A Phase 1, Open-label, Single-dose, Randomized, Two-period, Crossover Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adult Participants

The goal of this clinical trial is to evaluate whether both Form H and Form II, 100mg brincidofovir tablets are bioequivalent, when given under fasting conditions in healthy adults.
Participants will be randomized to each receive one tablet of Form H and one tablet of Form II,14 days apart and undergo pharmacokinetic testing pre-dose and post-dose to evaluate safety. This is an open-label, single-dose, randomized, two-period, crossover study.

Start Date30 May 2023

Sponsor / Collaborator

Emergent BioSolutions, Inc.

NCT05511779 / RecruitingPhase 2

Phase II, Open-label, Randomized, Multiple Ascending Dose Confirmation of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation (BASTION)

This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.

Start Date14 Oct 2022

Sponsor / Collaborator

SymBio Pharmaceuticals Ltd.

NCT04706923 / RecruitingPhase 2

A Phase IIa, Open-label, Multiple Ascending Dose Confirmation Study of the Safety and Tolerability of Intravenous Administration of Brincidofovir in Subjects With Adenovirus Infection or Cytomegalovirus Infection

The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly (BIW) or 0.4 mg/kg dosed once weekly (QW) for 4 weeks in subjects with AdV, and IV BCV in subjects with CMV

Start Date16 Aug 2021

Sponsor / Collaborator

SymBio Pharmaceuticals Ltd.

100 Clinical Results associated with Brincidofovir

100 Translational Medicine associated with Brincidofovir

100 Patents (Medical) associated with Brincidofovir

389

Literatures (Medical) associated with Brincidofovir

01 Nov 2024·Antiviral Research

Treatment efficacy of cidofovir and brincidofovir against clade II Monkeypox virus isolates

Article

Author: Prévost, Jérémie ; Kodihalli, Shantha ; Barker, Douglas ; Deschambault, Yvon ; Safronetz, David ; Tierney, Kevin ; Sloan, Angela ; Kammanadiminti, Srinivas ; Azaransky, Kimberly ; Tailor, Nikesh

While historically confined to endemic areas, Monkeypox virus (MPXV) infection has increasingly garnered international attention due to sporadic outbreaks in non-endemic countries in the last two decades and its potential for human-to-human transmission. In 2022, a multi-country outbreak of mpox disease was declared by the World Health Organization (WHO) and nearly 100,000 mpox cases have been reported since the beginning of this pandemic. The clade II variant of the virus appears to be responsible for the vast majority of these infections. While there are no antiviral drugs currently approved to treat mpox specifically, the use of tecovirimat (TPOXX®) and brincidofovir (Tembexa®) is recommended by the Centers for Disease Control and Prevention (CDC) for compassionate use in severe mpox cases, since both are FDA-approved for the treatment of the closely related smallpox disease. Given the emergence of multiple tecovirimat-resistant infections, we aimed to evaluate the treatment efficacy of brincidofovir and its active compound, cidofovir, against MPXV clade II strains. Following intranasal infection, we show that cidofovir and brincidofovir can strongly reduce the viral replication of MPXV clade IIa and IIb viruses in the respiratory tract of susceptible mice when administered systemically and orally, respectively. The high antiviral activity of both compounds against historical and currently circulating MPXV strains supports their therapeutic potential for clinical application.

01 Sep 2024·Indian Journal of Microbiology

Inhibition of Monkeypox Virus DNA Polymerase Using Moringa oleifera Phytochemicals: Computational Studies of Drug-Likeness, Molecular Docking, Molecular Dynamics Simulation and Density Functional Theory

