CLINICAL TRIALS PROFILE FOR DURACLON

All Clinical Trials for Duraclon

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00349921 ↗	Clonidine Versus Adenosine to Treat Neuropathic Pain	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-08-01	The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
NCT00349921 ↗	Clonidine Versus Adenosine to Treat Neuropathic Pain	Completed	Wake Forest School of Medicine	Phase 2	2004-08-01	The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
NCT00349921 ↗	Clonidine Versus Adenosine to Treat Neuropathic Pain	Completed	Wake Forest University Health Sciences	Phase 2	2004-08-01	The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
NCT00510016 ↗	Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome	Completed	Johns Hopkins University	Phase 2	2002-07-01	To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
NCT00510016 ↗	Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2002-07-01	To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
NCT00678379 ↗	Pediatric Tonsillectomy Pain Reduction Study	Completed	Vanderbilt University Medical Center	Phase 3	2008-04-01	Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).

Clinical Trial Conditions for Duraclon

Condition Name

Condition Name for Duraclon
Intervention	Trials
Postoperative Pain	2
Neonatal Abstinence Syndrome	2
Total Hip and Knee Arthroplasty	1
Total Hip Arthroplasty	1

Condition MeSH

Condition MeSH for Duraclon
Intervention	Trials
Neonatal Abstinence Syndrome	2
Pain, Postoperative	2
Neuralgia	1
Labor Pain	1

Clinical Trial Locations for Duraclon

Trials by Country

Trials by Country for Duraclon
Location	Trials
United States	7

Trials by US State

Trials by US State for Duraclon
Location	Trials
Maryland	3
Pennsylvania	1
New York	1
Tennessee	1
North Carolina	1

Clinical Trial Progress for Duraclon

Clinical Trial Phase

Clinical Trial Phase for Duraclon
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Duraclon
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for Duraclon

Sponsor Name

Sponsor Name for Duraclon
Sponsor	Trials
Johns Hopkins University	3
National Institute on Drug Abuse (NIDA)	2
Gauda, Estelle B., M.D.	2

Sponsor Type

Sponsor Type for Duraclon
Sponsor	Trials
Other	14
NIH	3

Clinical Trials Update, Market Analysis, and Projections for Larsucosterol (Not DURACLON)

Introduction

Larsucosterol, a drug developed by DURECT Corporation, is currently in the late stages of clinical development for the treatment of alcohol-associated hepatitis (AH). Here, we will provide an update on the clinical trials, market analysis, and projections for this promising therapeutic.

Clinical Trials Update

Phase 2b AHFIRM Trial

The AHFIRM Phase 2b trial has been a pivotal step in the development of larsucosterol. This trial demonstrated significant reductions in 90-day mortality among patients with AH. Specifically, the 30 mg and 90 mg doses of larsucosterol reduced mortality by 57% and 58%, respectively, compared to the placebo group[1][4].

Phase 3 Registrational Trial

Building on the success of the Phase 2b trial, DURECT Corporation has announced the design for its upcoming Phase 3 registrational trial. This single Phase 3 trial will enroll 200 U.S. patients and will have a primary endpoint of 90-day survival. The trial is expected to initiate soon, subject to securing sufficient funding, and topline results are anticipated within two years of trial initiation. The FDA has agreed that a single Phase 3 trial will be sufficient to support a New Drug Application (NDA) under the Breakthrough Therapy designation[1][4].

Market Analysis

Current Market Landscape

The life sciences industry is poised for significant transformation in 2025, driven by digital advancements and scientific innovations. Despite competitive pressures and business volatility, most global life sciences executives are optimistic about the future. Key trends include the integration of general artificial intelligence (gen AI), digital transformation, and the focus on personalized medicine[2].

Clinical Trials Market

The global clinical trials market was valued at USD 80.7 billion in 2023 and is projected to grow at a CAGR of 6.49% from 2024 to 2030. This growth is driven by factors such as the rapid technological evolution, rising prevalence of chronic diseases, and the globalization of clinical trials. Phase II clinical trials, in particular, are expected to witness considerable growth, which is relevant given the current stage of larsucosterol's development[3].

