CLINICAL TRIALS PROFILE FOR NIMOTOP

All Clinical Trials for Nimotop

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00781326 ↗	Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression	Terminated	National Institute of Mental Health (NIMH)	Phase 4	2008-08-01	This study will examine whether combined use of an antidepressant medication and the medication nimodipine reduces risk of depression relapse in patients with vascular depression.
NCT00781326 ↗	Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression	Terminated	University of Pittsburgh	Phase 4	2008-08-01	This study will examine whether combined use of an antidepressant medication and the medication nimodipine reduces risk of depression relapse in patients with vascular depression.
NCT01551368 ↗	Use of a Calcium Channel Blocker to Prevent Premature Luteinizing Hormone Surges in Infertility Patients	Terminated	Mount Sinai Hospital, Canada	Phase 2	2012-12-01	Nimodipine (Nimotop® Bayer Pharmaceuticals Corporation), unlike other calcium channel blockers is fat soluble and therefore is able to cross the blood-brain barrier1. Gonadotropin releasing hormone (GnRH) neurons are clustered in the hypothalamus and are dependent on calcium flux to release GnRH responsible for the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary. In a natural menstrual cycle a spontaneous LH surge occurs mid-cycle which triggers ovulation. The investigators hypothesized that nimodipine, by blocking calcium channels, may effectively suppress the release of GnRH and consequently the natural LH surge. In this prospective double-blinded randomized study the investigators will evaluate the efficacy of nimodipine to inhibit the natural LH surge in women undergoing controlled ovarian stimulation (COS) and intrauterine insemination (IUI). Nimodipine, if successful, may represent an inexpensive oral medication as an alternative to the currently used GnRH agonists or GnRH antagonists in assisted reproductive technologies like IVF.
NCT01672801 ↗	Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT	Completed	Village Fertility Pharmacy	N/A	2012-09-01	The main purpose of this study is to test the effectiveness of nimodipine in preventing a luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation to allow adequate recruitment of follicles, proper maturation of a dominant follicle before ovulation, and effectively time insemination with semen to allow fertilization of a mature egg to occur. The investigators are also conducting this study to determine medication side effect profile (including lightheadedness or dizziness from low blood pressure or rapid heart rate, headache, and nausea), patient treatment compliance, and clinical pregnancy (positive pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on these hormones. As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of gonadotropin releasing hormone in animal and preliminary human studies. The investigators hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients undergoing assisted reproduction with intrauterine insemination (IUI).
NCT01672801 ↗	Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT	Completed	Boston IVF	N/A	2012-09-01	The main purpose of this study is to test the effectiveness of nimodipine in preventing a luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation to allow adequate recruitment of follicles, proper maturation of a dominant follicle before ovulation, and effectively time insemination with semen to allow fertilization of a mature egg to occur. The investigators are also conducting this study to determine medication side effect profile (including lightheadedness or dizziness from low blood pressure or rapid heart rate, headache, and nausea), patient treatment compliance, and clinical pregnancy (positive pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on these hormones. As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of gonadotropin releasing hormone in animal and preliminary human studies. The investigators hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients undergoing assisted reproduction with intrauterine insemination (IUI).
NCT01835665 ↗	Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations	Completed	The Bluefield Project	Phase 1	2013-03-01	The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as the safety and tolerability of oral nimodipine in progranulin mutation carriers in preparation for longer term efficacy studies in patients with frontotemporal dementia due to progranulin gene mutations.
NCT01835665 ↗	Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations	Completed	The Bluefield Project to Cure Frontotemporal Dementia	Phase 1	2013-03-01	The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as the safety and tolerability of oral nimodipine in progranulin mutation carriers in preparation for longer term efficacy studies in patients with frontotemporal dementia due to progranulin gene mutations.

Clinical Trial Conditions for Nimotop

Condition Name

Condition Name for Nimotop
Intervention	Trials
Depression	2
Postictal Delirium	1
Acute Cerebrovascular Accident	1
Progranulin Mutation Carriers	1

Condition MeSH

Condition MeSH for Nimotop
Intervention	Trials
Depression	2
Infertility	2
Cerebrovascular Disorders	1
Subarachnoid Hemorrhage	1

Clinical Trial Locations for Nimotop

Trials by Country

Trials by Country for Nimotop
Location	Trials
United States	3
Canada	2
Netherlands	1
China	1
Austria	1

Trials by US State

Trials by US State for Nimotop
Location	Trials
California	1
Massachusetts	1
Pennsylvania	1

Clinical Trial Progress for Nimotop

Clinical Trial Phase

Clinical Trial Phase for Nimotop
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Nimotop
Clinical Trial Phase	Trials
Recruiting	3
Completed	2
Terminated	2

Clinical Trial Sponsors for Nimotop

Sponsor Name

Sponsor Name for Nimotop
Sponsor	Trials
Shenyang Dongxing Pharmaceutical Technology Co., Ltd.	1
National Institute of Mental Health (NIMH)	1
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	1

Sponsor Type

Sponsor Type for Nimotop
Sponsor	Trials
Other	15
NIH	1
Industry	1

Nimotop (Nimodipine): Clinical Trials, Market Analysis, and Projections

Introduction to Nimodipine

Nimodipine, marketed under the brand name Nimotop, is a calcium channel antagonist that plays a crucial role in the treatment of subarachnoid hemorrhage and other cerebrovascular disorders. Here, we will delve into the latest clinical trials, market analysis, and future projections for this vital medication.

