CLINICAL TRIALS PROFILE FOR CLOFAZIMINE

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All Clinical Trials for CLOFAZIMINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000641 ↗	A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
NCT00000796 ↗	A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDR	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00001047 ↗	Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients. Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
NCT00001058 ↗	A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis. It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.

Clinical Trial Conditions for CLOFAZIMINE

Condition Name

Condition Name for CLOFAZIMINE
Intervention	Trials
Tuberculosis	8
HIV Infections	6
Tuberculosis, Multidrug-Resistant	6
Tuberculosis, Pulmonary	5

Condition MeSH

Condition MeSH for CLOFAZIMINE
Intervention	Trials
Tuberculosis	27
Tuberculosis, Multidrug-Resistant	18
Tuberculosis, Pulmonary	16
Mycobacterium Infections	11

Clinical Trial Locations for CLOFAZIMINE

Trials by Country

Trials by Country for CLOFAZIMINE
Location	Trials
United States	88
China	80
South Africa	22
Uzbekistan	7
Australia	7

Trials by US State

Trials by US State for CLOFAZIMINE
Location	Trials
California	7
New York	6
Maryland	5
District of Columbia	5
Illinois	5

Clinical Trial Progress for CLOFAZIMINE

Clinical Trial Phase

Clinical Trial Phase for CLOFAZIMINE
Clinical Trial Phase	Trials
PHASE3	2
PHASE2	1
PHASE1	1

Clinical Trial Status

Clinical Trial Status for CLOFAZIMINE
Clinical Trial Phase	Trials
Recruiting	20
Completed	12
Not yet recruiting	7

Clinical Trial Sponsors for CLOFAZIMINE

Sponsor Name

Sponsor Name for CLOFAZIMINE
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	8
Beijing Chest Hospital	6
Huashan Hospital	6

Sponsor Type

Sponsor Type for CLOFAZIMINE
Sponsor	Trials
Other	206
Industry	12
NIH	9

Last updated: July 28, 2026

Clofazimine clinical trials update, market analysis, and projection: What to watch for efficacy, exclusivity, and commercialization

Clofazimine is an antibacterial candidate being developed primarily for multidrug-resistant leprosy and (in some programs) related mycobacterial indications. Public, decision-grade visibility is limited: the available record does not support a single, current, globally comprehensive view of Phase 2/3 status, registration-enabling timelines, or near-term commercial peak sales across jurisdictions. This report therefore cannot produce a complete, accurate clinical-trials update or market projection with defensible numbers.

What clinical trials are actively evaluating clofazimine, and what are the latest efficacy and safety readouts?

A complete clinical-trials update requires a verifiable, up-to-date trial inventory (registry status, last update dates, enrollment/completion dates, endpoints, and top-line results). The information necessary to produce that inventory is not available in the prompt.

Which clofazimine indications are in scope for the most material development timelines?

The answer depends on the current development branching, including whether programs are focused on leprosy relapse prevention, reaction management, rifampicin-resistant disease, or other mycobacterial targets.

What are the key endpoints used in clofazimine studies?

Endpoint selection changes the regulatory path and timeline risk: relapse rates, microbiologic conversion, histopathologic outcomes, time-to-event for leprosy reactions, and safety discontinuation rates.

Is clofazimine in Phase 2 or Phase 3 for leprosy, and when are readouts expected?

A credible timing outlook depends on the most recent registry records and sponsor communications. The prompt does not provide those data, so a Phase 2/3 schedule cannot be asserted.

What are the trial designs that could change FDA or EMA posture?

Design elements that affect interpretability include randomization, comparator selection (placebo vs standard multidrug therapy), stratification by baseline bacillary load, and handling of concomitant corticosteroid use in reaction outcomes.

How does clofazimine’s mechanism of action translate into differentiated efficacy versus standard leprosy regimens?

Clofazimine is a redox-active agent historically used in leprosy. Differentiation claims require evidence tied to relapse reduction, bacterial kill kinetics, and reaction risk tradeoffs, which are not provided.

What is the clinical safety profile risk for clofazimine in long-duration therapy?

Long-duration oral therapy safety questions typically include dermatologic discoloration, gastrointestinal tolerability, QT considerations, and hepatic effects. A trial-by-trial summary is not possible without the underlying datasets.

Does clofazimine show a meaningful reduction in leprosy reactions or adverse event discontinuations?

This requires safety endpoint reporting from current studies; absent that, no decision-grade claim can be made.

What is the market opportunity for clofazimine: addressable patient pool, pricing assumptions, and realistic adoption?

A market analysis requires quantified baselines: estimated incidence/prevalence for the target indication(s), current standard-of-care regimen penetration, resistance prevalence assumptions, and payer access dynamics, plus competitive entry timing.

What segments drive revenue exposure?

Revenue exposure typically depends on whether clofazimine is sold as:

• a component of multidrug therapy for resistant leprosy,
• a replacement for older agents with better tolerability,
• or a regimen for specific bacillary load subgroups.

No segment definitions with current evidence are supplied.

How sensitive is the commercial forecast to resistance prevalence and guideline adoption?

Forecast sensitivity hinges on the proportion of patients receiving resistant-leprosy regimens, national guideline updates, and procurement cycles.

Which geographies are most likely to adopt clofazimine first?

Geography-by-geography adoption requires:

• local guideline status,
• procurement ecosystems (tendering vs hospital formularies),
• and regulatory authorization pathways (national approval vs WHO/NGO distribution frameworks). Those inputs are not present.

How many competing products exist for the same clofazimine indications?

A defensible competitive set requires current competitor lists and their authorization status, including generic availability for existing multidrug therapy agents and any alternative repurposed drugs in development.

What does exclusivity look like for clofazimine, and when does it lose protection?

A protection and exclusivity timeline needs patent family mapping, Orange Book/EMA patent linkage, and jurisdictional filing/expiration. None is included.

What patents protect clofazimine formulations, dosage forms, or manufacturing?

Formulation and process patents can materially alter generic entry risk. No patent dataset is provided.

What generic or biosimilar entry risks exist for clofazimine?

Entry risk depends on patent status and regulatory pathway: Abbreviated New Drug Application timing (if applicable), Paragraph IV litigation likelihood (if any), and any pediatric exclusivity or data exclusivity overlays. These are not supplied.

Key Takeaways

No decision-grade clinical trials update or market projection can be produced from the information provided. A complete answer requires current, cited trial registry and market baseline data that are not present in the prompt.

FAQs

1. What phase is clofazimine in for leprosy treatment today based on clinical trial registries?
2. Which clofazimine endpoints most influence regulatory approval timing?
3. What is the expected safety and tolerability profile for long-duration clofazimine therapy?
4. How large is the addressable resistant-leprosy market by region?
5. What patents and regulatory exclusivities control clofazimine’s generic entry risk?

References

(No sources were provided in the prompt.)