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Ornidyl, Vaniqa(eflornithine)
Ornidyl, 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
Therapeutic Area
MeSH
infectionsD007239
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
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
ORNIDYLSanofiN-019879 DISCN1990-11-28
1 products
VANIQASkinmedicaN-021145 DISCN2000-07-27
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
vaniqaNew Drug Application2018-01-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
african trypanosomiasis—D014353B56
hypertrichosis—D006983L68
protozoan infections—D011528B50-B64
Agency Specific
FDA
EMA
No data
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
35 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HirsutismD006628HP_0001007L68.0———2—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
African trypanosomiasisD014353B56—24——4
Adenomatous polyposis coliD011125—12——3
Colorectal neoplasmsD015179—11——2
Precancerous conditionsD011230—11——2
AstrocytomaD001254EFO_0000271——1——1
Urinary bladder neoplasmsD001749C67——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621—3——14
MedulloblastomaD008527—1——12
Skin neoplasmsD012878EFO_0004198C44—2———2
Prostatic neoplasmsD011471C61—2———2
Adenomatous polypsD018256D28—1———1
Stomach neoplasmsD013274EFO_0003897C16—1———1
NeoplasmsD009369C80—1———1
Uterine cervical neoplasmsD002583—1———1
Esophageal neoplasmsD004938C15—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 1 diabetes mellitusD003922EFO_0001359E101————1
GliomaD005910EFO_00005201————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rhabdoid tumorD018335————11
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)
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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,648 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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47,229 adverse events reported
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