CLINICAL TRIALS PROFILE FOR XENAZINE

All Clinical Trials for Xenazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00632645 ↗	Neuroleptic and Huntington Disease Comparison of : Olanzapine, la Tetrabenazine and Tiapride	Completed	Assistance Publique - Hôpitaux de Paris	Phase 3	2009-04-01	Huntington's disease (HD) is autosomal dominant neurodegenerative disease, starting in average (with high variability) in the fourth decade. The disease progression is classically characterized by a cognitive deterioration (cortical-frontal dementia), motor disorders (associating chorea, dystonia and bradykinesia), psychiatric disturbances (combining depression and irritability) and metabolic disorder (cachexia). The disease is fatal within 15 to 20 years in most patients. HD has no cure. Neuroleptics are the main drug used and the only to demonstrate its efficacy on chorea in clinical trials. But neuroleptics have also beneficial and adverse effects on other disease characteristics (motor, psychiatric, cognitive or metabolic). Their profile between beneficial and adverse effects could be different according the neuroleptics and their classification. The aim of this study is to compare beneficial and adverse effects of 3 different neuroleptics in HD.
NCT01543321 ↗	Xenazine in Late Dyskinetic Syndrome With Neuroleptics	Completed	Centre Hospitalier Universitaire, Amiens	Phase 3	2012-05-14	Late dyskinetic syndrome with neuroleptics, or tardive dyskinesia, is the appearance of abnormal involuntary movements (AIM) in patients treated with antipsychotics for at least three months. This important public health issue arises for 15-20% of patients treated with neuroleptics, the most prescribed psychotropic drugs in mental disorders in France, and seriously impacts the patients' quality of life. In over 50% of cases, it is irreversible-that is to say that he will persist despite discontinuation of the offending drug. Risk factors have been described: the age and female gender are established, a higher dosage of antipsychotic, a long-term treatment, a psychiatric condition other than schizophrenia are likely risk factors, intermittent treatment, previous acute dyskinesia, neuroleptics or powerful, longer term use of corrective treatments including anticholinergics are still discussed. Apart from preventive treatment, which consists in using antipsychotics as being coerced, support is disappointing: the etiological treatment, which is to stop the offending antipsychotic, is effective only in less than 50% of cases, the syndrome is most often late irreversible. Must still have the possibility to interrupt the treatment, which is usually impossible in the risk of decompensation of the mental illness for which the neuroleptic was prescribed. Remains symptomatic treatment: functional neurosurgery is only for extreme cases, because it is not without risk, in terms of morbidity and mortality. So it's the medication that is most often offered: many drugs have been proposed, a direct result of the multiplicity of neurotransmitter systems implicated. However, in the vast majority of cases, this approach is disappointing not to say ineffective. The only exception is the tetrabenazine, marketed under the name of Xenazine®. Empirically, neurologists specializing in pathology of the movement are almost unanimous: its efficiency is very good, with good tolerance. Some preliminary studies have reinforced this impression. However, their level of evidence remains low and that is why the investigators propose to implement a prospective multicenter clinical trial, double-blind with placebo which will include two groups of 27 patients.
NCT02509793 ↗	A Pilot Study Assessing Impulsivity in Patients With Huntington's Disease on Xenazine (Tetrabenazine)	Recruiting	H. Lundbeck A/S	Phase 4	2018-08-01	The purpose of this research study is to see if tetrabenazine, which is commonly used to treat Huntington's Disease (HD), reduces the problems of impulsivity that are common in patients with HD. Investigators will also see how the medicine affects aspects of thinking and mood.

Clinical Trial Conditions for Xenazine

Condition Name

Condition Name for Xenazine
Intervention	Trials
Healthy	2
Huntington's Disease	1
Tardive Dyskinesia	1

Condition MeSH

Condition MeSH for Xenazine
Intervention	Trials
Huntington Disease	2
Impulsive Behavior	1
Tardive Dyskinesia	1

Clinical Trial Locations for Xenazine

Trials by Country

Trials by Country for Xenazine
Location	Trials
France	3
India	2
United States	2

Trials by US State

Trials by US State for Xenazine
Location	Trials
Michigan	1
Texas	1

Clinical Trial Progress for Xenazine

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Xenazine
Clinical Trial Phase	Trials
Completed	5
Recruiting	1

Clinical Trial Sponsors for Xenazine

Sponsor Name

Sponsor Name for Xenazine
Sponsor	Trials
Dr. Reddy's Laboratories Limited	2
The University of Texas Health Science Center, Houston	1
William Ondo, MD	1

Sponsor Type

Sponsor Type for Xenazine
Sponsor	Trials
Other	6
Industry	3

Xenazine (Tetrabenazine): Clinical Trials, Market Analysis, and Projections

Introduction to Xenazine

Xenazine, also known as tetrabenazine, is a medication specifically approved by the U.S. FDA for the treatment of chorea associated with Huntington’s disease (HD). Here, we will delve into the clinical trials that led to its approval, its current market standing, and future projections.

Clinical Trials Overview

TETRA-HD Clinical Trial

The pivotal clinical trial that led to Xenazine's approval was the TETRA-HD study (NCT00219804). This was a multicenter, placebo-controlled trial involving 84 patients with Huntington’s disease who could still walk. Participants were randomly assigned to receive either Xenazine or a placebo for 12 weeks. The primary goal was to assess the effect of Xenazine on the Total Maximal Chorea (TMC) score of the Unified Huntington’s Disease Rating Scale (UHDRS)[1][3][4].

