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Label indication 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… FDA label
Also known as tecovirimat
TPOXX · 3 trials · 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
To determine the safety and tolerability of oral tecovirimat
Number of participants with adverse events when TPOXX or TPOXX Placebo is coadministered with JYNNEOS
Least squared geometric mean
| 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) |
| Active | ACTIVE_COMPARATOR | 600 mg tecovirimat capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects |
| Placebo | PLACEBO_COMPARATOR | matching placebo capsules BID to assess safety and tolerability and pharmacokinetics of the anit-orthopoxvirus compound Tecovirimat when administered orally in healthy subjects |
| JYNNEOS + TPOXX | ACTIVE_COMPARATOR | An oral dose of 600 mg (3 × 200 mg capsules) TPOXX BID (every 12 hours \[±30 minutes\]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX concomitantly on Day 1 |
| JYNNEOS + matching TPOXX placebo | PLACEBO_COMPARATOR | An oral dose of placebo (3 capsules identical to TPOXX) BID (every 12 hours \[±30 minutes\]) for 28 days and a single AM SC dose of 0.5 mL JYNNEOS on Day 1 and Day 29. JYNNEOS will be administered with TPOXX placebo concomitantly on Day 1. |
| Name | Type | Description |
|---|---|---|
| TPOXX | DRUG | Study is based on Animal Regulatory Rule |
| TPOXX Placebo | OTHER | Does not apply |
| tecovirimat | DRUG | Study is based on Animal Regulatory Rule |
| Placebo | OTHER | Does not apply |
| Smallpox and Mpox Vaccine | DRUG | vaccine |
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.