Artesunate
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2020
- First approval year
- 2020
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Artesunate
- Molecular weight
- 384.43
- Structure (SMILES)
- C[C@H]1[C@H](OC(=O)CCC(=O)O)O[C@@H]2O[C@@]3(C)CC[C@H]4[C@H](C)CC[C@@H]1[C@@]24OO3
- arsumax
- Arsumax
- artesunate amivas
- Artesunate amivas
- .alpha.-artesunic acid
- 4 oxo 4 3r 5as 6r 8as 9r 10s 12r 12ar 3 6 9 trimethyldecahydro 3 12 epoxypyrano 4 3 j 1 2 benzodioxepin 10 yl hydrogen butanedioate
- 4-OXO-4-(3R,5AS,6R,8AS,9R,10S,12R,12AR)-3,6,9-TRIMETHYLDECAHYDRO-3,12-EPOXYPYRANO(4,3-J)-1,2-BENZODIOXEPIN-10-YL HYDROGEN BUTANEDIOATE
- alpha artesunic acid
- artemisinin artesunate
- artesunate
- Artesunate
- Artesunate (Comparator)
- Artesunate (Test)
- ARTESUNATE [HSDB]
- artesunate [INN]
- ARTESUNATE [MART.]
- ARTESUNATE [MI]
- ARTESUNATE [ORANGE BOOK]
- ARTESUNATE [USAN]
- ARTESUNATE [USP-RS]
- ARTESUNATE [VANDF]
- Artesunate [WHO-DD]
- ARTESUNATE [WHO-IP]
- Artesunate 200mg
- Artesunate for Injection
- artesunate hsdb
- Artesunate Injection
- artesunate inn
- artesunate mart
And 42 more, listed on the interactive page.
- ATC classification codes
- P01BE03
Sources for recorded values
- CAS registry numbers
- 88495-63-0
- ChEMBL ID
- CHEMBL361497
- InChIKey
- FIHJKUPKCHIPAT-AHIGJZGOSA-N
- PubChem compound IDs
- 6917864
- RxNorm IDs (RxCUI)
- 18346
- FDA ingredient codes (UNII)
- 60W3249T9M
- Applicant
- AMIVAS
- Approval date
- 26 May 2020
- Application number
- NDA213036
- Status
- Authorised
- Status date
- 22 Nov 2021
- Authorisation date
- 22 Nov 2021
- Approved indications
- Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children. Consideration should be given to official guidance on the appropriate use of antimalarial agents.
- Product number
- EMEA/H/C/005550
- Authorisation holder
- Amivas Ireland Ltd
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Malaria
European medicines record
- Patents
- 2
- Designations
- 8
- Earliest recorded loss of exclusivity
- 16 Feb 2044
- First in class
- No
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- artesunate
- Type
- Synthetic organic
- Drug name stem
- arte-
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Crohn Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Idiopathic Pulmonary Fibrosis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000768
- Subject identifier
- D054990
- Condition
- Cytomegalovirus Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001062
- Subject identifier
- D003586
- Condition
- Malaria
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001068
- Subject identifier
- D008288
- Condition
- Conjunctivitis, Allergic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007141
- Subject identifier
- D003233
- Condition
- Intestinal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007330
- Subject identifier
- D007414
- Condition
- Malaria, Falciparum
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007444
- Subject identifier
- D016778
- Condition
- Malaria, Vivax
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007445
- Subject identifier
- D016780
- Condition
- Schistosomiasis haematobia
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007530
- Subject identifier
- D012553
- Condition
- Schistosomiasis
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001475
- Subject identifier
- D012552
- Condition
- Fever
- Highest recorded phase
- 3
- Condition identifier
- HP:0001945
- Subject identifier
- D005334
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005575
- Subject identifier
- D015179
- Condition
- Breast Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Severe Acute Respiratory Syndrome
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0100096
- Subject identifier
- D045169
- Condition
- Friedreich Ataxia
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0100339
- Subject identifier
- D005621
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000768
- Highest recorded phase
- 1
- Condition identifier
- EFO_0001062
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001068
- Condition identifier
- EFO_0007444
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007445
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007530
- Condition identifier
- EFO_0022937
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000166
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001475
- Highest recorded phase
- 3
- Condition identifier
- HP_0001945
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002492
- Condition identifier
- MONDO_0005011
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005132
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005136
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005161
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005198
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005276
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005670
- Condition identifier
- MONDO_0005920
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005921
- Highest recorded phase
- 3
And 11 more, listed on the interactive page.
