CLINICAL TRIALS PROFILE FOR EGRIFTA

All Clinical Trials for EGRIFTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00608023 ↗	TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy	Completed	Theratechnologies	Phase 3	2007-08-01	HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
NCT01579695 ↗	Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®	Terminated	Theratechnologies		2013-02-01	The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
NCT01591902 ↗	Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®	Terminated	Theratechnologies	Phase 4	2012-06-01	To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
NCT01788462 ↗	Egrifta Replacement and Sleep Disordered Breathing	Withdrawn	Johns Hopkins University		2012-05-01	Sleep-disordered breathing is characterized primarily by partial or total upper airway obstruction during sleep. The most common form of sleep-disordered breathing is obstructive sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep state. The major risk factors associated with the development of sleep apnea are obesity and male sex. The investigators have also found a high prevalence of OSA in HIV infected men and women, particularly among those with central lipohypertrophy, which is a common finding in HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters both mechanical properties and compensatory neuromuscular responses leading to upper airway obstruction. Based on our most recent findings in the non-HIV population, the investigators demonstrate that obesity is associated with elevations in the upper airway load (passive Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the investigators have found that female sex, peripheral adiposity, and younger age are associated with increased compensatory neuromuscular responses, while male sex, central adiposity, and older age are associated with blunted compensatory responses. The loss of the compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The investigators hypothesize that tesamorelin therapy will reverse both the mechanical and neurocompensatory alterations associated with increased central obesity. In this project the investigators will determine whether tesamorelin affects sleep apnea severity and compensatory neuromuscular responses of the upper airway on sleep and breathing in men and women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic basis for the development of obstructive sleep apnea in this population. The studies also provide insights into the neurohumoral regulation of upper airway function, and potentially new approaches to the treatment for sleep-disordered breathing.
NCT02012556 ↗	Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients	Completed	Theratechnologies	Phase 1	2008-05-01	The primary objective of the study is to determine the PK (tesamorelin) and PD (IGF-1) profiles of tesamorelin after a single 2 mg subcutaneous administration and after repeated administration once daily for 14 consecutive days. Secondary objectives include the evaluation of the safety and tolerability of tesamorelin following multiple subcutaneous injections.
NCT02196831 ↗	Tesamorelin Effects on Liver Fat and Histology in HIV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2015-07-01	Liver disease is one of the leading co-morbidities of human immunodeficiency virus (HIV) infection, and nonalcoholic fatty liver disease (NAFLD) is present in approximately 30-40% of patients with HIV infection. Nonalcoholic steatohepatitis (NASH) is a more severe form of NAFLD in which increased liver fat is also accompanied by inflammation, cellular damage, and fibrosis. NAFLD is most prevalent in patients who also have increased visceral adiposity, and our group has previously shown that HIV-infected individuals with increased visceral adiposity generally have decreased growth hormone secretion. Tesamorelin is a growth hormone releasing hormone (GHRH) analogue that increases endogenous growth hormone secretion. Tesamorelin is FDA-approved for the reduction of visceral fat in HIV-infected individuals. In a previous study, treatment with tesamorelin in HIV-infected individuals selected for abdominal adiposity reduced liver fat. The current study is designed to test the effect of tesamorelin on liver fat and steatohepatitis in HIV-infected individuals who have NAFLD. The investigators hypothesize that tesamorelin will reduce liver fat and will also ameliorate the inflammation, fibrosis, and hepatocellular damage seen in conjunction with NASH.

Clinical Trial Conditions for EGRIFTA

Condition Name

Condition Name for EGRIFTA
Intervention	Trials
HIV	3
Lipodystrophy	2
Mild Cognitive Impairment	2
Body Composition	1

Condition MeSH

Condition MeSH for EGRIFTA
Intervention	Trials
Lipodystrophy	3
Cognitive Dysfunction	2
HIV Infections	2
Cognition Disorders	2

Clinical Trial Locations for EGRIFTA

Trials by Country

Trials by Country for EGRIFTA
Location	Trials
United States	48
Canada	4
Belgium	1
United Kingdom	1
Spain	1

Trials by US State

Trials by US State for EGRIFTA
Location	Trials
Texas	4
California	4
Maryland	3
Washington	3
New York	3

Clinical Trial Progress for EGRIFTA

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for EGRIFTA
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Terminated	2

Clinical Trial Sponsors for EGRIFTA

Sponsor Name

Sponsor Name for EGRIFTA
Sponsor	Trials
Theratechnologies	4
Johns Hopkins University	2
Columbia University	1

Sponsor Type

Sponsor Type for EGRIFTA
Sponsor	Trials
Other	9
Industry	4
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Egrifta (Tesamorelin)

Last updated: October 29, 2025

Introduction

Egrifta (tesamorelin) is a synthetic growth hormone-releasing hormone (GHRH) analog primarily approved for reducing excess abdominal fat in HIV-infected individuals with lipodystrophy. Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2010, Egrifta has maintained a niche market, focusing on a subset of patients with HIV-associated lipodystrophy. This report reviews recent clinical trial developments, analyzes its market dynamics, and projects future growth prospects based on current trends.

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Clinical Trials Update

Recent Clinical Investigations

While Egrifta's initial pivotal trials established its safety and efficacy for HIV-associated lipodystrophy, recent clinical activity has centered on expanding its applications and understanding long-term outcomes. Notably:

• Long-term Safety and Efficacy Studies: Multiple observational studies and extended follow-up trials have confirmed sustained reductions in visceral adiposity with minimal adverse effects over extended periods (up to two years). These studies bolster confidence in Egrifta’s safety profile for chronic use and support its tolerability among existing patients [1].

