NDAORALCAPSULEPriority Review
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
Priority Review
IMPAVIDO (miltefosine) by Knight Therapeutics is anti-leishmanial agent [see clinical pharmacology ( )] . First approved in 2014.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMPAVIDO (miltefosine) is an oral antileishmanial agent approved in 2014 for the treatment of leishmaniasis, a parasitic disease transmitted by sand flies. It works through an anti-leishmanial mechanism that disrupts parasite cell membranes and viability. This oral formulation addresses a significant unmet need in a disease endemic to tropical and subtropical regions.
$0.002BPart D
PeakAt peak lifecycle with modest Part D spending ($2M annually, 36 claims in 2023), this product supports a lean commercial team focused on maintaining market position in a niche neglected tropical disease indication.
Mechanism of Action
anti-leishmanial agent [see Clinical Pharmacology ( )] .
Pharmacologic Class:
Antileishmanial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
A Clinical Trial to Investigate Efficacy, Safety and Pharmacokinetics (PK) of Two LXE408 Oral Regimens and Oral Miltefosine as Active Control in Participants Aged ≥ 18 Years Old With Localized Cutaneous Leishmaniasis in the Region of the Americas (AMR).
Started Jun 2026
250 enrolled
Localized Cutaneous Leishmaniasis
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Started Dec 2015
42 enrolled
Mucocutaneous Leishmaniasis
Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
Started Jul 2015
0Leishmaniasis or Other Uses of Miltefosine
Spermiogram Assessment in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Started Jul 2015
55 enrolled
Mucocutaneous Leishmaniasis
Treatment of Leishmaniasis With Impavido® (Miltefosine): Higher-Weight Patient Registry
Started Jul 2015
0Leishmaniasis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.