CLINICAL TRIALS PROFILE FOR LUPRON

505(b)(2) Clinical Trials for Lupron

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.

All Clinical Trials for Lupron

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

Condition Name

Condition Name for Lupron
Intervention	Trials
Prostate Cancer	44
Prostate Adenocarcinoma	11
Infertility	7

Condition MeSH

Condition MeSH for Lupron
Intervention	Trials
Prostatic Neoplasms	71
Adenocarcinoma	19
Infertility	7

Clinical Trial Locations for Lupron

Trials by Country

Trials by Country for Lupron
Location	Trials
United States	631
Canada	39
United Kingdom	14
Germany	9
Netherlands	7

Trials by US State

Trials by US State for Lupron
Location	Trials
California	34
Texas	31
Maryland	29
New York	27
Colorado	24

Clinical Trial Progress for Lupron

Clinical Trial Phase

Clinical Trial Phase for Lupron
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	25
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Lupron
Clinical Trial Phase	Trials
Completed	62
Recruiting	26
Terminated	15

Clinical Trial Sponsors for Lupron

Sponsor Name

Sponsor Name for Lupron
Sponsor	Trials
National Cancer Institute (NCI)	27
M.D. Anderson Cancer Center	11
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	9

Sponsor Type

Sponsor Type for Lupron
Sponsor	Trials
Other	148
Industry	61
NIH	52

Lupron (Leuprolide Acetate): Clinical Trials, Market Analysis, and Projections

Introduction to Lupron (Leuprolide Acetate)

Lupron, or leuprolide acetate, is a gonadotropin-releasing hormone (GnRH) agonist widely used in the treatment of various medical conditions, including prostate cancer, endometriosis, uterine fibroids, and precocious puberty. This article delves into the current clinical trials, market analysis, and future projections for Lupron.

Clinical Trials Update

Cardiovascular Safety Comparison

A significant clinical trial compared the cardiovascular safety of leuprolide (a GnRH agonist) with degarelix (a GnRH antagonist) in patients. This international, randomized clinical trial, conducted from May 2016 to April 2020, involved 545 patients from 113 sites in 12 countries. The trial aimed to assess the composite outcome of major adverse cardiovascular events (MACE). Although the trial was initially planned for 900 patients, enrollment was closed early due to slower recruitment and lower-than-expected primary outcome rates. The results showed that over 12 months, the primary outcome event rates were projected to be 5.1% for degarelix and 10.2% for leuprolide, indicating a potential cardiovascular safety difference between the two treatments[1].

Central Precocious Puberty Treatment

Another ongoing clinical trial is focused on the use of leuprolide acetate depot in children with central precocious puberty. This trial, running from March 2023 to May 2025, involves 80 participants who receive injections of leuprorelin acetate depot every 12 weeks for 6 months. The primary outcome measure is the percentage of participants with peak luteinizing hormone (LH) suppression in GnRH stimulation at week 24. Secondary outcomes include Tanner stage regression or no progression, basal LH and FSH concentrations, and the ratio of bone age to chronological age[4].

Market Analysis

Market Size and Growth Projections

The leuprolide acetate market, which includes Lupron, is anticipated to experience significant growth. As of 2022, the market size was valued at over USD 2 billion. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6% between 2023 and 2032, reaching a valuation of approximately USD 3.5 billion by 2032. Alternatively, another projection suggests the market could reach USD 2,400 million by 2030 with a CAGR of 10.50% during the forecast period of 2022-2030[2][5].

Growth Drivers

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

• Increasing Prevalence of Cancer: The rising incidence of cancers, particularly prostate cancer and breast cancer, is a significant driver. Prostate cancer, for instance, requires testosterone for growth and spread, making leuprolide acetate a crucial treatment option[2][5].

• Endometriosis Treatment: The growing female population suffering from endometriosis is another key factor. Endometriosis affects approximately 176 million women worldwide and 11% of American women between the ages of 15 to 44[2].

• Veterinary Use: The demand for leuprolide acetate in veterinary treatments also contributes to the market's growth[2].

• Uterine Fibroids: The growing prevalence of uterine fibroids, which are the most common type of pelvic tumor in women of reproductive age, further fuels the market[5].

Product Forms and Distribution Channels

• Prefilled Syringes: These are a dominant form due to their convenience, safety, and accuracy. Prefilled syringes, such as those used for Lupron, provide a high degree of accuracy and maintain the drug's potency throughout its shelf life[5].

• Online Pharmacy: The preference for online shopping is increasing, and the online pharmacy segment is set to garner a notable share of the market. This shift is driven by the convenience, anonymity, and quick medication search and ordering capabilities offered by online pharmacies[5].

Regional Market Forecast

North American Market

The North American market is expected to hold the largest revenue share by 2037, driven by growing healthcare spending. This increased spending improves medical access, leading to more patients seeking diagnoses for diseases such as prostate cancer and fertility issues, thereby increasing the demand for leuprolide acetate[5].

European Market

The European market is estimated to be the second largest during the forecast period, led by advancements in medical care. More effective leuprolide acetate treatments are being developed in the region, increasing its adoption for managing conditions like fertility issues and prostate cancer[5].

Challenges

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

• Drug Price Control Policies: Strict drug price-control policies can hinder market expansion by standardizing medication costs, which can reduce R&D funding and impact business growth[2][5].

Key Takeaways

• The leuprolide acetate market, including Lupron, is expected to grow significantly due to the increasing prevalence of cancer and the growing need for endometriosis treatment.
• The market is projected to reach USD 3.5 billion by 2032 at a CAGR of 6% or USD 2,400 million by 2030 at a CAGR of 10.50%.
• Prefilled syringes are a dominant form due to their convenience and safety.
• The online pharmacy segment is gaining traction due to the convenience and anonymity it offers.
• Drug price-control policies pose a significant challenge to market growth.

FAQs

1. What is Lupron (Leuprolide Acetate) used for?

Lupron is used for the treatment of prostate cancer, endometriosis, uterine fibroids, and precocious puberty[2].

2. What is the projected market size of leuprolide acetate by 2032?

The market is projected to reach approximately USD 3.5 billion by 2032[2].

3. What are the main growth drivers for the leuprolide acetate market?

The main growth drivers include the increasing prevalence of cancer, the growing need for endometriosis treatment, and the demand for veterinary use[2][5].

4. How much does a typical dose of Lupron DEPOT cost?

The cost varies, but for example, a 7.5 mg/month intramuscular kit can cost around $2,161.94[2].

5. Are there any challenges facing the leuprolide acetate market?

Yes, strict drug price-control policies can hinder market expansion by reducing R&D funding and impacting business growth[2][5].

Citation

"Over 12 months, primary outcome event rates were projected to be 5.1% for degarelix and 10.2% for leuprolide," - Circulation: Journal of the American Heart Association[1].

Sources

1. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients ... - Circulation: Journal of the American Heart Association.
2. Pharmaceutical drug prices and trends for LUPRON DEPOT - DrugPatentWatch.
3. Prostate Cancer Therapeutics Market and Forecast 2024-2031 - iHealthcareAnalyst.
4. Leuprorelin-4002 | Clinical Trial Summary - ClinicalTrials.takeda.com.
5. Leuprolide Acetate Market Size & Share | Forecast Report 2037 - Research Nester.