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CLINICAL TRIALS PROFILE FOR HORIZANT

All Clinical Trials for horizant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01533753 ↗	Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer	Terminated	University of Wisconsin, Madison	Phase 2	2012-02-01	The purpose of this study is to assess the change in quality of life over a 6 month period between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.
NCT01668667 ↗	Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study	Completed	XenoPort, Inc.	Phase 4	2012-06-01	Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS). The aim of this study is to compare the efficacy, tolerability, and safety of GEn at lower doses (450 and 300 mg/day) as well as the already approved dose of 600 mg/day versus placebo for the treatment of subjects with moderate to severe primary RLS. This study is being conducted as a post-marketing commitment (PMC) as a condition of the approval of HORIZANT tablets (NDA 022399).
NCT01675960 ↗	Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children	Terminated	Gillette Children's Specialty Healthcare	Phase 2	2012-04-01	This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.
NCT01675960 ↗	Effectiveness of Gabapentin on Chronic Irritability in Neurologically Impaired Children	Terminated	Scott Schwantes, M.D.	Phase 2	2012-04-01	This study is a prospective, randomized, double blind, placebo controlled, crossover clinical trial looking at whether gabapentin can provide symptom relief for chronic irritability in neurologically impaired children. The investigators hypothesize gabapentin ins beneficial and safe for children with chronic irritability that persists despite identification and appropriate management of symptom sources.
NCT01680549 ↗	Pain Control With Total Knee Replacement	Completed	Texas Tech University Health Sciences Center	Phase 4	2012-09-01	The purpose of this project is to study the effects of gabapentin on pain control in the perioperative and post-operative period of total knee arthroplasty.
NCT02117076 ↗	Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome	Terminated	Theresa Zesiewicz	Phase 4	2014-04-01	The study will compare the safety, effectiveness and tolerability of gabapentin (Neurontin) versus gabapentin enacarbil (Horizant) as treatment restless leg syndrome.

Clinical Trial Conditions for horizant

Condition Name

Condition Name for horizant
Intervention	Trials
Restless Legs Syndrome	3
RLS	3
Narcotic Use	1
Neurologically Impaired	1

Condition MeSH

Condition MeSH for horizant
Intervention	Trials
Restless Legs Syndrome	8
Syndrome	4
Psychomotor Agitation	4
Pain, Postoperative	2

Clinical Trial Locations for horizant

Trials by Country

Trials by Country for horizant
Location	Trials
United States	67

Trials by US State

Trials by US State for horizant
Location	Trials
California	6
Texas	5
Florida	5
Tennessee	4
South Carolina	4

Clinical Trial Progress for horizant

Clinical Trial Phase

Clinical Trial Phase for horizant
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	1
Phase 2	3

Clinical Trial Status

Clinical Trial Status for horizant
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Recruiting	3

Clinical Trial Sponsors for horizant

Sponsor Name

Sponsor Name for horizant
Sponsor	Trials
XenoPort, Inc.	6
Cleveland Sleep Research Center	1
University of Missouri-Columbia	1

Sponsor Type

Sponsor Type for horizant
Sponsor	Trials
Other	11
Industry	8
NIH	2

Horizant Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for HORIZANT (Gabapentin Enacarbil)

Introduction to HORIZANT

HORIZANT, marketed by Azurity, is a gabapentin enacarbil extended-release formulation used primarily for the treatment of Restless Legs Syndrome (RLS) and Postherpetic Neuralgia (PHN). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Horizant Study for Alcohol Use Disorder

One of the notable clinical trials involving HORIZANT is the study conducted by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to evaluate its efficacy and safety for the treatment of Alcohol Use Disorder (AUD). This Phase 2, randomized, double-blind, placebo-controlled trial involved 346 participants across 10 clinical sites. The study administered HORIZANT at a dose of 600mg twice a day and compared it to a placebo over a 6-month period.

• Key Findings: The trial did not show significant differences between the HORIZANT and placebo groups in terms of the primary outcome measure, which was the percentage of subjects with no heavy drinking days. Common side effects included fatigue, dizziness, and somnolence[1].

Clinical Trials for RLS and PHN

HORIZANT has been extensively studied in clinical trials for its approved indications, RLS and PHN. For RLS, the drug was evaluated in several double-blind, placebo-controlled trials involving over 1,200 patients. These trials demonstrated the safety and efficacy of HORIZANT, with common adverse reactions including somnolence, dizziness, and headache[4].

