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Drug ReportsFostemsavir
Fostemsavir
Rukobia (fostemsavir) is a small molecule pharmaceutical. Fostemsavir 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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FDA Novel Drug Approvals 2020
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
rukobiaNew Drug Application2024-02-13
Indications
FDA
EMA
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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
22 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2016421122
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B20121——114
InfectionsD007239EFO_0000544—121———13
Immunologic deficiency syndromesD007153HP_0002721D84.9—1——12
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFostemsavir
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
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Structure (InChI/SMILES or Protein Sequence)
COc1cnc(-n2cnc(C)n2)c2c1c(C(=O)C(=O)N1CCN(C(=O)c3ccccc3)CC1)cn2COP(=O)(O)O
Identifiers
PDB—
CAS-ID864953-29-7
RxCUI—
ChEMBL IDCHEMBL3301594
ChEBI ID—
PubChem CID11319217
DrugBankDB11796
UNII ID97IQ273H4L (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 286 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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153 adverse events reported
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