CLINICAL TRIALS PROFILE FOR LUPRON DEPOT-PED

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

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

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.

Clinical Trial Conditions for LUPRON DEPOT-PED

Condition Name

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

Condition MeSH

Condition MeSH for LUPRON DEPOT-PED
Intervention	Trials
Prostatic Neoplasms	73
Adenocarcinoma	19
Infertility	7
Syndrome	6

Clinical Trial Locations for LUPRON DEPOT-PED

Trials by Country

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

Clinical Trial Progress for LUPRON DEPOT-PED

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for LUPRON DEPOT-PED

Sponsor Name

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

Last updated: April 28, 2026

Lupron Depot-Ped (leuprolide acetate) — Clinical Trials Update, Market Analysis, and 3-Year Projection

Lupron Depot-Ped is a long-acting, injectable gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of central precocious puberty (CPP) in pediatric patients (classically in girls; label details vary by market and formulation). The product competes in a pediatric CPP market where dosing schedules, injection burden, payer coverage, and total cost of therapy drive demand.

This market is dominated by established brands, with competitive pressure tied to (1) duration of effect, (2) site-of-care economics, and (3) formulary position rather than pure molecular differentiation.

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What is the current clinical development status for Lupron Depot-Ped?

No new, publicly identifiable late-stage (Phase 3) registrational program for Lupron Depot-Ped was found in the major trial registries at the time of this update. Available evidence for current market supply and uptake rests on the already-approved CPP indications and the ongoing use of long-acting leuprolide formulations across pediatric endocrine practice.

What is observable in the public trial record for this class/product

• Lupron Depot-type pediatric use has historically been supported by earlier pivotal studies leading to approval.
• Current activity in registries for “leuprolide acetate” in CPP frequently includes: pediatric endocrine cohorts, observational studies, dosing schedule comparisons, and real-world evidence rather than new Phase 3 registration.

Implication for R&D and forecasting

• The near-term commercial trajectory is driven by label maintenance, manufacturing continuity, and payer contracting.
• Competitive dynamics will center on existing branded and authorized alternatives, not rapid pipeline replacement.

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How big is the Lupron Depot-Ped addressable market?

Addressable population (macro)

Demand for pediatric CPP therapeutics tracks with:

• Incidence of CPP in the relevant pediatric age band
• Proportion of patients who receive medical evaluation and treatment
• Treatment persistence due to typical multi-year therapy

A meaningful driver is the screening and referral pathway in pediatric endocrinology, with treatment adoption influenced by diagnostic criteria, imaging practice, and regional clinical guideline adoption.

Commercial demand (where revenue comes from)

For long-acting CPP injectables, payer and provider behavior drives unit volume:

• Dosing cadence (monthly to longer intervals depending on formulation)
• Injection administration burden in outpatient/clinic settings
• Formulary placement and rebate positioning
• Site-of-care contracting (clinic buy-and-bill economics versus pharmacy benefit pathways where applicable)

Market reality: revenue is less about incremental clinical differentiation and more about the ability to maintain payer access across large and regional accounts.

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Who competes with Lupron Depot-Ped, and how do they win?

Competitive set in pediatric CPP (typical)

Key competitor categories include:

• Other long-acting GnRH agonists (leuprolide variants; triptorelin; goserelin and related depot products depending on geography)
• GnRH antagonists (where authorized for CPP in specific markets)

How competitors win

• Higher duration per injection: fewer visits, lower total administration cost
• Formulary position: managed care access, step edits, prior authorization simplification
• Patient access programs: co-pay support and contract coverage
• Switch flexibility: ability for clinicians to transition patients among depot options

Lupron Depot-Ped-specific competitiveness

• Strength comes from brand tenure, established clinical trust, and payer contracting maturity.
• Risk comes from any shift toward longer-interval analogs or antagonists with improved administration economics where reimbursement favors them.

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What is the market outlook for pediatric CPP injectables through 2028?

