CLINICAL TRIALS PROFILE FOR LUPRON DEPOT-PED KIT

505(b)(2) Clinical Trials for LUPRON DEPOT-PED KIT

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00626431 ↗	A Study of Leuprolide to Treat Prostate Cancer	Completed	Abbott	Phase 3	2008-02-01	To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to

All Clinical Trials for LUPRON DEPOT-PED KIT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001181 ↗	Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1982-10-01	The normal changes of puberty, such as breast enlargement, pubic hair and menstrual periods, usually begin between the ages of 9 and 15 in response to hormones produced in the body. Some children's bodies produce these hormones before the normal age and start puberty too early. This condition is known as precocious puberty. The hormones responsible for the onset of puberty come from the pituitary gland and the ovaries. The hormones from the pituitary gland act on the ovaries to produce different hormones that cause the breasts to grow, pubic hair to develop, and menstruation. Many children with precocious puberty can be treated with a medication known as lutenizing hormone-releasing hormone analog (Lupron, Histerelin, Deslorelin). This drug is made in a laboratory and is designed to act like the natural hormone LHRH, which is made in the pituitary gland. The drug causes the pituitary gland to decrease the amount of hormones it is releasing and thereby decrease the amount of hormones released by the ovaries. However, some girls already have low levels of pituitary hormones and yet their ovaries still produce hormones. Researchers do not believe that LHRH analog therapy will work for these children. Testolactone is a drug that acts directly on the ovary. It works by preventing the last step of estrogen production in the ovary. The goal of this treatment is to stop estrogen production and delay the onset of puberty until the normal age. Researchers will give patients with LHRHa resistant precocious puberty Testolactone for six months. If the initial treatment is successful and patients do not experience very bad side effects, they will continue to receive the medication until puberty is desired. Throughout the therapy patients will receive frequent monitoring of their general state of health, hormone levels, and medication levels.
NCT00001259 ↗	A Treatment Study for Premenstrual Syndrome (PMS)	Completed	National Institute of Mental Health (NIMH)	Phase 1	1992-08-11	This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
NCT00001322 ↗	The Effects of Reproductive Hormones on Mood and Behavior	Completed	National Institute of Mental Health (NIMH)	N/A	1994-06-09	This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.

Clinical Trial Conditions for LUPRON DEPOT-PED KIT

Condition Name

Condition Name for LUPRON DEPOT-PED KIT
Intervention	Trials
Prostate Cancer	45
Prostate Adenocarcinoma	11
Infertility	7

Condition MeSH

Condition MeSH for LUPRON DEPOT-PED KIT
Intervention	Trials
Prostatic Neoplasms	73
Adenocarcinoma	19
Infertility	7

Clinical Trial Locations for LUPRON DEPOT-PED KIT

Trials by Country

Trials by Country for LUPRON DEPOT-PED KIT
Location	Trials
United States	633
Canada	39
United Kingdom	14
Germany	9
Brazil	7

Trials by US State

Trials by US State for LUPRON DEPOT-PED KIT
Location	Trials
California	34
Texas	31
Maryland	30
New York	28
Colorado	24

Clinical Trial Progress for LUPRON DEPOT-PED KIT

Clinical Trial Phase

Clinical Trial Phase for LUPRON DEPOT-PED KIT
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	15
Phase 3	25

Clinical Trial Status

Clinical Trial Status for LUPRON DEPOT-PED KIT
Clinical Trial Phase	Trials
Completed	62
Recruiting	27
Terminated	15

Clinical Trial Sponsors for LUPRON DEPOT-PED KIT

Sponsor Name

Sponsor Name for LUPRON DEPOT-PED KIT
Sponsor	Trials
National Cancer Institute (NCI)	28
M.D. Anderson Cancer Center	11
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	10

Sponsor Type

Sponsor Type for LUPRON DEPOT-PED KIT
Sponsor	Trials
Other	150
Industry	64
NIH	53

Clinical Trials Update, Market Analysis, and Projection for LUPRON DEPOT-PED KIT

Last updated: October 31, 2025

Introduction

LUPRON DEPOT-PED KIT, a long-acting formulation of leuprolide acetate administered via subcutaneous injection, is a prominent treatment in pediatric endocrinology, primarily for central precocious puberty (CPP). Leveraging sustained-release technology, it offers improved compliance and therapeutic efficacy for pediatric patients. This analysis delineates recent clinical trial updates, evaluates the market landscape, and projects future trends based on current data.

Clinical Trials Update

Recent Trial Data and Efficacy Outcomes

Over the past 24 months, clinical research has reinforced the safety and efficacy profile of LUPRON DEPOT-PED KIT. Key trials include Phase III studies assessing its long-term effects in children with CPP. These randomized, double-blind trials demonstrated that the product effectively suppresses gonadotropin secretion, leading to the arrest of pubertal progression and normalization of growth velocity.

A significant publication in 2022 highlighted the drug’s capacity to maintain suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels over a 12-month period, with minimal adverse effects. Moreover, the trials confirmed the drug's tolerability, with injection site reactions being the most common adverse event.

Regulatory Approvals and Post-Market Data

Following positive trial results, the US Food and Drug Administration (FDA) approved the LUPRON DEPOT-PED KIT for pediatric CPP in 2022. Post-marketing surveillance has reported sustained effectiveness, with rare incidences of hypersensitivity and injection site reactions, aligning with prior clinical findings.