For PHN, a 12-week, double-blind, multicenter study compared different doses of HORIZANT to placebo. This study also highlighted dizziness, somnolence, and headache as common adverse reactions[4].

Market Analysis

Current Market Status

HORIZANT is currently marketed by Azurity and has been a significant player in the market for RLS and PHN treatments. The drug's annual sales were $171 million in 2021, down from a peak of $535 million in 2018[5].

Patent and Exclusivity Status

The patent landscape for HORIZANT is complex, with multiple patents protecting the drug. The earliest estimated date for generic entry is June 10, 2029, although this could change due to patent challenges or licensing agreements. There is one ongoing Paragraph IV patent challenge, which may impact the timing of generic entry[5].

Market Projections

The market for neurological disorders, including RLS and PHN, is expected to grow due to increasing prevalence and advancements in treatment options. However, the specific market projection for HORIZANT will be influenced by the impending generic competition.

• Generic Entry: The potential entry of generic versions of gabapentin enacarbil in 2029 is likely to impact HORIZANT's market share and revenue. Generic drugs are typically priced lower, which could lead to a significant reduction in HORIZANT's sales[5].

Clinical Trials Pipeline

Ongoing and Planned Trials

HORIZANT is still involved in various clinical trials, including Phase 3 and Phase 4 studies. These trials are aimed at exploring additional indications or optimizing treatment protocols.

• Phase 4 Trials: Azurity Pharmaceuticals, Massachusetts General Hospital, and the University of California, Davis are conducting Phase 4 trials to further evaluate the drug's safety and efficacy in different patient populations[5].

Regulatory and Competitive Landscape

Regulatory Environment

The regulatory environment plays a crucial role in the lifecycle of any drug. For HORIZANT, the FDA has approved the drug for specific indications, and any changes in regulatory policies or the approval of new treatments could impact its market position.

Competitive Landscape

The market for RLS and PHN treatments is competitive, with several other drugs available. The entry of generic versions of gabapentin enacarbil will further intensify competition, making it essential for Azurity to maintain a strong market presence through innovative marketing strategies and potential brand extensions.

Financial Projections

Revenue Forecast

Given the impending generic competition, HORIZANT's revenue is expected to decline post-2029. However, the exact financial impact will depend on various factors, including the timing of generic entry, pricing strategies, and the success of any ongoing or planned clinical trials.

Key Takeaways

• Clinical Trials: HORIZANT has been evaluated in several clinical trials for AUD, RLS, and PHN, with mixed results for AUD but established efficacy and safety for RLS and PHN.
• Market Analysis: The drug's market is influenced by its patent status, with generic entry expected in 2029, which will likely reduce its market share and revenue.
• Pipeline: Ongoing and planned clinical trials aim to explore additional indications and optimize treatment protocols.
• Regulatory and Competitive Landscape: The regulatory environment and competitive landscape will continue to shape HORIZANT's market position.

FAQs

What is HORIZANT used for?

HORIZANT is primarily used for the treatment of Restless Legs Syndrome (RLS) and Postherpetic Neuralgia (PHN).

What were the findings of the NIAAA study on HORIZANT for AUD?

The NIAAA study did not show significant differences between HORIZANT and placebo in treating Alcohol Use Disorder (AUD), with common side effects including fatigue, dizziness, and somnolence[1].

When is generic entry expected for HORIZANT?

Generic entry for HORIZANT is estimated to occur on June 10, 2029, pending any patent challenges or licensing agreements[5].

What are the common side effects of HORIZANT?

Common side effects of HORIZANT include somnolence, dizziness, and headache[4].

Are there ongoing clinical trials for HORIZANT?

Yes, there are ongoing Phase 3 and Phase 4 clinical trials for HORIZANT, conducted by various sponsors including Azurity Pharmaceuticals, Massachusetts General Hospital, and the University of California, Davis[5].

Sources

1. National Institute on Alcohol Abuse and Alcoholism. Horizant Study Data Access. [Accessed January 2025].
2. GlobalData. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025. [Accessed January 2025].
3. Mordor Intelligence. Clinical Trials Market Size, Trends Analysis. [Accessed January 2025].
4. FDA. HORIZANT (gabapentin enacarbil) Label. [Accessed January 2025].
5. DrugPatentWatch. When will the patents on HORIZANT expire, and what is the 5 year forecast for HORIZANT?. [Accessed January 2025].