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).

Clinical Trial Conditions for NANDROLONE DECANOATE

Condition Name

Condition Name for NANDROLONE DECANOATE
Intervention	Trials
Bone	1
HIV Wasting Syndrome	1
Bone Marrow Failure Syndromes	1
Idiopathic Pulmonary Fibrosis	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

Nandrolone Decanoate: Clinical-Development Status, Market Read-Through, and Revenue Projection

Last updated: April 26, 2026

What does the current clinical-trials landscape show for nandrolone decanoate?

Nandrolone decanoate (19-nortestosterone decanoate) is an approved androgenic anabolic steroid (AAS) active substance used in multiple indications, but it is not positioned today as a modern, label-expanding small-molecule biotech program. Trial activity in public registries is largely limited to (1) small investigator-led studies, (2) comparisons of anabolic androgenic steroids and related regimens, and (3) pharmacokinetic or pharmacodynamics work rather than late-stage pivotal programs intended for new regulatory endpoints.

Clinical trial visibility pattern (public record behavior)

• Low volume of contemporary Phase 3 registrations specifically for nandrolone decanoate.
• Intermittent registrable studies across years, often focusing on pharmacology, dosing, or clinical symptom measures rather than registrational endpoints.
• Geographic fragmentation: studies appear in different jurisdictions, with varying public registry completeness.

Implication for a business outlook

• A “new-label, Phase 3-to-registration” storyline for nandrolone decanoate has limited present-day support from late-stage trial infrastructure in public records.
• Near-term value capture is more consistent with generic/brand sustainment, formulation differentiation, and regulatory maintenance rather than incremental regulatory expansion driven by large pivotal trials.

What does the market look like for nandrolone decanoate today?

Nandrolone decanoate sells into markets where AAS demand is driven by three main channels:

1. Prescribed use in specific androgen-related or anabolic indications (where permitted by local approvals).
2. Off-label prescribing in oncology-supportive care or cachexia-adjacent practice in jurisdictions where clinician use exists.
3. Non-medical demand (sports performance and diversion), which creates supply volatility and regulatory pressure.

Market reality for nandrolone decanoate

• The molecule is mature, and supply tends to be dominated by generics and local branded generics depending on the country.
• Competitive dynamics are typically anchored on:
  • Availability and pricing of injectable depot formulations
  • Regulatory approvals for specific presentations (strength, pack size)
  • Import/export constraints and inspection enforcement
  • Controlled-substance classification and prescription gatekeeping rules

Supply chain constraint

• Depot injectables face distributor consolidation and inventory risk because demand is episodic and channel controls vary by country and by enforcement intensity.

How should revenue be modeled for nandrolone decanoate (base, downside, upside)?

Without assuming a new label, the revenue model should be built as a volume times net price framework where:

• Volume is driven by (a) treatable patient counts in approved indications and (b) prescribing practices plus diversion-driven demand.
• Net price declines over time in competitive generic markets, with resilience depending on supply tightness and enforcement.

Revenue drivers (what moves the line item)

• Country-level formulary and prescribing behavior
• Generic price erosion speed
• Regulatory enforcement intensity that affects diversion and supply availability
• Tender and hospital procurement in countries where androgen therapy is administered in clinical settings
• Depot injectable supply continuity (lead times, manufacturing capacity, and distribution licensing)

Projection framework (directional and decision-useful)

Because the molecule is mature and trial-led new approvals lack clear present-day late-stage support, projections should be anchored to:

• Market stability with modest growth tied to population-level patient needs
• Price erosion that partially offsets growth
• Risk scenarios that come from regulatory crackdowns and supply disruptions

3-scenario projection template (for internal forecasting use)

Use this as a modeling structure for business cases:

Scenario	Annual demand trend (units)	Net price trend	Primary reason
Downside	-3% to +1%	-2% to -6%	Faster generic price erosion plus tighter controls
Base	+1% to +4%	-1% to -3%	Stable prescribing mix and incremental supply availability
Upside	+4% to +8%	-0% to -2%	Supply constrained environment, fewer competitors, stable enforcement

What this means

• Even in an upside case, depot AAS economics tend to be volume-led with net price pressure as the counterweight.
• “Growth” generally reflects channel access and supply continuity, not label expansion.

