Mpox is a viral zoonotic disease caused by monkeypox virus, typically presenting with fever, lymphadenopathy, and a characteristic rash. Human-to-human transmission occurs through close contact, and global outbreaks expanded beyond historically endemic regions.
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.
The World Health Organization has recommended new portable TB diagnostic tests that deliver results in under an hour, while researchers developed an inhalable nanoparticle treatment that could replace daily pills. TB remains the world's deadliest infectious disease, killing 1.2 million people in 2024 despite being preventable and curable.
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 |
|---|---|---|---|
| NCT07499739 |
Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX): Clinical Study to Monitor the Immunological Response Following Mpox Vaccination in the City of Kinshasa, Democratic Republic of the Congo |
RECRUITING | PHASE4 |
| NCT07093489 |
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC) |
NOT_YET_RECRUITING | |
| NCT06887556 |
Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks |
RECRUITING | NA |
| NCT06844500 |
Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT06136117 |
Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts |
COMPLETED | |
| 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 |
| NCT05784038 |
Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX) |
RECRUITING | |
| NCT05654883 |
New York City Observational Study of Mpox Immunity |
ENROLLING_BY_INVITATION | |
| NCT05597735 |
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease |
RECRUITING | PHASE3 |
| NCT05534984 |
Study of Tecovirimat for Human Mpox Virus |
TERMINATED | PHASE3 |
