Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tecovirimat · 2 trials · 1 indication
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 |
|---|---|---|
| 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 |
|---|---|---|
| tecovirimat | DRUG | Study is based on Animal Regulatory Rule |
| Placebo | OTHER | Does not apply |
| Smallpox and Mpox Vaccine | DRUG | vaccine |
Inclusion Criteria: * 18 to 80 years old, inclusive * Available for clinical follow-up for the duration of the study * Able and willing to give informed consent * In good general health without clinically significant medical history; not have been hospitalized for a chronic medical condition for th...
Tecovirimat is an investigational small molecule drug being developed for smallpox, a viral infectious disease. It is currently in Phase 3 clinical development and is not yet approved by the FDA. Tecovirimat is being studied for its safety, tolerability, and pharmacokinetics in healthy volunteers.
Tecovirimat targets the VP37 protein, which is essential for the formation of the outer envelope of orthopoxviruses, including the smallpox virus. By inhibiting VP37, Tecovirimat is designed to prevent the virus from spreading within the host.
Tecovirimat is being developed by SIGA Technologies Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SIGA. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of smallpox.
Tecovirimat is in Phase 3 clinical development. It has completed one Phase 3 trial and has one active Phase 2 trial that is not recruiting participants. Tecovirimat is an investigational drug and has not received FDA approval.
Tecovirimat is being studied in two clinical trials. NCT02474589 is a completed Phase 3 trial assessing safety, tolerability, and pharmacokinetics in 449 healthy volunteers. NCT04957485 is an active Phase 2 trial evaluating safety and immunogenicity when administered orally for 28 days with JYNNEOS in 100 healthy volunteers.