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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR NATESTO


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All Clinical Trials for Natesto

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02611154 ↗ Intranasal Delivery of Testosterone and Its Effect on Doping Markers Completed Partnership for Clean Competition Phase 4 2015-11-18 Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic profile during anti-doping testing, which is different than the profile seen when testosterone is administered into muscle, on skin or under the tongue. Objective: The investigators aim to characterize the unique steroid doping profile following administration of intranasal testosterone to healthy, active volunteer subjects.
NCT02611154 ↗ Intranasal Delivery of Testosterone and Its Effect on Doping Markers Completed Sports Medicine Research and Testing Laboratory Phase 4 2015-11-18 Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic profile during anti-doping testing, which is different than the profile seen when testosterone is administered into muscle, on skin or under the tongue. Objective: The investigators aim to characterize the unique steroid doping profile following administration of intranasal testosterone to healthy, active volunteer subjects.
NCT02611154 ↗ Intranasal Delivery of Testosterone and Its Effect on Doping Markers Completed University of Utah Phase 4 2015-11-18 Hypothesis: Intranasal administration of exogenous testosterone results in a characteristic profile during anti-doping testing, which is different than the profile seen when testosterone is administered into muscle, on skin or under the tongue. Objective: The investigators aim to characterize the unique steroid doping profile following administration of intranasal testosterone to healthy, active volunteer subjects.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Natesto

Condition Name

Condition Name for Natesto
Intervention Trials
Hypogonadism, Male 4
Hypogonadism 2
Erectile Dysfunction 1
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Condition MeSH

Condition MeSH for Natesto
Intervention Trials
Hypogonadism 6
Eunuchism 4
Dry Eye Syndromes 1
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Clinical Trial Locations for Natesto

Trials by Country

Trials by Country for Natesto
Location Trials
United States 20
Canada 4
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Trials by US State

Trials by US State for Natesto
Location Trials
Florida 3
California 2
Utah 2
Texas 1
South Carolina 1
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Clinical Trial Progress for Natesto

Clinical Trial Phase

Clinical Trial Phase for Natesto
Clinical Trial Phase Trials
Phase 4 7
Phase 2 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Natesto
Clinical Trial Phase Trials
Recruiting 4
Completed 3
Not yet recruiting 2
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Clinical Trial Sponsors for Natesto

Sponsor Name

Sponsor Name for Natesto
Sponsor Trials
Acerus Pharmaceuticals Corporation 5
University of Miami 2
University of Utah 2
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Sponsor Type

Sponsor Type for Natesto
Sponsor Trials
Other 9
Industry 6
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Natesto: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction

Natesto, a testosterone nasal gel, has been a significant player in the testosterone replacement therapy (TRT) market since its FDA approval in 2014. Here, we will delve into the clinical trials, market analysis, and projections for this innovative drug.

Clinical Trials and Efficacy

Phase 3 Trials

Natesto has demonstrated robust efficacy in phase 3 clinical trials. These trials showed that Natesto helped men achieve an average daily testosterone concentration within the therapeutic range after 90 days, with a maximum concentration (C max) of 800 ng/dL, regardless of baseline testosterone levels. The trials also highlighted statistically significant improvements in sexual function and mood[1][4].

Long-Term Studies

In addition to the initial 90-day trial, Natesto was evaluated in extension periods, including a 90-day and a subsequent 180-day extension. These studies involved 78 patients who received Natesto three times daily, with 69 patients continuing into the 90-day extension period and 18 patients completing all three treatment periods. The results indicated that Natesto maintained its efficacy over the extended periods[1].

Safety and Side Effects

Common adverse reactions reported in the clinical trials included increased prostate-specific antigen (PSA), headache, rhinorrhea, epistaxis, nasal discomfort, nasopharyngitis, and bronchitis. Despite these side effects, the overall safety profile of Natesto was favorable, with only a few patients withdrawing from treatment due to adverse reactions[1].

