Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TPOXX · 1 trial · 1 indication
Cmin - Minimum TPOXX concentration in plasma
Peak exposure when administered TPOXX
Total systematic exposure when administered TPOXX
Median hours post dose when administered TPOXX
| Arm | Type | Description |
|---|---|---|
| TPOXX | ACTIVE_COMPARATOR | Treatment Group 1: An oral dose of 600 mg (3 x 200 mg capsules)TPOXX |
| TPOXX Placebo | PLACEBO_COMPARATOR | Treatment Group 2: An oral dose of placebo (3 capsules identical to TPOXX) |
| Name | Type | Description |
|---|---|---|
| TPOXX | DRUG | Study is based on Animal Regulatory Rule |
| TPOXX Placebo | OTHER | Does not apply |
Inclusion Criteria: 1. Subject is male or female between 18 and 80 years of age, inclusive. 2. Subject is available for clinical follow-up for the duration of the study. 3. Women of childbearing potential have a negative beta human chorionic gonadotropin pregnancy test (serum) at the screening visi...
TPOXX is an investigational small molecule drug being developed for smallpox. It is currently in Phase 3 clinical development. TPOXX is being studied for its safety, tolerability, and pharmacokinetics when administered orally for 28 days.
TPOXX is being developed by SIGA Technologies Inc., a company traded under the ticker symbol SIGA. The drug is currently in Phase 3 clinical development for the treatment of smallpox.
TPOXX is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 clinical trial has been completed, with no active trials currently ongoing.
TPOXX has one completed Phase 3 clinical trial with the identifier NCT04971109. This trial studied the safety, tolerability, and pharmacokinetics of TPOXX when administered orally for 28 days. The trial enrolled 467 participants in the United States.
TPOXX is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for smallpox. A Phase 3 clinical trial has been completed, but the drug remains under investigation and has not received regulatory approval.