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Miltefosine and Paromomycin
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, Cutaneous leishmaniasis.
At a glance
| Generic name | Miltefosine and Paromomycin |
|---|---|
| Sponsor | Drugs for Neglected Diseases |
| Drug class | Antiparasitic combination |
| Target | Leishmania cell membrane and ribosomal protein synthesis |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Neglected Tropical Diseases |
| 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 to enhance antiparasitic efficacy.
Approved indications
- Visceral leishmaniasis
- Cutaneous leishmaniasis
Common side effects
- Gastrointestinal disturbances (nausea, vomiting, diarrhea)
- Nephrotoxicity
- Ototoxicity
- Hepatotoxicity
Key clinical trials
- Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa (PHASE3)
- Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011) (PHASE2)
- 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 and Paromomycin CI brief — competitive landscape report
- Miltefosine and Paromomycin updates RSS · CI watch RSS
- Drugs for Neglected Diseases portfolio CI