial Hospital	Phase 2	2008-04-01	The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is being completed now and is conducted in preparation to NIH submission of the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is conducted in parallel with Dr. Surmeier's work on further development of the preclinical data. The focus of his work now is to establishing the correlation between the dose that demonstrated neuroprotective effect in animal model and the dose used for clinical practice. Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended dose range. We expect 10% attrition due to hypotensive effect of the agent. Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based on the blood pressure reading.
NCT00753636 ↗	Parkinson's Disease Isradipine Safety Study	Completed	Northwestern University	Phase 2	2008-04-01	The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is being completed now and is conducted in preparation to NIH submission of the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is conducted in parallel with Dr. Surmeier's work on further development of the preclinical data. The focus of his work now is to establishing the correlation between the dose that demonstrated neuroprotective effect in animal model and the dose used for clinical practice. Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended dose range. We expect 10% attrition due to hypotensive effect of the agent. Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based on the blood pressure reading.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	Michael J. Fox Foundation for Parkinson's Research	Phase 2	2009-07-01	The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	Northwestern University Dixon Fund	Phase 2	2009-07-01	The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	The Parkinson Study Group	Phase 2	2009-07-01	The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.
NCT00909545 ↗	Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease	Completed	Northwestern University	Phase 2	2009-07-01	The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.

Clinical Trial Conditions for ISRADIPINE

Condition Name

Condition Name for ISRADIPINE
Intervention	Trials
Hypertension	2
Parkinson Disease	2
Parkinson's Disease	1
Schizoaffective Disorder	1

Condition MeSH

Condition MeSH for ISRADIPINE
Intervention	Trials
Parkinson Disease	3
Hypertension	3
Opioid-Related Disorders	1
Substance-Related Disorders	1

Clinical Trial Locations for ISRADIPINE

Trials by Country

Trials by Country for ISRADIPINE
Location	Trials
United States	52
Canada	4
Bulgaria	1
Hungary	1

Trials by US State

Trials by US State for ISRADIPINE
Location	Trials
New York	4
Illinois	3
Pennsylvania	3
Massachusetts	3
Georgia	2

Clinical Trial Progress for ISRADIPINE

Clinical Trial Phase

Clinical Trial Phase for ISRADIPINE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ISRADIPINE
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
Terminated	1

Clinical Trial Sponsors for ISRADIPINE

Sponsor Name

Sponsor Name for ISRADIPINE
Sponsor	Trials
University of Arkansas	2
National Institute on Drug Abuse (NIDA)	2
Northwestern University	2

Sponsor Type

Sponsor Type for ISRADIPINE
Sponsor	Trials
Other	19
NIH	3
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Isradipine

Last updated: October 28, 2025

Introduction

Isradipine, a dihydropyridine calcium channel blocker primarily prescribed for hypertension and angina, has garnered renewed interest in neurodegenerative disease research, particularly Parkinson's disease (PD). Originally developed in the 1980s, its potential neuroprotective properties have prompted multiple clinical investigations, challenging its traditional cardiovascular indications. This article provides a comprehensive update on clinical trials involving isradipine, analyzes its market trajectory, and projects future trends supporting strategic decision-making for stakeholders.

Clinical Trials Update

Historical Context and Recent Developments

Isradipine’s repositioning as a neuroprotective agent originated from preclinical studies indicating its ability to limit calcium influx into dopaminergic neurons, thereby reducing neurodegeneration in Parkinson's models [1]. The initial promising data led to a series of clinical trials to evaluate its efficacy and safety for PD.

Key Clinical Trials and Outcomes

1. Phase II Clinical Trial (STEADY-PD III)

   Sponsored by the Parkinson’s Study Group, STEADY-PD III (NCT02141072) evaluated 300 early Parkinson’s patients over 36 months. The trial tested isradipine at 5 mg/day, assessing disease progression via the MDS-UPDRS scale. Results announced in 2020 indicated no significant difference in disease progression compared to placebo, ultimately leading to the discontinuation of further trials focused solely on disease modification [2].

2. Open-Label Studies and Safety Profile

   While the primary efficacy trial was inconclusive, subsequent smaller open-label studies confirmed its safety and tolerability in PD patients. No significant adverse cardiovascular effects were noted at doses used in trials, supporting further exploration in combination therapies or different disease stages [3].

3. Ongoing and Planned Trials

   Despite the setback from STEADY-PD III, several investigators advocate for exploring alternative doses, early-stage intervention, and combinatorial approaches. Currently, no large-scale active trials are registered for PD; however, research into its potential neuroprotective role continues, with smaller observational and pilot studies emerging.

4. Cardiovascular Indications

   Isradipine continues to be prescribed for hypertension based on extensive clinical data. Its patent has expired, and generics are available. Market activity in the cardiovascular space remains relatively stable, with ongoing research into its potential roles in other vascular or metabolic conditions.

Summary of Clinical Trials Insights

Trial	Phase	Purpose	Outcome	Status
STEADY-PD III	III	Disease progression in PD	Negative — no significant benefit	Discontinued 2020
Smaller open-label	N/A	Safety, tolerability	Confirmed safety	Ongoing or completed
Proposed studies	I/II	Early neuroprotection	Pending	Planning or recruitment

References:

[1] Rajput, et al., 2014. Neuroprotective potential of calcium channel blockers in PD. Movement Disorders.

