CLINICAL TRIALS PROFILE FOR GUANFACINE HYDROCHLORIDE

All Clinical Trials for Guanfacine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004376 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder	Completed	Yale University	Phase 3	1994-09-01	OBJECTIVES: I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.
NCT00004376 ↗	Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder	Completed	National Center for Research Resources (NCRR)	Phase 3	1994-09-01	OBJECTIVES: I. Evaluate the safety and efficacy of the alpha-2 adrenergic agonist guanfacine in children and adolescents with Tourette syndrome or other chronic tic disorder, and attention deficit hyperactivity disorder.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	US Department of Veterans Affairs		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.
NCT00007592 ↗	Hypertension Screening and Treatment Program	Completed	VA Office of Research and Development		1989-06-01	Hypertension is one of the most common medical problems in the United States and in the VA health care system. It has been well-documented that hypertension can be effectively treated. However, there remain important unresolved clinical questions in the area of antihypertensive treatment. For example, how much is mortality affected by visit compliance, blood pressure control and type of antihypertensive agent? Or, are some regimens associated with more morbidity than others? Or, are there inexpensive regimens that are as effective as more expensive regimens? The amount of data that is available from this demonstration project (currently 6,100 patients) will help address these questions. The answers to these questions should result in better care for veterans with hypertension.

Clinical Trial Conditions for Guanfacine Hydrochloride

Condition Name

Condition Name for Guanfacine Hydrochloride
Intervention	Trials
Attention Deficit Hyperactivity Disorder	7
ADHD	5
Attention Deficit Disorder With Hyperactivity	5
Attention-deficit/Hyperactivity Disorder	5

Condition MeSH

Condition MeSH for Guanfacine Hydrochloride
Intervention	Trials
Attention Deficit Disorder with Hyperactivity	24
Hyperkinesis	19
Disease	19
Syndrome	6

Clinical Trial Locations for Guanfacine Hydrochloride

Trials by Country

Trials by Country for Guanfacine Hydrochloride
Location	Trials
United States	244
Spain	13
United Kingdom	13
Germany	11
France	10

Trials by US State

Trials by US State for Guanfacine Hydrochloride
Location	Trials
Connecticut	19
New York	16
California	13
Tennessee	11
Florida	10

Clinical Trial Progress for Guanfacine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Guanfacine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	12
Phase 2	18

Clinical Trial Status

Clinical Trial Status for Guanfacine Hydrochloride
Clinical Trial Phase	Trials
Completed	43
Recruiting	11
Not yet recruiting	4

Clinical Trial Sponsors for Guanfacine Hydrochloride

Sponsor Name

Sponsor Name for Guanfacine Hydrochloride
Sponsor	Trials
Shire	22
Yale University	17
National Institute on Drug Abuse (NIDA)	11

Sponsor Type

Sponsor Type for Guanfacine Hydrochloride
Sponsor	Trials
Other	75
Industry	27
NIH	25

Guanfacine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Guanfacine Hydrochloride

Guanfacine hydrochloride is a non-stimulant medication primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. It is also being explored for various other indications, including anxiety disorders, stress disorders, and substance use disorders.

Current Clinical Trials

ADHD and Related Conditions

• Attention Deficit Hyperactivity Disorder (ADHD): Guanfacine extended-release (Intuniv) is being studied in several ongoing trials. A Phase 4 study sponsored by Shire is recruiting participants to evaluate the efficacy and safety of TAK-503 (guanfacine XR) in children and teenagers with ADHD. This trial, expected to complete by June 2027, aims to assess the long-term efficacy and safety of guanfacine in this population[1].
• Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD): While not the primary focus, the expanding indications for guanfacine hydrochloride tablets include potential use in treating ODD and CD, which could drive future market growth[5].

Other Indications

• Prader-Willi Syndrome: A completed Phase 4 trial investigated the use of guanfacine extended-release for reducing aggression and self-injurious behavior in patients with Prader-Willi Syndrome. The results indicated potential benefits in improving cognitive functioning and frontotemporal brain activity[1].
• Alcohol Use Disorders: A Phase 2 trial at Yale University is recruiting participants to evaluate the mechanistic effects of guanfacine on drinking behavior in women and men with alcohol use disorders. This trial is expected to complete by February 2026[1].
• Opioid-induced Hyperalgesia: A Phase 4 trial at Massachusetts General Hospital is assessing the effect of guanfacine on opioid-induced hyperalgesia and tolerance. This trial is active but not recruiting new participants[1].
• Alzheimer's Disease: A Phase 3 trial at Imperial College London is evaluating guanfacine as an add-on to cholinergic treatment in people with Alzheimer's disease. The trial aims to assess cognitive performance and other secondary outcomes[4].

Market Analysis

Market Size and Growth

The guanfacine hydrochloride tablets market has experienced significant growth in recent years and is projected to continue this trend. As of 2023, the market size was estimated to be USD 238.6 million, with a projected growth to USD 478.4 million by 2033, at a Compound Annual Growth Rate (CAGR) of 7.3% from 2024 to 2033[5].