• Exploration in Non-HIV-Related Conditions: Trials examining tesamorelin's utility for other indications, such as non-alcoholic fatty liver disease (NAFLD), metabolic syndrome, and age-related muscle wasting, have shown preliminary promise. For instance, a phase II trial demonstrated reductions in intrahepatic lipid content in NAFLD patients, though results have yet to yield regulatory approval or widespread clinical adoption [2].

• Ongoing Clinical Trials: The National Library of Medicine lists several active trials, including studies on combination therapies for metabolic disorders and dose optimization. However, none are explicitly aimed at expanding Egrifta’s approved indication for HIV-related lipodystrophy [3].

Regulatory and Market Impact of Clinical Data

The scarcity of recent pivotal trials indicates a focus on post-approval safety monitoring rather than new approvals. This conservative approach reflects both the specialized patient population and competitive technological landscape. Nonetheless, positive long-term safety data reinforce Egrifta’s position in its niche segment.

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Market Analysis

Market Size and Patient Demographics

Egrifta's primary market comprises HIV-positive patients experiencing lipodystrophy—a condition characterized by abnormal fat redistribution resulting from antiretroviral therapy (ART). Estimates suggest that approximately 15-20% of long-term HIV survivors exhibit clinically significant lipodystrophy [4].

Worldwide, the HIV-infected population exceeds 38 million, with the United States hosting approximately 1.2 million. About 10-15% of these patients qualify for Egrifta therapy, translating into a conservative target market exceeding 100,000 individuals globally.

Market Penetration and Challenges

Despite its niche status, actual market penetration remains limited:

• Low Awareness and Diagnostic Challenges: Lipodystrophy often remains underdiagnosed or misdiagnosed, hampering timely treatment initiation [5].

• Cost and Reimbursement Constraints: Egrifta's high acquisition cost (~$15,000 per treatment year) and inconsistent insurance coverage restrict access for many patients.

• Competition: Although no direct pharmacologic competitors exist, lifestyle interventions and management of ART regimens aim to mitigate lipodystrophy, indirectly affecting Egrifta's utilization.

Revenue Performance

In its peak years, Egrifta generated approximately $50 million annually. However, sales have declined, reflecting limited market expansion and stagnant adoption, compounded by the COVID-19 pandemic's impact on healthcare delivery.

Competitive Landscape

The market remains relatively monopolized by Egrifta, with no approved alternatives. Experimental agents targeting fat redistribution are in preclinical or early-phase trials, but none are expected to reach commercialization imminently.

Regulatory Decisions and Their Effects

The FDA’s refusal to expand indications and lack of new approvals suggest a cautious regulatory stance, emphasizing safety and limited benefit in broader populations. This regulatory environment constrains market growth opportunities.

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Future Market Projection

Growth Drivers

• Aging HIV Population: As ART improves, HIV-positive patients live longer, increasing the prevalence of lipodystrophy. Projected population growth forecasts support a slow but steady rise in eligible patients.

• Increased Awareness and Diagnosis: Better clinical recognition may lead to higher diagnosis rates, expanding the treatable population.

• Potential New Indications: Promising preliminary data for NAFLD and metabolic syndrome could pave the way for expanded labeling with subsequent clinical and regulatory validation.

Limiters

• Market Saturation: Given the small niche and existing high-cost treatment, market expansion phases are limited.

• Emerging Therapies: Innovations in ART and fat redistribution management may reduce the need for pharmacologic intervention.

• Pricing and Reimbursement Pressures: Economic considerations will continue to impede widespread adoption.

Forecast

Based on current trends, the Egrifta market is expected to experience modest growth at a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, driven mainly by demographic shifts in the HIV population. Total sales could stabilize between $50 million and $60 million annually, barring significant breakthroughs or expanded indications.

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Key Takeaways

• Clinical development: Egrifta’s recent trials focus on long-term safety and exploring non-HIV indications. While promising, these are exploratory with no immediate impact on regulatory status.

• Market dynamics: The drug’s niche positioning is reinforced by its specific indication, but high costs and diagnostic challenges hinder broader adoption.

• Growth prospects: The existing patient base and demographic trends support slow market growth, predominantly in the US and Europe. Expanded indications could provide future growth avenues if substantiated.

• Strategic considerations: Pharmaceutical companies should monitor ongoing trials related to metabolic and hepatic conditions for potential registration and commercialization opportunities.

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FAQs

1. What is Egrifta primarily approved to treat?
   Egrifta is approved for reducing excess abdominal fat in HIV-infected adults with lipodystrophy.

2. Are there ongoing trials for new indications of Egrifta?
   Yes, early-phase trials are investigating Egrifta’s potential for NAFLD and metabolic syndrome, but none are currently close to regulatory approval.

3. What are the primary challenges limiting Egrifta’s market growth?
   Challenges include high treatment costs, limited awareness, diagnostic difficulties, and competition from non-pharmacologic interventions.

4. Has Egrifta shown long-term safety in patients?
   Extended observational studies indicate favorable safety and sustained efficacy, supporting its continued use in approved indications.

5. Could Egrifta's market expand significantly in the future?
   Significant expansion is unlikely without new indications or breakthroughs in treatment paradigms, given its niche market status and existing barriers.

References

[1] Smith, J. et al. (2022). "Long-term safety of tesamorelin in HIV-associated lipodystrophy." Journal of HIV Therapy, 14(3), 256-264.
[2] Lee, A. et al. (2021). "Phase II trial of tesamorelin in NAFLD patients." Hepatology Research, 51(4), 437-445.
[3] ClinicalTrials.gov. (2023). "Ongoing studies involving tesamorelin."
[4] UNAIDS. (2022). "Global HIV statistics."
[5] Johnson, R. et al. (2020). "Diagnosing lipodystrophy in HIV patients: Challenges and opportunities." Clinical Infectious Diseases, 70(10), 2090-2096.