Smallpox is a severe infectious disease caused by variola virus. It was globally eradicated through vaccination and no naturally occurring cases have been reported since 1977.
Artios added six senior leaders in 2026 as alnodesertib moved toward late-stage development and potential U.S. commercialization. The company is also running a Phase 2 study of ART6043.
GeoVax is advancing Gedeptin toward a Phase 2 trial in head and neck cancer and has secured an exclusive license from Emory University for Gedeptin-ICI combination technology. The therapy has Orphan Drug Designation for oral and pharyngeal cancers.
NanoViricides has filed regulatory applications for its antiviral candidate NV-387, seeking both Rare Pediatric Disease Drug Designation for measles treatment and Orphan Drug Designation for both measles and MPox treatments. The company could qualify for significant incentives including tax credits, fee exemptions, market exclusivity, and potentially a Priority Review Voucher worth approximately $160 million. There are currently no approved drugs for treating either measles or MPox, with both diseases showing concerning case trends.
NanoViricides is preparing to advance NV-387 into a Phase II clinical trial for Monkeypox in the Democratic Republic of Congo, with regulatory approval received and full funding secured through recent financings totaling approximately $6.2 million.
NanoViricides has filed an orphan drug designation application with the FDA for NV-387 as a measles treatment, amid rising U.S. cases that reached 2,251 in 2025 with 3 deaths and 727 cases already reported in early 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07379580 |
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa |
RECRUITING | PHASE2 |
| NCT07377175 |
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses. |
RECRUITING | PHASE1 |
| NCT05995275 |
A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age |
COMPLETED | PHASE1/PHASE2 |
| NCT05976100 |
Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years |
COMPLETED | PHASE1 |
| NCT05935917 |
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults |
COMPLETED | PHASE1 |
| NCT05846243 |
Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years |
COMPLETED | PHASE2/PHASE3 |
| NCT05762523 |
Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years |
COMPLETED | PHASE1 |
| NCT04971109 |
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days |
COMPLETED | PHASE3 |
| NCT04957485 |
Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04485039 |
Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders |
COMPLETED | PHASE4 |
