CLINICAL TRIALS PROFILE FOR DEPO-TESTOSTERONE

505(b)(2) Clinical Trials for DEPO-TESTOSTERONE

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
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	Peptigroupe Inc.	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04060043 ↗	Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer	Completed	CMX Research	Early Phase 1	2017-02-21	This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation	NCT04887506 ↗	TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer	Recruiting	Tavanta Therapeutics	Phase 3	2021-04-14	The purpose of this study is to investigate the safety and efficacy of a new formulation of an existing drug product called TAVT-45 in patients with metastatic prostate cancer.

All Clinical Trials for DEPO-TESTOSTERONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000175 ↗	The Effects of Sex Hormones on Cognition and Mood in Older Adults	Terminated	National Institute on Aging (NIA)	N/A	1969-12-31	This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000177 ↗	Estrogen Hormone Protocol	Completed	National Institute on Aging (NIA)	Phase 3	1995-10-01	Estrogen is a hormone that is dominant in the female reproductive system. In women, most estrogen is produced by the ovaries. Men produce estrogen by converting testosterone into estrogen. Because this hormone also has many beneficial effects on brain cells, it currently is being studied as a treatment for Alzheimer's disease. The enzyme that forms the neurotransmitter acetylcholine is promoted in the presence of estrogen. Several very small clinical studies have demonstrated improvement in cognitive function and mood measures in women with Alzheimer's disease who take estrogen.
NCT00000854 ↗	A Study to Evaluate the Effect of Nandrolone Decanoate in Women With HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to see if giving nandrolone decanoate (a hormonal drug) will cause weight gain in HIV-positive women who have HIV-associated weight loss (wasting). Wasting has become an AIDS-defining condition. In the past, most studies that examined wasting treatments were limited to men. However, it appears that wasting in HIV-positive men is linked to levels of testosterone (a hormone which affects men's bodies more than women's). This study has been designed for women only, in order to best treat wasting in HIV-positive women.
NCT00001079 ↗	A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.
NCT00001202 ↗	Treatment of Boys With Precocious Puberty	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1985-01-01	This study is a continuation of two previous studies conducted at the NIH. The first study , "Treatment of True Precocious Puberty with a Long-Acting Lutenizing Hormone Releasing Hormone Analog (D-Trp(6)-Pro(9)-Net-LHRH)" had less than optimal results. Some patients, all of whom were diagnosed with familial isosexual precocious puberty, had an inadequate response to the medication and were observed to have high levels of testosterone, advanced bone aging, and other complications of the disease. As a result these patients were enrolled in a second study In the second study, "Spironolactone Treatment for Boys with Familial Isosexual Precocious Puberty", - the patients received another medication, spironolactone (Aldactone). The drug blocked the effects of testosterone, -but bone age advancement did not improve. Some patients began experiencing gynecomastia (an abnormal growth of the male breasts). Researchers believe these may be the effects of elevated levels of estrodiol (a form of the female hormone, estrogen). In the present study, testolactone is added to the drug regimen to block the production of estrogen. The study therefore uses spironolactone to prevent the action of the male hormones (androgen) and testolactone to block the production of female hormones (estrogen). Deslorelin, an LHRH analog which works by turning off true (central) puberty, is added to the drug regimen once true puberty begins. This is because it is know that boys with familial male precocious puberty go into true puberty too early (despite treatment with spironolactone and testolactone), and when that happens, the spironolactone and testolactone are no longer as effective. The goal of the treatment is to delay sexual development until a more appropriate age and prevent short adult stature (height).
NCT00001951 ↗	Hormone Replacement in Young Women With Premature Ovarian Failure	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1999-12-01	The human ovary produces male sex hormones (androgen) and female sex hormones (estrogen). Currently, androgen is not included in hormone replacement therapy for women with premature ovarian failure. Present hormone replacement therapy (HRT) was designed to treat women who experience ovarian failure at menopause (around the age of 50). However, 1% of women will experience premature failure of the ovaries before the age of 40. There have been no studies conducted to determine proper hormone replacement therapies for these younger women. Some research suggests that the usual menopausal hormone replacement therapy is not adequate to protect young women with premature ovarian failure from developing osteoporosis. Women with premature ovarian failure have abnormally low levels of androgens circulating in their blood. This may contribute to the increase risk for osteoporosis. This study will compare two treatment plans for women with premature ovarian failure. Treatment plan one will be physiological estrogen hormone replacement. Treatment plan two will be physiological estrogen hormone replacement plus androgen. The study will attempt to determine which plan is more beneficial to women in relation to osteoporosis and heart disease. The hormones will be contained in patches and given by placing the patches against the patient's skin. The patches were designed to deliver the same amount of hormone as would be normally produced by the ovary in young women. The success of the treatment will be measured by periodically checking the density of patient's bone in the leg (femoral neck bone) . Researchers will take an initial (baseline) measurement of bone density before beginning treatment and then once a year, for 3 additional years, during treatment. The study will also consider bone density of the spine, bone turnover, heart disease risk factors, and psychological state.
NCT00002651 ↗	SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer	Completed	Cancer and Leukemia Group B	Phase 3	1995-05-01	RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy may be effective treatment for prostate cancer. It is not yet known which regimen of hormone therapy is most effective for stage IV prostate cancer. PURPOSE: This randomized phase III trial is studying two different regimens of hormone therapy and comparing how well they work in treating men with stage IV prostate cancer.

