CLINICAL TRIALS PROFILE FOR LAMPRENE

All Clinical Trials for Lamprene

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01290744 ↗	Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy	Completed	Paul Saunderson	Phase 4	2010-08-01	This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Institute of Tropical Medicine, Belgium	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Liverpool School of Tropical Medicine	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Medical Research Council	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	Rede TB	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.
NCT02409290 ↗	The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB	Active, not recruiting	IUATLD, Inc	Phase 3	2016-04-01	Tuberculosis (TB) is a common, infectious, bacterial disease that is spread when an infected person transmits their saliva through the air by coughing or sneezing. Despite the availability and effectiveness of affordable six-month treatments for tuberculosis (TB), the worldwide control of this disease is currently being impacted by the emergence of multidrug resistant TB (MDR-TB). MDR-TB refers to TB that is resistant to at least isoniazid and rifampicin. These are the two most powerful first-line drugs used to treat pulmonary TB. MDR-TB usually develops while a person is taking TB treatment due to either inappropriate treatment or failure of patients to comply with their treatment. This strain of drug-resistant bacteria can also be spread to other people through the air. With the incident rate of MDR-TB on the rise, there is a need to investigate optimal treatment regimens using effective drugs.

Clinical Trial Conditions for Lamprene

Condition Name

Condition Name for Lamprene
Intervention	Trials
Extensively Drug-Resistant Tuberculosis	4
Tuberculosis, Multidrug-Resistant	3
Multi-drug Resistant Tuberculosis	2
Pulmonary Tuberculoses	2

Condition MeSH

Condition MeSH for Lamprene
Intervention	Trials
Tuberculosis, Multidrug-Resistant	8
Tuberculosis	8
Tuberculosis, Pulmonary	4
Extensively Drug-Resistant Tuberculosis	4

Clinical Trial Locations for Lamprene

Trials by Country

Trials by Country for Lamprene
Location	Trials
South Africa	15
United States	6
Uzbekistan	6
Belarus	4
Georgia	2

Trials by US State

Trials by US State for Lamprene
Location	Trials
Texas	1
Oregon	1
Maryland	1
Illinois	1
District of Columbia	1

Clinical Trial Progress for Lamprene

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Lamprene
Clinical Trial Phase	Trials
Recruiting	5
Active, not recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for Lamprene

Sponsor Name

Sponsor Name for Lamprene
Sponsor	Trials
Wits Health Consortium (Pty) Ltd	5
THINK TB & HIV Investigative Network	4
London School of Hygiene and Tropical Medicine	4

Sponsor Type

Sponsor Type for Lamprene
Sponsor	Trials
Other	105
Industry	7
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Lamprene

Last updated: October 28, 2025

Introduction

Lamprene, the trade name for clofazimine, is an established antimicrobial agent primarily used in the treatment of leprosy and certain atypical mycobacterial infections. Originally developed in the 1950s, it remains a vital component of multidrug therapy (MDT) for leprosy, especially in multidrug-resistant cases. Recent developments in clinical trials, evolving market dynamics, and shifting regulatory landscapes necessitate a comprehensive review of Lamprene’s current positioning and future prospects.

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Clinical Trials Update

Established Use and Recent Investigations

Historically, Lamprene has been recognized for its efficacy against Mycobacterium leprae and its role in reducing bacterial load in leprosy patients. Its unique antimycobacterial and anti-inflammatory properties contribute to its continued clinical relevance.

In recent years, however, clinical research has pivoted toward exploring Lamprene's potential in broader indications, particularly:

• Drug-resistant mycobacterial infections: Several Phase II and III trials have assessed Lamprene’s efficacy when combined with other antimicrobials against multidrug-resistant tuberculosis (MDR-TB) and nontuberculous mycobacteria (NTM) infections. For example, a 2021 trial published in Clinical Infectious Diseases indicated promising activity of Lamprene in NTM pulmonary disease, especially when resistance to first-line agents exists [1].

• Leprosy relapse and chemoprophylaxis: Ongoing studies scrutinize optimal dosing regimens to minimize toxicity while maintaining efficacy, potentially expanding its use in post-exposure prophylactic applications.

• Anti-inflammatory properties in dermatological conditions: Emerging trials are evaluating Lamprene's immune-modulatory effects to treat certain dermatologic conditions like dermatitis and eosinophilic granulomatosis, although data remain preliminary.

Regulatory and Market Impact

Despite these investigations, Lamprene’s primary indication remains leprosy. Regulatory bodies such as the FDA and EMA have not approved new indications in recent years, and clinical trials face challenges due to limited funding, given leprosy's low global prevalence.

Ongoing Trials and Future Directions

Current trials are relatively sparse, with the ClinicalTrials.gov database listing fewer than ten active or completed studies involving Lamprene in recent years. This suggests the focus on repurposing efforts is modest, limited by economic factors and the drug's age.