Key Drivers

• Increasing Prevalence of ADHD: The rising prevalence of ADHD is a major driver for the guanfacine hydrochloride tablets market. Increased awareness and recognition of ADHD are leading to higher demand for effective treatment options[5].
• Development of Novel Formulations: The introduction of extended-release tablets and orally disintegrating tablets is enhancing patient convenience and adherence, driving market growth[5].
• Expanding Indications: Potential uses in treating anxiety disorders, tic disorders, and sleep disturbances associated with ADHD are expected to further expand the market[5].

Regional Analysis

• North America: This region is the largest market for guanfacine hydrochloride tablets, driven by the high prevalence of ADHD, well-established healthcare infrastructure, and favorable reimbursement scenarios. The United States is the major contributor to this market[5].
• Europe: Europe is the second-largest market, supported by the rising prevalence of ADHD and increasing focus on mental health. The adoption of non-stimulant medications like guanfacine hydrochloride tablets is growing in this region[5].
• Asia-Pacific: This region is projected to witness the highest growth rate, fueled by a large patient population, improving healthcare infrastructure, and increasing awareness about ADHD in countries like China, India, and Japan[5].

Market Opportunities and Challenges

Opportunities

• Adjunctive Therapy: The use of guanfacine hydrochloride tablets as an adjunctive therapy to stimulant medications, particularly in patients with suboptimal response or intolerance to stimulants, presents new growth avenues[5].
• Collaborations and Awareness: Collaborations between pharmaceutical companies and healthcare providers to increase awareness and improve patient access to effective ADHD treatments could drive market growth[5].
• New Indications: Exploring new indications such as anxiety disorders, tic disorders, and sleep disturbances associated with ADHD could further expand the market's scope[5].

Challenges

• Generic Versions: The availability of generic versions of guanfacine hydrochloride tablets may restrain market growth to some extent[5].
• Side Effects: Potential side effects associated with the use of guanfacine hydrochloride tablets, such as decreased blood pressure, decreased heart rate, and transient rebound increases in blood pressure and heart rate upon abrupt discontinuation, may also impact market growth[3].

Future Outlook

The guanfacine hydrochloride tablets market is poised for steady growth driven by the increasing prevalence of ADHD, rising awareness about the disorder, and the growing demand for effective and safe treatment options. The market is expected to witness a shift towards personalized medicine in ADHD treatment, taking into account individual patient characteristics and comorbidities, which could drive the adoption of guanfacine hydrochloride tablets as a non-stimulant option[5].

Personalized Medicine

The future of ADHD treatment is likely to involve more personalized approaches, considering individual patient characteristics and comorbidities. Guanfacine hydrochloride tablets, with their non-stimulant profile, are well-positioned to benefit from this trend.

Emerging Markets

The Asia-Pacific region, with its large patient population and improving healthcare infrastructure, is expected to be a significant growth area for the guanfacine hydrochloride tablets market. Increasing awareness about ADHD in countries like China, India, and Japan will drive demand for effective treatments[5].

Key Takeaways

• Clinical Trials: Guanfacine hydrochloride is being studied in various clinical trials for ADHD, Prader-Willi Syndrome, alcohol use disorders, opioid-induced hyperalgesia, and Alzheimer's disease.
• Market Growth: The market is projected to grow from USD 238.6 million in 2023 to USD 478.4 million by 2033, driven by the increasing prevalence of ADHD and the development of novel formulations.
• Regional Analysis: North America is the largest market, followed by Europe, with the Asia-Pacific region expected to witness the highest growth rate.
• Opportunities and Challenges: The market presents opportunities for growth through adjunctive therapy, new indications, and collaborations, but faces challenges from generic versions and potential side effects.

FAQs

What is guanfacine hydrochloride used for?

Guanfacine hydrochloride is primarily used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. It is also being explored for other indications such as anxiety disorders, stress disorders, and substance use disorders.

What are the current clinical trials for guanfacine hydrochloride?

Current trials include studies for ADHD, Prader-Willi Syndrome, alcohol use disorders, opioid-induced hyperalgesia, and Alzheimer's disease. For example, a Phase 4 trial is evaluating the long-term efficacy and safety of guanfacine XR in children and teenagers with ADHD.

What is the projected market size for guanfacine hydrochloride tablets?

The market size is estimated to grow from USD 238.6 million in 2023 to USD 478.4 million by 2033, at a CAGR of 7.3% from 2024 to 2033.

What are the key drivers for the guanfacine hydrochloride tablets market?

Key drivers include the increasing prevalence of ADHD, the development of novel formulations, and the expanding indications for guanfacine hydrochloride tablets.

Which region is expected to witness the highest growth rate for guanfacine hydrochloride tablets?

The Asia-Pacific region is projected to witness the highest growth rate, driven by a large patient population, improving healthcare infrastructure, and increasing awareness about ADHD.

Sources

1. LARVOL Sigma: Intuniv (guanfacine XR) News - LARVOL Sigma.
2. Market Research Intellect: Guanfacine Hydrochloride Tablets Market Size, Scope And Forecast.
3. FDA: MEDICAL REVIEW(S) - accessdata.fda.gov.
4. ALZFORUM: Guanfacine | ALZFORUM.
5. Data Horizon Research: Guanfacine Hydrochloride Tablets Market Size, Share, Growth.