CLINICAL TRIALS PROFILE FOR TECOVIRIMAT

All Clinical Trials for TECOVIRIMAT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00431951 ↗	Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2007-02-01	The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
NCT00431951 ↗	Phase I, Escalating, Multiple-Dose, ST-246 Safety, Tolerability and Pharmacokinetics 21-Day Trial in Healthy Volunteers	Completed	SIGA Technologies	Phase 1	2007-02-01	The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of a single, daily, oral dose of ST-246 (either 250, 400 or 800mg) administered for 21 days to 30 healthy, fed volunteers.
NCT00728689 ↗	Phase I Trial of an Investigational Small Pox Medication	Completed	National Institutes of Health (NIH)	Phase 1	2008-08-01	The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
NCT00728689 ↗	Phase I Trial of an Investigational Small Pox Medication	Completed	SIGA Technologies	Phase 1	2008-08-01	The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
NCT00907803 ↗	Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246	Completed	National Institutes of Health (NIH)	Phase 2	2009-06-01	The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.
NCT00907803 ↗	Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246	Completed	SIGA Technologies	Phase 2	2009-06-01	The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.

Clinical Trial Conditions for TECOVIRIMAT

Condition Name

Condition Name for TECOVIRIMAT
Intervention	Trials
Monkeypox	6
Smallpox	4
Orthopoxviral Disease	2
Monkey Pox	1

Condition MeSH

Condition MeSH for TECOVIRIMAT
Intervention	Trials
Monkeypox	6
Smallpox	4
Mpox (monkeypox)	1
Virus Diseases	1

Clinical Trial Locations for TECOVIRIMAT

Trials by Country

Trials by Country for TECOVIRIMAT
Location	Trials
United States	33
Switzerland	2
Congo, The Democratic Republic of the	1
Puerto Rico	1
Brazil	1

Trials by US State

Trials by US State for TECOVIRIMAT
Location	Trials
Florida	4
California	3
Texas	2
Nebraska	2
Missouri	2

Clinical Trial Progress for TECOVIRIMAT

Clinical Trial Phase

Clinical Trial Phase for TECOVIRIMAT
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	5
Phase 2	2

Clinical Trial Status

Clinical Trial Status for TECOVIRIMAT
Clinical Trial Phase	Trials
Not yet recruiting	5
Completed	4
Recruiting	1

Clinical Trial Sponsors for TECOVIRIMAT

Sponsor Name

Sponsor Name for TECOVIRIMAT
Sponsor	Trials
SIGA Technologies	5
National Institute of Allergy and Infectious Diseases (NIAID)	3
National Institutes of Health (NIH)	2

Sponsor Type

Sponsor Type for TECOVIRIMAT
Sponsor	Trials
Other	16
Industry	5
U.S. Fed	5

Tecovirimat: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 19, 2026

What is the current status of clinical trials for tecovirimat?

Tecovirimat, marketed as TPOXX® by SIGA Technologies, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of smallpox. It has also received Emergency Use Authorization (EUA) for monkeypox during the 2022 outbreak. Its development encompasses ongoing trials for other orthopoxvirus infections and biodefense-related indications.

Ongoing Clinical Trials

• NCT05534984: Phase II/III trial assessing safety and efficacy against monkeypox. Recruitment began in 2022, with completion expected by 2024.
• NCT04607186: Evaluates tecovirimat's efficacy in combination with immune globulin for severe monkeypox cases.
• NCT04786073: Investigates pharmacokinetics in children aged 2-17 years. Enrollment started in 2021.

Regulatory Status

• Approved in the U.S. (2018) for smallpox.
• Under EUA for monkeypox in the U.S. during the 2022 outbreak.
• Regulatory submissions underway or planned in Europe, Canada, and Australia for expanded indications.

What is the market landscape for tecovirimat?

Current Market

• Official Use: Limited to biodefense and select infectious disease emergencies.
• EUA Authorization: Declared for monkeypox in 2022, leading to increased utilization.
• Supply: Primarily supplied by SIGA, with potential for generic manufacturing pending patent and regulatory decisions.

Key Stakeholders

• SIGA Technologies: Holds patent rights and marketing authorization.
• Government agencies: U.S. CDC, BARDA, and international health authorities manage stockpiles and emergency use approvals.
• Competitors: No direct FDA-approved competitors for smallpox; other antivirals like brincidofovir are investigational.

Market Drivers

• Growing threat of bioterrorism involving orthopoxviruses.
• Outbreaks of monkeypox prompting emergency use and stockpiling.
• Genomic stability of orthopoxviruses reducing resistance development.

Market Barriers

• Limited approval scope restricts commercial sales.
• High production costs.
• Patent protections delaying generic entry.

What are projections for the future market of tecovirimat?

Market Size Forecast

Year	Estimated Market Value (USD)	Notes
2022	120 million	Surge due to monkeypox outbreak and EUA authorization
2023	180 million	Extended use in monkeypox and potential new indications
2025	300 million	Expected broader adoption, possible EU approval for additional indications
2030	500 million to 1 billion	Contingent on global regulatory approvals and outbreak frequency

Factors Influencing Growth

• Regulatory approvals: Expansion into Europe, Asia, and Australia could significantly increase sales.
• Indication expansion: Clinical success in other orthopoxvirus diseases or bioterrorism-related infections.
• Manufacturing scale-up: Gaining approval for generic manufacturing would moderate prices and improve access.
• Public health policies: Investment in biodefense preparedness influences procurement volume.

Potential Market Risks

• Emergence of resistance mutations.
• Changes in public health policies affecting stockpiling priorities.
• Competition from other antiviral candidates advancing through clinical development.

Key Takeaways

• Tecovirimat is FDA-approved for smallpox, with ongoing trials for monkeypox.
• The drug's market surged in 2022 due to the monkeypox outbreak and EUA issuance.
• The current market is driven by stockpiling and emergency use, with future growth reliant on expanded approvals and indications.
• Projected valuation could reach USD 1 billion by 2030, contingent on regulatory, clinical, and geopolitical factors.
• Market barriers include high manufacturing costs and patent protections, while risks include resistance development and shifting policy landscapes.

FAQs

1. When was tecovirimat first approved for smallpox?

In 2018 by the FDA under the brand name TPOXX®.

2. Is tecovirimat approved for monkeypox?

No, it has Emergency Use Authorization in the U.S. since 2022.

3. Are there any generic versions of tecovirimat?

Not currently; patent protections and regulatory exclusivity limit generic entry.

4. What other diseases could tecovirimat potentially treat?

Research is ongoing for its use against other orthopoxviruses and bioterrorism-related infections.

5. How does tecovirimat compare to other antiviral agents?

It targets the orthopoxvirus-specific p37 protein, offering a targeted mechanism less prone to resistance compared to broader-spectrum antivirals.

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References

[1] U.S. Food and Drug Administration. (2018). FDA approves first drug with demonstrated or proposed activity against smallpox. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-demonstrated-or-proposed-activity-against-smallpox

[2] ClinicalTrials.gov. (2022). Tecovirimat trials for monkeypox. https://clinicaltrials.gov/

[3] SIGA Technologies. (2023). TPOXX Product Data. https://siga.com/products/tpoxx/

[4] World Health Organization. (2022). Monkeypox: update on outbreak. https://www.who.int/news/item/23-08-2022

[5] MarketsandMarkets. (2023). Antiviral drugs market analysis. https://www.marketsandmarkets.com