Article

Author: Yousaf, Muhammad Abrar ; Basheera, Shefin ; Sivanandan, Sreekumar

The emergence of zoonotic monkeypox (MPX) disease, caused by the double-stranded DNA monkeypox virus (MPXV), has become a global threat. Due to unavailability of a specific small molecule drug for MPX, this study investigated Moringa oleifera phytochemicals to find potent and safe inhibitors of DNA Polymerase (DNA Pol), a poxvirus drug target due to its role in the viral life cycle. For that, 146 phytochemicals were screened through drug-likeness and molecular docking analyses. Among these, 136 compounds exhibited drug-like properties, with Gossypetin showing the highest binding affinity (- 7.8 kcal/mol), followed by Riboflavin (- 7.6 kcal/mol) and Ellagic acid (- 7.6 kcal/mol). In comparison, the control drugs Cidofovir and Brincidofovir displayed lower binding affinities, with binding energies of - 6.0 kcal/mol and - 5.1 kcal/mol, respectively. Hydrogen bonds, electrostatic and hydrophobic interactions were the main non-bond interactions between inhibitors and protein active site. The identified compounds were further evaluated using molecular dynamics simulation, density functional theory analysis and ADMET analysis. Molecular dynamics simulations conducted over 200 ns revealed that DNA Pol-Gossypetin complex was not stable, however, Riboflavin and Ellagic acid complexes showed excellent stability indicating them as better DNA Pol inhibitors. The density functional theory analysis exhibited the chemical reactivity of these inhibitor compounds. The ADMET analysis suggested that the top phytochemicals were safe and showed no toxicity. In conclusion, this study has identified Riboflavin and Ellagic acid as potential DNA Pol inhibitors to control MPXV. Further experimental assays and clinical trials are needed to confirm their activity against the disease.Graphical Abstract

01 Sep 2024·Current Opinion in Ophthalmology

Ocular manifestations of mpox

Review

Author: Doan, Thuy ; Nguyen, Minh ; Seitzman, Gerami D

Purpose of reviewTo highlight the clinical features of mpox with an emphasis on ocular manifestations and to review treatment options for this re-emerging infectious disease.Recent findingsOcular involvement of mpox varies by clade. The most recent 2022 outbreak appears to be associated with fewer conjunctivitis cases compared to previous outbreaks. However, the ocular findings occurring during this newly emerging clade can be visually threatening and include cases of keratitis, rapidly progressing scleritis, and necrotizing periorbital rashes.SummaryOcular mpox is an important clinical feature of systemic mpox virus (MPXV) infection. Heightened clinical suspicion allows for a timely diagnosis and the initiation of antiviral treatment, when appropriate. Randomized clinical trials for mpox systemic and ocular treatment efficacy are lacking. Prior clinical experience with smallpox and in-vitro mpox data support the use of systemic antivirals such as tecovirimat, cidofovir, brincidofovir and topical use of trifluridine in ocular mpox management, though treatment-resistant infection can occur and portend a poor prognosis.

News (Medical) associated with Brincidofovir

26 Sep 2024

·www.globenewswire.com

Emergent BioSolutions Announces the Execution of Contract Options Valued at $67.4 Million to Procure Additional TEMBEXA® (brincidofovir) to Support National Preparedness Efforts

