Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 TPOXX, ST-246, ST-246 Days 1 - 3, ST-246 Days 11 - 13
Tecovirimat · 4 trials · 2 indications
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
Subjects were administered a single, daily oral dose of ST-246 (400 or 600 mg)and changes in safety parameteres were monitored. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms. The DAIDS AE grading table is a list of common terms and severity (intensity) of parameters used to describe adverse events occurring in NIAID-sponsored clinical studies/trials.
| 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. |
| ST-246 400 mg | EXPERIMENTAL | ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days |
| ST-246 600 mg | EXPERIMENTAL | ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days |
| 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 |
| ST-246 400 mg | DRUG | Capsules, 400 mg daily for 14 days |
| ST-246 600 mg | DRUG | Capsules, 600 mg daily for 14 days |
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...
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.