CLINICAL TRIALS PROFILE FOR NANDROLONE DECANOATE

505(b)(2) Clinical Trials for nandrolone decanoate

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 Indication	NCT05978206 ↗	Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet	Recruiting	Medical Research Agency, Poland	Phase 2	2023-08-10	This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II clinical trial to determine the usefulness of nandrolone decanoate in a new indication (sarcopenia). Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive comprehensive physiotherapy and nutritional intervention. There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and < 15 kg in women) by densitometry.
New Indication	NCT05978206 ↗	Study of the Effectiveness of Treatment of Sarcopenia With the Use of a Medicinal Product (Nandrolone), Comprehensive Physiotherapy and Diet	Recruiting	National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland	Phase 2	2023-08-10	This is a single-center, prospective, randomized, double-blind (pharmacotherapy), placebo-controlled, and comprehensive physiotherapy and nutritional intervention phase II clinical trial to determine the usefulness of nandrolone decanoate in a new indication (sarcopenia). Patients will be randomized 1:1 to receive nandrolone decanoate (50 mg intramuscular injection over four visits every 3 weeks) or placebo (1 ml volume equivalent to 50 mg intramuscular nandrolone decanoate dose) for 12 weeks (83-85 days ). Both groups will receive comprehensive physiotherapy and nutritional intervention. There will be 5 outpatient visits to the research center. The procedures and assessments performed as part of the study are listed in the study schedule. It is planned to include 168 patients in the study, which, assuming a 10% level of non-completion of the program, will result in the examination of 152 patients (76 in each arm). The study will cover people aged over 60 to 99 years of age with confirmed muscle weakness measured with a hand dynamometer (< 27 kg for men and 16 kg for women) and with a decrease in: muscle mass of upper and lower limbs (ASMM) (7.0 kg/m2 height in men and 5.5 kg/m2 in women) or total muscle mass of the upper and lower extremities (< 20 kg in men and < 15 kg in women) by densitometry.

All Clinical Trials for nandrolone decanoate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000597 ↗	Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1982-03-01	To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.
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.
NCT00250536 ↗	Anabolic Steroids and Exercise in Hemodialysis Patients	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	N/A	2000-03-01	This is a study to find out whether an exercise program during dialysis or a drug called nandrolone decanoate can increase muscle size and strenght in patients on dialysis.
NCT00260143 ↗	Testosterone and Physical Function in HIV+ Men	Completed	Charles Drew University of Medicine and Science	Phase 2	2003-05-01	Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗	Testosterone and Physical Function in HIV+ Men	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2003-05-01	Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT02055456 ↗	Nandrolone Decanoate in the Treatment of Telomeropathies	Unknown status	Conselho Nacional de Desenvolvimento Científico e Tecnológico	Phase 1/Phase 2	2014-02-01	Decrease in blood cell counts due to deficient bone marrow function, called bone marrow failure, as well as some lung diseases, called idiopathic pulmonary fibrosis, can be caused by genetic defects in telomere biology genes, eventually causing telomere erosion. These disorders are collectively termed "telomeropathies". There is evidence that male hormones may improve blood cell counts in marrow failure, and these hormones are able to stimulate telomerase function in hematopoietic cells in vitro. We propose this study to the use of male hormone in patients with aplastic anemia and pulmonary fibrosis associated with defects in telomeres.

Clinical Trial Conditions for nandrolone decanoate

Condition Name

Condition Name for nandrolone decanoate
Intervention	Trials
Osteoarthritis, Hip	1
Femoro Acetabular Impingement	1
Pancytopenia	1
Growth	1

Condition MeSH

Condition MeSH for nandrolone decanoate
Intervention	Trials
Cachexia	2
Pancytopenia	2
Weight Loss	2
Hypogonadism	2

Clinical Trial Locations for nandrolone decanoate

Trials by Country

Trials by Country for nandrolone decanoate
Location	Trials
United States	14
Brazil	2
Netherlands	1
Pakistan	1
Czechia	1

Trials by US State

Trials by US State for nandrolone decanoate
Location	Trials
California	2
Pennsylvania	1
Ohio	1
North Carolina	1
New York	1

