TPOXX

Peak

tecovirimat monohydrate

NDAORALCAPSULEPriority Review
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5

Mechanism of Action

Cytochrome P450 3A Inducers

Pharmacologic Class:

Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor

Clinical Trials (5)

NCT04485039Phase 4Completed

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

Started Jun 2022
44 enrolled
Smallpox
NCT04957485Phase 2Active Not Recruiting

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

Started Apr 2022
100 enrolled
Smallpox
NCT04971109Phase 3Completed

Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days

Started Mar 2022
467 enrolled
Smallpox
NCT03972111N/AWithdrawn

A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

Started Jan 2020
0
Smallpox
NCT04392739Phase 4Completed

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

Started Jul 2019
34 enrolled
Smallpox

Loss of Exclusivity

LOE Date
Aug 8, 2032
78 months away
Patent Expiry
Aug 8, 2032

Patent Records (5)

Patent #ExpiryTypeUse Code
8039504
Jul 23, 2027
Product
12433868
Mar 23, 2031
Product
9339466
Mar 23, 2031
SubstanceProduct
7737168
Sep 4, 2031
U-2346
11890270
Aug 8, 2032
U-2346