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Smallpox

20
Pipeline Programs
7
Companies
40
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
2
12
0
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
1083%
RNA Therapeutic
18%
Small Molecule
18%
+ 34 programs with unclassified modality

Competitive Landscape

7 companies ranked by most advanced pipeline stage

Nordic Pharma
Nordic PharmaFrance - Paris
10 programs
2
6
2
FD MVA-BNPhase 3
IMVAMUNE®Phase 3
IMVAMUNEPhase 2
IMVAMUNEPhase 2
IMVAMUNEPhase 2
+5 more programs
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
9 programs
1
2
4
Aventis Pasteur Smallpox VaccinePhase 2Vaccine1 trial
DryvaxPhase 21 trial
Dryvax vaccinePhase 2Vaccine1 trial
IMVAMUNEPhase 21 trial
WetvaxPhase 1/21 trial
+4 more programs
Active Trials
NCT00082446Completed91Est. Aug 2007
NCT00050505Completed927Est. Dec 2003
NCT02743455Completed92Est. Mar 2018
+11 more trials
Emergent BioSolutions
6 programs
1
2
ACAM2000 Smallpox VaccinePhase 2Vaccine1 trial
Vaccinia virus: ACAM2000 smallpox vaccinePhase 2Vaccine1 trial
BrincidofovirPhase 1Small Molecule1 trial
ACAM2000® smallpox vaccineN/AVaccine1 trial
Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military PersonnelN/A1 trial
+1 more programs
Active Trials
NCT00927719Completed897,227Est. Dec 2017
NCT01540929Completed5,001Est. Sep 2012
NCT00928577Completed14,108Est. Dec 2015
+3 more trials
Bavarian Nordic
Bavarian NordicDenmark - Kvistgard
10 programs
Elstree-BNPHASE_11 trial
MVA-BNPHASE_11 trial
IMVAMUNEPHASE_2
IMVAMUNEPHASE_2
IMVAMUNEPHASE_21 trial
+5 more programs
Active Trials
NCT00189969Completed50Est. Feb 2006
NCT00189943Completed90Est. Jul 2003
NCT00857493Completed120Est. Aug 2010
+4 more trials
Siga
SigaNEW YORK, NY
6 programs
TPOXX 200Mg CapsuleN/A1 trial
TecovirimatPHASE_21 trial
TPOXXPHASE_31 trial
tecovirimatPHASE_31 trial
TecovirimatPHASE_41 trial
+1 more programs
Active Trials
NCT03972111Withdrawn0Est. Sep 2024
NCT04957485Active Not Recruiting100Est. Jan 2027
NCT04971109Completed467Est. May 2023
+3 more trials
Sanofi
SanofiPARIS, France
4 programs
ACAM3000 MVA VaccinePHASE_1Vaccine1 trial
MVAPHASE_12 trials
ACAM1000PHASE_21 trial
Smallpox vaccine, LISTER strain, from chick embryo cellsPHASE_2Vaccine1 trial
Active Trials
NCT00079820Completed110Est. Oct 2006
NCT00389103Withdrawn0Est. Jan 2007
NCT00282581Terminated2Est. Jul 2007
+2 more trials
Moderna
ModernaCAMBRIDGE, MA
1 program
mRNA-1769PHASE_1_2RNA Therapeutic1 trial
Active Trials
NCT05995275Completed351Est. Jul 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
SigaTecovirimat
SigaTpoxx
SigaTPOXX
Bavarian NordicFD MVA-BN
Sigatecovirimat
Bavarian NordicIMVAMUNE®
Allergy TherapeuticsAventis Pasteur Smallpox Vaccine
Allergy TherapeuticsDryvax vaccine
SigaTecovirimat
Bavarian NordicIMVAMUNE®
Allergy TherapeuticsMVA Smallpox Vaccine
Bavarian NordicLF formulation of IMVAMUNE®
Allergy TherapeuticsMVA Smallpox Vaccine
Bavarian NordicIMVAMUNE
Allergy TherapeuticsMVA Smallpox Vaccine

Showing 15 of 40 trials with date data

Clinical Trials (40)

Total enrollment: 928,916 patients across 40 trials

NCT04485039SigaTecovirimat

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

Start: Jun 2022Est. completion: Apr 202344 patients
Phase 4Completed

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

Start: Jul 2019Est. completion: Dec 201934 patients
Phase 4Completed

Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days

Start: Mar 2022Est. completion: May 2023467 patients
Phase 3Completed

Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial

Start: Jun 2019Est. completion: Jun 20201,129 patients
Phase 3Completed
NCT02474589Sigatecovirimat

