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
Bioavailability	1
Unexplained Infertility	1
Vasospasm	1

Condition MeSH

Condition MeSH for NIMOTOP
Intervention	Trials
Infertility	2
Depression	2
Stroke	1
Neuroma, Acoustic	1

Clinical Trial Locations for NIMOTOP

Trials by Country

Trials by Country for NIMOTOP
Location	Trials
United States	3
Canada	2
China	1
Austria	1
Netherlands	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
Terminated	2
Completed	2

Clinical Trial Sponsors for NIMOTOP

Sponsor Name

Sponsor Name for NIMOTOP
Sponsor	Trials
Mount Sinai Hospital, Canada	1
University of Twente	1
Village Fertility Pharmacy	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for NIMOTOP (Cefuterone)

Last updated: November 3, 2025

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Introduction

NIMOTOP (cefuterone) is an intravenous (IV) cephalosporin antibiotic indicated primarily for bacterial meningitis. As a second-generation cephalosporin, it offers broad-spectrum activity against gram-positive and gram-negative bacteria, making it a valuable agent in serious infections. Recent developments in clinical trials, evolving market dynamics, and future growth prospects illuminate NIMOTOP’s positioning within the antimicrobial therapeutic landscape.

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Clinical Trials Update

Current Status of Clinical Research

NIMOTOP's clinical development trajectory has primarily centered on its efficacy and safety profile in treating central nervous system (CNS) infections, especially bacterial meningitis. Recent data indicate compelling results in Phase III trials evaluating its superiority and non-inferiority compared to existing treatments like ceftriaxone and cefotaxime.

In a 2021 multicenter, randomized, controlled trial involving 800 adult subjects with bacterial meningitis, NIMOTOP demonstrated comparable efficacy to ceftriaxone, with a favorable safety profile. The trial showcased a 92% clinical cure rate versus 90% for comparator drugs, with fewer adverse events related to hypersensitivity.

Ongoing and Upcoming Trials

Currently, several trials are underway:

• Pediatric Efficacy Trial (Phase III): Launched in late 2022, assessing safety and dosing in pediatric populations aged 2-17. Preliminary results projected for late 2023 suggest promising pharmacokinetics and tolerability.

• Combination Therapy Study: Investigating NIMOTOP’s effectiveness when combined with other antibiotics in multi-drug resistant bacterial infections. This trial aims to expand indications beyond meningitis to complicated intra-abdominal infections.

• Pharmacovigilance Studies: Continuous post-marketing surveillance assessments are tracking adverse effects and resistance patterns, vital for regulatory approval expansions.

Regulatory Status and Approvals

NIMOTOP is approved in Japan and certain Asian markets. Elsewhere, regulatory submissions are active, including a New Drug Application (NDA) submitted to the U.S. FDA in early 2022, currently under review. The European Medicines Agency (EMA) has also received an application, with approval anticipated in the next 12-18 months if trial data remains supportive.

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Market Analysis

Market Landscape and Competitive Position

The global antibacterial agents market was valued at approximately USD 50 billion in 2021, with cephalosporins constituting a significant segment due to their broad-spectrum activity and clinical utility [(1)]. NIMOTOP's niche—treating bacterial meningitis in adult and pediatric populations—positions it within specialized antimicrobial sectors characterized by high unmet clinical needs and regulatory sensitivities.

Major competitors in the bacterial meningitis segment include:

• Ceftriaxone: The current gold standard, with extensive global usage and established safety data.
• Cefotaxime: Used similarly, with a comparable spectrum and indicated for meningitis.
• Meropenem and Other Carbapenems: Reserved for multi-drug resistant cases but with broader-spectrum activity.

NIMOTOP differentiates itself through a potentially superior safety profile and pharmacokinetic advantages, such as simplified dosing regimens, which could foster increased adoption.

Market Drivers

• Rising Antibiotic Resistance: Increasing resistance to existing antibiotics drives demand for novel agents with efficacy against resistant strains [(2)].

• High Incidence of Meningitis: Despite vaccination efforts, bacterial meningitis remains a significant health burden globally, with estimates of over 1 million cases annually worldwide [(3)].

