Last reviewed 2026-04-20 · How we verify

Impavido (MILTEFOSINE)

Impavido works by inhibiting the RAC-alpha serine/threonine-protein kinase, which is essential for the survival of Leishmania parasites.

Impavido (MILTEFOSINE) is a small molecule antileishmanial drug developed by Knight Theraps. It targets the RAC-alpha serine/threonine-protein kinase and is approved by the FDA for the treatment of American mucocutaneous leishmaniasis, cutaneous leishmaniasis, and visceral leishmaniasis. Impavido is off-patent, but there are currently no generic manufacturers. It was originally developed by Knight Theraps and remains under their ownership. Impavido was FDA approved in 2014.

At a glance

Mechanism of action

Miltefosine is an anti-leishmanial agent [see Microbiology (12.4)].

Approved indications

• American mucocutaneous leishmaniasis
• Cutaneous leishmaniasis
• Visceral leishmaniasis

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY IMPAVIDO may cause fetal harm. Fetal death and teratogenicity occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Females of reproductive potential should be advised to use effective contraception during IMPAVIDO therapy and for 5 months after therapy [see Contraindications ( 4.1 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.8 ) and Nonclinical Toxicology ( 13.1 )] . WARNING: EMBRYO-FETAL TOXICITY See full prescribing information for complete boxed warning. IMPAVIDO may cause fetal harm. Fetal death and teratogenicity, occurred in animals administered miltefosine at doses lower than the recommended human dose. Do not administer IMPAVIDO to pregnant women. Obtain a serum or urine pregnancy test in females of reproductive potential prior to prescribing IMPAVIDO. Advise females of reproductive potential to use effective contraception during therapy and for 5 months after therapy ( 4.1 , 5.1 , 8.1 , 8.8 , 13.1 ).

Common side effects

• Diarrhea
• Vomiting
• Asthenia
• Decreased Appetite
• Motion Sickness
• Abdominal Pain
• Diarrhea
• Nausea
• Vomiting
• Malaise
• Pyrexia
• Dizziness

Key clinical trials

• Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) (PHASE3)
• Repurposing Ivermectin for PKDL Treatment (EARLY_PHASE1)
• Pilot Study: Miltefosine Gel (G-MTF) in Patients With Cutaneous Leishmaniasis (PHASE1)
• 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). (PHASE2)
• Randomised Clinical Trial for New Treatment Modalities for Cutaneous Leishmaniasis Caused by Leishmania Tropica, in Pakistan (PHASE3)
• Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World (PHASE3)
• Treatment of Leishmaniasis With Impavido® (Miltefosine): Pregnancy Registry
• Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis with Inhaled Pentamidine Plus Oral Miltefosine (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Impavido CI brief — competitive landscape report
• Impavido updates RSS · CI watch RSS
• Knight Theraps portfolio CI