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Rukobia(fostemsavir tromethamine)
Rukobia (fostemsavir tromethamine) is a small molecule pharmaceutical. Fostemsavir tromethamine was first approved as Rukobia on 2020-07-02. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Rukobia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fostemsavir tromethamine
Tradename
Company
Number
Date
Products
RUKOBIAViiV HealthcareN-212950 RX2020-07-02
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rukobiaNew Drug Application2020-07-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
Agency Specific
FDA
EMA
Expiration
Code
FOSTEMSAVIR TROMETHAMINE, RUKOBIA, VIIV HLTHCARE
2025-07-02NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Fostemsavir Tromethamine, Rukobia, Viiv Hlthcare
77456252027-11-19DP
81686152025-02-25DP
84613332025-02-25DP
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AX: Other antivirals in atc
— J05AX29: Fostemsavir
HCPCS
No data
Clinical
Clinical Trials
41 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary tract infectionsD014552EFO_0003103N39.0—348318
CystitisD003556EFO_1000025N30———123
InfectionsD007239EFO_0000544——11—2
Asymptomatic diseasesD058070———2—2
EndocarditisD004696EFO_0000465I33———1—1
Prostatic neoplasmsD011471C61———1—1
HospitalizationD006760———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—2—1——3
GonorrheaD006069DOID_7551A54——1——1
BacteremiaD016470EFO_0003033R78.81——1——1
Febrile neutropeniaD064147——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AppendicitisD001064EFO_0007149K37—2———2
Bacterial pneumoniaD018410EFO_1001272J15.9—2———2
Urinary bladder neoplasmsD001749C67—1———1
Urologic surgical proceduresD013520—1———1
Neonatal sepsisD000071074HP_0040187—1———1
PouchitisD019449EFO_0003921K91.85011———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pseudomonas infectionsD011552EFO_00010761————1
Bacterial infectionsD001424A491————1
Multiple drug resistanceD0184321————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urologic diseasesD014570N39.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFOSTEMSAVIR TROMETHAMINE
INNfostemsavir
Description
Fostemsavir, sold under the brand name Rukobia, is an antiretroviral medication for adults living with HIV/AIDS who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations.
Classification
Small molecule
Drug classphosphoro-derivatives; antivirals
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1cnc(-n2cnc(C)n2)c2c1c(C(=O)C(=O)N1CCN(C(=O)c3ccccc3)CC1)cn2COP(=O)(O)O.NC(CO)(CO)CO
Identifiers
PDB—
CAS-ID864953-29-7
RxCUI—
ChEMBL IDCHEMBL3301598
ChEBI ID—
PubChem CID11319217
DrugBankDB11796
UNII ID97IQ273H4L (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 211 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,336 adverse events reported
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