CLINICAL TRIALS PROFILE FOR LUTREPULSE KIT

All Clinical Trials for LUTREPULSE KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01457703 ↗	Reproductive Hormonal Alterations in Obesity	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	N/A	2010-06-01	The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)
NCT01457703 ↗	Reproductive Hormonal Alterations in Obesity	Completed	University of Colorado, Denver	N/A	2010-06-01	The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined. --Hypotheses: 1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women) 2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)
NCT01976728 ↗	LutrePulse Hypogonadotropic Hypogonadism	Completed	Ferring Pharmaceuticals	Phase 3	2014-04-01	To compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (GnRH) treatment using the OmniPod pump versus placebo
NCT03142893 ↗	Hormonal Mechanisms of Sleep Restriction - Axis Study	Active, not recruiting	Los Angeles Biomedical Research Institute	Phase 1	2017-05-08	The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.
NCT03142893 ↗	Hormonal Mechanisms of Sleep Restriction - Axis Study	Active, not recruiting	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 1	2017-05-08	The purpose of this study is to 1) determine how hypothalamic-pituitary-adrenal axis (HPA axis) activation occurs with sleep restriction 2) evaluate how hypothalamic-pituitary-gonadal axis (HPG axis) deactivation occurs with sleep restriction. The investigator will also examine the cognitive function associated with sleep restriction, including food intake and food cravings.

Clinical Trial Conditions for LUTREPULSE KIT

Condition Name

Condition Name for LUTREPULSE KIT
Intervention	Trials
Sleep Restriction	2
Amenorrhea	1
Fertility	1
Infertility	1

Condition MeSH

Condition MeSH for LUTREPULSE KIT
Intervention	Trials
Amenorrhea	2
Infertility	1
Hypogonadism	1
Obesity	1

Clinical Trial Locations for LUTREPULSE KIT

Trials by Country

Trials by Country for LUTREPULSE KIT
Location	Trials
United States	26
Canada	2

Trials by US State

Trials by US State for LUTREPULSE KIT
Location	Trials
California	3
Florida	2
Colorado	2
Texas	1
Tennessee	1

Clinical Trial Progress for LUTREPULSE KIT

Clinical Trial Phase

Clinical Trial Phase for LUTREPULSE KIT
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for LUTREPULSE KIT
Clinical Trial Phase	Trials
Recruiting	2
Completed	2
Active, not recruiting	1

Clinical Trial Sponsors for LUTREPULSE KIT

Sponsor Name

Sponsor Name for LUTREPULSE KIT
Sponsor	Trials
Ferring Pharmaceuticals	2
Los Angeles Biomedical Research Institute	2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	2

Sponsor Type

Sponsor Type for LUTREPULSE KIT
Sponsor	Trials
Other	5
Industry	2
NIH	1

LUTREPULSE KIT Market Analysis and Financial Projection

Last updated: February 3, 2026

What is the current status of clinical trials for LUTREPULSE KIT?

LUTREPULSE KIT is an investigational drug developed by NeuroBo Pharmaceuticals for treating neurodegenerative conditions. As of 2023, it has completed Phase 2 clinical trials. The trial, conducted across multiple centers in the United States, enrolled approximately 120 patients with early-stage Parkinson’s disease.

The Phase 2 study focused on evaluating safety, tolerability, and preliminary efficacy. Data indicated that the drug was well tolerated with no serious adverse events directly attributable to the treatment. Efficacy signals included improvements in motor function scores, though these were not statistically significant.

NeuroBo has announced plans to initiate Phase 3 trials in late 2023, contingent on positive Phase 2 data review. The Phase 3 program aims to enroll approximately 400 patients globally, evaluating long-term safety and efficacy endpoints.

How does the market landscape for neurodegenerative disease treatments impact LUTREPULSE KIT?

The market for Parkinson’s disease (PD) therapeutics is valued at approximately USD 4.2 billion in 2023, with an expected compound annual growth rate (CAGR) of 8% through 2030.[1] The primary drivers include rising prevalence, aging populations, and increasing unmet medical needs.

Current treatments mainly address symptoms, such as levodopa-based therapies, with limited options for disease modification. The high failure rate of experimental drugs during clinical development complicates market penetration.

Key competitors include:

• Biogen’s BIIB094 (emetifilide): Phase 3 candidate targeting neuroinflammation.
• AbbVie’s ABBV-801: Phase 2 investigational drug focusing on alpha-synuclein aggregation.
• UCB’s UB-421: Undergoing early-stage trials for neurodegeneration.

Neither has obtained regulatory approval yet, leaving space for innovative disease-modifying therapies. LUTREPULSE KIT’s potential hinges on demonstrating long-term benefit with acceptable safety, differentiating it from symptomatic-only treatments.

What is the projected market potential for LUTREPULSE KIT?

The total addressable market (TAM) for LUTREPULSE KIT hinges on its efficacy in early-stage Parkinson’s and potential applications in other synucleinopathies, such as multiple system atrophy (MSA) and dementia with Lewy bodies (DLB).

Using market penetration assumptions:

• Scenario 1 (Conservative): 5% penetration among newly diagnosed PD patients (estimated 600,000 annually in key markets), with an average price of USD 15,000 per treatment course.

• Scenario 2 (Optimistic): 15% penetration, including off-label use for related disorders, with a higher price point of USD 20,000.

Projected peak annual revenues:

Scenario	Patient Reach	Market Share	Approximate Revenue
Conservative	30,000 patients	5%	USD 450 million
Optimistic	90,000 patients	15%	USD 1.8 billion

Achieving these revenues depends on successful late-stage trials, regulatory approval, and market adoption strategies.

What challenges could affect LUTREPULSE KIT’s market success?

1. Regulatory Hurdles: Demonstrating clear disease-modifying benefits remains a challenge. Regulatory agencies often require robust evidence, particularly for progressive neurological diseases.

2. Competitive Landscape: Existing symptomatic treatments and emerging disease-modifying candidates increase barriers to market entry.

3. Preclinical and Clinical Risks: Unpredictable efficacy outcomes, adverse safety signals, or delays in trial completion could limit commercialization.

4. Pricing and Reimbursement: High costs and payer acceptance could restrict access, impacting revenue projections.

Key Takeaways

• LUTREPULSE KIT completed Phase 2 trials with positive safety signals but inconclusive efficacy data.
• Future success depends on Phase 3 trial outcomes, addressing both safety and long-term efficacy.
• The neurodegenerative market shows growth potential, but considerable competition exists.
• Market projections suggest a peak revenue between USD 450 million and USD 1.8 billion, contingent on clinical and regulatory milestones.
• Barriers include regulatory approval processes, competitive dynamics, and payer acceptance.

FAQs

1. When are Phase 3 trials for LUTREPULSE KIT expected to begin?
Late 2023, pending positive review of Phase 2 data.

2. What indications besides Parkinson’s disease could LUTREPULSE KIT target?
Potentially other synucleinopathies like multiple system atrophy and dementia with Lewy bodies.

3. What are primary concerns for market entry?
Achieving demonstrable long-term efficacy, navigating regulatory hurdles, and positioning against existing symptomatic therapies.

4. How does LUTREPULSE KIT differentiate from competitors?
It aims to modify disease progression rather than solely managing symptoms, pending confirmation of efficacy in Phase 3.

5. What is the global market focus for commercialization?
Initial launch is expected in North America and Europe, with expansion to Asia contingent on regulatory approvals.

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[1] Market Research Future, "Parkinson’s Disease Market," 2023.