Tecovirimat
Also known as Tpoxx
SIGA TECHNOLOGIES INC SIGA · Smallpox
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
Approved
NDA208627,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- SIGA TECHNOLOGIES INC SIGA Source: Company record for SIGA TECHNOLOGIES INC (opens in a new tab)
- Indication
- Smallpox Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 208627 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 208627 (opens in a new tab)
- NDA 214518 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 214518 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 19 Jun 20152 linked trials
- Filed Completed
- Approved Current stageFirst approval 13 Jul 2018
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Tecovirimat. Editors add each one with its source.
Filed application
No filed application is on record for Tecovirimat. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Tecovirimat.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT04971109ClinicalTrials.gov record for NCT04971109 (opens in a new tab) | Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days | Phase 3 | Completed | 467 (actual) | 12 May 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04971109 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04971109 Serious adverse events (Adverse event data was collected from Day 1 though the Day 58 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor.): TPOXX 1 of 369; TPOXX Placebo 1 of 95 Source: ClinicalTrials.gov results for NCT04971109 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT02474589ClinicalTrials.gov record for NCT02474589 (opens in a new tab)SIGA246-008 | A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat | Phase 3 | Completed | 449 (actual) | 24 Aug 2016 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02474589 (opens in a new tab) |
Posted results on ClinicalTrials.gov for SIGA246-008 Serious adverse events (Adverse event data was collected from Day 1 Randomization Visit after study drug dosing through the Day 28 Follow-up Visit. Subjects with unresolved AE/SAE at the Day 28 Follow-up Visit were required to complete a Day 45 AE/SAE only Follow up Visit. All AEs/SAEs were to be followed until the subject was no longer participating in the study, or the AE/SAE was stable or until resolution.): Active 1 of 359; Placebo 0 of 90 Source: ClinicalTrials.gov results for NCT02474589 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing SIGA246-008 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA208627Action letter for NDA208627 (opens in a new tab) | Supplement 7 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA214518Action letter for NDA214518 (opens in a new tab) | Original 1 Type 3 - New Dosage Form | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208627Action letter for NDA208627 (opens in a new tab) | Supplement 6 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA208627Action letter for NDA208627 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Tecovirimat SIGA (EMEA/H/C/005248)
- Authorised
- Therapeutic area
- Poxviridae Infections;Cowpox;Monkeypox;Vaccinia;Smallpox
- Marketing authorisation holder
- SIGA Technologies Netherlands B.V.
- Active substance (INN)
- tecovirimat monohydrate
- ATC code
- J05AX24
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Tecovirimat SIGA (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 208627 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04971109 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02474589 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA208627 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA214518 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.