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tpoxx

Generic: tecovirimat

tpoxx: developed by 1 company · 2 FDA decisions.

tpoxx evidence translation

What we can confirm

What it means

Source-backed records connect tpoxx to SIGA; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could tpoxx → SIGA affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Smallpox

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
SIGA TECHNOLOGIES INC (SIGA)
Smallpox
Approved
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. ( 1.1 ) Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. ( (SIGA)FDA ↗
NDA214518Type 3 - New Dosage FormOrphan DrugStandardIntravenousSolution
Approval1 INDICATIONS AND USAGE TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. ( 1.1 ) Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. ( (SIGA)FDA ↗
NDA208627Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Who is developing tpoxx?

tpoxx is being developed by SIGA TECHNOLOGIES INC.

What is tpoxx's latest FDA decision?

The most recent tracked FDA decision for tpoxx is Approval for 1 INDICATIONS AND USAGE TPOXX is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. ( 1.1 ) Limitations of Use: The effectiveness of TPOXX for treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. ( , dated May 18, 2022.