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Disease

Smallpox

Late-stage therapeutic developmentEmerging research
MeSHSmallpox
1
Publications
11
Clinical trials
2022
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 2 clinical trials expected to report results, the earliest in Q1 2027.
  • 2 industry developments reported.
Upcoming Milestones
Clinical Milestones3View
Results expected 2
Recently completed 1
Industry & Market2View
Activity timeline5

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Tecovirimatapproved

Approval — Tecovirimat SIGA is indicated for the treatment of the following viral infections in adul… (2022)

Clinical trials

7 sponsors · 2 new · 0 completed in the last 12 months (net +2)

The current development programme across all trial phases.

Clinical programme
11
All trials
3
Active
5
Late-stage
5
Completed
Late-stage studies

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of TPOXX When Administered Orally for 28 Days in Adult Subjects

Phase 3 · Completed · SIGA Technologies

Double-blind, Comparative, Randomized, Placebo-controlled Study on Immunogenicity, Reactogenicity and Safety of Live Cell-based Vaccine Against Smallpox and Other Orthopoxvirus Infections (VACΔ6 Vaccine) in Volunteers Aged 18-60 Years

Phase 2/3 · Completed · Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)

Phase 4 · Completed · Emergent BioSolutions

A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN® Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

Phase 3 · Completed · Bavarian Nordic

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Phase 3 · Completed · SIGA Technologies
Recently completed

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of TPOXX When Administered Orally for 28 Days in Adult Subjects

Phase 3 · Completed · SIGA Technologies

Double-blind, Comparative, Randomized, Placebo-controlled Study on Immunogenicity, Reactogenicity and Safety of Live Cell-based Vaccine Against Smallpox and Other Orthopoxvirus Infections (VACΔ6 Vaccine) in Volunteers Aged 18-60 Years

Phase 2/3 · Completed · Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

Vaccinia Vaccination (ACAM2000®) of Plasma Donors for the Production of Vaccinia Immune Globulin Intravenous (VIGIV)

Phase 4 · Completed · Emergent BioSolutions

A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN® Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

Phase 3 · Completed · Bavarian Nordic

An Expanded Double-Blind, Placebo Controlled, Multicenter Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti Orthopoxvirus Compound Tecovirimat When Administered Orally for 14 Days in Subjects

Phase 3 · Completed · SIGA Technologies

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
2022emaApproval — Tecovirimat· Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13kg: Smallpox Cowpox Tecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13kg . Tecovirimat SIGA should be used in accordance with official recommendations. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

1 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Major themes7
  • HIV Infections1
  • Mpox, Monkeypox1
  • Proctitis1
  • Sexual and Gender Minorities1
  • Sexually Transmitted Diseases1
  • Smallpox1
  • Tonsillitis1
Leading journals1
  • Lancet (London, England)1
Leading researchers8
  • Acosta-Velásquez KS1
  • Agud-Dios M1
  • Alemany A1
  • Antón A1
  • Arando M1
  • Arroyo-Andrés J1
  • Cabrera JM1
  • Calderón-Lozano L1
Affiliations (unnormalised)6
  • Clinical Laboratory North Metropolitan Area1
  • Clinical Research Department1
  • Hospital Universitari Vall d'Hebron1
  • Hospital Universitario 12 de Octubre1
  • Hospital Universitario La Paz1
  • University Hospital Germans Trias i Pujol1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

An acute, highly contagious, often fatal infectious disease caused by an orthopoxvirus characterized by a biphasic febrile course and distinctive progressive skin eruptions. Vaccination has succeeded in eradicating smallpox worldwide. (Dorland, 28th ed)

Identifiers
MeSHSmallpox
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.