- Event
- agranulocytosis
- Reports
- 7
- Reporting signal score
- 19.5902
- Event
- autoimmune haemolytic anaemia
- Reports
- 2
- Reporting signal score
- 6.73622
- Event
- death neonatal
- Reports
- 3
- Reporting signal score
- 21.6445
- Event
- drug-induced liver injury
- Reports
- 4
- Reporting signal score
- 8.03998
- Event
- glioblastoma multiforme
- Reports
- 2
- Reporting signal score
- 10.4192
- Event
- haemolysis
- Reports
- 4
- Reporting signal score
- 13.8366
- Event
- haemolytic anaemia
- Reports
- 28
- Reporting signal score
- 139.946
- Event
- hepatotoxicity
- Reports
- 5
- Reporting signal score
- 12.6448
- Event
- herbal interaction
- Reports
- 2
- Reporting signal score
- 11.0856
- Event
- hookworm infection
- Reports
- 1
- Reporting signal score
- 7.51402
- Event
- local swelling
- Reports
- 4
- Reporting signal score
- 10.3365
- Event
- nematodiasis
- Reports
- 1
- Reporting signal score
- 8.52549
- Event
- palmar-plantar erythrodysaesthesia syndrome
- Reports
- 5
- Reporting signal score
- 12.0052
- Event
- premature baby
- Reports
- 5
- Reporting signal score
- 10.5939
- Event
- prolonged labour
- Reports
- 2
- Reporting signal score
- 10.4102
- Event
- small for dates baby
- Reports
- 6
- Reporting signal score
- 23.1943
- Event
- stillbirth
- Reports
- 5
- Reporting signal score
- 19.9228
- Event
- superimposed pre-eclampsia
- Reports
- 1
- Reporting signal score
- 7.96593
- NCT00118807
- NCT00119132
- NCT00119145
- NCT00123552
- NCT00132548
- NCT00132561
- NCT00140361
- NCT00146731
- NCT00158548
- NCT00164255
- NCT00238017
- NCT00243737
- NCT00292929
- NCT00292942
- NCT00297882
- NCT00298610
- NCT00316329
- NCT00330902
- NCT00354380
- NCT00373607
- NCT00378625
- NCT00386503
- NCT00393679
- NCT00406146
- NCT00422084
And 107 more, listed on the interactive page.
- Hydrogen bond acceptors
- 7
- Hydrogen bond donors
- 1
- Polar surface area
- 100.52
- Calculated partition coefficient (ALogP)
- 2.6
- Calculated partition coefficient (XLogP)
- 2.5
- Prodrug
- Yes
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 27
- Molecular formula
- C19H28O8
- Monoisotopic mass
- 384.17841785
- Natural product
- Yes
- Recorded assays
- 1,028
- Active assays
- 338
- Confirmatory
- Screening
- Antimalarials
- Antineoplastic Agents
- Antiviral Agents
- Schistosomicides
Distribution coefficient (LogD)
- Median
- 3.5
- Mean
- 3.5
- Minimum
- 3.5
- Maximum
- 3.5
- Unit
- unitless
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- LogD
Related records
Trials (512)
- 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
- 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)
- A 12 Week Study of MK0653A in Patients Who Have Been Hospitalized for a Possible Heart Problem (0653A-808)
- A 2-Month Safety Follow-Up Trial
- A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
- A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
- A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults
- A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor
- A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
- A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
- A Clinical Trial of Vorinostat (MK0683, SAHA) in Combination With FDA Approved Cancer Drugs in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)(0683-056)
- A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)
- A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan
- A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)
- A Crossover Bioavailability Clinical Trial of Parenteral Pyronaridine and Artesunate
- A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)
- A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
- A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease Subjects
- A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)
- A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)
Approved for (1)
In development for (16)
- Atopic conjunctivitis Phase 2
- Breast cancer Phase 1
- Cervical intraepithelial neoplasia grade 2/3 Phase 2
- Colorectal cancer Phase 2
- COVID-19 Phase 3
- Crohn disease Phase 2
- Cytomegalovirus infection Phase 3
- Friedreich ataxia Phase 1
- Hepatocellular carcinoma Phase 1
- Idiopathic pulmonary fibrosis Phase 1
- Intestinal cancer Phase 2
- Neoplasm Phase 1
- Plasmodium falciparum malaria Phase 3
- Plasmodium vivax malaria Phase 3
- Schistosomiasis Phase 3
- Urinary schistosomiasis Phase 3