IMPAVIDO (miltefosine)
Impavido is an antileishmanial medication used for adults and adolescents at least 12 years old who weigh 30 kg or more. It helps patients with visceral, cutaneous, and mucosal forms of leishmaniasis caused by specific Leishmania species. Because clinical response can vary by region, the drug's effectiveness may depend on where the infection was acquired.
How IMPAVIDO Works
Miltefosine works as an anti-leishmanial agent. It is used to target and manage infections caused by various species of the Leishmania parasite.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2014-03-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE
IMPAVIDO Approval History
What IMPAVIDO Treats
3 indicationsIMPAVIDO is approved for 3 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Visceral Leishmaniasis
- Cutaneous Leishmaniasis
- Mucosal Leishmaniasis
IMPAVIDO Boxed 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 ), ...
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 ).
IMPAVIDO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
14 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07463040 | MAMS4CL | Ph 3 | not yet recruiting | Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) |
| NCT04515186 | DNDi-MILT-08-CL | Ph 3 | completed | Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World |
| NCT03129646 | DNDi-MILT/PM-01-VL | Ph 3 | completed | Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa |
| NCT02530697 | 40068714.1.0000.5558 | Ph 2 | active not recruiting | The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil |
| NCT03829917 | AB-2018-02 | Ph 2, Ph 3 | completed | Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis |
| NCT01050907 results posted | PBL-MILT-201 | Ph 2 | completed | Miltefosine to Treat Mucocutaneous Leishmaniasis |
| NCT02687971 | DNDi-MILT-07-CL | Ph 2 | completed | Thermotherapy + a Short Course of Miltefosine for the Treatment of Uncomplicated Cutaneous Leishmaniasis in the New World¨ |
| NCT02193022 | PR-13045 | Ph 3 | completed | Miltefosine for Children With PKDL |
| NCT02011958 | HIV/VL 0511 | Ph 3 | completed | Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. |
| NCT01067443 | LEAP 0208 | Ph 2 | completed | Clinical Trial to Assess the Safety and Efficacy of Sodium Stibogluconate (SSG) and AmBisome® Combination, Miltefosine and AmBisome® and Miltefosine Alone for the Treatment Visceral Leishmaniasis in Eastern Africa |
| NCT01170949 MIARCU results posted | MIARCU 01/2008 EudraCT Number: 2007-007657-31 | Ph 2 | terminated | Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria |
| NCT02431143 | LEAP 0714 | Ph 2 | completed | Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa |
| NCT01462500 PK | 2229-519-28930 | Ph 4 | completed | Pharmacokinetics of Miltefosine in Children and Adults |
| NCT01377974 | MILTHUB | Ph 2 | completed | Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMPAVIDO FDA Label Details
Indications & Usage
FDA Label (PDF)IMPAVIDO is indicated for the treatment of Visceral Leishmaniasis; Cutaneous Leishmaniasis; Mucosal Leishmaniasis.
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 po...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment