Tembexa

Pipeline

Status by Indication[3][1]

Competition

Competitive Landscape

Progressive Multifocal LeukoencephalopathyAdenovirus Infections

9 competitors in Progressive Multifocal Leukoencephalopathy

#DrugCompanyPhaseTrials

1

Keytruda

Merck & Co.

Phase 3

12

Tembexa

Emergent BioSolutions

Phase 3

13

Vistide

Gilead

Preclinical

14

Intron a

Merck & Co.

Preclinical

15

Retrovir

BBp Consulting, Inc

Preclinical

26

Benemid

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

17

Tysabri

Biogen

Preclinical

18

Collection of Stools

UUniversity Hospital, Toulouse

Preclinical

1

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

Timeline

Expected Milestones

Clinical

Trials by Indication[1]

Adenovirus Infection3 trials

Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

No longer available·Jazz Pharmaceuticals··NCT02596997

A Multicenter Study to Obtain Retrospective Data for Subjects Previously Diagnosed With Adenovirus Infection to Serve as Matched Historical Controls for Study CMX001-304

Terminated·Jazz Pharmaceuticals··NCT02420080·100 enrolled

Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection

Completed·Jazz Pharmaceuticals·Phase 3·NCT02087306·201 enrolled

Prevention2 trials

Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease

Completed·Jazz Pharmaceuticals·Phase 2·NCT01241344·52 enrolled

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

Terminated·Jazz Pharmaceuticals·Phase 3·NCT02439957·6 enrolled

Cytomegalovirus Disease1 trial

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease

Terminated·Jazz Pharmaceuticals·Phase 3·NCT02439970·5 enrolled

Adult1 trial

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

Completed·Emergent BioSolutions·Phase 1·NCT05935917·44 enrolled

Transplant Recipient1 trial

Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia

Withdrawn·Jazz Pharmaceuticals·Phase 2·NCT03532035

10 more indications

BK Virus1 trial

CMX001 in Post-transplant Patients With BK Virus Viruria

Completed·Jazz Pharmaceuticals·Phase 1/2·NCT00793598·29 enrolled

Prophylaxis1 trial

An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola

Withdrawn·Jazz Pharmaceuticals·Phase 2·NCT04268966

Cytomegalovirus Infection1 trial

Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients

Completed·Jazz Pharmaceuticals·Phase 2·NCT00942305·239 enrolled

Safety and Efficacy1 trial

A Study of the Safety and Efficacy of CMX001 for the Prevention of CMV Infection in CMV-seropositive HCT Recipients

Completed·Jazz Pharmaceuticals·Phase 3·NCT01769170·452 enrolled

Lymphoma1 trial

A Phase 1b/2 Study of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma

Suspended·SSymBio Pharmaceuticals·Phase 1/2·NCT06761677·43 enrolled

Kidney Transplant1 trial

Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

Terminated·SSymBio Pharmaceuticals·Phase 2·NCT05511779·1 enrolled

Treatment1 trial

Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA Viruses

Completed·Jazz Pharmaceuticals·Phase 3·NCT01143181·210 enrolled

Transplantation1 trial

The AdAPT Trial; Adenovirus After Allogeneic Pediatric Transplantation

Terminated·Jazz Pharmaceuticals·Phase 2·NCT03339401·29 enrolled

Adenovirus Infections1 trial

A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir Versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

Recruiting·SSymBio Pharmaceuticals·Phase 3·NCT07387367·180 enrolled

Progressive Multifocal Leukoencephalopathy1 trial

Safety and Tolerability of Intravenous Brincidofovir as an Antiviral for Treatment of Progressive Multifocal Leukoencephalopathy: A Pilot Study

Recruiting·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT07511049·24 enrolled

Regulatory

FDA Approval Timeline[4]

Details

Drug Info

Patent Landscape[5]

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