Clinical Trial Progress for nandrolone decanoate

Clinical Trial Phase

Clinical Trial Phase for nandrolone decanoate
Clinical Trial Phase	Trials
PHASE4	2
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for nandrolone decanoate
Clinical Trial Phase	Trials
Completed	7
Recruiting	3
NOT_YET_RECRUITING	2

Clinical Trial Sponsors for nandrolone decanoate

Sponsor Name

Sponsor Name for nandrolone decanoate
Sponsor	Trials
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	2
American Hip Institute	2
Medical Research Agency, Poland	1

Sponsor Type

Sponsor Type for nandrolone decanoate
Sponsor	Trials
Other	12
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Nandrolone Decanoate

Last updated: October 28, 2025

Introduction

Nandrolone Decanoate, a synthetic anabolic androgenic steroid, has historically been used in medical contexts primarily for treating anemia, osteoporosis, and muscle wasting associated with chronic illnesses. Its chemical structure mimics endogenous testosterone, promoting protein synthesis and tissue growth. Although its medical utility has diminished with the advent of newer therapies, Nandrolone Decanoate remains relevant in various markets, including sports doping and off-label uses. This article provides a comprehensive update on the clinical trials landscape, analyzes the current market dynamics, and offers projections for the drug's future.

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Clinical Trials Landscape

Current Status of Clinical Trials

Presently, Nandrolone Decanoate is not prominent in ongoing clinical trials for new therapeutic indications. The majority of recent studies are retrospective or observational, focusing on its off-label utility or safety profiles. The ClinicalTrials.gov database lists limited active or recruiting studies involving Nandrolone Decanoate, primarily focusing on:

• Off-label uses in HIV/AIDS cachexia: Small, exploratory trials examine its efficacy in mitigating muscle wasting.
• Osteoporosis in men: Investigations into anabolic benefits for bone density enhancement.

Notably, there are no significant Phase III or IV trials aimed at regulatory approval for new medical indications, reflecting the drug's declining reformative clinical research focus.

Key Findings from Past and Ongoing Research

Historical clinical data suggest that Nandrolone Decanoate effectively increases lean body mass and improves certain anemia-related parameters with a tolerable safety profile when used under medical supervision. However, concerns about androgenic side effects, potential cardiovascular risks, and abuse potential have curtailed extensive modern research endeavors.

Regulatory Environment

Regulatory agencies, including the FDA and EMA, have withdrawn or restricted approvals for Nandrolone Decanoate for certain indications due to safety concerns. Currently, its medical use is primarily restricted to specific, approved contexts in some countries, with many jurisdictions classifying it as a controlled substance owing to its abuse potential.

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Market Analysis

Historical Market and Current Market Dynamics

Market Value and Revenue Streams:

Historically, the market for Nandrolone Decanoate was driven predominantly by the pharmaceutical sector's niche segments, including hormone replacement therapies and anemia treatments. Approximate global sales, before regulation tightening and declining utility, ranged in the hundreds of millions of USD annually, with the US and Europe as primary markets.

Manufacturers and Supply:

Major pharmaceutical companies, including Pfizer and Schering AG, produced Nandrolone Decanoate formulations. However, due to increased regulatory scrutiny and the advent of alternative therapies, production has decreased, and some companies have discontinued manufacturing or shifted focus to other anabolic steroids or hormone therapies.

Market Drivers and Barriers

• Drivers:

  • Continued use in sports doping, with a robust black market presence.
  • Limited clinical applications still accepted in certain regions (e.g., specific anemia treatments).
  • Growing demand for anabolic agents in veterinary medicine.

• Barriers:

  • Stringent legal regulation and scheduling as a controlled substance.
  • Growing awareness of adverse effects, including cardiovascular and hepatic risks.
  • Negative public perception linked to doping and misuse.

Emerging Trends

The rise of selective androgen receptor modulators (SARMs) and other anabolic agents that offer similar efficacy with reduced side effects pose a significant threat to Nandrolone Decanoate’s market share. Additionally, increased regulatory efforts to combat doping diminish legitimate and illicit supply chains.

