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
End-Stage Renal Disease	1
Osteoarthritis, Hip	1
Femoro Acetabular Impingement	1
Pancytopenia	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
Czechia	1
Denmark	1
Poland	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
Charles Drew University of Medicine and Science	1

Sponsor Type

Sponsor Type for NANDROLONE DECANOATE
Sponsor	Trials
Other	12
NIH	4

Last updated: July 28, 2026

Nandrolone Decanoate Clinical Trials Update, Market Analysis, and Forecast (2026-2036)

Is nandrolone decanoate still in clinical trials?

No active, clearly identifiable late-stage (Phase 2/3) clinical development program for nandrolone decanoate is publicly confirmed as of the current search window. Publicly available trial registries and major oncology/rare-disease pipelines do not show a consistent, sponsor-attributable Phase 2 to Phase 3 roadmap for nandrolone decanoate specifically (rather than for nandrolone/related anabolic-androgenic steroid (AAS) compounds broadly).

What trial types have historically involved nandrolone decanoate?

Nandrolone decanoate has been studied historically across anabolic indications and off-label use patterns, often with older study designs and small cohorts. Current public records do not support an up-to-date, sponsor-driven late-stage program that would materially change market timing.

Why lack of recent Phase 2/3 matters commercially

For forecasting, the absence of identifiable late-stage activity means:

• Market demand is driven by existing commercial supply and regulatory availability by country rather than by new global launches.
• Any future growth is more likely to come from product life-cycle changes (formulation, dosing formats, branded supply continuity) and regulatory access shifts than from new clinical outcomes.

What is the current commercial market for nandrolone decanoate?

The market for nandrolone decanoate is best characterized as a regulated pharmaceutical AAS niche with significant dependence on:

• National approval status and controlled-substance scheduling,
• Import availability,
• Enforcement and diversion controls,
• Prescribing and compounding or repackaging activity depending on jurisdiction.

Demand drivers and constraints

Key demand drivers:

• Niche clinician use and continuing availability where approved.
• Veterinary and human use overlap in some regions, though regulatory paths diverge.

Key constraints:

• Tight controls in many jurisdictions as a controlled substance.
• Competition from other AAS ester options, testosterone formulations, and more modern hormone-related therapies depending on indication.
• Safety scrutiny (cardiovascular risk, androgenic effects) that affects prescriber willingness.

Pricing and revenue structure: branded versus generic dynamics

Nandrolone decanoate is typically a low-to-mid price generics market where supply continuity is more important than differentiation. Revenue is usually dominated by:

• Generic injectable supply,
• Contract manufacturing and regional distributors,
• Channel-based sales where specialty prescribing exists.

Where is nandrolone decanoate marketed and regulated globally?

Market access is fragmented by country due to:

• Licensing status and controlled-substance rules,
• Product availability via authorized marketing authorization holders or importation programs,
• National requirements for labeling, packaging, and reporting.

Global regulatory pattern

Nandrolone decanoate generally appears in markets where:

• It remains historically approved or has ongoing product approvals, and
• National drug control frameworks allow legal medical use.

In countries where it is unavailable, illegal distribution may exist but does not translate into legitimate pharmaceutical revenue and is not captured in standard forecast models.

How many units and what share does nandrolone decanoate have versus other anabolic androgenic steroids?

No credible, consistently audited public datasets exist to quantify global units or share for nandrolone decanoate with enough granularity to support a single-definitive market share percentage.

Competitive substitution landscape

Nandrolone decanoate competes with other:

• Long-ester nandrolone formulations (where available),
• Testosterone esters and other AAS with different pharmacokinetic profiles,
• Non-AAS anabolic regimens in certain indications (where standards of care exist).

Because AAS switching is common, forecasting must treat nandrolone decanoate as a supply-and-access business rather than a differentiated therapy business.

What is the exclusivity and patent position for nandrolone decanoate?

Nandrolone decanoate is an older, well-established molecule, and the commercial market typically reflects:

• Expired or near-expired composition-of-matter and early formulation IP,
• Remaining country-specific process/formulation or packaging IP that does not usually prevent generic competition at the active ingredient level.

Practical IP impact on market forecasting

For revenue projections, this implies:

• Limited long-duration brand protection,
• Pricing pressure from generics and multi-source supply,
• Lower probability of IP-driven “new entrant” lag effects.

What is the FDA status of nandrolone decanoate?

Nandrolone decanoate has historical presence as an anabolic steroid, but FDA availability for specific dosage forms varies by product and time period. Public FDA product listing status is not consistent enough across all markets to support a single-state “current approval” claim without a product-level Orange Book or FDA label reference.

Key forecast implication

If FDA or US-market supply is absent, US revenue is effectively zero. If supply exists through legacy or authorized products, revenue remains limited and supply driven.

Does nandrolone decanoate face Paragraph IV or ANDA litigation?

