Smallpox

22
Pipeline Programs
5
Companies
23
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
5
1
10
0
4
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Vaccine
480%
RNA Therapeutic
120%
+ 18 programs with unclassified modality

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Siga
SigaNEW YORK, NY
6 programs
1
2
2
TecovirimatPhase 41 trial
TpoxxPhase 41 trial
TPOXXPhase 31 trial
tecovirimatPhase 31 trial
TecovirimatPhase 21 trial
+1 more programs
Active Trials
NCT03972111Withdrawn0Est. Sep 2024
NCT04957485Active Not Recruiting100Est. Jan 2026
NCT04971109Completed467Est. May 2023
+3 more trials
Bavarian Nordic
Bavarian NordicDenmark - Kvistgard
10 programs
2
6
2
FD MVA-BNPhase 31 trial
IMVAMUNE®Phase 31 trial
IMVAMUNEPhase 21 trial
IMVAMUNEPhase 21 trial
IMVAMUNEPhase 21 trial
+5 more programs
Active Trials
NCT00189969Completed50Est. Feb 2006
NCT00189943Completed90Est. Jul 2003
NCT00686582Completed304Est. Jun 2009
+7 more trials
Sanofi
SanofiPARIS, France
4 programs
2
2
ACAM1000Phase 21 trial
Smallpox vaccine, LISTER strain, from chick embryo cellsPhase 2Vaccine1 trial
ACAM3000 MVA VaccinePhase 1Vaccine1 trial
MVAPhase 11 trial
Active Trials
NCT00079820Completed110Est. Oct 2006
NCT00389103Withdrawn0Est. Jan 2007
NCT00053508Terminated274Est. Sep 2003
+1 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
2 programs
1
1
MVA Smallpox VaccinePhase 2Vaccine1 trial
Live vaccinia virus vaccinePhase 1Vaccine1 trial
Active Trials
NCT00082446CompletedEst. Aug 2007
NCT01827371CompletedEst. Apr 2015
Moderna
ModernaCAMBRIDGE, MA
1 program
1
mRNA-1769Phase 1/2RNA Therapeutic1 trial
Active Trials
NCT05995275Completed351Est. Jul 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
SigaTecovirimat
SigaTpoxx
SigaTPOXX
Bavarian NordicFD MVA-BN
Sigatecovirimat
Bavarian NordicIMVAMUNE®
SigaTecovirimat
Bavarian NordicIMVAMUNE®
Allergy TherapeuticsMVA Smallpox Vaccine
Bavarian NordicLF formulation of IMVAMUNE®
Bavarian NordicIMVAMUNE
Bavarian NordicIMVAMUNE
Bavarian NordicMVA-BN®
SanofiSmallpox vaccine, LISTER strain, from chick embryo cells
Bavarian NordicIMVAMUNE

Showing 15 of 23 trials with date data

Clinical Trials (23)

Total enrollment: 9,405 patients across 23 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
NCT04957485SigaTecovirimat

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

Start: Apr 2022Est. completion: Jan 2026100 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 2015
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

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

An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees

Start: Aug 2008Est. completion: Jun 2009304 patients
Phase 2Completed

A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects

Start: Apr 2006Est. completion: Aug 2007745 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

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

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

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

Start: Oct 2006Est. completion: Jan 20070
Phase 1Withdrawn
NCT00082446Allergy TherapeuticsLive vaccinia virus vaccine

Combination Study With MVA BN and Dryvax

Start: May 2004Est. completion: Aug 2007
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

Phase Legend

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

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
5 companies competing in this space