NDAINTRAVENOUSSOLUTION
Approved
May 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
4/8 — Partial
TPOXX (tecovirimat monohydrate) by Siga is cytochrome p450 3a inducers [moa]. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TPOXX (tecovirimat monohydrate) is an intravenous small-molecule orthopoxvirus VP37 envelope wrapping protein inhibitor approved in 2022 for treating orthopoxvirus infections, including monkeypox. It works by blocking viral protein maturation through CYP3A induction, preventing viral dissemination. The drug represents a novel mechanism of action in an historically underserved rare infectious disease category.
Peak5.2 years to LOE
Peak lifecycle positioning with zero competitive pressure suggests strong market ownership but dependent on sustained outbreak demand and government procurement cycles.
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.