CLINICAL TRIALS PROFILE FOR AXIRON

All Clinical Trials for axiron

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00702650 ↗	A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations	Completed	Eli Lilly and Company	Phase 3	2008-06-01	Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.
NCT00857454 ↗	A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations	Completed	Eli Lilly and Company	Phase 3	2008-10-01	Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.
NCT00857961 ↗	A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations	Completed	Eli Lilly and Company	Phase 2	2007-10-01	Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also assess safety of the product.
NCT01419236 ↗	A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels	Completed	Eli Lilly and Company	Phase 2	2011-08-01	The purpose of this study is to see if testosterone solution 2% can impact symptoms of ejaculatory dysfunction in men with low testosterone.
NCT01725451 ↗	A Study of Effect of Deodorant and Axillary Hair on Testosterone Absorption in Healthy Participants	Completed	Eli Lilly and Company	Phase 1	2012-11-01	This study will evaluate the effect of deodorant and antiperspirant use and the presence of underarm hair on the absorption of testosterone. Each participant in this study will receive 6 single doses of 30 milligrams (mg) testosterone applied as a solution to each underarm. There is a minimum one day washout period between each dose. This study will last approximately 24 days not including screening. Screening is required within 30 days prior to the start of the study.
NCT01816295 ↗	A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy	Completed	Eli Lilly and Company	Phase 3	2013-05-01	The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.

Clinical Trial Conditions for axiron

Condition Name

Condition Name for axiron
Intervention	Trials
Hypogonadism	7
Healthy Participants	1
Healthy Volunteers	1
Ejaculatory Dysfunction	1

Condition MeSH

Condition MeSH for axiron
Intervention	Trials
Hypogonadism	7

Clinical Trial Locations for axiron

Trials by Country

Trials by Country for axiron
Location	Trials
United States	70
Canada	5
United Kingdom	4
Australia	4
Germany	2

Trials by US State

Trials by US State for axiron
Location	Trials
California	6
Texas	5
Florida	5
Colorado	4
Arizona	4

Clinical Trial Progress for axiron

Clinical Trial Phase

Clinical Trial Phase for axiron
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
Phase 2	2

Clinical Trial Status

Clinical Trial Status for axiron
Clinical Trial Phase	Trials
Completed	9

Clinical Trial Sponsors for axiron

Sponsor Name

Sponsor Name for axiron
Sponsor	Trials
Eli Lilly and Company	8
INC Research	1
Syneos Health	1

Sponsor Type

Sponsor Type for axiron
Sponsor	Trials
Industry	9
Other	2

Axiron Market Analysis and Financial Projection

AXIRON: Clinical Trials, Market Analysis, and Projections

Introduction to AXIRON

AXIRON, a testosterone topical solution, was approved by the U.S. Food and Drug Administration (FDA) in 2010 for replacement therapy in men with certain conditions associated with a deficiency or absence of endogenous testosterone. It is the first testosterone replacement therapy applied via an underarm applicator[1].

Clinical Trials Overview

Efficacy and Safety

Clinical trials for AXIRON demonstrated its efficacy in restoring blood concentrations of testosterone within the normal range in most men. The trials involved doses ranging from 30 mg to 120 mg per day, with the majority of patients starting and maintaining a dose of 60 mg testosterone[3][4].

Adverse Reactions

The clinical trials reported several adverse reactions associated with AXIRON. Common adverse reactions included application site irritation, application site erythema, headache, increased hematocrit, diarrhea, vomiting, and increased PSA values. These reactions were generally mild, and no serious adverse events related to the treatment were reported during the 120-day and 180-day trials[3][4].

Long-Term Safety

There is limited data on the efficacy and safety of AXIRON in geriatric males (>65 years of age) and on its long-term use. The trials indicated an overall increase in mean PSA values, but the clinical significance of this is not fully understood. Additionally, AXIRON has not been shown to be safe and effective for enhancing athletic performance or treating sexual dysfunction without established testosterone deficiency[3].

Market Analysis

Current Market Conditions

The global market for Testosterone Replacement Therapy (TRT) is competitive, with several products vying for market share. AXIRON faces tough market conditions, including competition from other topical gels and patches, as well as impending patent expiries that could lead to generic competition[5].

Sales Performance

AXIRON's sales have been impacted by various factors, including market competition and FDA mandates. Despite these challenges, AXIRON has managed to attract users through co-pay schemes and other strategic initiatives. However, its sales have not been as robust as some of its competitors, such as AndroGel by AbbVie[5].

Market Projections

The TRT market is expected to continue growing, driven by increasing awareness and diagnosis of testosterone deficiency. However, the market share of branded drugs like AXIRON is likely to be affected by the entry of generics. The US market for TRT is projected to see changes in market share among different product segments, with topicals, patches, and other forms competing for dominance[5].

Key Players and Competitive Landscape

Major Competitors

The TRT market is dominated by several key players, including AbbVie with AndroGel, and other companies offering various forms of testosterone replacement therapies. AXIRON, developed by Eli Lilly and Acrux, faces competition from these established brands as well as from newer entrants in the market[5].

Strategic Developments

To maintain market share, companies are engaging in strategic corporate developments, such as product launches, approvals, and co-pay schemes. These strategies aim to attract and retain patients in a highly competitive market[5].

Regulatory Environment

FDA Mandates

The FDA has mandated labeling changes for TRT products, including AXIRON, related to potential cardiac events. This has added a layer of complexity to the market, as there is ongoing debate about the risk of cardiac events associated with testosterone replacement therapy[5].

Future Outlook

Market Growth Drivers

The TRT market is expected to grow driven by increasing awareness of testosterone deficiency, particularly among men over 45 years of age. It is estimated that up to 13 million men in the U.S. over 45 may have symptoms associated with low testosterone, providing a significant market opportunity[1].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as impending patent expiries, generic competition, and regulatory scrutiny. Companies will need to innovate and adapt their strategies to maintain market share and capitalize on the growing demand for TRT products[5].

Key Takeaways

• Clinical Efficacy: AXIRON has been shown to restore normal testosterone levels in most men.
• Safety Profile: Common adverse reactions include application site irritation and increased PSA values, with no serious treatment-related adverse events reported.
• Market Competition: AXIRON faces significant competition from other TRT products and impending generic competition.
• Regulatory Environment: FDA mandates on labeling changes related to cardiac events add complexity to the market.
• Future Outlook: The TRT market is expected to grow, driven by increasing awareness and diagnosis of testosterone deficiency.

FAQs

What is AXIRON used for?

AXIRON is used for replacement therapy in men with certain conditions associated with a deficiency or absence of endogenous testosterone.

How is AXIRON applied?

AXIRON is the first testosterone replacement therapy applied via an underarm applicator.

What are the common adverse reactions associated with AXIRON?

Common adverse reactions include application site irritation, application site erythema, headache, increased hematocrit, diarrhea, vomiting, and increased PSA values.

Why is AXIRON not recommended for certain uses?

AXIRON should not be used to improve body composition, bone and muscle mass, increase lean body mass, decrease total fat mass, or enhance athletic performance without established testosterone deficiency.

What are the market projections for AXIRON and the TRT market?

The TRT market is expected to grow, but AXIRON's market share is likely to be affected by generic competition and regulatory changes.

Sources

1. FiercePharma: Lilly and Acrux Receive FDA Approval for Axiron® (Testosterone) Topical Solution CIII.
2. Drug Development: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. Health Canada: Axiron - Product Monograph Template - Standard.
4. FDA: AXIRON (testosterone) topical solution.
5. Markets Insider: Global Testosterone Replacement Therapy (TRT) Pharmaceuticals Market.