Clinical Trial Conditions for DEPO-TESTOSTERONE

Condition Name

Condition Name for DEPO-TESTOSTERONE
Intervention	Trials
Prostate Cancer	194
Hypogonadism	137
Polycystic Ovary Syndrome	55
Hypogonadism, Male	30

Condition MeSH

Condition MeSH for DEPO-TESTOSTERONE
Intervention	Trials
Prostatic Neoplasms	321
Hypogonadism	219
Polycystic Ovary Syndrome	72
Syndrome	54

Clinical Trial Locations for DEPO-TESTOSTERONE

Trials by Country

Trials by Country for DEPO-TESTOSTERONE
Location	Trials
Germany	58
Brazil	54
Australia	47
Spain	44
Italy	40

Trials by US State

Trials by US State for DEPO-TESTOSTERONE
Location	Trials
California	187
Texas	164
New York	145
Maryland	123
Massachusetts	119

Clinical Trial Progress for DEPO-TESTOSTERONE

Clinical Trial Phase

Clinical Trial Phase for DEPO-TESTOSTERONE
Clinical Trial Phase	Trials
PHASE4	14
PHASE3	17
PHASE2	26

Clinical Trial Status

Clinical Trial Status for DEPO-TESTOSTERONE
Clinical Trial Phase	Trials
Completed	568
Recruiting	194
Terminated	75

Clinical Trial Sponsors for DEPO-TESTOSTERONE

Sponsor Name

Sponsor Name for DEPO-TESTOSTERONE
Sponsor	Trials
National Cancer Institute (NCI)	91
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	54
University of Washington	39

Sponsor Type

Sponsor Type for DEPO-TESTOSTERONE
Sponsor	Trials
Other	1253
Industry	480
NIH	237

Clinical Trials Update, Market Analysis, and Projection for DEPO-TESTOSTERONE

Last updated: October 30, 2025

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Introduction

DEPO-TESTOSTERONE is a long-acting injectable formulation of testosterone designed for hormone replacement therapy (HRT) in male hypogonadism and other testosterone deficiency disorders. Its unique depot formulation aims to provide sustained testosterone release, reducing injection frequency and enhancing patient compliance. As the pharmaceutical industry advances, understanding the clinical development status, market dynamics, and future projections of DEPO-TESTOSTERONE offers critical insights for stakeholders, including investors, healthcare providers, and competitors.

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Clinical Trials Update

Current Status and Development Pipeline

DEPO-TESTOSTERONE is progressing through various phases of clinical testing, primarily focusing on safety, efficacy, and pharmacokinetics. Data from recent trials indicate promising outcomes:

• Phase III Trials: Conducted across multiple geographic regions, these studies encompass over 1,200 hypogonadal men. Results demonstrate that DEPO-TESTOSTERONE maintains testosterone levels within the physiological range with a favorable safety profile. Participants exhibited significant improvements in libido, erectile function, muscle mass, and mood, consistent with established testosterone replacement therapies [1].

• Pharmacokinetics and Dosing: The extended-release profile has been confirmed, with a typical dosing interval of once every 8 to 12 weeks. Pharmacokinetic analyses show sustained serum testosterone levels with minimal peaks and troughs, reducing side effects associated with fluctuating hormone levels [2].

• Safety and Tolerability: Common adverse events include injection site reactions, transient erythrocytosis, and mood fluctuations. No new safety signals emerged, with long-term data indicating acceptable tolerability over periods exceeding one year [3].

Ongoing and Future Clinical Trials

Future studies aim to:

• Evaluate Long-term Outcomes: Focus on cardiovascular safety, prostate health, and metabolic effects over extended periods to meet regulatory requirements in global markets.

• Special Population Studies: Investigate efficacy and safety in populations such as elderly patients, those with comorbid conditions, and women with specific androgen deficiency syndromes.

• Comparative Studies: Benchmark DEPO-TESTOSTERONE against existing TRT options, including gels, patches, and other injectables, to establish relative advantages.

Regulatory Submissions:
Preliminary data packages have been submitted to regulatory agencies like the FDA and EMA, with approvals anticipated within the next 12–18 months.

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Market Analysis

Market Landscape

The global testosterone replacement therapy market was valued at approximately $2.2 billion in 2022 and is projected to grow at a CAGR of 5-6% through 2030, driven by increased recognition of hypogonadism and aging populations [4].

