Product Description
Miltefosine is the first oral drug licensed for the treatment of leishmaniasis. Miltefosine (hexadecylphosphocholine, HePC), an alkyl phospholipids compound, was originally intended for breast cancer and other solid tumors. (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2376078/)
Mechanisms of Action: Akt Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Candidiasis|Candidiasis, Invasive *
Approval Status: Approved
Approved Countries: Bangladesh | Brazil | Chile | Colombia | Czech | Germany | Greece | India | Ireland | Israel | Italy | Lithuania | Pakistan | Peru | Romania | Slovenia | South Africa | Sweden | United Kingdom | United States | Venezuela
Approved Indications: Leishmaniasis | Leishmaniasis, Cutaneous | Leishmaniasis, Visceral
Known Adverse Events: Abdominal Pain | Dizziness | Headache | Pain Unspecified | Pruritus | Diarrhea
Company: Knight
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 4: Leishmaniasis, Visceral|Leishmaniasis, Cutaneous
Phase 3: Leishmaniasis, Visceral|Leishmaniasis, Cutaneous|Leishmaniasis, Mucocutaneous
Phase 2: Leishmaniasis|Leishmaniasis, Mucocutaneous|Leishmaniasis, Cutaneous|Leishmaniasis, Visceral|Urticaria|Dermatitis, Atopic|Pruritus|Mastocytosis, Systemic|Mastocytosis, Cutaneous
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ABF-BO-100-10 | P2 |
Not yet recruiting |
Leishmaniasis, Cutaneous|Leishmaniasis, Mucocutaneous |
2027-05-01 |
|
| OPTIMILEISH | N/A |
Recruiting |
Leishmaniasis, Cutaneous |
2025-12-30 |
|
| NCT02530697 | P2 |
Active, not recruiting |
Leishmaniasis, Cutaneous |
2025-08-01 |
|
| Pregnancy Registry | N/A |
Recruiting |
Leishmaniasis |
2025-03-01 |