Where do the highest-probability business opportunities cluster?

Given the mature status, the opportunity set is mostly operational and regulatory maintenance rather than innovation-led.

Formulation and product-lifecycle levers

• Presentation optimization: vial size, concentration, and pack configuration for procurement workflows
• Supply reliability: lead-time improvements and inventory depth for distributers
• Regulatory posture: ensuring ongoing manufacturing compliance and consistent product availability

Commercial levers

• Tender coverage and hospital access where depot androgen therapies are reimbursed or routine
• Country-specific distribution partnerships to reduce stocking risk

What are the key constraints and risks that should drive a go-to-market plan?

• Controlled substance classification: affects distribution licensing and pharmacy access.
• Regulatory enforcement variability: can rapidly change demand mechanics.
• Adverse-event and abuse risk: can trigger label tightening or supply restrictions.
• Switching risk: prescribers may switch to alternatives (other nandrolone esters or other AAS) when supply or pricing shifts.

Clinical-trials update: what does this imply for near-term development spend?

For nandrolone decanoate, the expected ROI profile for new clinical programs is constrained because:

• The active substance is already established.
• Public records do not show a clear late-stage pathway designed to create new regulatory endpoints in the near term.
• Most feasible studies would likely need to justify:
  • bioequivalence,
  • safety updates for particular populations,
  • or formulation bridging.

From a portfolio perspective, that typically points to:

• limited incremental clinical spend unless a specific jurisdiction requires it for a lifecycle change,
• and a greater emphasis on manufacturing compliance, distribution, and access.

Market projection summary: what to expect over the next 3 to 5 years

Given the maturity of nandrolone decanoate and typical generic-market behavior:

• Demand: tends to track stable patient need plus channel-driven dynamics.
• Price: tends to erode gradually unless supply constraints improve margins.
• Total revenue: most often shows modest growth at best, with large swings driven by regulatory enforcement and supply continuity.

Practical forecast ranges (use in financial model)

Build revenue forecasts using:

• a unit volume growth rate in the -3% to +8% band (scenario-dependent),
• and a net price change rate in the -6% to 0% band.

Then apply:

• gross-to-net adjustments (tender rebates, distributor margins),
• inventory write-offs in enforcement downturns,
• and cost-of-goods changes tied to manufacturing scale.

Key Takeaways

• Nandrolone decanoate is a mature AAS with limited evidence of new, late-stage label-expanding trials; public clinical activity is generally pharmacology or small-scale rather than pivotal registration.
• Market economics are dominated by generic competition, supply continuity, and controlled-substance distribution constraints rather than innovation-led differentiation.
• Revenue projections should use a volume-and-net-price framework with scenario-based ranges reflecting enforcement and supply risk.
• Highest-probability growth levers sit in operational execution: formulation/presentation continuity, regulatory maintenance, tender access, and distribution reliability.

FAQs

1. Is nandrolone decanoate currently in Phase 3 trials for label expansion?
   Public registries show limited late-stage pivotal activity for new regulatory endpoints specific to nandrolone decanoate, consistent with a mature product profile.

2. What drives demand for nandrolone decanoate most strongly?
   Prescribing behavior where approved, off-label clinician use in some settings, and non-medical demand dynamics shaped by enforcement and supply constraints.

3. How does pricing typically behave in nandrolone decanoate markets?
   Net pricing usually erodes over time due to generic competition, with margin resilience only when supply tightness or fewer competitors occur.

4. What are the biggest commercial risks?
   Controlled-substance regulatory tightening, enforcement shocks that alter channel demand, and supply interruptions that disrupt distributor inventory.

5. What is the most realistic near-term “growth” story?
   Market share gains through procurement access and distribution execution rather than a new-label clinical development program.

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References (APA)

1. US National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov/
2. European Medicines Agency. (n.d.). Medicine information and EPARs. https://www.ema.europa.eu/
3. World Health Organization. (n.d.). ATC classification and related guidance. https://www.who.int/