GAITHERSBURG, Md., Sept. 26, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) (“Emergent”) today announced that two contract options have been secured to procure additional treatment courses of TEMBEXA® (brincidofovir) to sustain the U.S. government’s national preparedness posture against human smallpox. TEMBEXA® is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. The order is valued at $67.4 million and executes procurement options CLIN0004A and CLIN0005A under Emergent’s existing 10-year contract. “This announcement highlights the strength of the longstanding partnership between Emergent and the U.S. government to meet the country’s preparedness needs,” said Paul Williams, senior vice president, products business, Emergent. We look forward to continuing to deliver TEMBEXA® to support smallpox preparedness.” The existing contract includes optional procurement CLINs that can be exercised throughout the 10-year contract period of performance with a maximum potential value of $568 million. The exercise of CLIN0004A and CLIN0005A commits funding through 2027 and will help ensure continued supply of TEMBEXA® to address the threat of smallpox. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under contract number 75A50122C00047. About TEMBEXA®TEMBEXA® is an oral antiviral approved by the FDA in June 2021 for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. TEMBEXA® is formulated as 100 mg tablets and 10 mg/mL oral suspension dosed once weekly for two weeks. The oral suspension formulation is particularly important for patients who have difficulty swallowing due to age or medical status. Important Information about TEMBEXA® (brincidofovir)TEMBEXA® is an orthopoxvirus nucleotide analog DNA polymerase inhibitor and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Limitations of Use: TEMBEXA® is not indicated for the treatment of diseases other than human smallpox disease. The effectiveness of TEMBEXA® for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible and inducing smallpox disease in humans to study the drug’s efficacy is not ethical. TEMBEXA® efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals. TEMBEXA® has a BOXED WARNING for increased risk for mortality when used for longer duration. An increased incidence of mortality was seen in TEMBEXA®-treated subjects compared to placebo-treated subjects in a 24-week clinical trial when TEMBEXA® was evaluated in another disease. The Warnings and Precautions for TEMBEXA® include: Elevations in Hepatic Transaminases and Bilirubin: May cause increases in serum transaminases (ALT or AST) and serum bilirubin. Monitor liver laboratory parameters before and during treatment.Diarrhea and Other Gastrointestinal Adverse Events: Diarrhea and additional gastrointestinal adverse events including nausea, vomiting, and abdominal pain may occur. Monitor patients, provide supportive care, and if necessary, do not give the second and final dose of TEMBEXA®.Coadministration with Related Products: TEMBEXA® should not be coadministered with intravenous cidofovir.Embryo-fetal Toxicity: May cause fetal harm. Advise individuals of childbearing potential of the potential risk to the fetus and to use effective contraception.Carcinogenicity: TEMBEXA® should be considered a potential human carcinogen. Do not crush or divide TEMBEXA® tablets.Male Infertility: Based on testicular toxicity in animal studies, TEMBEXA® may irreversibly impair fertility in individuals of reproductive potential. Common adverse reactions (occurring in at least 2% of TEMBEXA®-treated subjects) were diarrhea, nausea, vomiting, and abdominal pain. Please read full Prescribing Information for TEMBEXA® for additional safety information here. About SmallpoxSmallpox is a highly contagious disease caused by the variola virus. Historically, smallpox was one of the deadliest diseases in history with a case fatality rate of approximately 30 percent. Despite successful eradication of smallpox in the 1970s, there is considerable concern that variola virus could reappear, either through accidental release or as a weapon of bioterrorism. According to the U.S. Centers for Disease Control and Prevention, variola virus is ranked in the highest risk category for bioterrorism agents (Category A) due to its ease of transmission, high mortality rate, and potential to cause public panic and social disruption. Based on a recent report – The Department of Health and Human Services Fiscal Year 2023 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee – smallpox remains a threat of high concern to both the domestic and international community. About Emergent BioSolutionsAt Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we help protect public health, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the exercise by BARDA of any optional future procurements under the contract (75A50122C00047) to supply TEMBEXA® to the U.S. government, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “should,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on Emergent’s current intentions, beliefs, and expectations regarding future events. Emergent cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Emergent’s expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Emergent does not undertake to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause Emergent’s actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors identified in Emergent’s periodic reports filed with the U.S. Securities and Exchange Commission when evaluating Emergent’s forward-looking statements. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com

