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Drug ReportsTecovirimat
Tpoxx, Tecovirimat siga(tecovirimat)
Tecovirimat Monohydrate, Tpoxx (tecovirimat) is a small molecule pharmaceutical. Tecovirimat was first approved as Tpoxx on 2018-07-13. It is used to treat smallpox in the USA. It has been approved in Europe to treat cowpox, mpox (monkeypox), poxviridae infections, smallpox, and vaccinia.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
animal diseasesD000820
Trade Name
FDA
EMA
Tpoxx
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tecovirimat
Tradename
Company
Number
Date
Products
TPOXXSIGA TechnologiesN-208627 RX2018-07-13
1 products, RLD, RS
TPOXXSIGA TechnologiesN-214518 RX2022-05-18
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tpoxxNew Drug Application2024-07-03
Agency Specific
FDA
EMA
Expiration
Code
TECOVIRIMAT, TPOXX, SIGA TECHNOLOGIES
2025-07-13ODE-200
Patent Expiration
Patent
Expires
Flag
FDA Information
Tecovirimat, Tpoxx, Siga Technologies
118902702032-08-08U-2346
77371682031-09-04U-2346, U-3377
92330972031-08-02DP
99078592031-08-02U-3377
105761652031-08-02DP
93394662031-03-23DS, DP
80395042027-07-23DP
81246432024-06-18DS, DP
85305092024-06-18DP
88027142024-06-18U-3377
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AX: Other antivirals in atc
— J05AX24: Tecovirimat
HCPCS
No data
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SmallpoxD012899—B03112228
Mpox (monkeypox)D045908—B04112116
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Virus diseasesD014777—B34——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OrthopoxvirusD018155——11———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
VacciniaD014615——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Poxviridae infectionsD011213EFO_0007370B08.04————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTecovirimat
INNtecovirimat
Description
Tecovirimat, sold under the brand name Tpoxx among others, is an antiviral medication with activity against orthopoxviruses such as smallpox and mpox. In 2018 it became the first antipoxviral drug approved in the United States.
Classification
Small molecule
Drug classantivirals: antiviral, disrupts viral maturation
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C(NN1C(=O)[C@H]2[C@H]3C=C[C@H]([C@@H]4C[C@H]34)[C@H]2C1=O)c1ccc(C(F)(F)F)cc1
Identifiers
PDB—
CAS-ID816458-31-8
RxCUI—
ChEMBL IDCHEMBL1257073
ChEBI ID—
PubChem CID16124688
DrugBankDB12020
UNII IDF925RR824R (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 1,503 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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102 adverse events reported
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