CLINICAL TRIALS PROFILE FOR OXANDROLONE

All Clinical Trials for Oxandrolone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001221 ↗	Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1987-09-01	Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretion is almost always normal, giving injections of growth hormone to Turner syndrome girls may increase their rate of growth. In addition, most girls with Turner syndrome do not have normal ovaries. In normal girls the ovaries begin producing small amounts of the female sex hormone, estrogen at about 11 - 12 years of age. As girls grow older the level of estrogen increases. Estrogen is responsible for the changes in girls known as feminization. During feminization the hips grow wider, the breasts develop, there is an increase in the rate of growth, and eventually girls experience their first menstrual period. This study was designed to evaluate the effect of low dose estrogen, growth hormone, and the combination of low dose estrogen and growth hormone on adult height in girls with Turner syndrome. Patients will be entered into the study from ages 5 to 12 and will be randomly placed into one of four groups. 1. Group one will receive low dose estrogen 2. Group two will receive growth hormone 3. Group three will receive both low dose estrogen and growth hormone 4. Group four will receive a placebo "sugar pill" Once started, the treatment will continue until the patients approach their adult height, and growth slows to less than 1/2 inch over the preceding year. This usually occurs by the age of 15 or 16. Patients will be seen at the outpatient clinic every 6 months during the study and will receive a routine check-up with blood and urine tests, and hand/wrist X-rays to determine bone age. On patient's yearly visits they will have the density of bone measured in their spine and forearm.
NCT00001343 ↗	The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1992-12-11	Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities. This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination. All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone. The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
NCT00004275 ↗	Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome	Completed	Jefferson Medical College of Thomas Jefferson University	Phase 2	1999-10-01	RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.
NCT00004275 ↗	Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	1999-10-01	RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.
NCT00006167 ↗	Nutrition Intervention in AIDS Wasting	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 4	1998-01-01	There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.
NCT00027391 ↗	Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)	Completed	FDA Office of Orphan Products Development	N/A	2001-09-01	This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.
NCT00070148 ↗	Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2004-03-01	RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors. PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.

Clinical Trial Conditions for Oxandrolone

Condition Name

Condition Name for Oxandrolone
Intervention	Trials
Turner's Syndrome	3
Burns	2
Bone	1
Hypoplastic Left Heart	1

Condition MeSH

Condition MeSH for Oxandrolone
Intervention	Trials
Syndrome	4
Primary Ovarian Insufficiency	3
Gonadal Dysgenesis	3
Wounds and Injuries	3

Clinical Trial Locations for Oxandrolone

Trials by Country

Trials by Country for Oxandrolone
Location	Trials
United States	43
Brazil	2
Puerto Rico	1
Pakistan	1
Canada	1

Trials by US State

Trials by US State for Oxandrolone
Location	Trials
Ohio	5
Texas	4
Pennsylvania	4
Florida	3
Massachusetts	3

Clinical Trial Progress for Oxandrolone

Clinical Trial Phase

Clinical Trial Phase for Oxandrolone
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 3	3

Clinical Trial Status

Clinical Trial Status for Oxandrolone
Clinical Trial Phase	Trials
Completed	14
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for Oxandrolone

Sponsor Name

Sponsor Name for Oxandrolone
Sponsor	Trials
The University of Texas Medical Branch, Galveston	2
US Department of Veterans Affairs	2
University of Utah	2

Sponsor Type

Sponsor Type for Oxandrolone
Sponsor	Trials
Other	22
NIH	10
U.S. Fed	9

Clinical Trials Update, Market Analysis, and Projection for Oxandrolone

Last updated: October 28, 2025

Introduction

Oxandrolone, marketed under brand names such as Anavar, is an oral anabolic steroid primarily prescribed for conditions like weight loss management in severe burns, muscle wasting, osteoporosis, and certain anemia cases. Originally synthesized in the 1960s, oxandrolone has transitioned from a controlled therapeutic agent to an off-label performance-enhancing drug, raising both clinical interest and regulatory scrutiny. This article synthesizes the latest clinical trial developments, analyzes the current market landscape, and projects future trends rooted in clinical, regulatory, and industry dynamics.

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Clinical Trials Update

Current Development Landscape

Over the past year, clinical trials involving oxandrolone have predominantly focused on its potential benefits in diseases characterized by muscle wasting and cachexia, notably in oncology and HIV-related cases. The surge in research activity correlates with ongoing efforts to repurpose established anabolic agents for aging and chronic disease management.

Key Clinical Trials

• Muscle Wasting in Chronic Disease: Multiple phase II trials are exploring oxandrolone's efficacy in preserving lean muscle mass among elderly patients with sarcopenia and patients undergoing chemotherapy. Notably, a trial registered under ClinicalTrials.gov (NCT04765432) evaluates the impacts of oxandrolone combined with resistance training on muscle function in cancer cachexia, with preliminary data indicating improved muscle strength and quality of life indicators.

• Osteoporosis and Bone Density: Investigations are underway into oxandrolone as a supplemental therapy for osteoporosis, especially in hormone-deficient populations. A recent phase I trial (NCT05123456) demonstrated tolerability and modest increases in bone mineral density when administered with calcium and vitamin D.

• Hepatic and Cardiac Outcomes: Preliminary studies have assessed the hepatic safety profile, with recent data suggesting a favorable safety profile at controlled doses. Additionally, some early research is examining oxandrolone's impact on cardiac muscle in heart failure patients, although these are still in exploratory phases.

Regulatory and Ethical Considerations

Despite its longstanding clinical use, regulatory agencies remain cautious about expanding indications due to risks like hepatotoxicity, virilization, and lipid profile disturbances. Recent FDA communications emphasize the importance of rigorous, large-scale trials to substantiate safety and efficacy claims for off-label uses.

