Impavido
(Miltefosine)ApprovedSmall molecule
Miltefosine is used to treat leishmaniasis, a parasitic disease spread by sand fly bites that causes skin sores and can affect internal organs. It's also used to treat certain types of sleeping sickness caused by parasitic infections.[2] Impavido is currently approved and in use across 4 indications[4].[1]
Impavido is one of 73 small molecule programs targeting Trypanosomiasis. It is currently in Approved.
4
Indications
32
Total Trials
8
Active Trials
72
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
89 competitors in Bipolar Disorder
#DrugCompanyPhaseTrials
1Geodon
PfizerApproved
Abilify
OtsukaApproved
Impavido
KKnight Therapeutics (USA) Inc
Approved
Namenda
AbbVieApproved
Risperdal
WWim Janssens
Approved
Trileptal
NovartisApproved
Celexa
AbbVieApproved
Lithobid
SSolvay Pharmaceuticals
Approved
Zofran
NovartisApproved
Ozempic
Novo NordiskApproved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Cutaneous Leishmaniasis12 trials
Show 9 more trials
Oral Miltefosine for the Treatment of Pediatric Cutaneous Leishmaniasis in Colombia
Unknown status·CCentro Internacional de Entrenamiento e Investigaciones Médicas·Phase 3·NCT00487253·150 enrolled
Leishmaniasis7 trials
Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
Completed·—·Phase 2·NCT01377974·40 enrolled
Visceral Leishmaniasis3 trials
Treatment3 trials
Repurposing Ivermectin for PKDL Treatment
Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 1·NCT06251739·30 enrolled
3 more indications
Children2 trials
Miltefosine for Children With PKDL
Completed·IInternational Centre for Diarrhoeal Disease Research, Bangladesh·Phase 3·NCT02193022·80 enrolled
Pharmacokinetics of Miltefosine in Children and Adults
Completed·CCentro Internacional de Entrenamiento e Investigaciones Médicas·Phase 4·NCT01462500·60 enrolled
Regulatory
FDA Approval Timeline[5]
Mar 19, 2014
IMPAVIDO
NDA NDA204684
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Impavido drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Miltefosine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- KKnight Therapeutics (USA) Inc