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 |
---|---|
infections | D007239 |
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 |
---|---|---|---|---|
ARTESUNATE | Amivas | N-213036 RX | 2020-05-26 | 1 products, RLD, RS |
Labels
FDA
EMA
No data
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
ARTESUNATE, ARTESUNATE, AMIVAS | |||
2027-05-26 | ODE-290 | ||
2025-05-26 | NCE |
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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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Malaria | D008288 | EFO_0001068 | B54 | 10 | 18 | 34 | 28 | 18 | 102 |
Falciparum malaria | D016778 | EFO_0007444 | B50 | 3 | 17 | 18 | 19 | 12 | 64 |
Vivax malaria | D016780 | EFO_0007445 | B51 | — | 1 | 4 | 3 | 1 | 9 |
Covid-19 | D000086382 | U07.1 | — | 5 | 3 | 1 | — | 8 | |
Anemia | D000740 | EFO_0004272 | D64.9 | — | — | 2 | 1 | 2 | 5 |
Healthy volunteers/patients | — | 1 | — | — | 1 | — | 2 | ||
Lupus nephritis | D008181 | EFO_0005761 | — | — | — | 1 | — | 1 | |
Parasitic diseases | D010272 | EFO_0001067 | B88 | — | — | — | 1 | — | 1 |
Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Schistosoma haematobium | D012548 | — | 1 | 2 | — | — | 2 | ||
Schistosoma mansoni | D012550 | NCBITaxon_6183 | — | — | 2 | — | — | 2 | |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 1 | 2 | — | — | 2 |
Fever | D005334 | HP_0001945 | R50.9 | — | — | 1 | — | 1 | 2 |
Asymptomatic diseases | D058070 | — | — | 1 | — | — | 1 | ||
Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Papillomavirus infections | D030361 | — | 2 | — | — | — | 2 | ||
Precancerous conditions | D011230 | 1 | 1 | — | — | — | 2 | ||
Colorectal neoplasms | D015179 | — | 2 | — | — | — | 2 | ||
Crohn disease | D003424 | EFO_0000384 | K50 | — | 1 | — | — | — | 1 |
Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | 1 | — | — | — | 1 | |
Schistosomiasis haematobia | D012553 | EFO_0007530 | B65.0 | — | 1 | — | — | — | 1 |
Uterine cervical dysplasia | D002578 | EFO_1000910 | N87 | — | 1 | — | — | — | 1 |
Bone neoplasms | D001859 | EFO_0003820 | D16 | — | 1 | — | — | — | 1 |
Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | 1 | — | — | — | 1 |
Friedreich ataxia | D005621 | Orphanet_95 | G11.11 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cerebral malaria | D016779 | B50.0 | 2 | — | — | — | — | 2 | |
Vulvar diseases | D014845 | 1 | — | — | — | — | 1 | ||
Papillomaviridae | D027383 | 1 | — | — | — | — | 1 | ||
Cervical intraepithelial neoplasia | D018290 | D06 | 1 | — | — | — | — | 1 | |
Neoplasms | D009369 | C80 | 1 | — | — | — | — | 1 | |
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
Hiv | D006678 | O98.7 | 1 | — | — | — | — | 1 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Drug resistance | D004351 | Z16.30 | — | — | — | — | 1 | 1 | |
Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | ARTESUNATE |
INN | artesunate |
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 class | antimalarials (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-ID | 88495-63-0 |
RxCUI | 18346 |
ChEMBL ID | CHEMBL361497 |
ChEBI ID | 63918 |
PubChem CID | 6917864 |
DrugBank | DB09274 |
UNII ID | 60W3249T9M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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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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