> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/artesunate-586f50f5-bb73-43da-8a18-5a2743da577b > Record changed: 2026-10-13 # Artesunate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) First approval year 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) ## Development status **First approval year** 2020 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **Drug name** Artesunate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **Molecular weight** 384.43 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **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 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) ### Brand names (4) - arsumax - Arsumax - artesunate amivas - Artesunate amivas ### Other names (67) - .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. ## Identifiers **ATC classification codes** - P01BE03 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **CAS registry numbers** - 88495-63-0 **ChEMBL ID** CHEMBL361497 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **InChIKey** FIHJKUPKCHIPAT-AHIGJZGOSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL361497) **PubChem compound IDs** - 6917864 **RxNorm IDs (RxCUI)** - 18346 **FDA ingredient codes (UNII)** - 60W3249T9M ## Regulatory information ### United States **Applicant** AMIVAS **Approval date** 26 May 2020 **Application number** NDA213036 ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/artesunate-amivas) ### Other regulatory facts **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 ### Drug classification **Pharmacology name** artesunate **Type** Synthetic organic **Drug name stem** arte- **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Investigated indications (17) - **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 ### Open Targets indications (36) - **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. ### Reported adverse events (18) - **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 ### Trial references (132) - NCT00118807 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00118807) - NCT00119132 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00119132) - NCT00119145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00119145) - NCT00123552 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00123552) - NCT00132548 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00132548) - NCT00132561 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00132561) - NCT00140361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00140361) - NCT00146731 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00146731) - NCT00158548 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00158548) - NCT00164255 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00164255) - NCT00238017 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00238017) - NCT00243737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00243737) - NCT00292929 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00292929) - NCT00292942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00292942) - NCT00297882 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00297882) - NCT00298610 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00298610) - NCT00316329 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00316329) - NCT00330902 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00330902) - NCT00354380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00354380) - NCT00373607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00373607) - NCT00378625 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00378625) - NCT00386503 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00386503) - NCT00393679 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00393679) - NCT00406146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00406146) - NCT00422084 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00422084) And 107 more, listed on the interactive page. ## Chemical properties **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 ## Evidence counts **Recorded assays** 1,028 **Active assays** 338 ### Active assay types (2) - Confirmatory - Screening ## Pharmacologic actions - Antimalarials Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000962.html) - Antineoplastic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html) - Antiviral Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000998.html) - Schistosomicides Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D012556.html) ## Biological measurements ### Observed measurements #### 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) - [Malaria](https://trialight.com/data/condition/malaria-54828cac-9b96-5833-93e2-e012d4505853.md) ### In development for (16) - Atopic conjunctivitis Phase 2 - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 1 - [Cervical intraepithelial neoplasia grade 2/3](https://trialight.com/data/condition/cervical-intraepithelial-neoplasia-grade-2-3-2b698f17-3747-50ed-89d6-a8d45617703c.md) Phase 2 - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 - [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Phase 2 - [Cytomegalovirus infection](https://trialight.com/data/condition/cytomegalovirus-infection-33aa640c-a359-5979-84a0-c70ac00df24d.md) Phase 3 - Friedreich ataxia Phase 1 - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 1 - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Phase 1 - Intestinal cancer Phase 2 - Neoplasm Phase 1 - [Plasmodium falciparum malaria](https://trialight.com/data/condition/plasmodium-falciparum-malaria-5e0103dd-4e60-581d-924b-3435883b51f8.md) Phase 3 - Plasmodium vivax malaria Phase 3 - Schistosomiasis Phase 3 - Urinary schistosomiasis Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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