Market Projections for Larsucosterol

Addressing Unmet Need

Alcohol-associated hepatitis is a condition with a high mortality rate, approximately 30% at 90 days. The current lack of effective therapies creates a significant unmet need, which larsucosterol is positioned to address. Based on the Phase 2b data, larsucosterol has the potential to save the lives of tens of thousands of patients yearly who currently have very limited options[1][4].

Competitive Landscape

The life sciences industry is facing several challenges, including the patent cliff, competition from generic drugs and biosimilars, and regulatory uncertainties. However, the Breakthrough Therapy designation for larsucosterol provides a competitive advantage, allowing for a faster and more streamlined regulatory process[2].

Revenue Potential

Given the high mortality rate associated with AH and the lack of effective treatments, larsucosterol has significant revenue potential. If approved, it could capture a substantial share of the market for AH treatments, contributing to the growth of DURECT Corporation and the broader life sciences industry.

Impact of Digital Transformation

Role of Gen AI

The integration of gen AI is expected to have a transformative impact on the life sciences industry. For biopharma companies, AI can reduce costs in research and development, streamline back-office operations, and enhance self-service capabilities for customers. This could further accelerate the development and commercialization of drugs like larsucosterol[2].

Regulatory Environment

FDA Interactions

DURECT Corporation has had collaborative interactions with the FDA, including a Type B meeting under the Breakthrough Therapy designation. This has allowed for agreement on key aspects of the Phase 3 trial protocol, ensuring a clear path forward for regulatory approval[1][4].

Global Regulatory Changes

The life sciences industry is also navigating global regulatory changes and geopolitical uncertainties. However, the Breakthrough Therapy designation for larsucosterol provides a level of stability and support from regulatory bodies, which is crucial for its successful development and approval[2].

Key Takeaways

• Clinical Trials Success: Larsucosterol has shown significant reductions in 90-day mortality in the Phase 2b AHFIRM trial.
• Phase 3 Trial: A single Phase 3 trial is planned to enroll 200 U.S. patients with a primary endpoint of 90-day survival.
• Market Potential: Larsucosterol addresses a significant unmet need in the treatment of AH, with substantial revenue potential.
• Digital Transformation: The integration of gen AI and digital transformation is expected to enhance the development and commercialization of larsucosterol.
• Regulatory Support: The Breakthrough Therapy designation provides a clear and supportive regulatory path.

FAQs

What is the current status of larsucosterol in clinical trials?

Larsucosterol is preparing to enter a Phase 3 registrational trial, following the successful completion of the Phase 2b AHFIRM trial.

What is the primary endpoint of the Phase 3 trial for larsucosterol?

The primary endpoint of the Phase 3 trial is 90-day survival.

How does larsucosterol compare to current treatments for AH?

Larsucosterol has shown a nearly 60% reduction in 90-day mortality compared to standard of care in the Phase 2b trial.

What role does digital transformation play in the development of larsucosterol?

Digital transformation, particularly through the use of gen AI, is expected to streamline operations, reduce costs, and enhance the development and commercialization process.

What are the regulatory implications for larsucosterol?

The Breakthrough Therapy designation allows for a faster and more streamlined regulatory process, including the possibility of a rolling submission for a New Drug Application (NDA).

Sources

1. PR Newswire: DURECT Corporation Announces Phase 3 Registrational Trial Design for Larsucosterol in Alcohol-Associated Hepatitis.
2. Deloitte Insights: 2025 life sciences outlook.
3. Grand View Research: Global Clinical Trials Market Size, Share And Growth Report, 2030.
4. DURECT Corporation: DURECT Corporation Announces Phase 3 Registrational Trial Design for Larsucosterol in Alcohol-Associated Hepatitis.

Last updated: 2025-01-03