Preserving Reproductive Capacity

A key benefit of Natesto is its ability to preserve semen parameters in men with hypogonadism. Studies by Dr. Ramasamy and his team found that Natesto increased testosterone levels into the normal range, improved symptoms of low testosterone, and preserved semen parameters in 90% of men. This is attributed to the drug's short half-life, which mimics the body's natural testosterone levels and maintains the pulsatile release of reproductive hormones[4].

Market Analysis

Market Growth

The testosterone nasal gel market, led by Natesto, is expected to experience substantial growth. According to Fact.MR, the market is projected to grow from $145.36 million in 2024 to $306.08 million by 2034, with a compound annual growth rate (CAGR) of 7.7%[5].

Regional Dominance

North America dominates the testosterone nasal gel market, primarily due to the presence of major players like Acerus Pharmaceuticals Corporation. The prevalence of hypogonadism, affecting approximately 4 to 5 million males in the U.S., further drives market growth in this region[5].

Competitive Landscape

Acerus Pharmaceuticals Corporation is the key player in the market, with Natesto being the only FDA-approved testosterone nasal gel. Collaborations with other companies, such as Hyundai Pharm Co., have expanded Natesto's global reach. Other notable players include Endo Pharmaceuticals Inc.[5].

Market Projections

Revenue and CAGR

The testosterone nasal gel market is anticipated to grow significantly, driven by the increasing prevalence of hypogonadism and the launch of new products. The market's CAGR is expected to be around 3% to 7.7% during the forecast period from 2024 to 2034[5].

Distribution Channels

The market is segmented by distribution channels, including hospital pharmacies, retail pharmacies, and mail-order pharmacies. The ease of self-administration and patient compliance with nasal gels are expected to drive growth across these channels[5].

Impact of COVID-19

The COVID-19 pandemic has acted as a catalyst for the nasal gels market, including testosterone nasal gels. Increased demand for self-administration and non-invasive drug delivery methods has boosted market growth. However, stringent regulatory policies may pose some challenges[2].

Key Takeaways

  • Efficacy and Safety: Natesto has shown strong efficacy in clinical trials, achieving therapeutic testosterone levels and improving symptoms of hypogonadism while maintaining a favorable safety profile.
  • Market Growth: The testosterone nasal gel market is projected to grow significantly, driven by the prevalence of hypogonadism and the convenience of nasal administration.
  • Regional Dominance: North America leads the market due to the presence of major players and a high prevalence of hypogonadism.
  • Competitive Landscape: Acerus Pharmaceuticals Corporation is the key player, with Natesto being the only FDA-approved testosterone nasal gel.

FAQs

What is the primary indication for Natesto?

Natesto is indicated for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, specifically hypogonadism[1].

How does Natesto compare to other testosterone therapies?

Natesto's short half-life allows the brain to continue regulating reproductive hormones, potentially leading to a more favorable side-effect profile compared to long-acting testosterone injections[4].

What are the common side effects of Natesto?

Common adverse reactions include increased PSA, headache, rhinorrhea, epistaxis, nasal discomfort, and nasopharyngitis[1].

Which region dominates the testosterone nasal gel market?

North America dominates the market due to the presence of major players and a high prevalence of hypogonadism[5].

What is the projected growth rate for the testosterone nasal gel market?

The market is expected to grow with a CAGR of 3% to 7.7% from 2024 to 2034[5].

Sources

  1. Natesto Efficacy: NATESTO® (testosterone) nasal gel healthcare professional information.
  2. Nasal Gels Market: Fairfield Market Research - Nasal Gels Market Size, Share, Growth.
  3. Acerus Financial Results: Acerus Reports Third Quarter 2022 Financial Results - BioSpace.
  4. Treating Low Testosterone: Research Outreach - Treating low testosterone in males: A nasal gel shows promising results.
  5. Testosterone Nasal Gel Market: Fact.MR - Testosterone Nasal Gel Market Share and Statistics.

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