Tecovirimat (ST-246) Clinical Trials

Size	Price	Qty
5mg	USD 297
25mg	USD 957

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate tecovirimat for the prevention and treatment of orthopoxviral diseases—specifically smallpox and mpox—as well as its safety and pharmacokinetics in healthy volunteers. Sponsored by industry leaders such as SIGA Technologies alongside government and institutional organizations including NIAID and the U.S. Army, these studies range from completed early-phase evaluations to active or suspended Phase 3 trials. Overall, this clinical portfolio underscores tecovirimat's ongoing evaluation as a targeted antiviral therapeutic against pathogenic orthopoxviruses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04957485	ACTIVE_NOT_RECRUITING	Smallpox	SIGA Technologies	2022-04-05	PHASE2
NCT05597735	ACTIVE_NOT_RECRUITING	Monkeypox; Mpox	ANRS, Emerging Infectious Diseases	2023-03-03	PHASE3
NCT06156566	UNKNOWN	Monkeypox	Miquel Ekkelenkamp	2024-08-09	PHASE4
NCT05534165	SUSPENDED	Monkeypox	Marina Klein	2023-08-14	PHASE3
NCT05534984	TERMINATED	MPOX	National Institute of Allergy and Infectious Diseases (NIAID)	2022-09-08	PHASE3
NCT05559099	COMPLETED	Monkeypox	National Institute of Allergy and Infectious Diseases (NIAID)	2022-10-10	PHASE2
NCT04485039	COMPLETED	Smallpox	SIGA Technologies	2022-06-08	PHASE4
NCT02474589	COMPLETED	Smallpox	SIGA Technologies	2015-06-19	PHASE3
NCT00907803	Completed	Orthopoxviral Disease	SIGA Technologies\|National Institutes of Health (NIH)	2009-06	Phase 2
NCT00728689	Completed	Orthopoxviral Disease\|Smallpox\|Monkey Pox	SIGA Technologies\|National Institutes of Health (NIH)	2008-08	Phase 1
NCT00431951	Completed	Healthy	SIGA Technologies\|National Institute of Allergy and Infectious Diseases (NIAID)	2007-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-04-02)

Check the Tecovirimat (ST-246) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tecovirimat specifically targets and binds the orthopoxvirus p37 envelope protein, preventing the formation of the viral maturation complex required for wrapped virus particle production. By blocking intracellular viral transport and subsequent cellular egress, tecovirimat halts viral dissemination, demonstrating direct therapeutic relevance for mitigating viral spread in patients with orthopoxviral infections such as smallpox and mpox.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).