Base-case demand drivers

• Continued diagnosis and treatment of CPP in eligible pediatric patients
• Ongoing guideline use and pediatric endocrine referral pathways
• Substitution that follows injection economics and payer access

Base-case downside risks

• Payer tightening, including more restrictive prior authorization and preferential contracting
• Pricing pressure via formulary repositioning and biosimilar-like dynamics (where manufacturers pursue competitive pricing rather than new endpoints)
• Safety or adherence-related switching within depot classes (clinic practice variance)

Base-case upside factors

• Expanded clinical adoption in secondary centers
• Contract wins that reduce patient out-of-pocket barriers
• Any incremental label/regimen clarity that reduces administrative friction

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3-Year projection: unit demand and revenue trajectory

Projection framework

A production-grade projection requires:

• Country-level unit forecasts for pediatric CPP treated patients
• Depot share by interval frequency
• Net pricing assumptions reflecting rebates, discounts, and payer contract outcomes

This update is restricted to publicly verifiable baseline facts and does not introduce speculative trial endpoints. As a result, the projection is framed as a directional forecast anchored on market structure: mature product, stable share, and competitive substitution risk.

Projection (directional)

• Year 1 (2026): low-to-mid single digit growth driven by underlying treated population and incremental access in contracted networks
• Year 2 (2027): growth slows as competition and payer preference intensify
• Year 3 (2028): stabilizes; upside depends on contract durability and interval advantage of competitors versus any uptake of antagonists where reimbursed

Directional revenue outlook (global, product-equivalent basis):

• 2026: +2% to +6%
• 2027: +1% to +4%
• 2028: -1% to +3%

Share shift expectations

• Depot class competition likely pulls incremental patients toward the most convenient interval where reimbursement supports it.
• If GnRH antagonists expand in the authorized markets, some share dilution from agonist depots is possible, but the magnitude depends on payer coverage and clinician conversion behavior.

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Patent and market exclusivity posture (commercial risk lens)

Lupron Depot (leuprolide acetate) is a mature brand with established lifecycle management. The pediatric-specific “Lupron Depot-Ped” labeling sits within broader leuprolide portfolio protection and manufacturing/trade dress realities, but the decisive foreclosure period for follow-on entrants depends on:

• Country-by-country patent landscape for leuprolide depot formulations
• Composition of matter and use-related claims
• Formulation and method-of-use coverage
• Regulatory exclusivity and brand-specific lifecycle patents
• Litigation outcomes if any, and the timing of generic or authorized follow-on depot launches in each market

Given the mature market, the near-term competitive pressure is typically less about legal entry and more about contracting, pricing strategy, and therapy selection protocols.

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Where are the biggest commercial levers for investors and R&D leaders?

1) Payer contracting and net price

• Depot injectables are highly rebate and contract sensitive.
• Net price stability depends on formulary placement and step-edit complexity.

2) Clinical switching rules

• Clinicians switch across depot analogs based on interval preference, tolerability, and access.
• Antagonists, where reimbursed and authorized, can change the switching baseline.

3) Site-of-care economics

• Buy-and-bill and outpatient administration costs influence payer decisions.
• Any shift in preferred setting (specialty pharmacy versus clinic administration) impacts total cost of therapy.

4) Manufacturing continuity

• Long-acting depots require robust supply chain execution.
• Any sustained supply disruption can create temporary share loss and delayed reimbursement correction.

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Key Takeaways

• Lupron Depot-Ped is a mature pediatric CPP therapy with no clear public late-stage registrational activity driving near-term label expansion.
• Market growth is expected to come from continued treated population expansion and incremental access, not from new clinical registrations.
• The main commercial variable over 2026 to 2028 is payer contracting and substitution toward more convenient CPP therapies, including longer interval depot options or antagonists where covered.
• Directional revenue outlook is modest growth through 2026, slowing in 2027, then stabilizing with low risk of decline by 2028 depending on contracting outcomes.

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FAQs

1. Is Lupron Depot-Ped currently in active Phase 3 clinical development?
   No new publicly identifiable Phase 3 registrational program was evident in major trial registries based on this update.

2. What drives demand more: incidence or payer access?
   Both matter, but payer access and formulary placement typically determine whether diagnosed patients convert to treated patients and persist on therapy.

3. What therapy changes most affect depot GnRH agonist share?
   Longer-interval alternatives and any GnRH antagonist penetration where reimbursement and authorization allow switching.

4. Does clinical evidence need to be generated before commercial impact?
   Not in a mature product category; clinical practice and payer contracting often drive near-term volume more than incremental evidence.

5. What is the most likely revenue pattern for 2026 to 2028?
   Low growth that slows over time, with stabilization by 2028 and a downside path if payer preference shifts or substitution accelerates.

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References (APA)

[1] ClinicalTrials.gov. (n.d.). Search results for leuprolide acetate central precocious puberty and related terms. https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. (n.d.). Drug approvals and label information for Lupron Depot and related leuprolide acetate products. https://www.accessdata.fda.gov/