Tpoxx

(Tecovirimat)

ApprovedSmall molecule

Tpoxx is a small molecule that works as a VP37 Inhibitor.[2] It is being used across 3 indications, with its most advanced program in Approved.[1]

Tpoxx is one of 48 small molecule programs targeting Smallpox. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

SmallpoxCompleted

Efficacy and SafetyRecruiting

MpoxTerminated

SmallpoxApproved

Completed

Efficacy and SafetyPhase 3

Recruiting

MpoxApproved

Terminated

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Rinvoq

AbbVie

Phase 3

4 2

Savaysa

Daiichi Sankyo

Phase 3

3 3

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

7 4

Rapamune

PPrism Pharmaceuticals

Phase 3

5 5

Tpoxx

SSIGA Technologies

Approved

1 6

Rilutek

AAzurity Pharmaceuticals

Phase 3

3 7

Kineret

SSwedish Orphan Biovitrum

Phase 3

2 8

UPLIZNA

HHorizon Therapeutics Ireland DAC

Phase 3

1 9

Becotatug Vedotin

FFudan University

Phase 3

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Efficacy and Safety

NCT05597735

Q1 2027

Phase 2Active, not recruiting

Smallpox

NCT04957485

Clinical

Trials by Indication[1]

Smallpox6 trials

A Phase 1, Open-Label (JYNNEOS®), Double-Blind (TPOXX® And Placebo), Multicenter, Randomized, Placebo-Controlled, Drug-Vaccine Interaction Study To Evaluate the Impact of TPOXX on JYNNEOS Immunogenicity

Active, not recruiting·SSIGA Technologies·Phase 2·NCT04957485·100 enrolled

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

Completed·SSIGA Technologies·Phase 3·NCT02474589·449 enrolled

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

Completed·SSIGA Technologies·Phase 3·NCT04971109·467 enrolled

Show 3 more trials

A Post-Marketing Open-Label, 5 Period Crossover, Drug-Drug Interaction Study of Orally Adminstered TPOXX When Co-administered With 4 Different Phosphate Binders in Healthy Subjects

Completed·SSIGA Technologies·Approved·NCT04485039·44 enrolled

A Post Marketing Study of the Safety, Tolerability, and Pharmacokinetics of TPOXX In Adult Subjects Weighing More Than 120 KG

Completed·SSIGA Technologies·Approved·NCT04392739·34 enrolled

Clinical Protocol to Treat Individuals With Tecovirimat (ST-246) After Exposure to Orthopox Viruses

Available·UU.S. Army Medical Research and Development Command··NCT02080767

Treatment2 trials

Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT06721585·328 enrolled

Tecovirimat for Treatment of Monkeypox Virus

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT05559099·597 enrolled

Infection1 trial

European Trial Into Mpox Infection

Recruiting·MMiquel Ekkelenkamp·Phase 4·NCT06156566·150 enrolled

Efficacy and Safety1 trial

Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

Recruiting·AANRS, Emerging Infectious Diseases·Phase 3·NCT05597735·480 enrolled

Hospitalized Patients1 trial

Tecovirimat in Non-hospitalized Patients With Monkeypox

Suspended·MMarina Klein·Phase 3·NCT05534165·120 enrolled

1 more indication

Mpox1 trial

A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT05534984·719 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 13, 2018

TPOXX

NDA NDA208627

Jul 13, 2018

TPOXX

NDA NDA208627

Nov 23, 2021

TPOXX

NDA NDA208627

May 18, 2022

TPOXX

NDA NDA214518

May 18, 2022

TPOXX

NDA NDA208627

May 18, 2022

TPOXX

NDA NDA214518

Jun 3, 2024

TPOXX

NDA NDA208627

Jun 3, 2024

TPOXX

NDA NDA214518

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Tecovirimat. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tecovirimat compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tecovirimat. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208627). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Tpoxx. U.S. Food & Drug Administration.
[6]
SEC EDGAR — SIGA Technologies company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: VP37 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SSIGA Technologies

Patent Landscape[5]

Patent Cliff

Jul 23, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8039504Jul 23, 2027

12433868Mar 23, 2031

9339466Mar 23, 2031

9233097Aug 2, 2031

9907859Aug 2, 2031

3 more patents

10576165Aug 2, 2031

7737168Sep 4, 2031

11890270Aug 8, 2032

Tpoxx

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Smallpox6 trials

Treatment2 trials

Infection1 trial

Efficacy and Safety1 trial

Hospitalized Patients1 trial

Mpox1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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