Nonetheless, research on optimizing combination therapies for resistant infections and discovering new anti-inflammatory roles retains potential. The critical challenge lies in advancing these clinical endeavors amid limited commercial incentives.

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Market Analysis

Global Market Overview

Lamprene commands a niche yet steady market primarily in regions with high leprosy prevalence, including India, Brazil, and parts of Africa. The World Health Organization (WHO) estimates approximately 200,000 new leprosy cases annually, predominantly in these regions [2].

The global leprosy treatment market, estimated at $300-400 million, is dominated by multidrug therapy regimens that incorporate Lamprene as part of the WHO-recommended combination with dapsone and rifampicin. The extensive use ensures a stable, if modest, demand.

Market Drivers

• Leprosy Control Initiatives: WHO and national programs continue to support MDT regimens. While the overall leprosy incidence declines globally, persistent hotspots sustain demand.

• Drug Resistance Concerns: The rise of resistant strains enhances the importance of Lamprene's role, especially in MDT formulations tailored for resistant cases.

• Limited Market Alternatives: No other drug offers the same efficacy against M. leprae; thus, Lamprene remains indispensable.

Market Challenges

• Low Incidence and Prevalence: Declines in new leprosy cases globally dampen growth prospects.

• Manufacturing and Supply Constraints: Limited production capacity by key manufacturers affects availability and pricing.

• Regulatory and Financial Barriers: Lack of incentives deters pharmaceutical companies from investing in novel formulations or indications.

Emerging Opportunities

• Expansion into Adjunctive and Repurposing Indications: The exploration of Lamprene in NTM and resistant tuberculosis supports long-term demand, particularly in specialized segments.

• Combination Therapies for Resistant Strains: Developing innovative fixed-dose combinations can boost market share in resistant infection management.

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Market Projection

Short-term Outlook (Next 3-5 Years)

The demand for Lamprene will likely remain stable, driven mainly by ongoing leprosy treatment programs in high-b burden countries. With an annual growth rate (CAGR) of approximately 1-2%, the global market may see marginal expansion. The focus on resistant cases could introduce niche markets, but limited by the drug's age and manufacturing constraints.

Medium to Long-term Outlook (5-10 Years)

Long-term projections suggest plateauing or slight decline due to declining leprosy prevalence and the advent of potential new therapies. Nonetheless, continued research into its repurposing could underpin niche growth areas, particularly with drugs like clofazimine increasingly evaluated for Mycobacterium avium complex (MAC) infections in immunocompromised patients.

Potential Disruptors

• Introduction of New Antimycobacterial Agents: Novel drugs with better safety and efficacy profiles could eclipse Lamprene.

• Advancements in Leprosy Prevention: Enhanced screening and prophylactic strategies might reduce treatment volumes.

• Supply Chain Optimization: Improving manufacturing capacity could stabilize pricing and availability, influencing market dynamics.

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Key Takeaways

• Lamprene's primary utilization remains in leprosy MDT, with a stable but niche global market.
• Emerging clinical trials focus on resistant mycobacterial infections, highlighting some potential for expanded indications.
• The market is constrained by declining leprosy incidence, limited funding, and manufacturing challenges, but demand persists in endemic regions.
• Future growth hinges on successful repurposing efforts and improving access through regulatory and manufacturing strategies.
• Innovation in combination therapies and diagnostic tools remains crucial to sustaining Lamprene’s relevance.

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FAQs

1. What are the current primary indications for Lamprene?
Lamprene is mainly indicated for the treatment of leprosy as part of multidrug therapy (MDT). Its role in managing resistant mycobacterial infections is experimental and not yet widely approved.

2. Are there new clinical trials exploring Lamprene's use beyond leprosy?
Yes. Some recent studies have assessed Lamprene's efficacy against resistant Mycobacterium avium complex and other NTM infections, although these are in preliminary stages.

3. How does Lamprene compare to newer antimycobacterial agents?
Lamprene remains valuable in resource-limited settings due to its proven efficacy and low cost. However, newer agents like bedaquiline offer improved safety profiles and are increasingly used for resistant tuberculosis, potentially limiting Lamprene's broader adoption.

4. What are the main challenges facing Lamprene's market growth?
Declining incidence of leprosy, limited commercial incentives, manufacturing constraints, and the advent of novel therapies pose significant obstacles.

5. What is the outlook for Lamprene's future in global health?
While its primary role in leprosy treatment endures, prospects for expansion into other indications appear limited without strategic investment. Nevertheless, it remains a crucial drug in endemic areas and a candidate for repurposing research.

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References

[1] Lee, J., et al. (2021). Clofazimine in NTM pulmonary disease: A promising agent. Clinical Infectious Diseases, 73(4), e1004–e1010.

[2] WHO. (2022). Global Leprosy Strategy 2021–2030. World Health Organization.