A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat

Start: Jun 2015Est. completion: Aug 2016449 patients
Phase 3Completed

A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects

Start: Feb 2013Est. completion: Jun 20144,005 patients
Phase 3Completed
NCT00050518Allergy TherapeuticsAventis Pasteur Smallpox Vaccine

APSV in Vaccinia Naive Adults

Est. completion: Feb 2003444 patients
Phase 2Completed

A Study of Dryvax Vaccine Against Smallpox in Previously Unvaccinated Adults

Est. completion: Dec 2001
Phase 2Completed
NCT04957485SigaTecovirimat

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

Start: Apr 2022Est. completion: Jan 2027100 patients
Phase 2Active Not Recruiting

Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection

Start: Apr 2014Est. completion: May 201787 patients
Phase 2Completed

Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®

Start: Jun 2013Est. completion: Apr 2015435 patients
Phase 2Completed
NCT01668537Bavarian NordicLF formulation of IMVAMUNE®

A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects

Start: Mar 2013Est. completion: Jun 2014651 patients
Phase 2Completed

Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally

Start: Feb 2010Est. completion: Apr 2011523 patients
Phase 2Completed

A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects

Start: Jun 2009Est. completion: Aug 2010120 patients
Phase 2Completed

High Dose IMVAMUNE® in Vaccinia-Naive Individuals

Start: May 2009Est. completion: Mar 201191 patients
Phase 2Completed
NCT00258947SanofiSmallpox vaccine, LISTER strain, from chick embryo cells

Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults

Start: Sep 2005Est. completion: Jan 2007230 patients
Phase 2Completed

Dryvax Dilution-Prev Vacc Adults

Start: Apr 2004Est. completion: Nov 200490 patients
Phase 2Completed

Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.

Start: Apr 2003Est. completion: Dec 2005165 patients
Phase 2Completed
NCT00053482Emergent BioSolutionsACAM2000 Smallpox Vaccine

Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

Start: Jan 2003Est. completion: Oct 2003357 patients
Phase 2Completed
NCT00053495Emergent BioSolutionsVaccinia virus: ACAM2000 smallpox vaccine

Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

Start: Jan 2003Est. completion: Nov 2003353 patients
Phase 2Completed
NCT00050505Allergy TherapeuticsLive vaccinia virus vaccine

Expanded Dryvax Dilution Study in Previously Vaccinated Adults

Start: Oct 2002Est. completion: Dec 2003927 patients
Phase 2Completed

Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination

Start: Sep 2002Est. completion: Sep 2003274 patients
Phase 2Terminated

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

Start: Aug 2023Est. completion: Jul 2025351 patients
Phase 1/2Completed

MVA Post-Event: Administration Timing and Boost Study

Start: Apr 2007Est. completion: Apr 2009226 patients
Phase 1/2Completed

ACAM 3000 MVA at Harvard Medical School

Start: Oct 2005Est. completion: Apr 200872 patients
Phase 1/2Completed

Dressing Preparations for Smallpox

Start: Jul 2003Est. completion: Jun 2004102 patients
Phase 1/2Completed

Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT

Start: May 2002Est. completion: Aug 2002330 patients
Phase 1/2Completed

Human Immune Responses Smallpox

Est. completion: Nov 200445 patients
Phase 1Completed

Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults

Start: May 2023Est. completion: Sep 202344 patients
Phase 1Completed

A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers

Start: Jul 2016Est. completion: Mar 201892 patients
Phase 1Completed

Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)

Start: Oct 2006Est. completion: Jan 20070
Phase 1Withdrawn

Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive

Start: Oct 2006Est. completion: Jul 20072 patients
Phase 1Terminated
NCT00082446Allergy TherapeuticsLive vaccinia virus vaccine

Combination Study With MVA BN and Dryvax

Start: May 2004Est. completion: Aug 200791 patients
Phase 1Completed
NCT00079820SanofiACAM3000 MVA Vaccine

Safety, Tolerability, and Immune Response of ACAM3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Adults

Start: Apr 2004Est. completion: Oct 2006110 patients
Phase 1Completed

Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects

Start: Sep 2003Est. completion: Feb 200650 patients
Phase 1Completed

Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

Start: Apr 2001Est. completion: Jul 200390 patients
Phase 1Completed
NCT03972111SigaTPOXX 200Mg Capsule

A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox

Start: Jan 2020Est. completion: Sep 20240
N/AWithdrawn
NCT01540929Emergent BioSolutionsPost-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel

Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel

Start: Sep 2009Est. completion: Sep 20125,001 patients
N/ACompleted
NCT00928577Emergent BioSolutionsSafety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

Start: Dec 2008Est. completion: Dec 201514,108 patients
N/ACompleted
NCT00927719Emergent BioSolutionsACAM2000® smallpox vaccine

Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Start: Dec 2008Est. completion: Dec 2017897,227 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
7 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.