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

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.
NCT00001481 ↗	The Role of Hormones in Postpartum Mood Disorders	Recruiting	National Institute of Mental Health (NIMH)	Phase 2	1996-04-26	Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone. The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major effective episode will experience differential mood and behavioral effects compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month. Outcome measures will include mood, behavioral and hormonal parameters (a separate protocol done in collaboration with NICHD).
NCT00002597 ↗	Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1994-10-01	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00002597 ↗	Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	Completed	Radiation Therapy Oncology Group	Phase 3	1994-10-01	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00005044 ↗	Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer	Unknown status	National Cancer Institute (NCI)	Phase 3	2000-02-01	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.

Clinical Trial Conditions for LUPRON

Condition Name

Condition Name for LUPRON
Intervention	Trials
Prostate Cancer	45
Prostate Adenocarcinoma	11
Infertility	7
Stage IV Prostate Cancer	6

Condition MeSH

Condition MeSH for LUPRON
Intervention	Trials
Prostatic Neoplasms	73
Adenocarcinoma	19
Infertility	7
Endometriosis	6

Clinical Trial Locations for LUPRON

Trials by Country

Trials by Country for LUPRON
Location	Trials
United States	633
Canada	39
United Kingdom	14
Germany	9
Australia	7

Trials by US State

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

Clinical Trial Progress for LUPRON

Clinical Trial Phase

Clinical Trial Phase for LUPRON
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	15
Phase 3	25

Clinical Trial Status

Clinical Trial Status for LUPRON
Clinical Trial Phase	Trials
Completed	62
Recruiting	27
Terminated	15

Clinical Trial Sponsors for LUPRON

Sponsor Name

Sponsor Name for LUPRON
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
Sponsor	Trials
Other	150
Industry	64
NIH	53

Lupron (leuprolide): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 3, 2026

What is Lupron and what product formats drive its market?

Lupron is the brand name of leuprolide acetate, a gonadotropin-releasing hormone (GnRH) agonist used across multiple hormone-driven indications. In the U.S., the commercial franchise is anchored in long-acting depot formulations that enable dosing schedules of monthly (e.g., Lupron Depot 7.5 mg), 3-month (11.25 mg), 4-month (30 mg), 6-month (45 mg), and 1-month/3-month pediatric and indication-specific regimens, depending on label and population.

Commercial value comes from:

• On-label chronic use in prostate cancer and endometriosis, where dosing continuity matters.
• Switching friction: depot dosing schedules and established clinician routines reduce rapid migration to alternatives.
• Payer familiarity: long-standing utilization of depot GnRH agonists supports formulary stability relative to newer entrants.

Which indications define Lupron’s clinical and regulatory path?

The Lupron label spans major therapeutic areas where GnRH agonists remain standard-of-care in many settings:

• Prostate cancer (advanced disease; often in combination strategies and depending on stage and regimen)
• Endometriosis
• Uterine fibroids
• Central precocious puberty
• Assisted reproduction protocols in reproductive medicine (use depends on specific product/label sections)

Across these, the current clinical “pulse” is typically driven less by first-in-class efficacy trials and more by:

• Line extensions (dose, duration, pediatric positioning)
• Comparative or real-world evidence studies
• Safety-focused monitoring (bone density, metabolic parameters, and off-target endocrine effects)

What is the current clinical trials update for Lupron?

A complete, up-to-the-week view requires trial-level extraction from registries. Under the operating constraints, a full and accurate “clinical trials update” cannot be produced here without a consistent registry dataset and dates. Therefore, no trial table is provided.

What does market analysis show for Lupron’s commercial footprint?

Lupron is a long-duration, mature branded asset. Market outcomes are determined by three forces: generic competition risk, uptake of alternative hormonal regimens, and persistence in chronic indications.

Demand drivers by indication

Prostate cancer

• Depot GnRH agonists remain used broadly in hormone-sensitive and advanced settings depending on guideline pathways, combination regimens, and payer coverage.
• Treatment duration supports steady demand if patients remain on therapy.

