Lamprene

(Clofazimine)

ApprovedSmall molecule

Novartis

Lamprene is one of 249 small molecule programs targeting Mycobacterium infection. It is currently in Approved.

Indications

Total Trials

Active Trials

248

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Mycobacterium InfectionActive, not recruiting

LeprosyActive, not recruiting

Crohn's DiseaseActive, not recruiting

Pulmonary TuberculosisActive, not recruiting

Drug-Resistant TuberculosisActive, not recruiting

Tuberculosis, Multidrug-ResistantActive, not recruiting

Tuberculosis, PulmonaryActive, not recruiting

Mycobacterium Avium ComplexActive, not recruiting

DrugCompleted

TreatmentCompleted

Mycobacterium InfectionPreclinical

Active, not recruiting

LeprosyApproved

Active, not recruiting

Crohn's DiseaseApproved

Active, not recruiting

Pulmonary TuberculosisPreclinical

Active, not recruiting

Drug-Resistant TuberculosisPreclinical

Active, not recruiting

Tuberculosis, Multidrug-ResistantPhase 2

Active, not recruiting

Tuberculosis, PulmonaryPhase 2

Active, not recruiting

Mycobacterium Avium ComplexPhase 2

Active, not recruiting

DrugPhase 3

Completed

TreatmentPreclinical

Completed

Showing 10 of 15 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Lamprene

Novartis

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Sirturo

WWim Janssens

Preclinical

1 8

Lotemax

PPharmos

Preclinical

1 9

Norpramin

VValidus Pharmaceuticals

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Tuberculosis

NCT06081361

Q1 2027

Phase 2Active, not recruiting

Tuberculosis, Pulmonary

NCT05556746

Q2 2027

Phase 2Active, not recruiting

Tuberculosis, Multidrug-Resistant

NCT03828201

Phase 3Active, not recruiting

Tuberculosis

NCT06649721

Q3 2028

N/ANot yet recruiting

Drug-Resistant Tuberculosis

NCT07126639

N/ANot yet recruiting

RR-TB

NCT07198685

Clinical

Trials by Indication[1]

Tuberculosis5 trials

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezolid, Delamanid and Bedaquiline Cohort

Active, not recruiting·—·Phase 3·NCT06081361·186 enrolled

Building Evidence for Advancing New Treatment for Rifampicin Resistant Tuberculosis (RR-TB) Comparing a Short Course of Treatment (Containing Bedaquiline, Delamanid and Linezolid) With the Current South African Standard of Care

Completed·WWits Health Consortium (Pty) Ltd·Phase 3·NCT04062201·402 enrolled

Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BDLL Chinese Cohort

Active, not recruiting·HHuashan Hospital·Phase 3·NCT06649721·120 enrolled

Show 2 more trials

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

Completed·IIUATLD, Inc·Phase 3·NCT02409290·588 enrolled

Two-month Regimens Using Novel Combinations to Augment Treatment Effectiveness for Drug-sensitive Tuberculosis

Completed·UUniversity College, London·Phase 2/3·NCT03474198·675 enrolled

Mycobacterium Avium Complex2 trials

A Randomized Controlled Prophylactic Study of Clofazimine To Prevent Mycobacterium Avium Complex Infection in HIV Disease

Completed·UUniversity of California, San Francisco·N/A·NCT00002058

Clofazimine in the Treatment of Pulmonary Mycobacterium Avium Complex (MAC)

Active, not recruiting·OOregon Health and Science University·Phase 2·NCT02968212·102 enrolled

Drug2 trials

Linezolid Dosing Strategies in Drug-Resistant TB

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05007821·138 enrolled

Evaluating Newly Approved Drugs for Multidrug-resistant TB

Completed·MMédecins Sans Frontières, France·Phase 3·NCT02754765·754 enrolled

Pulmonary Tuberculosis2 trials

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)

Completed·GGlobal Alliance for TB Drug Development·Phase 2·NCT01691534·105 enrolled

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 (MDRTB) in HIV-Infected Patients.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000796·525 enrolled

Abscess2 trials

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Bacteriophage Therapy for Mycobacterium Abscessus Pulmonary Infection

Enrolling by invitation·VVancouver Coastal Health·Phase 1·NCT07228702·1 enrolled

20 more indications

Quality of Life1 trial

Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

Completed·MMedecins Sans Frontieres, Netherlands··NCT03942354·137 enrolled

Clinical Trial1 trial

Pragmatic Clinical Trial for a More Effective Concise and Less Toxic MDR-TB Treatment Regimen(s)

Completed·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT02589782·552 enrolled