No broad, molecule-level ANDA Paragraph IV litigation pattern is reliably observable in public dockets for nandrolone decanoate akin to modern small-molecule branded blockbuster dynamics.

Why litigation data is thin for older AAS

• Generic entry is often not bottlenecked by active composition IP.
• Market access is constrained more by controlled-substance compliance than by patent-driven exclusivity fights.

What formulations are used and what delivery risks affect supply?

Nandrolone decanoate is administered as an injectable oil formulation (typical long-ester depot characteristics). Main supply and risk factors:

• Sterile manufacturing and oil formulation consistency,
• Quality control for ester content, particle sizing, and sterility assurance,
• Controlled-substance storage, distribution, and chain-of-custody requirements.

Technical subtopics that affect competitiveness

• Concentration and injection volume limits per vial.
• Stability data for oil formulations.
• Needle compatibility and user training requirements for depots.

Market projection (2026-2036): base case, bull case, bear case

Given the lack of identifiable late-stage clinical development and the typical AAS market structure, projections should be framed around supply continuity and regulatory access rather than on new clinical adoption.

Base case (most likely): low-growth, supply-led

• Modest global demand stability with periodic supply disruptions in certain geographies.
• Pricing pressure from multi-source generics keeps margins constrained.

Bear case: regulatory tightening or substitution

• Stricter enforcement or scheduling changes reduces prescriber access.
• Continued substitution by other injectable AAS and non-AAS anabolic regimens in select indications.

Bull case: localized access expansions and stable supply

• Improved authorized supply in regulated markets increases legal prescribing.
• Fewer distribution disruptions increase fill rates and reduce stockouts.

Quantification needed for investment decisions

No auditable dataset is available in this response to quantify:

• Current global nandrolone decanoate sales,
• Unit volume baselines,
• Country-level approval and market size inputs,
• Historical growth rates that can be verified against authoritative sources.

For business planning, treat this as a qualitative forecast unless sales baselines are sourced from paid commercial datasets.

What clinical trial updates could change the market outlook next?

A market inflection would require one of the following:

• A credible sponsor-led Phase 2/3 program with a defined, medically reimbursable indication and clear endpoints,
• A regulatory re-evaluation that expands access in major markets,
• A differentiated formulation with improved safety or compliance that supports broader prescribing.

No such pipeline signal is confirmed in publicly visible late-stage development records for nandrolone decanoate.

Key risks in market entry, licensing, or manufacturing of nandrolone decanoate

• Controlled-substance licensing and supply chain compliance costs.
• Sterile injectables regulatory burden and batch release time.
• Channel risk: distributors may restrict inventory due to diversion concerns.
• Patient safety and pharmacovigilance obligations, including signal management.
• Product recalls and sterility/quality events have outsized revenue impact in small markets.

How does nandrolone decanoate compare with related AAS on market dynamics?

Nandrolone decanoate’s market behavior typically resembles:

• Other depot injectable AAS: concentrated to regions with legal prescribing.
• Similar low differentiation and strong generic supply effects.

Differences tend to be:

• Product-specific availability and concentration formats,
• Local approval status persistence,
• Prescriber preference for ester half-life profiles.

Key Takeaways

• Nandrolone decanoate does not show publicly confirmed late-stage clinical development that would drive a near-term adoption cycle.
• The commercial market is best modeled as a regulated, controlled-substance injectable AAS supply business with fragmented geographic access.
• Forecasts should focus on authorized availability, pricing pressure from generics, and distribution continuity rather than on new clinical data.
• Quantitative revenue projection requires audited sales baselines and country-level approval/access mapping that are not included in the available dataset underpinning this response.

FAQs

1) What is the difference between nandrolone decanoate and other nandrolone esters for market adoption?
Market adoption shifts mainly with local availability, dosing preferences, and prescriber familiarity tied to ester pharmacokinetics, not with new clinical differentiation.

2) Can nandrolone decanoate be substituted by testosterone esters in practice?
Yes, substitution is common where prescribing patterns favor alternative depots, especially when access or availability changes.

3) Are safety concerns a major determinant of legal market volume for nandrolone decanoate?
Yes. Safety scrutiny affects prescribing behavior and regulatory tolerance for distribution and promotion.

4) Does manufacturing quality risk affect supply more than patent risk?
For older injectable AAS products, yes. Batch release, sterility assurance, and controlled-substance logistics often matter more than patent barriers.

5) What would be the fastest regulatory change that could expand nandrolone decanoate sales?
A country-level approval/access expansion for authorized products or a reduction in prescription restrictions, assuming supply continuity.

References

1. U.S. Food and Drug Administration. Orange Book and drug approvals databases. (accessed via FDA resources).
2. ClinicalTrials.gov. Public trial registry entries related to nandrolone/nandrolone decanoate. (accessed via ClinicalTrials.gov).
3. European Medicines Agency. Public assessment and substance-related resources for anabolic agents. (accessed via EMA resources).