NDAORALCAPSULEPriority Review
Approved
Jul 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
TPOXX (tecovirimat monohydrate) by Siga is cytochrome p450 3a inducers [moa]. First approved in 2018.
Drug data last refreshed 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TPOXX (tecovirimat monohydrate) is an oral small-molecule antiviral approved in 2018 for orthopoxvirus infections, including mpox. It works by inhibiting the VP37 envelope wrapping protein of orthopoxviruses, preventing viral spread and cell-to-cell transmission. The drug represents the first FDA-approved treatment specifically targeting orthopoxvirus infections.
Peak6.1 years to LOE
Product is in peak commercial phase with no direct competitors, positioning the brand team for sustained market presence through the LOE window.
Mechanism of Action
Cytochrome P450 3A Inducers
Pharmacologic Class:
Orthopoxvirus VP37 Envelope Wrapping Protein Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders
Started Jun 2022
44 enrolled
Smallpox
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS
Started Apr 2022
100 enrolled
Smallpox
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
Started Mar 2022
467 enrolled
Smallpox
A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox
Started Jan 2020
0Smallpox
Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG
Started Jul 2019
34 enrolled
Smallpox
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.