Ornidyl, Vaniqa(eflornithine)
Iwilfin, Vaniqa (eflornithine) is a small molecule pharmaceutical. Eflornithine was first approved as Ornidyl on 1990-11-28. It is used to treat african trypanosomiasis, hypertrichosis, and protozoan infections in the USA. It has been approved in Europe to treat hirsutism. The pharmaceutical is active against ornithine decarboxylase.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Iwilfin (discontinued: Ornidyl, Vaniqa)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Eflornithine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IWILFIN | US WorldMeds | N-215500 RX | 2023-12-13 | 1 products, RLD, RS |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| african trypanosomiasis | — | D014353 | B56 |
| protozoan infections | — | D011528 | B50-B64 |
| hypertrichosis | — | D006983 | L68 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
EFLORNITHINE HYDROCHLORIDE, IWILFIN, USWM | |||
| 2030-12-13 | ODE-462 | ||
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D11: Other dermatological preparations in atc
— D11A: Other dermatological preparations in atc
— D11AX: Other dermatological preparations in atc
— D11AX16: Eflornithine
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01C: Agents against leishmaniasis and trypanosomiasis
— P01CX: Other agents against leishmaniasis and trypanosomiasis in atc
— P01CX03: Eflornithine
HCPCS
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Clinical
Clinical Trials
50 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| African trypanosomiasis | D014353 | — | B56 | — | 2 | 4 | 1 | — | 5 |
| Trypanosomiasis | D014352 | DOID_10113 | B57.2 | — | 2 | 3 | 1 | — | 4 |
| Hirsutism | D006628 | — | L68.0 | — | — | — | 3 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 1 | 2 | 1 | — | — | 3 |
| Adenomatous polyposis coli | D011125 | — | D13.91 | — | 1 | 2 | — | — | 3 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 1 | 1 | — | — | 3 |
| Precancerous conditions | D011230 | — | — | — | 2 | 1 | — | — | 3 |
| Basal cell neoplasms | D018295 | — | — | — | 1 | 1 | — | — | 2 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | 1 | — | — | 1 |
| Astrocytoma | D001254 | EFO_0000271 | — | — | — | 1 | — | — | 1 |
| Colonic polyps | D003111 | — | K63.5 | — | — | 1 | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroblastoma | D009447 | EFO_0000621 | — | 4 | 7 | — | — | 1 | 10 |
| Neoplasms | D009369 | — | C80 | 2 | 3 | — | — | — | 4 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | 3 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | — | 3 | — | — | — | 3 |
| Diffuse intrinsic pontine glioma | D000080443 | — | — | 3 | 2 | — | — | — | 3 |
| Medulloblastoma | D008527 | — | — | — | 1 | — | — | 1 | 2 |
| Rhabdoid tumor | D018335 | — | — | 1 | 1 | — | — | 1 | 2 |
| Primitive neuroectodermal tumors | D018242 | — | — | 1 | 1 | — | — | 1 | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | 2 | — | — | — | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | — | 2 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eflornithine |
| INN | eflornithine |
| Description | Eflornithine is a fluoroamino acid that is ornithine substituted by a difluoromethyl group at position 2. It has a role as a trypanocidal drug. It is a fluoroamino acid and an alpha-amino acid. It is functionally related to an ornithine. |
| Classification | Small molecule |
| Drug class | Fc fusion protein |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCCCC(N)(C(=O)O)C(F)F |
Identifiers
| PDB | — |
| CAS-ID | 70052-12-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL830 |
| ChEBI ID | 41948 |
| PubChem CID | 3009 |
| DrugBank | DB03856 |
| UNII ID | ZQN1G5V6SR (ChemIDplus, GSRS) |
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Estimated US medical usage
Eflornithine
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Safety
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431 adverse events reported
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