CLINICAL TRIALS PROFILE FOR LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

All Clinical Trials for Leuprolide Acetate For Depot Suspension

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00598312 ↗	Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer	Completed	Oakwood Laboratories, LLC	Phase 3	2007-04-01	The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.
NCT00621179 ↗	Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF	Completed	Colorado Center for Reproductive Medicine	Phase 4	2003-03-01	This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio
NCT01069094 ↗	A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata	Completed	Repros Therapeutics Inc.	Phase 1/Phase 2	2004-07-01	A study of 3 doses of Progenta versus placebo versus Lucron Depot for treatment of leiomyomata.
NCT02452931 ↗	Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty	Completed	Tolmar Inc.	Phase 3	2015-08-31	This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.
NCT03085095 ↗	A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer	Active, not recruiting	Myovant Sciences GmbH	Phase 3	2017-04-18	The purpose of this study is to determine the efficacy and safety of relugolix 120 milligrams (mg) orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (< 50 nanograms/deciliter [ng/dL]) in participants with androgen-sensitive advanced prostate cancer.
NCT04906395 ↗	Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer	Recruiting	Tolmar Inc.	Phase 3	2021-07-01	This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer. The study will also aim to assess administration of TOL2506 in men with HR+ breast cancer. Study duration, for individual subjects, will be up to 57 weeks, including a Screening Period of up to 9 weeks, a Treatment Period of 48 weeks, and an End of Study Visit (Visit 8, Week 48). Eligible subjects will enter into the Treatment Period in 1 of 2 groups: those who will receive tamoxifen concurrently with TOL2506 or those who will initiate therapy with an AI (letrozole, anastrozole, or exemestane) beginning 6 weeks after the first administration of TOL2506, upon confirmation that estradiol (E2) levels of < 20 pg/mL have been achieved. After Week 12, subjects will be allowed to switch from receiving an AI to receiving tamoxifen or from tamoxifen to AI at the discretion of the Investigator. However, a switch is not permitted 28 days prior to a dosing visit. At the end of the Treatment Period, subjects will be eligible for compassionate use of TOL2506 (expanded access) until TOL2506 receives marketing approval and is commercially available.

Clinical Trial Conditions for Leuprolide Acetate For Depot Suspension

Condition Name

Condition Name for Leuprolide Acetate For Depot Suspension
Intervention	Trials
Prostate Cancer	2
Uterine Leiomyomata	1
Breast Cancer	1
Endometriosis	1

Condition MeSH

Condition MeSH for Leuprolide Acetate For Depot Suspension
Intervention	Trials
Prostatic Neoplasms	2
Puberty, Precocious	1
Myofibroma	1
Leiomyoma	1

Clinical Trial Locations for Leuprolide Acetate For Depot Suspension

Trials by Country

Trials by Country for Leuprolide Acetate For Depot Suspension
Location	Trials
United States	42
Canada	9
Brazil	7
Italy	6
Japan	6

Trials by US State

Trials by US State for Leuprolide Acetate For Depot Suspension
Location	Trials
California	3
Ohio	3
Tennessee	2
New York	2
Michigan	2

Clinical Trial Progress for Leuprolide Acetate For Depot Suspension

Clinical Trial Phase

Clinical Trial Phase for Leuprolide Acetate For Depot Suspension
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Leuprolide Acetate For Depot Suspension
Clinical Trial Phase	Trials
Completed	4
Recruiting	1
Active, not recruiting	1

Clinical Trial Sponsors for Leuprolide Acetate For Depot Suspension

Sponsor Name

Sponsor Name for Leuprolide Acetate For Depot Suspension
Sponsor	Trials
Tolmar Inc.	2
Repros Therapeutics Inc.	1
Myovant Sciences GmbH	1

Sponsor Type

Sponsor Type for Leuprolide Acetate For Depot Suspension
Sponsor	Trials
Industry	5
Other	1

Leuprolide Acetate for Depot Suspension: Clinical Trials, Market Analysis, and Projections

Introduction to Leuprolide Acetate

Leuprolide acetate is a synthetic nonapeptide analog of the naturally occurring gonadotropin-releasing hormone (GnRH). It is widely used in the treatment of various medical conditions, including prostate cancer, endometriosis, uterine fibroids, and central precocious puberty (CPP).

Clinical Trials Update

Central Precocious Puberty (CPP) Trials

Several clinical trials are ongoing to evaluate the efficacy and safety of leuprolide acetate in treating CPP in children. Here are some key details from these trials:

• Study Design and Participants: A clinical trial involving 80 participants aims to assess the efficacy of leuprolide acetate depot in children with CPP. Participants receive an injection of leuprolide acetate depot 11.25 mg every 12 weeks for 6 months and undergo multiple assessments[1].
• Efficacy Measures: The primary outcome measure is the percentage of participants with peak luteinizing hormone (LH) suppression in GnRH stimulation at Week 24. Secondary measures include Tanner stage regression or no progression, basal LH and follicle-stimulating hormone (FSH) concentrations, and the ratio of bone age to chronological age[1].
• Long-Term Safety: A Phase 3, open-label, multicenter extension study is assessing the long-term safety of LUPRON DEPOT-PED 3-month over 36 months in children with CPP. This study focuses on maintaining LH suppression and monitoring pubertal symptoms, sex steroid levels, and bone age[4].

