7 completed, 1 active not recruiting, 1 no longer available, 1 terminated. 3 Phase 3, 2 Phase 1, 2 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
| Phase 2 | 2 | Active not recruiting 1, Completed 1 |
| Phase 4 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Tecovirimat for Human Mpox Virus Tecovirimat Oral Capsule, Placebo for Tecovirimat, Tecovirimat Oral Capsule (Open Label) - MPOX | Phase 3 | Terminated | National Institute of Allergy and Infectious Diseases (NIAID) | 719 | 2022-09-08 | 2026-06-23 |
| Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders Tecovirimat, sevelamer carbonate oral tablet, sucroferric oxyhydroxide chewable tablet - Smallpox | Phase 4 | Completed | SIGA Technologies | 44 | 2022-06-08 | 2026-09-11 |
| Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS Tecovirimat, Smallpox and Mpox Vaccine, Placebo - Smallpox | Phase 2 | Active not recruiting | SIGA Technologies | 100 | 2022-04-05 | 2026-09-14 |
| Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days TPOXX, TPOXX Placebo - Smallpox | Phase 3 | Completed | SIGA Technologies | 467 | 2022-03-29 | 2026-09-11 |
| A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox TPOXX 200Mg Capsule - Smallpox | Withdrawn | SIGA Technologies | 2020-01-01 | 2026-09-10 | ||
| Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG Tpoxx - Smallpox | Phase 4 | Completed | SIGA Technologies | 34 | 2019-07-19 | 2026-09-11 |
| A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat tecovirimat, Placebo - Smallpox | Phase 3 | Completed | SIGA Technologies | 449 | 2015-06-19 | 2026-09-11 |
| Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246 ST-246 400 mg, ST-246 600 mg, Placebo - Orthopoxviral Disease | Phase 2 | Completed | SIGA Technologies | 107 | 2009-06-01 | 2026-09-11 |
| Phase I Trial of an Investigational Small Pox Medication ST-246 Days 1 - 3, ST-246 Days 11 - 13 - Orthopoxviral Disease, Smallpox | Phase 1 | Completed | SIGA Technologies | 12 | 2008-08-01 | 2026-10-01 |
| Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers ST-246, Placebo - Healthy | Phase 1 | Completed | SIGA Technologies | 30 | 2007-02-01 | 2026-10-01 |
| Tecovirimat Intravenous Treatment for Orthopox Virus Exposure TPOXX IV (Tecovirimat Injection, 10 mg/mL) - Orthopox Virus Infection | No longer available | U.S. Army Medical Research and Development Command | 2025-03-10 |
Smallpox (8) · Mpox, Monkeypox (2)
tecovirimat (11) · Sevelamer (1) · Smallpox Vaccine (1) · calcium acetate (1) · lanthanum carbonate (1) · smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic (1) · sucroferric oxyhydroxide (1)
United States (10) · Argentina (1) · Brazil (1) · Mexico (1) · Peru (1) · Thailand (1)
Dennis Hruby, Ph.D. (2) · Dennis Hruby, PhD (2) · Thomas C Marbury, MD (2) · Dennis E. Hruby, PhD (1) · Dennis Hruby (1) · Erik Ross, MD (1) · Jon Ruckle, MD (1) · Thomas Marbury, MD (1) · Timothy Wilkin, MD, MPH (1)