Clinical Trials Update

Intraventricular Administration

A significant clinical trial, the NEWTON study, has been conducted to evaluate the safety and efficacy of intraventricular nimodipine (EG-1962) in patients with aneurysmal subarachnoid hemorrhage (aSAH). This phase 1/2a trial compared intraventricular EG-1962 with standard enteral nimodipine. The results showed that patients receiving intraventricular EG-1962 had a higher incidence of favorable Glasgow Outcome Scores and fewer serious adverse events, such as delayed cerebral ischemia, infarction, and hemorrhage. However, there was a higher incidence of ventriculitis in the EG-1962 cohort, attributed to the study protocol's repeated cerebrospinal fluid sampling[1].

IV Nimodipine (GTX-104)

Acasti Pharma is conducting clinical trials for GTX-104, an intravenous (IV) formulation of nimodipine. Phase 1 clinical data from two studies involving 104 healthy volunteers compared IV GTX-104 with oral nimodipine. The results indicated similar pharmacokinetic profiles between the two formulations, with IV GTX-104 showing less variability in pharmacokinetic parameters. This study is part of the 505(b)(2) regulatory pathway, leveraging the established safety and efficacy of oral nimodipine[4].

Market Analysis

Current Market Size and Growth

The nimodipine market was valued at USD 100 billion in 2023 and is projected to reach USD 147.4 billion by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031. This growth is driven by the increasing incidence of subarachnoid hemorrhage and stroke, as well as the drug's efficacy in improving neurological outcomes[2].

Market Segmentation

The market is segmented by product type (tablets, capsules, liquid, extended-release, intravenous injections), application (subarachnoid hemorrhage, stroke, migraine, neuroprotection, cerebral vasospasm), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The demand for nimodipine is particularly high in critical care settings due to its role in managing post-hemorrhagic complications[2].

Key Drivers and Restraints

• Drivers: The growing incidence of subarachnoid hemorrhage and stroke, the need for efficient post-hemorrhagic complication management, and ongoing clinical trials exploring new therapeutic applications and improved formulations are key drivers of the market.
• Restraints: Adverse effects such as bradycardia, hypotension, and headache, as well as patient compliance issues, are significant restraints on the market growth[5].

Market Projections

Future Growth Opportunities

The nimodipine market is expected to benefit from several factors:

• Increasing Awareness: Rising awareness about the treatment of subarachnoid hemorrhage and supportive healthcare policies will drive market demand.
• Novel Drug Therapies: The launch of new drug therapies and advancements in delivery methods, such as intraventricular and IV formulations, will provide lucrative opportunities for market expansion[2][5].

Geographical Trends

The market is expected to grow significantly in regions with high incidence rates of cerebrovascular disorders. North America and Europe are currently leading the market, but the Asia-Pacific region is anticipated to show substantial growth due to its large population and increasing healthcare infrastructure[2].

Clinical and Market Impact

Improved Patient Outcomes

Clinical trials have consistently shown that nimodipine improves neurological outcomes in patients with subarachnoid hemorrhage. The NEWTON study, for example, demonstrated better clinical outcomes with intraventricular administration, highlighting the potential for improved patient care through innovative delivery methods[1].

Economic Impact

The growing market size of nimodipine reflects its economic significance. With a projected value of USD 147.4 billion by 2031, nimodipine is a critical component of the pharmaceutical industry, particularly in the segment of cerebrovascular disorder treatments[2].

Key Takeaways

• Clinical Trials: Ongoing trials, such as the NEWTON study and Acasti Pharma's GTX-104, are exploring new delivery methods and confirming the safety and efficacy of nimodipine.
• Market Growth: The nimodipine market is expected to grow at a CAGR of 5% from 2024 to 2031, driven by increasing incidence of subarachnoid hemorrhage and stroke.
• Drivers and Restraints: The market is driven by the need for efficient post-hemorrhagic complication management and restrained by adverse effects and patient compliance issues.
• Future Opportunities: Novel drug therapies, improved delivery methods, and rising awareness about cerebrovascular disorders will provide significant growth opportunities.

FAQs

What is the primary use of Nimotop (Nimodipine)?

Nimotop (Nimodipine) is primarily used to treat subarachnoid hemorrhage and to improve neurological outcomes in patients with this condition.

What are the key findings of the NEWTON study?

The NEWTON study found that patients receiving intraventricular nimodipine (EG-1962) had better clinical outcomes and fewer serious adverse events compared to those receiving standard enteral nimodipine, although there was a higher incidence of ventriculitis in the EG-1962 cohort[1].

What is the projected market size of Nimotop by 2031?

The nimodipine market is projected to reach USD 147.4 billion by 2031, growing at a CAGR of 5% from 2024 to 2031[2].

What are the main drivers of the Nimotop market?

The main drivers include the increasing incidence of subarachnoid hemorrhage and stroke, the need for efficient post-hemorrhagic complication management, and ongoing clinical trials exploring new therapeutic applications and improved formulations[2][5].

What are the potential restraints on the Nimotop market?

Adverse effects such as bradycardia, hypotension, and headache, as well as patient compliance issues, are significant restraints on the market growth[5].

How does the IV formulation of Nimotop (GTX-104) compare to oral nimodipine?

The IV formulation (GTX-104) shows similar pharmacokinetic profiles to oral nimodipine but with less variability in pharmacokinetic parameters[4].

Sources

1. Intraventricular Nimodipine for Aneurysmal Subarachnoid Hemorrhage: Journal of Neurosurgery, 2017.
2. Nimodipine Market Size By Product, By Application, By Geography: Market Research Intellect, 2024.
3. What is the current valuation of Acasti Pharma's Nimodipine: Pharmaceutical Technology, 2024.
4. Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Administration): MedRxiv, 2024.
5. Nimodipine Market Size & Share | Industry Forecast By: Allied Market Research, 2021.