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clofazimine

Trade name: lamprene

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 15, 1986

Clofazimine (Lamprene®) is a fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine (Lamprene®) exerts a slow bactericidal effect on Mycobacterium leprae (Hansen’s bacillus). It inhibits mycobacterial growth and binds preferentially to mycobacterial DNA. It also exerts anti-inflammatory properties in controlling erythema nodosum leprosum reactions. However, its precise mechanisms of action are unknown. — NCATS

Clinical trial activity

44 trials · 96 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
22
Phase 3
17
Phase 4
6

Earliest trial started Jan 1, 1994 (NCT00002331)

Timeline

1980s

  1. Jun 11, 1984

    Orphan Drug Designation

  2. Dec 15, 1986

    Novartis — Earliest FDA Approval

  3. Dec 15, 1986

    Novartis — NDA Organization

  4. Dec 15, 1986

    Novartis — NDA Secondary Org

1990s

  1. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • DNAINHIBITOR

    DNA inhibitor

    Direct DNA binding

Approval history

  • approvedPriority reviewDec 15, 1986

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)\N=C1/C=C2N(C3=CC=C(Cl)C=C3)C4=C(C=CC=C4)N=C2C=C1NC5=CC=C(Cl)C=C5
Mol. weight
473.396 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • chlofazimine
  • clofazimin
  • clofazimin
  • clofazimina
  • clofazimina
  • clofazimine
  • clofazimine
  • clofazimine
  • clofazimine
  • clofazimine
  • clofazimine
  • clofazimine
  • clofazimine
  • clofazimine
  • clofaziminum
  • clofaziminum
  • g-30320
  • g-30320
  • lamprene
  • lamprene
  • lamprene
  • lamprene
  • lamprene
  • lamprene
  • lamprene
  • riminophenazine
  • riminophenazine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07198685N/ASep 30, 2025Huazhong University of Science and Technology
NCT07126639N/ASep 1, 2025Huazhong University of Science and Technology
NCT06649721Phase 3Nov 15, 2024Capital Medical University, Fudan University
NCT06418711Phase 3Sep 11, 2024MannKind Corp
NCT06081361Phase 3Nov 1, 2023Capital Medical University
NCT05556746Phase 2Mar 31, 2023Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Harvard University, Stellenbosch University, University of California, Los Angeles, University of Cape Town
NCT05306223Phase 4May 10, 2022Capital Medical University
NCT05294146Phase 2Feb 14, 2022Radboud University
NCT05007821Phase 2Sep 13, 2021National Institute of Allergy and Infectious Diseases (NIAID)
NCT05278988Phase 4Apr 1, 2021Anhui Medical University, Fudan University, Huazhong University of Science and Technology, Jiao Tong University, Weifang People's Hospital, Zhengzhou University
NCT04717908N/AJan 20, 2021Fudan University
NCT04465695Phase 2Jul 14, 2020The University of Hong Kong
NCT04311502Phase 2Jun 18, 2020National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco
NCT04310930Phase 2/Phase 3 (Phase 3)Mar 31, 2020Cystic Fibrosis Foundation, Erasmus University Rotterdam, Government of Australia, Griffith University, James Cook University Hospital, Middlesbrough, UK, Monash University, Murdoch University, Newcastle University, South Australian Health and Medical Research Institute, University of Copenhagen, University of Manitoba, University of Melbourne, University of Paris, University of Queensland
NCT03828201Phase 3Jan 31, 2020Boston University, Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), Novartis, Otsuka, Pfizer, University of California, San Francisco, University of Colorado, Denver, Westat
NCT04207112Phase 2/Phase 3 (Phase 3)Jan 31, 2020Government of Belarus, Government of Uzbekistan, Medecins Sans Frontieres, TB & HIV Investigative Network (THINK), University of Liverpool, University of London, Wits Health Consortium (Pty) Ltd
NCT04081077Phase 2/Phase 3 (Phase 3)Oct 1, 2019Drugs for Neglected Diseases Initiative, ERT Clinical, Global Alliance for TB Drug Development, Government of Belarus, Government of Uzbekistan, Hackensack University Medical Center, Medecins Sans Frontieres, Republican Research and Practical Centre for Pulmonology and Tuberculosis, TB & HIV Investigative Network (THINK), University of Basel, University of California, San Francisco, University of Liverpool, University of London, Wits Health Consortium (Pty) Ltd, World Health Organization
NCT04062201Phase 3Aug 31, 2019University of California, San Francisco, University of Cape Town, University of the Witwatersrand, Wits Health Consortium (Pty) Ltd
NCT03942354Phase 2/Phase 3 (Phase 3)Jul 1, 2019Don McKenzie Hospitals, Kwazulu Natal, South Africa, Doris Goodwin Hospitals, Kwazulu Natal, South Africa, Medecins Sans Frontieres, Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital, Republican specialised scientific-practical medical centre, Tashkent, Republican TB Hospital No. 2, Nukus, University of London, University of Sussex
NCT03896685Phase 3Jun 30, 2019Epicentre, Harvard University, Institute of Tropical Medicine, Belgium, Interactive Research and Development, Medecins Sans Frontieres, Partners in Health, Socios En Salud, Peru
Showing 20 of 44 trials
Page 1 / 3

Organizations

Research & Development (96)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government8641999
Medecins Sans FrontieresAcademic/Hospital6612016
University of California, San FranciscoAcademic/Hospital5131999
University of LondonAcademic/Hospital5112017
Capital Medical UniversityAcademic/Hospital4332019
Fudan UniversityAcademic/Hospital4332019
Harvard UniversityAcademic/Hospital4122016
Global Alliance for TB Drug DevelopmentAcademic/Hospital3122012
Government of BelarusGovernment3012017
Government of UzbekistanGovernment3012017
Huazhong University of Science and TechnologyAcademic/Hospital3322021
RedHill BiopharmaFor profit3322013
TB & HIV Investigative Network (THINK)Academic/Hospital3012017
University of LiverpoolAcademic/Hospital3022017
Wits Health Consortium (Pty) LtdAcademic/Hospital3112019
Baylor UniversityAcademic/Hospital2012013
Boston UniversityAcademic/Hospital2122003
Drugs for Neglected Diseases InitiativeAcademic/Hospital2012017
EpicentreFor profit2012016
ERT ClinicalFor profit2012017
96 organizations
Page 1 / 5

Marketing (2)

OrganizationOrg typeRelationshipDate
NovartisFor profitNDADec 15, 1986
NovartisFor profitNDA2Dec 15, 1986