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Artesunate, Artesunate amivas(artesunate)
Artesunate is a small molecule pharmaceutical. Artesunate was first approved as Artesunate on 2020-05-26. It has been approved in Europe to treat malaria.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
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)
Artesunate
Tradename
Company
Number
Date
Products
ARTESUNATEAmivasN-213036 RX2020-05-26
1 products, RLD, RS
Labels
FDA
EMA
No data
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
ARTESUNATE, ARTESUNATE, AMIVAS
2027-05-26ODE-290
2025-05-26NCE
Patent Expiration
No data
ATC Codes
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01B: Antimalarials
— P01BE: Artemisinin and derivatives, plain
— P01BE03: Artesunate
— P01BF: Artemisinin and derivatives, combinations
— P01BF02: Artesunate and mefloquine
— P01BF03: Artesunate and amodiaquine
— P01BF04: Artesunate, sulfalene and pyrimethamine
— P01BF06: Artesunate and pyronaridine
— P01BF09: Artesunate, sulfadoxine and pyrimethamine
HCPCS
No data
Clinical
Clinical Trials
198 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalariaD008288EFO_0001068B541018342818102
Falciparum malariaD016778EFO_0007444B5031718191264
Vivax malariaD016780EFO_0007445B51—14319
Covid-19D000086382U07.1—531—8
AnemiaD000740EFO_0004272D64.9——2125
Healthy volunteers/patients—1——1—2
Lupus nephritisD008181EFO_0005761———1—1
Parasitic diseasesD010272EFO_0001067B88———1—1
MalnutritionD044342EFO_0008572E40-E46———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Schistosoma haematobiumD012548—12——2
Schistosoma mansoniD012550NCBITaxon_6183——2——2
PregnancyD011247EFO_0002950Z33.1—12——2
FeverD005334HP_0001945R50.9——1—12
Asymptomatic diseasesD058070——1——1
Cytomegalovirus infectionsD003586EFO_0001062B25——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Papillomavirus infectionsD030361—2———2
Precancerous conditionsD01123011———2
Colorectal neoplasmsD015179—2———2
Crohn diseaseD003424EFO_0000384K50—1———1
Severe acute respiratory syndrome-related coronavirusD045473NCBITaxon_227859—1———1
Schistosomiasis haematobiaD012553EFO_0007530B65.0—1———1
Uterine cervical dysplasiaD002578EFO_1000910N87—1———1
Bone neoplasmsD001859EFO_0003820D16—1———1
Sickle cell anemiaD000755EFO_0000697D5711———1
Friedreich ataxiaD005621Orphanet_95G11.1111———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cerebral malariaD016779B50.02————2
Vulvar diseasesD0148451————1
PapillomaviridaeD0273831————1
Cervical intraepithelial neoplasiaD018290D061————1
NeoplasmsD009369C801————1
Liver neoplasmsD008113EFO_1001513C22.01————1
HivD006678O98.71————1
Breast neoplasmsD001943EFO_0003869C501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug resistanceD004351Z16.30————11
Hiv infectionsD015658EFO_0000764B20————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameARTESUNATE
INNartesunate
Description
Artesunate is an artemisinin derivative that is the hemisuccinate ester of the lactol resulting from the reduction of the lactone carbonyl group of artemisinin. It is used, generally as the sodium salt, for the treatment of malaria. It has a role as an antimalarial, a ferroptosis inducer and an antineoplastic agent. It is an artemisinin derivative, a sesquiterpenoid, a dicarboxylic acid monoester, a cyclic acetal, a semisynthetic derivative and a hemisuccinate.
Classification
Small molecule
Drug classantimalarials (artemisin derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1CC[C@H]2[C@@H](C)[C@H](OC(=O)CCC(=O)O)O[C@@H]3O[C@@]4(C)CC[C@@H]1[C@@]23OO4
Identifiers
PDB—
CAS-ID88495-63-0
RxCUI18346
ChEMBL IDCHEMBL361497
ChEBI ID63918
PubChem CID6917864
DrugBankDB09274
UNII ID60W3249T9M (ChemIDplus, GSRS)
Target
Agency Approved
No data
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 12,271 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,801 adverse events reported
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