nifurtimox

Trade name: Lampit

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 6, 2020

Nifurtimox, sold under the brand name Lampit, is a medication used to treat Chagas disease and sleeping sickness. For sleeping sickness it is used together with eflornithine in nifurtimox-eflornithine combination treatment. In Chagas disease it is a second-line option to benznidazole. It is given by mouth. — Wikipedia

Clinical trial activity

15 trials · 23 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
5
Phase 3
6
Phase 4
1

Earliest trial started Mar 1, 2001 (NCT00330148)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Aug 5, 2010

    Orphan Drug Designation

2020s

  1. Aug 6, 2020

    Bayer — Earliest FDA Approval

  2. Aug 6, 2020

    Bayer — Marketing Organization

  3. Aug 6, 2020

    Bayer — NDA Secondary Org

  4. Aug 6, 2020

    Bayer — NDA Organization

Indications

Mechanism of action

  • Radical scavenging activity activator

  • DNAINHIBITOR

    DNA inhibitor

    Not fully elucidated but reactive metabolites are throught to damage nuclear and kinetoplast DNA.

Approval history

  • approvedPriority reviewAcceleratedAug 6, 2020

Chemistry & pharmacology

Loading structure…

SMILES

CC1CS(=O)(=O)CCN1/N=C/c1ccc([N+](=O)[O-])o1
Mol. weight
287.3 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • bay-2502
  • bay-2502
  • bay-a2502
  • bay-a2502
  • bayer 2502
  • bayer-2502
  • bayer-2502
  • dndi1613515
  • dndi1613515
  • lampit
  • lampit
  • lampit
  • lampit
  • lampit
  • nifurtimox
  • nifurtimox
  • nifurtimox
  • nifurtimox
  • nifurtimox
  • nifurtimox
  • nifurtimox

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03981523Phase 2Sep 1, 2019Drugs for Neglected Diseases Initiative, Food and Drug Administration, Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES), Institute of Parasitology and Biomedicine Lopez Neyra, Mundo Sano Foundation, National Institute of Allergy and Infectious Diseases (NIAID), University of Barcelona, University of Texas, El Paso
NCT03334838Phase 1Mar 4, 2019Bayer
NCT03708133Phase 1Dec 5, 2018Bayer
NCT03350295Phase 1Jun 14, 2018Bayer
NCT02625974Phase 3Jan 27, 2016Bayer
NCT02606864Phase 1Dec 1, 2015Bayer
NCT02369978Phase 2/Phase 3 (Phase 3)Aug 1, 2015Fundación Cardioinfantil Instituto de Cardiología, Instituto Nacional de Salud (Colombia), Universidad Autónoma de Bucaramanga
NCT01927224Phase 1Nov 1, 2013Bayer
NCT01685827Phase 2/Phase 3 (Phase 3)Nov 1, 2012Drugs for Neglected Diseases Initiative, HAT National Control Program in DRC
NCT00906880Phase 4Apr 1, 2009Drugs for Neglected Diseases Initiative, Government of the Democratic Republic of the Congo, University of Basel
NCT00601003Phase 2Feb 1, 2008Bayer, The Spectrum Health Group
NCT00486564Phase 1Nov 1, 2006St. Louis University, University of Vermont
NCT00146627Phase 3Sep 6, 2005Drugs for Neglected Diseases Initiative, Epicentre, Medecins Sans Frontieres, University of Basel, World Health Organization
NCT00489658Phase 2/Phase 3 (Phase 3)Oct 1, 2002Epicentre, Medecins Sans Frontieres
NCT00330148Phase 3Mar 1, 2001Epicentre, Government of France, Medecins Sans Frontieres, National Sleeping Sickness Control Program, Uganda
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (23)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BayerFor profit7632008
Drugs for Neglected Diseases InitiativeAcademic/Hospital4332005
EpicentreFor profit3212001
Medecins Sans FrontieresAcademic/Hospital3012001
University of BaselAcademic/Hospital2022005
Food and Drug AdministrationGovernment1012019
Fundación Cardioinfantil Instituto de CardiologíaAcademic/Hospital1012015
Fundación Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES)Academic/Hospital1012019
Government of FranceGovernment1012001
Government of the Democratic Republic of the CongoGovernment1012009
HAT National Control Program in DRCAcademic/Hospital1012012
Institute of Parasitology and Biomedicine Lopez NeyraAcademic/Hospital1012019
Instituto Nacional de Salud (Colombia)Academic/Hospital1012015
Mundo Sano FoundationAcademic/Hospital1012019
National Institute of Allergy and Infectious Diseases (NIAID)Government1012019
National Sleeping Sickness Control Program, UgandaGovernment1012001
St. Louis UniversityAcademic/Hospital1012006
The Spectrum Health GroupAcademic/Hospital1112008
Universidad Autónoma de BucaramangaAcademic/Hospital1112015
University of BarcelonaAcademic/Hospital1012019
23 organizations
Page 1 / 2

Marketing (3)

OrganizationOrg typeRelationshipDate
BayerFor profitMKTGAug 6, 2020
BayerFor profitNDA2Aug 6, 2020
BayerFor profitNDAAug 6, 2020