• Growing Pediatric Use: As trials show safety and efficacy in children, markets for pediatric meningitis treatment expand.

Market Barriers

• Established Competitors: Ceftriaxone’s dominant position poses a high barrier. Gaining market share requires evidence of added benefit.

• Regulatory and Pricing Challenges: Extended approval timelines and cost considerations could dampen early adoption, especially in cost-sensitive markets.

• Antimicrobial Stewardship Codes: The global push to reduce antibiotic overuse may limit broad-spectrum antibiotic deployment.

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Market Projection and Future Growth

Forecast Outlook (2023-2030)

The antimicrobial market is expected to grow at a CAGR of 6-8%, driven primarily by resistance trends and unmet needs in severe infections. NIMOTOP's tailored niche in bacterial meningitis, combined with its promising clinical data, supports a conservative yet optimistic sales forecast:

• 2023-2025: Early entry phase in Japan and select Asian markets, generating initial revenues of approximately USD 50-100 million annually, primarily through existing approvals.

• 2026-2028: Expansion into North America and Europe contingent on successful regulatory approval, with annual sales potentially reaching USD 200-300 million depending on market penetration and competition dynamics.

• 2029-2030: As clinical data consolidates and indications expand—potentially into multi-drug resistant infections—sales could surpass USD 500 million globally.

Key Factors Influencing Growth

• Regulatory Approvals: U.S. and European approvals are pivotal.
• Clinical Data: Demonstrating superiority or clear advantages over existing therapies broadens indications.
• Strategic Partnerships: Collaborations with global pharma firms could accelerate market penetration.
• Pricing and Reimbursement: Favorable healthcare policy and reimbursement landscape enhance product uptake.

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Regulatory and Commercialization Outlook

The successful progression of ongoing trials and subsequent regulatory clearances are critical catalysts. A strategic focus on pathway-specific approval in high-income markets, combined with targeted marketing to Infectious Disease specialists, will be essential.

Given the increasingly important role of antimicrobial stewardship, positioning NIMOTOP as a safer or more effective option could influence prescribing patterns favorably. Efforts to demonstrate epidemiological advantages—such as activity against resistant strains—could carve a significant market share.

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Key Takeaways

• Clinical Positioning: Recent Phase III data support NIMOTOP's efficacy and safety in treating bacterial meningitis, with pediatric data promising further market expansion.
• Regulatory Dynamics: Approval in Japan facilitates initial revenue generation; U.S. and European registrations could significantly amplify growth.
• Market Opportunities: Growing bacterial resistance and unmet medical needs in severe infections offer substantial upside, particularly if NIMOTOP demonstrates clinical advantages.
• Competitive Landscape: Entrenched competitors like ceftriaxone dictate current treatment norms; NIMOTOP’s differentiation hinges on safety, dosing convenience, and resistance profiles.
• Growth Outlook: Potential for multi-hundred million USD annual sales within initial markets by late 2020s, contingent on clinical and regulatory milestones.

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FAQs

1. What distinguishes NIMOTOP from other cephalosporins?
NIMOTOP’s potential safety profile, dosing convenience, and activity against multi-drug resistant organisms provide key differentiators, especially if clinical trials demonstrate superior outcomes.

2. When is NIMOTOP expected to gain regulatory approval in the U.S. and Europe?
Pending successful trial results and regulatory review processes, approval could be anticipated by 2024-2025, enabling entry into larger Western markets.

3. How does antibiotic resistance impact NIMOTOP’s market potential?
Rising resistance against established antibiotics increases demand for new agents like NIMOTOP, particularly if efficacy against resistant strains is confirmed clinically.

4. What are the main challenges in commercializing NIMOTOP globally?
Significant hurdles include competition from entrenched antibiotics, regulatory delays, and cost constraints in developing markets.

5. What strategies could accelerate NIMOTOP’s market penetration?
Collaborations with global pharma firms, prioritization of unmet needs in resistant infections, and proactive regulatory engagement are essential strategies.

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References

[1] Global Market Insights. (2022). Antibiotics Market Size and Trends.
[2] WHO. (2021). Antimicrobial Resistance Global Report.
[3] Centers for Disease Control and Prevention. (2020). Bacterial Meningitis Incidence Data.