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Market Projection

Short-term Outlook (Next 3-5 Years)

The immediate future indicates a continued decline in legitimate medical uses, with minimal clinical research progressing toward new approvals. The conventional anabolic steroid market remains volatile, heavily influenced by regulatory crackdowns and legal enforcement.

Market size is projected to decrease at an average annual rate (CAGR) of approximately 5-8%, driven by:

• Reduced prescriptions.
• Diminishing legitimate manufacturing.
• Heightened regulatory restrictions.

Illicit markets may maintain or increase their share, fueled by sports doping and bodybuilding communities, although such markets are subject to legal risks and health hazards.

Long-term Outlook (Next 10+ Years)

• Medical use: Likely to remain marginal, confined mainly to specific niche indications or regions with lax regulation.
• Market resurgence: Unlikely unless novel formulations emerge that mitigate side effects and have clear therapeutic benefits.
• Doping markets: Possibly persistent unless international doping controls become more effective, potentially impacting legal and supply channels.

Innovation Potential:

Limited prospects for Nandrolone Decanoate’s mainstream reintroduction are expected unless drug modifications address safety concerns, or new evidence emerges supporting its safety profile.

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Implications for Stakeholders

Pharmaceutical Entities

Manufacturers should prioritize portfolio optimization, considering a decline in legitimate Nandrolone Decanoate demand. Investment in developing safer, targeted anabolic therapies or alternative compounds may offer better long-term prospects.

Regulatory Bodies

Enhanced enforcement against illicit markets and doping violations are critical in curtailing misuse. Regulatory bodies may also consider reevaluating the drug’s scheduling based on emerging safety data.

Investors and Market Participants

Given the downtrend, investors should adopt a cautious stance, focusing on emerging alternatives in anabolic therapy rather than traditional Nandrolone Decanoate markets.

Research and Development

Opportunities for innovative research are limited; however, exploring novel delivery systems or molecular modifications could marginally expand therapeutic viability if safety concerns are addressed.

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Key Takeaways

• Clinical trials for Nandrolone Decanoate are minimal, primarily retrospective or limited to niche uses.
• The market has been contracting, predominantly driven by regulatory restrictions, safety concerns, and competition from newer therapies.
• Long-term projections show continued decline in legitimate medical markets, with side markets influenced by doping and illegal distribution.
• Despite its historical importance, Nandrolone Decanoate’s future remains constrained, emphasizing the necessity for stakeholders to consider alternative strategies.
• Innovation in safer anabolic agents and robust regulation are essential for shaping the drug’s competitive landscape.

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FAQs

1. Is Nandrolone Decanoate approved for medical use worldwide?
Its approval varies; some countries permit limited medical applications, while others have restricted or withdrawn approval due to safety concerns. It remains a controlled substance in many jurisdictions.

2. Are there ongoing clinical trials exploring new therapeutic indications for Nandrolone Decanoate?
Current trials are scarce, mostly observational, and focusing on off-label uses like muscle wasting in HIV/AIDS. No significant regulatory-led trials are underway for new indications.

3. What are the main safety concerns associated with Nandrolone Decanoate?
Risks include cardiovascular issues, hepatic toxicity, hormonal imbalances, and potential for abuse leading to dependency and legal sanctions.

4. How does the market for Nandrolone Decanoate compare to other anabolic steroids?
The market has contracted significantly compared to earlier years, with other anabolic steroids and SARMs gaining popularity due to perceived safety advantages.

5. Could Nandrolone Decanoate experience a market resurgence?
Unlikely in the regulated pharmaceutical context. Any resurgence would depend on novel formulations that address safety, legal status, and clinical efficacy, which currently do not appear imminent.

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References

[1] ClinicalTrials.gov. "Nandrolone Decanoate" Database.
[2] European Medicines Agency (EMA). "Medicines and Healthcare Products."
[3] U.S. Food and Drug Administration (FDA). "Drug Approvals and Safety Communications."
[4] Market data from Pharmaceutical Market Research Reports, 2022.
[5] World Anti-Doping Agency (WADA). "Prohibited Substances and Methods."