[2] Simón, et al., 2020. Results from STEADY-PD III. Neurology.

[3] Thomas, et al., 2018. Safety profile of isradipine in PD patients. Clinical Neuropharmacology.

Market Analysis

Current Market Landscape

Isradipine’s primary market relates to hypertension management, historically dominated by branded products like Dynacirc® and generic formulations following patent expiration. The global antihypertensive market was valued at approximately $30 billion in 2021 and is projected to grow at a CAGR of 4% through 2028 [4].

In the neurodegenerative domain, the market remains nascent, with limited approved options offering disease-modifying therapies for PD. Existing treatments, such as levodopa and dopamine agonists, focus on symptom control rather than disease progression, leaving unmet needs for neuroprotective drugs.

Market Drivers and Barriers

• Drivers:

  • Growing prevalence of PD, projected to reach over 12 million globally by 2040 [5].
  • Ongoing interest in drug repurposing to reduce development costs and timelines.
  • Established safety and tolerability profile of isradipine in cardiovascular indications.

• Barriers:

  • Failure of recent large-scale trials (STEADY-PD III) dampens enthusiasm about neuroprotective indications.
  • Limited patent protection for new formulations diminishes profit incentives.
  • Competition from other calcium channel blockers and emerging neuroprotective agents.

Market Projections

Cardiovascular Market:
Sales of isradipine as an antihypertensive are expected to remain stable, driven by the aging population and ongoing generic availability, with minimal impact from pipeline developments.

Neurodegenerative Market:
Given current clinical setbacks, the potential market for isradipine as a PD disease-modifying agent is projected to be limited over the next 5 years unless new evidence emerges. The focus is likely to shift toward niche research collaborations and early-phase trials.

Opportunities for Stakeholders:

• Life sciences companies may explore combinational therapies or alternative dosing strategies.
• Academic institutions may pursue mechanistic studies to identify biomarkers predicting neuroprotective response.
• Pharmaceutical firms might re-evaluate patent strategies and formulations to extend product lifecycle.

Long-term Outlook

The overall pharmaceutical opportunity for isradipine hinges on demonstrating clear neuroprotective efficacy. Given the clinical failures, the immediate outlook for PD-specific indications remains cautious. However, its well-characterized cardiovascular use and safety profile sustain a steady revenue base. Strategic repositioning in combination therapies or new indication investigations could revitalize interest.

Future Projections and Strategic Implications

• Near Term (1–3 years): Limited growth in the cardiovascular segment; minimal activity in neurodegenerative indications.
• Medium Term (3–5 years): Potential emergence of niche research collaborations focusing on biomarker-driven patient selection.
• Long Term (>5 years): Market revival possible if novel clinical evidence surfaces or if patent extensions enable innovative formulations.

Key Takeaways

• Clinical trials for isradipine targeting Parkinson's disease have largely concluded with negative results, dampening prospects for its neuroprotective application.
• Its longstanding approval and safety profile sustain its core market in hypertension, with continued steady sales primarily driven by generics.
• Opportunities exist in research domains, especially exploring combinational therapies, early-stage interventions, or repurposing strategies, though substantial hurdles remain.
• The overall market outlook hinges on future clinical evidence, regulatory developments, and innovative formulation or licensing strategies.
• Stakeholders should weigh the high costs and risks associated with neuroprotective indications against sustained revenues from cardiovascular uses.

Frequently Asked Questions (FAQs)

1. What was the primary outcome of the STEADY-PD III trial involving isradipine?
The trial showed no significant benefit of isradipine in slowing Parkinson's disease progression, leading to its discontinuation for this indication.

2. Is isradipine still used for hypertension management?
Yes, isradipine remains an approved treatment for hypertension, with generic formulations widely available.

3. Are there ongoing clinical trials investigating isradipine for neurodegenerative diseases?
Currently, no large-phase clinical trials are active for Parkinson's disease or other neurodegenerative conditions, though small studies may continue exploring its potential.

4. How does the market for isradipine look in the cardiovascular space?
The market remains stable due to its safety profile and the widespread use of generics; future growth is expected to be modest.

5. Could isradipine's repositioning be viable with new data?
While possible, it depends heavily on emerging evidence demonstrating efficacy in early intervention, combination therapy, or novel biomarkers to identify responsive patient subgroups.

References

1. Rajput, et al., 2014. Neuroprotective potential of calcium channel blockers in PD. Movement Disorders.

2. Simón, et al., 2020. Results from STEADY-PD III. Neurology.

3. Thomas, et al., 2018. Safety profile of isradipine in PD patients. Clinical Neuropharmacology.

4. Fortune Business Insights, 2022. Global Hypertension Market Forecast.

5. Dorsey, et al., 2018. Global Parkinson’s disease prevalence. Lancet Neurology.

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This comprehensive analysis aims to inform pharmaceutical and biotech stakeholders contemplating the strategic positioning of isradipine amid evolving clinical and market landscapes.