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miltefosine + Paromomycin sulfate
miltefosine + Paromomycin sulfate is a Antiparasitic combination therapy Small molecule drug developed by Banaras Hindu University. It is currently in Phase 3 development for Visceral leishmaniasis (kala-azar), Cutaneous leishmaniasis. Also known as: Impavido.
Miltefosine disrupts parasite cell membranes while paromomycin inhibits protein synthesis, together providing synergistic activity against Leishmania parasites.
Miltefosine disrupts parasite cell membranes while paromomycin inhibits protein synthesis, together providing synergistic activity against Leishmania parasites. Used for Visceral leishmaniasis (kala-azar), Cutaneous leishmaniasis.
At a glance
| Generic name | miltefosine + Paromomycin sulfate |
|---|---|
| Also known as | Impavido |
| Sponsor | Banaras Hindu University |
| Drug class | Antiparasitic combination therapy |
| Target | Leishmania cell membrane and ribosomal protein synthesis |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Parasitology |
| Phase | Phase 3 |
Mechanism of action
Miltefosine is an alkylphospholipid that accumulates in parasite cells and disrupts membrane integrity and mitochondrial function. Paromomycin is an aminoglycoside antibiotic that inhibits bacterial-like protein synthesis in Leishmania ribosomes. The combination targets multiple pathways simultaneously, enhancing efficacy against visceral and cutaneous leishmaniasis.
Approved indications
- Visceral leishmaniasis (kala-azar)
- Cutaneous leishmaniasis
Common side effects
- Gastrointestinal disturbances (nausea, vomiting, diarrhea)
- Ototoxicity
- Nephrotoxicity
- Hepatotoxicity
Key clinical trials
- Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) (PHASE3)
- Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa (PHASE3)
- Oral Miltefosine Plus Topical Paromomycin In American Cutaneous Leishmaniasis (PHASE2, PHASE3)
- Short Course Regimens for Treatment of PKDL (Sudan) (PHASE2)
- Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh (PHASE3)
- Combination Therapy in Indian Visceral Leishmaniasis (PHASE3)
- Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- miltefosine + Paromomycin sulfate CI brief — competitive landscape report
- miltefosine + Paromomycin sulfate updates RSS · CI watch RSS
- Banaras Hindu University portfolio CI
Frequently asked questions about miltefosine + Paromomycin sulfate
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Related
- Drug class: All Antiparasitic combination therapy drugs
- Target: All drugs targeting Leishmania cell membrane and ribosomal protein synthesis
- Manufacturer: Banaras Hindu University — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Parasitology
- Indication: Drugs for Visceral leishmaniasis (kala-azar)
- Indication: Drugs for Cutaneous leishmaniasis
- Also known as: Impavido
- Compare: miltefosine + Paromomycin sulfate vs similar drugs
- Pricing: miltefosine + Paromomycin sulfate cost, discount & access