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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR LEUPROLIDE ACETATE


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505(b)(2) Clinical Trials for Leuprolide Acetate

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 <= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Leuprolide Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00002580 ↗ Tamoxifen, Ovarian Ablation, and/or Combination Chemotherapy in Treating Premenopausal Women With Stage I, Stage II, or Stage IIIA Invasive Breast Cancer Completed Scottish Cancer Therapy Network Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 ↗ Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Completed Cancer Research Campaign Clinical Trials Centre Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 ↗ Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Completed Scottish Cancer Therapy Network Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Leuprolide Acetate

Condition Name

Condition Name for Leuprolide Acetate
Intervention Trials
Prostate Cancer 73
Prostate Adenocarcinoma 14
Infertility 12
Endometriosis 10
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Condition MeSH

Condition MeSH for Leuprolide Acetate
Intervention Trials
Prostatic Neoplasms 111
Adenocarcinoma 26
Infertility 13
Puberty, Precocious 10
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Clinical Trial Locations for Leuprolide Acetate

Trials by Country

Trials by Country for Leuprolide Acetate
Location Trials
Canada 82
Italy 22
United Kingdom 19
Japan 18
Germany 14
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Trials by US State

Trials by US State for Leuprolide Acetate
Location Trials
Texas 48
California 46
New York 46
Florida 39
Michigan 33
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Clinical Trial Progress for Leuprolide Acetate

Clinical Trial Phase

Clinical Trial Phase for Leuprolide Acetate
Clinical Trial Phase Trials
Phase 4 27
Phase 3 48
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Leuprolide Acetate
Clinical Trial Phase Trials
Completed 88
Recruiting 28
Terminated 23
[disabled in preview] 37
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Clinical Trial Sponsors for Leuprolide Acetate

Sponsor Name

Sponsor Name for Leuprolide Acetate
Sponsor Trials
National Cancer Institute (NCI) 49
M.D. Anderson Cancer Center 11
Southwest Oncology Group 7
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Sponsor Type

Sponsor Type for Leuprolide Acetate
Sponsor Trials
Other 204
Industry 88
NIH 68
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Leuprolide Acetate: Clinical Trials, Market Analysis, and Projections

Introduction to Leuprolide Acetate

Leuprolide acetate is a luteinizing hormone-releasing hormone (LHRH) agonist widely used in the treatment of various hormone-related conditions, including prostate cancer, endometriosis, uterine fibroids, and central precocious puberty. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Central Precocious Puberty

One ongoing clinical trial is focused on evaluating the efficacy of leuprolide acetate in treating central precocious puberty in children. This study involves administering leuprorelin acetate depot 11.25 mg every 12 weeks for 6 months. The primary outcome measure is the percentage of participants with peak luteinizing hormone (LH) suppression in gonadotropin-releasing hormone (GnRH) stimulation at week 24. Secondary outcomes 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].

Prostate Cancer

A significant clinical trial related to prostate cancer involves a new 3-month depot formulation of leuprolide mesylate. This phase 3 trial has shown promising results, with 97.9% of patients achieving target testosterone suppression by day 28 and maintaining it through day 168. This formulation is pending FDA approval and is expected to provide a ready-to-use option for patients with advanced prostate cancer[4].

Market Analysis

Current Market Size

The leuprolide acetate market was valued at approximately USD 2.3 billion in 2024. This market is driven by the increasing prevalence of cancer, particularly prostate cancer, and other hormone-related conditions such as uterine fibroids and endometriosis[2][5].

Growth Drivers

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

  • Increasing Prevalence of Cancer: Prostate cancer is a major driver, as most forms of this cancer require testosterone to grow and spread. The global incidence of cancer is expected to rise, with over 28 million new cases projected by 2040[2][5].
  • Uterine Fibroids: Leuprolide acetate is widely used to reduce the size of fibroids, which are common in women of reproductive age. More than 50% of women have fibroids by the age of 50[2][5].
  • Improvements in Healthcare Infrastructure: Better access to medical facilities and early diagnosis have increased the demand for leuprolide acetate. The growing elderly population also contributes to the market growth, as conditions like prostate cancer are more prevalent in older age groups[3].

Market Segments

The leuprolide acetate market can be segmented based on product type, application, and route of administration:

  • Product Type: Prefilled syringes are expected to gain a significant revenue share due to their convenience, accuracy, and safety. These syringes, such as those used for LUPRON DEPOT, are disposable and maintain the drug's potency throughout its shelf life[5].
  • Application: The prostate cancer segment is the largest and is expected to continue growing. The precocious puberty segment, though smaller, is also significant[3].
  • Route of Administration: Intramuscular injections are the most common and effective route, expected to grow at the fastest rate due to their higher efficacy and longer duration of action[3].

