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Drug ReportsEflornithine
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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Variants
Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
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
IWILFINUS WorldMedsN-215500 RX2023-12-13
1 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
florexaunapproved drug other2023-12-26
iwilfinNew Drug Application2023-12-21
vaniqaNew Drug Application2012-09-18
Agency Specific
FDA
EMA
Expiration
Code
EFLORNITHINE HYDROCHLORIDE, IWILFIN, USWM
2030-12-13ODE-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
No data
Clinical
Clinical Trials
47 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 trypanosomiasisD014353—B56—241—5
TrypanosomiasisD014352DOID_10113B57.2—241—5
Hair diseasesD006201———1—1—2
HirsutismD006628HP_0001007L68.0———2—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——123——5
Skin neoplasmsD012878EFO_0004198C44—41——5
Adenomatous polyposis coliD011125—D13.91—12——3
Nasopharyngeal neoplasmsD009303———12——3
Precancerous conditionsD011230———21——3
RecurrenceD012008——111——2
AstrocytomaD001254EFO_0000271———1——1
AdenomaD000236————1——1
Urinary bladder neoplasmsD001749—C67——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621—47——110
NeoplasmsD009369—C8034———5
Prostatic neoplasmsD011471—C61—3———3
Diffuse intrinsic pontine gliomaD000080443——32———3
MedulloblastomaD008527———1——12
Rhabdoid tumorD018335——11——12
Stomach neoplasmsD013274EFO_0003897C1612———2
Diabetes mellitusD003920HP_0000819E08-E1311———2
Type 1 diabetes mellitusD003922EFO_0001359E1011———2
Uterine cervical neoplasmsD002583HP_0030159—12———2
Show 23 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GlioblastomaD005909EFO_0000515—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primitive neuroectodermal tumorsD018242——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEflornithine
INNeflornithine
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 classFc fusion protein
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NCCCC(N)(C(=O)O)C(F)F
Identifiers
PDB—
CAS-ID70052-12-9
RxCUI—
ChEMBL IDCHEMBL830
ChEBI ID41948
PubChem CID3009
DrugBankDB03856
UNII IDZQN1G5V6SR (ChemIDplus, GSRS)
Target
Agency Approved
ODC1
ODC1
Organism
Homo sapiens
Gene name
ODC1
Gene synonyms
NCBI Gene ID
Protein name
ornithine decarboxylase
Protein synonyms
Uniprot ID
Mouse ortholog
Odc1 (18263)
ornithine decarboxylase (Q6PB87)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
No data
Estimated US medical usage
Eflornithine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,414 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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407 adverse events reported
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