Drugs / Tecovirimat
Tecovirimat
also known as
TPOXX · ST-246 · SIGA-246 · ST-246 MONOHYDRATE · TECOVIRIMAT MONOHYDRATE · Tecovirimat siga
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | TPOXX | — | 2021-11-23 – 2022-05-18 | fda.gov ↗ |
| Approved | EU (EMA) | Tecovirimat SIGA | — | 2022-01-06 | europa.eu ↗ |
| Approved | US (FDA) | TPOXX | — | 2018-07-13 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00431951 | Feb 2007 → Feb 2008 | — | SIGA Technologies | Completed | No outcome recorded |
| Phase 1 | NCT00303225 | Mar → Aug 2006 | vaccinia | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05559099 | Oct 2022 → Sep 2024 | monkeypox | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Missed primary |
| Phase 2 | NCT00907803 | Jun 2009 → Jan 2010 | human infection by orthopoxvirus | SIGA Technologies | Completed | No outcome recorded |
| Phase 33 trials · 1 missed | ||||||
| Phase 3 | NCT05534165 | Aug 2023 → Mar 2025 | monkeypox | Marina Klein | Suspended | No outcome recorded |
| Phase 3 | NCT05597735 | Mar 2023 → Sep 2026 overdue | monkeypox | ANRS, Emerging Infectious Diseases | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05534984 | Sep 2022 → Oct 2024 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT04485039 | Jun → Dec 2022 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 4 | NCT04392739 | Jul → Dec 2019 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT05380752 | — | human infection by orthopoxvirus | U.S. Army Medical Research and Development Command | No longer available | No outcome recorded |
| — | NCT02080767 | — | monkeypox, smallpox | U.S. Army Medical Research and Development Command | Available | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 1 | NCT00728689 Comparator | Aug → Oct 2008 | human infection by orthopoxvirus, monkeypox, smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 2 | NCT04957485 Comparator | Apr 2022 → Jan 2027 expected | smallpox | SIGA Technologies | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04971109 Comparator | Mar 2022 → May 2023 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 3 | NCT02474589 Comparator | Jun 2015 → Aug 2016 | smallpox | SIGA Technologies | Completed | No outcome recorded |
| Phase 4 | NCT06156566 Comparator | Aug 2024 → Dec 2025 overdue | monkeypox | Miquel Ekkelenkamp | Recruiting | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tecovirimat | “tecovirimat” NCT04971109 ↗ |
| Known as | SIGA-246 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00303225 ↗ |
| Known as | ST-246 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00728689 ↗ |
| Known as | ST-246 MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1257073 ↗ |
| Known as | TECOVIRIMAT MONOHYDRATE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1257073 ↗ |
| Known as | Tecovirimat siga | ChEMBL registry synonym — accepted as the source's own label CHEMBL1257073 ↗ |
| Known as | TPOXX | “Tecovirimat (TPOXX®, SIGA Technologies Inc.) is a treatment for smallpox, monkeypox and cowpox.” NCT05597735 ↗4“Tecovirimat (TPOXX) is approved by FDA for treatment of smallpox.” NCT02080767 ↗ “TPOXX IV (Tecovirimat Injection, 10 mg/mL)” NCT05380752 ↗ |
| Modality | Small molecule | — CHEMBL1257073 ↗ |
| Route | Oral | “Participants are randomly assigned to receive a one-time dose of SIGA-246 (either 500 mg, 1000 mg, or 2000 mg) or a placebo (sugar pill) taken by mouth.” NCT00303225 ↗ |