Distribution Channels

The market is also influenced by distribution channels:

  • Retail Pharmacy: Traditional but still a major channel.
  • Hospital Pharmacy: Significant due to the medical nature of the drug.
  • Online Pharmacy: Growing in popularity due to convenience, anonymity, and time-saving benefits[5].

Market Projections

Forecasted Market Size

The leuprolide acetate market is projected to grow significantly:

  • By 2036, the market is expected to reach USD 5.09 billion, with a compound annual growth rate (CAGR) of around 6.9% between 2024 and 2036[2].
  • Another forecast indicates the market will cross USD 5.41 billion by 2037, with a CAGR of more than 6.8% between 2025 and 2037[5].

Regional Market Forecast

  • North America: Expected to hold the largest revenue share by 2037, driven by increasing healthcare spending and better medical access. In 2021, health spending in the US increased by over 2%[5].
  • Europe: The second largest market, driven by advancements in medical care and the development of more effective leuprolide acetate formulations[5].

Challenges and Opportunities

Challenges

Despite the growth, the leuprolide acetate market faces several challenges:

  • Competition from Alternative Treatments: Other hormone therapies, surgical interventions, and novel medications pose competition to leuprolide acetate[3].
  • Side Effects: Patients may experience side effects such as hot flashes, fatigue, mood swings, and bone density loss, which can affect treatment compliance[3].

Opportunities

  • Emerging Markets: Regions like Asia and Latin America offer untapped potential due to improving healthcare infrastructure, rising disposable incomes, and increasing awareness of advanced treatment options[3].
  • Strategic Collaborations: Partnerships between pharmaceutical companies and research institutions can accelerate drug development and expand market reach[3].
  • Biosimilars: The introduction of biosimilar versions of leuprolide acetate provides cost-effective alternatives, increasing competition and accessibility[3].

Key Takeaways

  • Leuprolide acetate is a crucial drug in treating hormone-related conditions, with ongoing clinical trials showing promising results.
  • The market is driven by the increasing prevalence of cancer and other conditions, as well as improvements in healthcare infrastructure.
  • The market is expected to grow significantly, reaching over USD 5 billion by 2037.
  • Regional markets, particularly North America and Europe, will play a significant role in the market's growth.
  • Despite challenges from alternative treatments and side effects, emerging markets and strategic collaborations offer opportunities for growth.

FAQs

What is leuprolide acetate used for?

Leuprolide acetate is used to treat conditions such as prostate cancer, endometriosis, uterine fibroids, and central precocious puberty by acting as a luteinizing hormone-releasing hormone (LHRH) agonist.

What is the current market size of leuprolide acetate?

The leuprolide acetate market was valued at approximately USD 2.3 billion in 2024.

What drives the growth of the leuprolide acetate market?

The growth is driven by the increasing prevalence of cancer, particularly prostate cancer, improvements in healthcare infrastructure, and the growing elderly population.

What are the primary segments of the leuprolide acetate market?

The market is segmented by product type (e.g., prefilled syringes), application (e.g., prostate cancer), and route of administration (e.g., intramuscular injections).

What are the challenges faced by the leuprolide acetate market?

Challenges include competition from alternative treatments, side effects such as hot flashes and bone density loss, and the need for management of these side effects.

What are the opportunities for the leuprolide acetate market?

Opportunities include emerging markets in Asia and Latin America, strategic collaborations between pharmaceutical companies and research institutions, and the introduction of biosimilar versions.

Sources

  1. Clinical Trials Summary: "A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty" - ClinicalTrials.takeda.com
  2. Leuprolide Acetate Market Size: "Leuprolide Acetate Market Size - Research Nester" - ResearchNester.com
  3. Leuprolide Acetate Market Analysis: "Leuprolide Acetate Market: An In-Depth Market Analysis & Forecast" - MaximizeMarketResearch.com
  4. Ready-to-Use 3-Month Leuprolide Depot Formulation: "Ready-to-Use 3-Month Leuprolide Depot Formulation Nears FDA Approval" - TargetedOnc.com
  5. Leuprolide Acetate Market Forecast: "Leuprolide Acetate Market Size & Share | Forecast Report 2037" - ResearchNester.com

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