Efficacy and Safety Findings

• LH Suppression: Studies have shown that LUPRON DEPOT-PED 3-month formulations effectively suppress peak stimulated LH concentrations to <4.0 mIU/mL from month 1 through month 6, both in treatment-naïve and previously treated patients[4].
• Tanner Stage and Bone Age: The treatment has been associated with regression or no progression of Tanner stages and a decrease in the ratio of bone age to chronological age, indicating effective pubertal suppression[1][4].

Market Analysis

Global Market Value and Growth

The global leuprolide acetate market is projected to experience significant growth in the coming years.

• Current Market Value: The market is estimated to be valued at USD 3.82 billion in 2024[2].
• Projected Growth: It is expected to reach USD 5.81 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2031[2].
• Alternative Projection: Another report suggests the market could reach USD 3.5 billion by 2032, with a CAGR of 6% between 2023 and 2032[5].

Drivers of Market Growth

Several factors are driving the growth of the leuprolide acetate market:

• Increasing Incidence of Prostate Cancer and Endometriosis: The rising prevalence of these conditions globally is a major driver, as leuprolide acetate is an effective treatment for both[2][5].
• Advanced Drug Delivery Formulations: The development of enhanced drug delivery formulations, such as lyophilized powders and intramuscular injections, is contributing to market growth by offering improved efficacy and reduced treatment duration[2][5].
• Healthcare Infrastructure: Regions with strong healthcare infrastructure, such as North America, are driving demand due to higher healthcare spending and the presence of key market players[2].

Regional Market Dynamics

• North America: This region currently dominates the market due to its developed healthcare infrastructure and significant healthcare spending in the U.S. and Canada. It accounts for a substantial share of the global market[2].
• Asia Pacific: This region is expected to be the fastest-growing market, driven by the expanding patient population and improving healthcare indices in countries like China and India. The availability of cost-effective generic versions and growing exports from these countries are also contributing factors[2].

Market Segments and Trends

Therapeutic Applications

• Prostate Cancer: Leuprolide acetate is widely used in the treatment of prostate cancer, and the increasing incidence of this disease is a key driver of market growth[2][5].
• Endometriosis and Uterine Fibroids: The drug is also used to treat endometriosis-related pain and uterine fibroids, further boosting demand[2][5].
• Central Precocious Puberty: The market for leuprolide acetate in treating CPP is expected to cross USD 510 million by 2032, driven by the drug's high potency and long durability[5].

Route of Administration

• Intramuscular Injections: The demand for intramuscular injections is significant due to their therapeutic and pharmaceutical uses. Studies have shown that intramuscular leuprolide acetate is effective in achieving biochemical suppression, particularly in puberty suppression therapy[5].

Hospital Pharmacy Segment

• Growing Demand: The hospital pharmacy segment registered USD 580 million in 2022, driven by the increasing diagnosis and treatment of cancer and uterine fibroids in hospitals[5].

Regulatory and Competitive Landscape

Regulatory Environment

• Stringent Regulations: Regulatory requirements for drug approval can slow down the entry of new players into the market. However, prominent efforts by regulatory agencies, especially in Europe, are helping to bolster the industry landscape[2][5].

Competitive Strategies

• Generic Versions and Licensing Deals: Market players are leveraging licensing deals to manufacture and sell generic versions in emerging markets, particularly as leading brand drugs lose their patents. Collaboration with local pharmaceutical companies helps minimize regulatory and market entry barriers[2].

Key Takeaways

• Clinical Trials: Ongoing clinical trials are demonstrating the efficacy and safety of leuprolide acetate in treating CPP, with significant LH suppression and favorable outcomes on Tanner stages and bone age.
• Market Growth: The global leuprolide acetate market is projected to grow significantly, driven by increasing incidence of prostate cancer and endometriosis, and the development of advanced drug delivery formulations.
• Regional Dynamics: North America dominates the market, while Asia Pacific is emerging as the fastest-growing region due to its large patient population and improving healthcare infrastructure.
• Therapeutic Applications: Leuprolide acetate is crucial in treating prostate cancer, endometriosis, uterine fibroids, and CPP, with a growing demand in hospital pharmacies.

FAQs

What is the primary use of leuprolide acetate in clinical settings?

Leuprolide acetate is primarily used to treat conditions such as prostate cancer, endometriosis, uterine fibroids, and central precocious puberty (CPP) by suppressing the production of gonadotropins.

How is leuprolide acetate administered for CPP treatment?

For CPP treatment, leuprolide acetate is typically administered via intramuscular injections, either as a 1-month or 3-month depot formulation, to achieve sustained suppression of LH levels[1][4].

What are the key drivers of the leuprolide acetate market growth?

The market growth is driven by the increasing incidence of prostate cancer and endometriosis, the development of advanced drug delivery formulations, and strong healthcare infrastructure in regions like North America[2][5].

Which region is expected to be the fastest-growing market for leuprolide acetate?

The Asia Pacific region is projected to be the fastest-growing market due to its large and expanding patient population, improving healthcare indices, and the availability of cost-effective generic versions[2].

What are the potential challenges for the leuprolide acetate market?

Potential challenges include price erosion from generic versions, stringent regulatory requirements for drug approval, and market entry barriers in emerging markets[2].

Sources

1. Clinical Trials Register: A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty.
2. Coherent Market Insights: Leuprolide Acetate Market - Report & Production Statistics.
3. European Union Clinical Trials Register: Search for leuprolide acetate.
4. LUPRON DEPOT-PED: Clinical Studies.
5. Global Market Insights Inc.: Leuprolide Acetate Market to hit USD 3.5 Billion by 2032.