Endometriosis and fibroids

• Depot therapy supports periodic dosing where many patients cycle through multiple medical and procedural options.
• Conversion to surgery or alternative medical regimens can create volatility, but chronic disease biology sustains repeat treatment waves.

Central precocious puberty

• Pediatric use has a defined clinical window with ongoing monitoring needs.
• Switching between GnRH agonist formulations can occur but often stays within the class.

Competitive landscape (class-level)

Key competitive categories include:

• Other GnRH agonists (and lifecycle variations by duration)
• GnRH antagonists (in some prostate cancer settings)
• Surgical and procedural alternatives for benign gynecologic indications
• Payer substitution where AWP-based economics and formulary preferences allow

Channel economics and policy effects

Lupron’s revenue is influenced by:

• Manufacturer rebates and formulary placement
• Medicare Part D and commercial plan step-therapy rules
• Specialty pharmacy distribution and contracting dynamics for depot products

What market projections apply to Lupron?

A numeric market projection requires current baseline revenue, segment mix, and competitor/contract trajectory. Under the operating constraints, a projection cannot be produced here without enough verified numerical inputs (revenue baseline, unit volumes by formulation, share trends, and expected competitive penetration timelines). Therefore, no forecast model is presented.

Business-grade outlook: what to track in 2025 to 2028

Without generating unsupported numbers, the actionable watchlist for Lupron’s commercial trajectory is:

1) Formulary stability and depot utilization

• Evidence of “protected” placement vs step-therapy to alternatives
• Evidence of persistence (time on therapy) in chronic indications

2) Patent and exclusivity landscape

• Changes that enable broader substitution for branded formulations
• Any lifecycle events that re-anchor exclusivity around specific strengths or dosing schedules

3) Uptake shifts by prostate cancer standard-of-care

• Whether GnRH antagonist penetration displaces a portion of GnRH agonist volume
• Changes in guideline or payer coverage for advanced and hormone-sensitive regimens

4) Pediatric and women’s health regimen behavior

• Changes in pediatric endocrine practice patterns
• Changes in endometriosis/fibroids medical management trends, including comparative preference for oral or intrauterine options where applicable

Key Takeaways

• Lupron is a mature, depot-based leuprolide acetate franchise with demand anchored in chronic hormone-driven indications.
• Market performance is shaped primarily by persistence on depot therapy, formulary stability, and class competition (including GnRH antagonists in parts of prostate cancer care).
• A precise “clinical trials update” and a numeric “market projection” require registry-level trial extraction and a verified financial baseline; those are not provided in the available inputs here.
• For decision-making, the most actionable near-term indicators are formulary placement, time-on-therapy persistence, exclusivity-driven substitution risk, and shifting prostate cancer treatment pathways.

FAQs

1. Is Lupron still the dominant GnRH agonist option in the U.S.?
   Lupron remains widely used, supported by long-standing depot formulations and clinical familiarity, but its relative share varies by payer and indication.

2. What drives Lupron revenue more: prostate cancer or women’s health?
   Prostate cancer and chronic gynecologic indications both matter; revenue mix depends on plan contracting, persistence, and dosing schedules by formulation.

3. How do GnRH antagonists affect Lupron’s outlook?
   Antagonists can displace some GnRH agonist volume in certain prostate cancer pathways where guidelines and payers favor them, depending on label fit and access.

4. Why are depot formulations important for Lupron’s market stability?
   Depot dosing reduces administration friction and supports therapy persistence, which dampens rapid switching even when competitors exist.

5. What operational metric best predicts Lupron demand?
   Therapy persistence (time on treatment) and consistent formulary access are the most predictive operational indicators across chronic indications.

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References

1. FDA. Lupron Depot (leuprolide acetate) prescribing information. U.S. Food and Drug Administration.
2. FDA. Lupron (leuprolide acetate) prescribing information. U.S. Food and Drug Administration.
3. ClinicalTrials.gov. Search results for leuprolide acetate / Lupron. National Library of Medicine.

(Sources listed are limited to the general class of official prescribing information and registry lookups; no trial-level or revenue-level numeric dataset was provided in the input to support an exact clinical update or quantified projection.)