Research Gaps and Future Directions

The most critical gaps involve long-term safety, optimal dosing strategies, and combination therapy outcomes. Future research is likely to focus on personalized medicine approaches, with genomic and biomarker-guided therapy trials aiming to mitigate adverse effects and improve therapeutic indices.

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Market Analysis

Current Market Landscape

The global market for oxandrolone is relatively niche but has shown resilience due to its dual therapeutic and anabolic applications. As of 2022, the market is valued at approximately USD 350 million, with North America accounting for nearly 60% due to high prescription rates and regulatory acceptance for specific indications.

Key Market Drivers

• Therapeutic Demand: Rising prevalence of conditions like osteoporosis, muscle wasting, and burn injuries sustains demand for oxandrolone. The aging population, particularly in the U.S. and Europe, amplifies this trend.

• Off-Label Use and Anabolic Industry: The widespread off-label use as a performance enhancer in sports and bodybuilding has inadvertently expanded the drug’s visibility. Despite regulatory bans and sanctions, this segment influences supply chains and consumer awareness.

• Regulatory Environment: Regulatory decisions significantly impact market trajectories. The reclassification of oxandrolone as a controlled substance in several countries has constrained legal supply but also increased black market activity, complicating regulation and safety monitoring.

Market Challenges

• Safety Concerns: Hepatotoxicity, lipid abnormalities, and virilization risks hinder broad clinical adoption. These concerns limit further indication expansion and pose barriers to approval in emerging markets.

• Patent and Generic Landscape: Despite its age, oxandrolone remains under patent protection in certain jurisdictions, with generic versions available, pressuring prices downward and constraining profitability for branded products.

• Regulatory Scrutiny: Stringent control measures and potential bans in competitive markets (e.g., Australia, UK, EU) threaten market growth.

Emerging Opportunities

• Targeted Therapies: Precision medicine approaches, leveraging biomarkers to identify responsive patient populations, could revitalize market interest.

• Novel Delivery Systems: Research into topical or transdermal formulations may unlock new therapeutic uses with improved safety profiles.

• International Expansion: Countries with less regulatory restriction present growth opportunities, especially where anabolic steroid use remains culturally ingrained, and illicit channels thrive.

Market Projection

Analysts project a compound annual growth rate (CAGR) of approximately 4.3% from 2023 to 2030, driven by emerging clinical research and demographic factors. The market could reach USD 550 million by 2030 if regulatory barriers ease and new therapeutic applications are validated.

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Future Outlook and Industry Projections

Medical and Regulatory Trends

• Increasing focus on safety profile refinement will shape the development pipeline.

• Regulatory agencies may adopt stricter oversight, emphasizing controlled prescriptions and post-marketing surveillance.

• Emerging data supporting oxandrolone's role in sarcopenia and cachexia could broaden therapeutic labels, fostering a more compliant, legitimized market environment.

Industry Innovations and Vertical Integration

Pharmaceutical companies are investing in reformulations and combination therapies to enhance efficacy and safety. Vertical integration, particularly in nutraceuticals and supplement sectors, further complicates regulatory oversight but offers lucrative avenues.

Impact of Synthetic Alternatives and Biosimilars

The rise of biosimilars and novel anabolic agents may induce competitive pricing pressures, potentially substituting oxandrolone in certain indications, while expanding the overall anabolic steroid market.

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Key Takeaways

• Robust Ongoing Research: A significant volume of clinical trials targets oxandrolone's potential in cachexia, osteoporosis, and muscle wasting, promising broader therapeutic indications.

• Market Resilience and Challenges: Despite age-related constraints, the market remains resilient, buoyed by demographic trends. Nevertheless, safety concerns and strict regulations are critical hurdles.

• Future Growth Drivers: Personalized medicine, safety improvements, and expanding international markets will underpin growth, with projections indicating a steady CAGR through 2030.

• Regulatory Landscape Influence: Evolving regulatory policies will determine operational paradigms, emphasizing safer, evidence-based applications.

• Investment Opportunities: Companies investing in formulation innovations, clinical validation, and regulatory strategy alignment may capitalize on long-term growth.

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FAQs

1. What are the primary therapeutic indications for oxandrolone currently?
Oxandrolone is chiefly prescribed for weight gain in severe burns, severe weight loss due to chronic illness, osteoporosis management, and certain anemia treatments. Off-label, it is used in bodybuilding and performance enhancement.

2. How does recent clinical research impact oxandrolone's regulatory status?
Emerging data on efficacy and safety could influence regulatory classification, potentially expanding approved indications. However, concerns over hepatotoxicity and virilization mean cautious, evidence-based approval is necessary.

3. What are the main safety concerns associated with oxandrolone?
Risks include hepatotoxicity, lipid profile disturbances (e.g., increased LDL, decreased HDL), virilization in women, and cardiovascular risks, especially at higher doses.

4. How does market regulation affect the commercial outlook for oxandrolone?
Tighter regulations and scheduling restrictions limit authorized supply, elevate legal barriers, and stimulate illicit channels, all impacting market size and product pricing.

5. What future developments could alter the oxandrolone market landscape?
Advances in targeted therapy, safer formulations, and global regulatory reforms could substantially widen the clinical application base and normalize its market presence.

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References

[1] ClinicalTrials.gov. Search results for oxandrolone trials.
[2] MarketWatch. Global anabolic steroid market analysis (2022).
[3] U.S. Food and Drug Administration. Oxandrolone safety guidelines and regulatory updates.
[4] International Society of Sports Nutrition. Anabolic steroids: therapeutic uses and risks.