• Results: Xenazine significantly reduced chorea severity, with a mean decrease of 5 points on the UHDRS’ TMC score, compared to a 1.5-point drop in the placebo group. A higher proportion of Xenazine-treated patients experienced significant reductions in chorea scores and showed minimal global improvement[1][3][4].

Extension Study

An extension study allowed participants from the TETRA-HD trial to receive Xenazine for up to 80 weeks. This study demonstrated sustained benefits with longer-term treatment, showing a significant 4.6-point reduction on the UHDRS’ TMC score. However, chorea reemerged with an average score increase of 5.3 points after discontinuing Xenazine[1].

Withdrawal Study

A separate study examined the effects of withdrawing Xenazine. Patients who had been on Xenazine for at least two months were switched to a placebo, and the results showed a greater increase in TMC scores compared to those who remained on Xenazine. This study highlighted the rapid reemergence of chorea upon discontinuation of the drug[1].

Ongoing Clinical Trials

Currently, a Phase 4 clinical trial is ongoing to assess whether Xenazine can reduce impulsivity in patients with Huntington’s disease and to evaluate its effects on mood and thinking. This trial includes evaluations for suicidal ideation, depression, and impulsivity before and during treatment[4].

Market Analysis

Market Share and Sales

Xenazine has been a leading drug in the Huntington’s disease treatment market. Between 2012 and 2016, Xenazine's sales ranked highest in this space. However, from 2017 to 2022, Austedo (deutetrabenazine) was forecasted to grow significantly, peaking at $983 million in 2022[2].

Market Size and Growth

The Huntington’s disease treatment market is projected to grow substantially. In 2024, the market size is estimated at USD 555.4 million and is expected to reach USD 6.9 billion by 2037, growing at a CAGR of around 21.5% during the forecast period. The tetrabenazine segment, which includes Xenazine, held the highest market share of 53.6% in 2024 and is expected to continue growing due to its effectiveness in managing chorea[5].

Competitive Landscape

The branded segment of the Huntington’s disease treatment market, which includes Xenazine and Austedo, is witnessing steady growth. These drugs benefit from growing awareness and increased research and development activities aimed at improving efficacy and reducing side effects. Deutetrabenazine, in particular, is gaining traction due to its longer half-life and fewer doses required, which can reduce side effects such as fatigue and depression[5].

Side Effects and Clinical Considerations

Xenazine is associated with several significant side effects, including a slight worsening of mood, cognition, rigidity, and functional capacity. These effects are particularly challenging to distinguish from the natural progression of Huntington’s disease. The drug's short serum half-life and high inter-individual variability in serum levels due to CYP2D6 enzyme activity can complicate therapy and lead to substantial drug-drug interactions[1][3].

Future Projections

Market Growth

The increasing awareness of Huntington’s disease and the demand for effective symptom management medications are driving the growth of the tetrabenazine segment. Novel formulations and treatments involving tetrabenazine with fewer side effects are expected to open new opportunities and continue to increase the revenue share of this segment[5].

Emerging Treatments

Advancements in gene therapies and emerging treatments aimed at slowing the progression of Huntington’s disease are also contributing to market growth. The approval of new drug formulations, such as Austedo XR (deutetrabenazine extended-release tablets), is further enhancing the treatment landscape for HD patients[5].

Key Takeaways

• Clinical Efficacy: Xenazine significantly reduces chorea severity in Huntington’s disease patients, as demonstrated in the TETRA-HD clinical trial.
• Market Standing: Xenazine has been a leading drug in the HD treatment market, though Austedo is gaining prominence.
• Side Effects: The drug is associated with significant side effects, including mood and cognitive worsening, which need careful management.
• Future Growth: The market is expected to grow substantially, driven by increasing awareness and advancements in treatments.
• Emerging Treatments: New formulations and gene therapies are expected to further enhance the treatment options for HD patients.

FAQs

What is Xenazine used for?

Xenazine (tetrabenazine) is used for the treatment of chorea associated with Huntington’s disease.

What were the key findings of the TETRA-HD clinical trial?

The TETRA-HD trial showed that Xenazine significantly reduced chorea severity, with a mean decrease of 5 points on the UHDRS’ TMC score, and a higher proportion of patients experienced significant chorea score reductions and global improvement.

What are the common side effects of Xenazine?

Common side effects include worsening of mood, cognition, rigidity, and functional capacity, as well as potential drug-drug interactions due to CYP2D6 enzyme activity.

How is the Huntington’s disease treatment market projected to grow?

The market is estimated to grow from USD 555.4 million in 2024 to USD 6.9 billion by 2037, with a CAGR of around 21.5%.

What are the emerging treatments in the Huntington’s disease market?

Emerging treatments include new formulations like Austedo XR (deutetrabenazine extended-release tablets) and advancements in gene therapies aimed at slowing the disease progression.

Sources

1. Huntington’s Disease News: Xenazine (tetrabenazine) for Huntington’s disease.
2. Business Wire: Huntington’s Disease Market Spotlight 2017.
3. Small-Cap Research: Tetrabenazine’s Therapeutic Profile.
4. Rare Disease Advisor: Xenazine (Tetrabenazine).
5. Research Nester: Huntington’s Disease Treatment Market Size & Share, Forecast.