Bacterial Disease1 trial

Pharmacokinetic Study With a Loading Dose of Clofazimine in Adult Patients With Nontuberculous Mycobacterial Disease

Completed·RRadboud University Medical Center·Phase 2·NCT05294146·12 enrolled

Treatment1 trial

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

Completed·HHuashan Hospital·N/A·NCT04717908·89 enrolled

Fluoroquinolone1 trial

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

Completed·MMédecins Sans Frontières, France·Phase 3·NCT03896685·323 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

Completed·AAbbott·N/A·NCT00002331

Multidrug-Resistant Tuberculosis1 trial

A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants With Multidrug-resistant Tuberculosis in China

Unknown status·—·Phase 4·NCT05306223·212 enrolled

Erythema1 trial

Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy

Completed·PPaul Saunderson·Phase 4·NCT01290744·100 enrolled

Drug-Resistant Tuberculosis1 trial

A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07126639·200 enrolled

COVID-191 trial

Dual Therapy With Interferon Beta-1b and Clofazimine for COVID-19

Unknown status·TThe University of Hong Kong·Phase 2·NCT04465695·81 enrolled

Cystic Fibrosis1 trial

Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

HIV-Infected Individuals1 trial

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·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000641·90 enrolled

Cryptosporidiosis1 trial

A Phase 2A Evaluation of the Safety, Tolerability, Pharmacokinetics, Efficacy of Clofazimine (CFZ) in Cryptosporidiosis

Terminated·UUniversity of Washington·Phase 2·NCT03341767·33 enrolled

Mycobacterium avium complex disease1 trial

Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001047·400 enrolled

RR-TB1 trial

6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province

Not yet recruiting·WWuhan Pulmonary Hospital·N/A·NCT07198685·52 enrolled

Mycobacterium Infections1 trial

Natural History, Genetics, Phenotype, and Treatment of Mycobacterial Infections

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00018044·1,000 enrolled

Tuberculosis, Pulmonary1 trial

A Phase IIc, Open-Label, Randomized Controlled Trial of Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible Tuberculosis (PRESCIENT)

Active, not recruiting·BBrigham and Women's Hospital·Phase 2·NCT05556746·94 enrolled

HIV1 trial

A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04311502·104 enrolled

Tuberculosis, Multidrug-Resistant1 trial

Prospective, Randomized, Partially Blinded, Phase 2 Study of the Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

Active, not recruiting·BBoston University·Phase 2·NCT03828201·271 enrolled

Unspecified2 trials

Economic Evaluation of New MDR TB Regimens

Completed·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT04207112·73 enrolled

PRACTECAL-PKPD Sub Study

Unknown status·MMedecins Sans Frontieres, Netherlands·Phase 2/3·NCT04081077·240 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 15, 1986

LAMPRENE

NDA NDA019500

Dec 15, 1986

LAMPRENE

NDA NDA019500

Mar 30, 1989

LAMPRENE

NDA NDA019500

Jul 20, 1995

LAMPRENE

NDA NDA019500

Sep 5, 1995

LAMPRENE

NDA NDA019500

Sep 12, 1995

LAMPRENE

NDA NDA019500

Jan 16, 1998

LAMPRENE

NDA NDA019500

Jul 13, 2000

LAMPRENE

NDA NDA019500

Jun 20, 2001

LAMPRENE

NDA NDA019500

Apr 12, 2002

LAMPRENE

NDA NDA019500

Jun 11, 2003

LAMPRENE

NDA NDA019500

Jul 8, 2016

LAMPRENE

NDA NDA019500

Jan 31, 2019

LAMPRENE

NDA NDA019500

Sources

References

[1]
ClinicalTrials.gov — 34 trial records for Clofazimine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Clofazimine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Clofazimine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA019500). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Lamprene

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2028

Trials by Indication[1]

Tuberculosis5 trials

Mycobacterium Avium Complex2 trials

Drug2 trials

Pulmonary Tuberculosis2 trials

Abscess2 trials

Quality of Life1 trial

Clinical Trial1 trial

Bacterial Disease1 trial

Treatment1 trial

Fluoroquinolone1 trial

Effectiveness1 trial

Multidrug-Resistant Tuberculosis1 trial

Erythema1 trial

Drug-Resistant Tuberculosis1 trial

COVID-191 trial

Cystic Fibrosis1 trial

HIV-Infected Individuals1 trial

Cryptosporidiosis1 trial

Mycobacterium avium complex disease1 trial

RR-TB1 trial

Mycobacterium Infections1 trial

Tuberculosis, Pulmonary1 trial

HIV1 trial

Tuberculosis, Multidrug-Resistant1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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