Drugs / Nifurtimox

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) LAMPIT 2023-06-02 fda.gov
Approved US (FDA) LAMPIT 2020-08-06 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT03334838 Jun → Nov 2019 Chagas disease Bayer Completed No outcome recorded
Phase 1 NCT03350295 Jun → Sep 2018 Chagas disease Bayer Completed No outcome recorded
Phase 1 NCT02606864 Dec 2015 → Apr 2016 Chagas disease Bayer Completed No outcome recorded
Phase 1 NCT00486564 Nov 2006 → Nov 2007 neuroblastoma University of Vermont Completed No outcome recorded
Phase 22 trials
Phase 2 NCT03981523 Dec 2019 → May 2024 Chagas disease University of Texas, El Paso Completed No outcome recorded
Phase 2 NCT00601003 Jan 2008 → Apr 2020 medulloblastoma, neuroblastoma Giselle Sholler Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02369978 Aug 2015 → Aug 2018 Chagas disease Universidad Autónoma de Bucaramanga Unknown No outcome recorded
Phase 2/3 NCT00489658 Oct 2002 → ? human African trypanosomiasis Epicentre Terminated No outcome recorded
Phase 33 trials
Phase 3 NCT02625974 Jan 2016 → Jul 2018 Chagas disease Bayer Completed No outcome recorded
Phase 3 NCT00330148 Mar 2001 → Jun 2004 human African trypanosomiasis Epicentre Terminated No outcome recorded
Phase 3 NCT00146627 ? → Jun 2008 human African trypanosomiasis Drugs for Neglected Diseases Completed No outcome recorded
Phase 41 trial
Phase 4 NCT00906880 Apr 2009 → Sep 2010 human African trypanosomiasis Drugs for Neglected Diseases Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/3 NCT01685827 Comparator Oct 2012 → Nov 2016 human African trypanosomiasis Drugs for Neglected Diseases Completed No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as Nifurtimox ClinicalTrials.gov intervention name — accepted as the source's own label NCT00601003
12

NCT00486564

NCT00146627

NCT03334838

NCT03981523

NCT01685827

NCT00906880

NCT02606864

NCT02369978

NCT00489658

NCT02625974

NCT00330148

NCT03350295

Known as BAY 2502 ChEMBL registry synonym — accepted as the source's own label CHEMBL290960
Known as BAYA2502 “Drug: Nifurtimox (Lampit, BAYA2502)” NCT03334838
3

“Nifurtimox (Lampit, BAYA2502)” NCT03350295

“Nifurtimox (Lampit, BAYA2502)” NCT02625974

“Nifurtimox (BAYa2502)” NCT02606864

Known as BAYER 2502 ChEMBL registry synonym — accepted as the source's own label CHEMBL290960
Known as DNDI1613515 ChEMBL registry synonym — accepted as the source's own label CHEMBL290960
Known as Lampit “Drug: Nifurtimox (Lampit, BAYA2502)” NCT03334838
2

“Nifurtimox (Lampit, BAYA2502)” NCT03350295

“Nifurtimox (Lampit, BAYA2502)” NCT02625974

Known as NFX “Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection.” PMID 31307503 Jul 2019
1

“Current approved specific treatments for CD include nifurtimox (NFX) and benznidazole (BZN)” NCT03981523

Known as nifurtimox (Lampit) nifurtimox (Lampit)NCT00906880
Known as Nifurtimoxum ChEMBL registry synonym — accepted as the source's own label CHEMBL290960
Modality Small molecule CHEMBL290960
Route Oral “with oral nifurtimox” PMID 19559476 Jun 2009