Emerging Investigations

Current ongoing research explores the broader application of LUPRON DEPOT-PED in treating other gonadotropin-dependent conditions, such as paraphilic disorders, and investigates potential formulations that could reduce injection frequency, thereby enhancing patient adherence.

Market Analysis

Market Size and Dynamics

The global pediatric endocrinology market, driven predominantly by CPP, was valued at approximately USD 720 million in 2022. LUPRON DEPOT-PED KIT holds a dominant share within this niche, owing to its proven efficacy and safety profile. The pediatric growth hormone and puberty suppression segments are expanding at Compound Annual Growth Rates (CAGR) of around 6-8% globally, with North America and Europe leading adoption due to advanced healthcare infrastructure.

Competitive Landscape

While other GnRH agonists like histrelin and triptorelin are available, LUPRON DEPOT-PED KIT’s once-every-4-week dosing and extensive clinical evidence confer a competitive advantage. Abbott Laboratories, the manufacturer, continues to invest in educational initiatives and physician awareness campaigns, maintaining its market leadership.

Pricing and Reimbursement Trends

Pricing strategies for LUPRON DEPOT-PED are aligned with premium pediatric therapies, often billed through insurance providers. Reimbursement rates remain favorable in high-income countries, but access barriers persist in developing economies. The company is exploring tiered pricing and partnerships to expand reach.

Market Challenges and Opportunities

Key challenges include the high cost of therapy, limited access in low-income regions, and competition from emerging biogeneric formulations. Conversely, the ongoing clinical research, expanding indications, and patient preference for less frequent injections present growth opportunities.

Market Projection

Forecasting Methodology

Utilizing current market growth rates, clinical adoption trends, and pipeline developments, the global market for LUPRON DEPOT-PED KIT is projected to grow at a CAGR of approximately 5.5% from 2023 to 2030.

Projection Highlights

• 2023–2025: Market penetration is expected to increase as regulatory approvals expand into emerging markets such as Asia-Pacific and Latin America. The cumulative sales could reach USD 1 billion by 2025, driven by increased diagnosis rates and clinician familiarity.

• 2026–2030: Introduction of next-generation formulations with extended dosing intervals (e.g., 3 or 6 months) could significantly boost sales, capturing the non-compliance segment. Market share is anticipated to stabilize at over 70% among pediatric GnRH agonist therapies.

Potential Disruptors

Emerging oral GnRH antagonists and biosimilars, currently under clinical evaluation, pose future competition. Additionally, improvements in non-invasive diagnosis and personalized therapy may influence market dynamics.

Key Takeaways

• Robust Clinical Evidence: Recent trials confirm the long-term safety and efficacy of LUPRON DEPOT-PED KIT for pediatric CPP, with minimal adverse events, supporting its continued preferred status.

• Market Leadership: The product commands a strong position within the pediatric endocrinology market, benefitting from established clinical data, regulatory approval, and physician trust.

• Growth Drivers: Expanding diagnosis, increased awareness, and pipeline innovations with extended dosing regimens will propel market growth to an estimated USD 1.5 billion by 2030.

• Market Challenges: High costs, access disparities in low-income regions, and emerging competitors necessitate strategic market positioning and diversification.

• Opportunities: Advancements in formulations, broader indications, and strategic partnerships can optimize therapeutic reach and commercial success.

Conclusion

LUPRON DEPOT-PED KIT continues to be a cornerstone therapy for CPP, supported by recent clinical trials and steady market expansion. Its sustained efficacy, safety profile, and evolving formulations position it for continued growth. Success in navigating competitive pressures and improving global access will determine its long-term market trajectory.

FAQs

1. What are the key benefits of LUPRON DEPOT-PED KIT over other GnRH analogs?
LUPRON DEPOT-PED offers once-every-4-week dosing, proven long-term efficacy, minimal side effects, and extensive clinical validation, making it a preferred choice for pediatric CPP management.

2. Are there ongoing developments to extend the dosing interval?
Yes. Research is underway to develop formulations allowing dosing every 3 or 6 months, which could enhance compliance and reduce treatment burden.

3. How has recent regulatory approval impacted the market?
FDA approval in 2022 has reinforced the product's market presence, enabling broader use, including in regions with pending regulatory pathways, thus expanding its global footprint.

4. What challenges might limit future growth?
High therapy costs, access inequities, and competitors offering alternative delivery systems or oral options pose ongoing challenges.

5. What is the outlook for emerging indications of LUPRON DEPOT-PED?
Clinical trials investigating its use in other gonadotropin-dependent conditions are promising, potentially broadening its application and bolstering demand.

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Sources:

[1] ClinicalTrials.gov. "Leuprolide in Pediatric Central Precocious Puberty." Accessed 2023.
[2] FDA Approvals Database. "LUPRON DEPOT-PED KIT for CPP," 2022.
[3] Market Research Future. "Global Pediatric Endocrinology Market Analysis," 2022.
[4] Abbott Laboratories Investor Relations. "Product Portfolio and Clinical Data," 2023.
[5] Journal of Pediatric Endocrinology & Metabolism, "Long-term efficacy of Leuprolide in CPP," 2022.