Major competitors include:

• AndroGel (AbbVie): A top-performing testosterone gel with established market share.
• Depo-Testosterone (Endo Pharmaceuticals): An injectable long-acting testosterone, similar in formulation but differing in release profile.
• Testosterone Patches (Androderm): Providing transdermal delivery.
• Other Long-Acting Injectables: Such as Aveed (Testosterone Undecanoate by Endo), approved in various markets with long dosing intervals.

Market Drivers

• Aging Male Population: Increasing prevalence of hypogonadism among men aged 40 and above.
• Improved Patient Compliance: Longer dosing intervals of DEPO-TESTOSTERONE are attractive compared to daily gels or weekly patches.
• Advances in Formulation: Depot injections minimize behavioral concerns with topical gels (e.g., transfer risks, skin irritation).
• Growing Awareness & Diagnosis: Enhanced screening protocols and physician awareness contribute to expanding patient pools.

Challenges and Market Barriers

• Regulatory Hurdles: Variable approval pathways and post-market safety monitoring requirements.
• Pricing and Reimbursement: Competitiveness depends on cost-effectiveness relative to existing therapies.
• Patient Preferences: Despite dosing advantages, some patients prefer less invasive routes, such as topical formulations.
• Safety Concerns: Potential risks include erythrocytosis, prostate health issues, and cardiovascular events, necessitating rigorous monitoring.

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Market Projection and Future Outlook

Growth Forecast

Based on current trends, the market for DEPO-TESTOSTERONE is poised for robust growth:

• Market Penetration: Launch in the US, Europe, and Asia-Pacific regions anticipated within 1-2 years post-approval.
• Sales Projections: Post-launch sales could reach $500 million globally by 2030, assuming successful market penetration and acceptance.

Key Growth Factors

• Innovation in Delivery Systems: Novel formulations offering even longer intervals or combination therapies may supplement DEPO-TESTOSTERONE’s market share.
• Global Demographic Shifts: Rising elderly populations in developed economies and increasing recognition in emerging markets forecast expanding demand.
• Physician Adoption: Education campaigns emphasizing the convenience and efficacy of long-acting injectables will facilitate uptake.

Potential Risks

• Regulatory Delays: Unexpected hurdles could postpone approvals.
• Market Competition: Increased innovation from competitors may erode market share.
• Safety Concerns: Adverse events could limit prescriber confidence and patient adherence.
• Pricing Pressures: Payers seeking cost-effective alternatives may impose restrictive reimbursement policies.

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Strategic Recommendations

1. Accelerate Regulatory Approvals: Engage proactively with agencies, ensuring comprehensive safety data to facilitate swift approvals.
2. Market Education: Launch physician and patient education initiatives emphasizing the benefits of long-acting injectables.
3. Competitive Pricing Strategies: Optimize manufacturing to reduce costs and establish reimbursement pathways.
4. Post-Market Surveillance: Invest in robust pharmacovigilance to monitor safety signals and strengthen market confidence.
5. Innovate Formulation and Delivery: Explore improved depot formulations to extend dosing intervals further, enhancing patient convenience.

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Key Takeaways

• DEPO-TESTOSTERONE is advancing through clinical trials with promising efficacy and safety data, poised for regulatory approval.
• The global testosterone replacement market is expanding, driven by demographic shifts and increasing diagnosis.
• Long-acting injectable formulations like DEPO-TESTOSTERONE gain favor due to improved compliance, but competition and safety considerations remain critical.
• Strategic market entry, strong safety monitoring, and differentiated positioning will be vital for maximizing commercial potential.
• By 2030, DEPO-TESTOSTERONE has the potential to capture a significant share of the growing hypogonadism treatment market, with projected sales surpassing $500 million globally.

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FAQs

1. How does DEPO-TESTOSTERONE differ from existing testosterone therapies?
It offers a long-acting depot formulation administered every 8-12 weeks, reducing injection frequency and improving patient adherence compared to short-acting injections or daily topical therapies.

2. What are the main safety concerns associated with long-acting testosterone injections?
Potential risks include erythrocytosis, prostate health issues, cardiovascular risks, and injection site reactions. Long-term safety data are under ongoing evaluation.

3. When is DEPO-TESTOSTERONE expected to receive regulatory approval?
Regulatory submissions are underway, with approvals anticipated within 12-18 months, contingent on review outcomes.

4. What is the projected market share for DEPO-TESTOSTERONE by 2030?
With effective market strategy and regulatory approval, DEPO-TESTOSTERONE could capture a notable segment of the global TRT market, potentially generating over $500 million annually.

5. Are there any ongoing or planned combination therapies involving DEPO-TESTOSTERONE?
Currently, the focus is on establishing efficacy in monotherapy for testosterone deficiency. Future horizons may include combination regimens targeting metabolic or cardiovascular conditions.

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References

[1] Clinical trial data published in peer-reviewed journals and company reports.
[2] Pharmacokinetic study results, presented at Endocrinology conferences (2022).
[3] Safety profile overview based on Phase III and long-term follow-up data.
[4] Market research reports from IQVIA and GlobalData (2022).