Miltefosine
Impavido (miltefosine) is a small molecule pharmaceutical. Miltefosine was first approved as Impavido on 2014-03-19. It is used to treat cutaneous leishmaniasis, leishmaniasis, and visceral leishmaniasis in the USA. It is known to target RAC-alpha serine/threonine-protein kinase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Impavido
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Miltefosine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IMPAVIDO | Knight Therapeutics | N-204684 RX | 2014-03-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| impavido | New Drug Application | 2025-04-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cutaneous leishmaniasis | — | D016773 | B55.1 |
| visceral leishmaniasis | — | D007898 | B55.0 |
| leishmaniasis | EFO_0005044 | D007896 | B55 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
49 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leishmaniasis | D007896 | EFO_0005044 | B55 | 3 | 19 | 10 | 2 | 7 | 37 |
| Cutaneous leishmaniasis | D016773 | — | B55.1 | 1 | 10 | 7 | 1 | 3 | 21 |
| Visceral leishmaniasis | D007898 | — | B55.0 | 1 | 5 | 6 | 1 | — | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mucocutaneous leishmaniasis | D007897 | EFO_0007379 | B55.2 | 1 | 5 | 3 | — | 2 | 9 |
| Hiv seropositivity | D006679 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Chronic urticaria | D000080223 | — | L50.8 | — | 1 | — | — | — | 1 |
| Urticaria | D014581 | EFO_0005531 | L50 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Topical administration | D000287 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug evaluation | D004341 | — | — | — | — | — | — | 1 | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Miltefosine |
| INN | miltefosine |
| Description | Miltefosine is a phospholipid that is the hexadecyl monoester of phosphocholine. It has a role as an antineoplastic agent, an antiprotozoal drug, an antifungal agent, an immunomodulator, an anti-inflammatory agent, an apoptosis inducer, a protein kinase inhibitor and an anticoronaviral agent. It is a member of phosphocholines and a phospholipid. |
| Classification | Small molecule |
| Drug class | phosphoro-derivatives; cytostatic phospholipid derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCCCCCCCCCOP(=O)([O-])OCC[N+](C)(C)C |
Identifiers
| PDB | — |
| CAS-ID | 58066-85-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL125 |
| ChEBI ID | 75283 |
| PubChem CID | 3599 |
| DrugBank | DB09031 |
| UNII ID | 53EY29W7EC (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
AKT1
AKT1
Organism
Homo sapiens
Gene name
AKT1
Gene synonyms
PKB, RAC
NCBI Gene ID
Protein name
RAC-alpha serine/threonine-protein kinase
Protein synonyms
AKT1m, PKB, PKB alpha, Protein kinase B, Protein kinase B alpha, Proto-oncogene c-Akt, rac protein kinase alpha, RAC-PK-alpha, serine-threonine protein kinase, v-akt murine thymoma viral oncogene homolog 1, v-akt murine thymoma viral oncogene-like protein 1
Uniprot ID
Mouse ortholog
Akt1 (11651)
RAC-alpha serine/threonine-protein kinase (Q6GSA6)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Impavido
Adverse Events
Top Adverse Reactions
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267 adverse events reported
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