Drugs / Nifurtimox
Nifurtimox
also known as
BAYa2502 · Lampit · NFX · BAY 2502 · BAYER 2502 · DNDI1613515 · nifurtimox (Lampit) · Nifurtimoxum
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 Stop: Enrollment |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT02625974 | Jan 2016 → Jul 2018 | Chagas disease | Bayer | Completed | Met primary |
| 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 | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT00906880 | Apr 2009 → Sep 2010 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT01685827 Comparator | Oct 2012 → Nov 2016 | human African trypanosomiasis | Drugs for Neglected Diseases | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2017-11-03 | Drugs for Neglected Diseases | Results Phase II/III studies show high efficacy and safety of fexinidazole, the first oral treatment for sleeping sickness | DNDi dndi.org ↗
Treatment success rates of 91.2% were measured for fexinidazole, with 97.6% for NECT, 18 months after the end of treatment. |
| 2013-07-10 | Drugs for Neglected Diseases | Regulatory Three Neglected-Disease Treatments Newly Added to WHO Essential Medicines List for Paediatric Use | DNDi dndi.org ↗
Nifurtimox-eflornithine combination therapy (NECT) was added to the EMLc for the treatment of late-stage sleeping sickness (human African trypanosomiasis) in children. |
| 2009-05-14 | Drugs for Neglected Diseases | Regulatory NECT Added to WHO Essential Medicines List as Combination Treatment Against Sleeping Sickness | DNDi dndi.org ↗
According to the WHO, NECT can now be used in patients and will provide an opportunity to improve the management of sleeping sickness cases. |
| 2008-12-08 | Drugs for Neglected Diseases | Results Positive Results for Improved Treatment Against Sleeping Sickness | DNDi dndi.org ↗
Pivotal Phase III clinical trial results conclusively show that Nifurtimox-Eflornithine Combination Therapy (NECT) is well tolerated and effective against the advanced stage of T. b. gambiense sleeping sickness, a fatal disease that threatens 60 million people in sub-Saharan Africa. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-11-03 | Drugs for Neglected Diseases | Phase II/III studies show high efficacy and safety of fexinidazole, the first oral treatment for sleeping sickness | DNDi dndi.org ↗ |
| 2013-07-10 | Drugs for Neglected Diseases | Three Neglected-Disease Treatments Newly Added to WHO Essential Medicines List for Paediatric Use | DNDi dndi.org ↗ |
| 2009-05-14 | Drugs for Neglected Diseases | NECT Added to WHO Essential Medicines List as Combination Treatment Against Sleeping Sickness | DNDi dndi.org ↗ |
| 2008-12-08 | Drugs for Neglected Diseases | Positive Results for Improved Treatment Against Sleeping Sickness | DNDi dndi.org ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nifurtimox | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00330148 ↗ |
| 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 ↗ |
| Known as | NFX | “Either benznidazole (BZN) or nifurtimox (NFX) is recommended as equivalent to treat Trypanosoma cruzi infection.” PMID 31307503 ↗ Jul 20191“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 |