tpoxx
tpoxx: sourced relationships with 1 company · 3 clinical trials tracked · 2 FDA decisions.
tpoxx evidence translation
What we can confirm
2 FDA records · 3 tracked trials
What it means
What to watch
Prepared research question
How could tpoxx → SIGA affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| SIGA TECHNOLOGIES INC (SIGA) | Phase 3 |
Clinical Trial Registry Records (3)
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of TPOXX When Administered Orally for 28 Days in Adult Subjects
Primary endpoint: Cmin
A Phase 4, Observational Field Study to Evaluate the Safety and Clinical Benefit of TPOXX (Tecovirimat)-Treated Patients Following Exposure to Variola Virus and Clinical Diagnosis of Smallpox Disease
Primary endpoint: Assess survival
A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX In Adult Subjects Weighing More Than 120 KG
Primary endpoint: AUC0-t
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with tpoxx?
tpoxx has dated SEC/FDA relationship records for SIGA TECHNOLOGIES INC.
How many clinical trials involve tpoxx?
BioSniper tracks 3 clinical trials involving tpoxx.
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. ( 1.2 ) TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models. ( 1.2 ) 1.1 Treatment of Human Smallpox Disease TPOXX ® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg. 1.2 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 [see Clinical Studies ( 14 )] . TPOXX efficacy may be reduced in immunocompromised patients based on studies demonstrating reduced efficacy in immunocompromised animal models., dated May 18, 2022.