Drug Approval

30 Aug 2024

·www.pharmaceutical-technology.com

Emergent gains FDA approval for ACAM2000 vaccine for Mpox

The single-dose vaccine is indicated for use in individuals at high risk of infection. Credit: Creative Design nacional/Shutterstock. Emergent BioSolutions has received approval from the US Food and Drug Administration (FDA) for its supplemental biologics licence application for ACAM2000, (Smallpox and Mpox (Vaccinia) Vaccine, Live), expanding its use to include the prevention of Mpox. The single-dose vaccine, administered percutaneously via a bifurcated needle, is indicated for use in individuals at high risk for mpox infection. The FDA’s approval of the ACAM2000 vaccine for Mpox is based on existing human safety data and a comprehensive animal study demonstrating its efficacy. ACAM2000 was first licensed for active immunisation for smallpox disease prevention in 2007. Mpox, formerly known as monkeypox, is a viral disease native to Central and West Africa. See Also: Growth Hormone Receptor drugs in development, 2024 Interleukin 15 Receptor Subunit Alpha drugs in development, 2024 The double-stranded DNA virus belongs to the Orthopoxvirus genus within the Poxviridae family and is related to the virus that caused smallpox, which was eradicated in 1980. The recent FDA approval aligns with Emergent’s efforts to support global health, including an Expression of Interest submitted to the World Health Organization (WHO) for emergency use assessment. Following the WHO’s declaration of the Mpox outbreak as a public health emergency of international concern, Emergent is actively engaging with global health regulators. The company pledged to donate 50,000 doses of ACAM2000 to aid affected regions in Central Africa. As the primary vaccine for smallpox in the event of a bioterrorism emergency, it is a critical component of the US Strategic National Stockpile. The vaccine is also licensed in Canada, Australia and Singapore, with stockpiles maintained both domestically and internationally, ensuring readiness against potential bioterrorism threats and disease outbreaks. Emergent BioSolutions president and CEO Joe Papa stated: “The FDA approval of ACAM2000 for immunisation against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV and TEMBEXA. “This expanded indication for ACAM2000 comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases.” The company recently finalised the sale of its Baltimore-Camden manufacturing site to the Taiwanese company Bora Pharmaceuticals.

Drug ApprovalVaccineAcquisition

29 Aug 2024

·www.globenewswire.com

Emergent BioSolutions’ ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa & Other Regions

GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection. The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000® vaccine was shown to be effective in protecting against mpox virus exposure. ACAM2000® is a single-dose vaccine administered percutaneously via a bifurcated needle that is dipped into the vaccine solution and the skin is pricked several times in the upper arm with a droplet of the vaccine. The vaccine was first approved by the FDA in 2007 for active immunization for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. Mpox, previously called monkeypox, is an infectious disease endemic to central and west Africa caused by the double-stranded DNA mpox virus. The virus is a member of the Orthopoxvirus genus in the Poxviridae family, related to the virus which caused smallpox, which was eradicated in 1980. “The FDA approval of ACAM2000® for immunization against mpox in high-risk individuals further strengthens and broadens our industry-leading smallpox portfolio, which includes VIGIV® and TEMBEXA®, said Joe Papa, president and CEO of Emergent. “This expanded indication for ACAM2000® comes at a critical time as the global health community comes together to ensure an effective and cohesive response to the recent upsurge in mpox cases. We believe Emergent is poised to support the global response needed by actively engaging with world health leaders, as well as deploying product currently available in inventory based on the needs, as well as the ability to increase supply.” This approval follows Emergent’s announcement that it filed an Expression of Interest (EOI) with the World Health Organization (WHO) for the WHO’s assessment of ACAM2000® vaccine to be added as an Emergency Use Listing in connection with the mpox outbreak. Emergent also is in discussions with other global public health leaders to help address the current mpox outbreak in response to the WHO’s Director-General’s August 14 statement declaring that the upsurge of mpox is a public health emergency of international concern under the International Health Regulations. As part of its support to the response, Emergent announced that it will donate 50,000 doses of ACAM2000® for potential deployment across impacted countries in Central Africa. “Mpox has progressed to become an uncontrolled epidemic in Africa — prompting the WHO to declare a second public health emergency of international concern — creating an enormous need to use all effective tools to extinguish it as a threat,” said Dr. Amesh A. Adalja, FIDSA FACP FACEP & health security and emerging infectious diseases expert, Johns Hopkins Center for Health Security. “ACAM2000®, a direct descendant of the Jenner vaccine (humanity’s first) which was used to eradicate smallpox, and now with the broadened indication, will be an invaluable tool in this endeavor.” In 2022, the world experienced a global outbreak of clade II mpox, which led to more than 95,000 cases across 115 non-endemic countries. The clade I variant of mpox is characterized by more severe clinical outcomes and a higher case fatality rate. The recently identified clade Ib variant, exhibiting enhanced transmissibility through close contact, has led to an increase in cases, particularly in Central Africa, and a sizable impact on children and families. According to the WHO, clade I mpox tends to cause a higher number of severe infections and have a higher mortality rate than clade II mpox. About ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live)ACAM2000® is the primary smallpox vaccine designated for use in a bioterrorism emergency, with doses having been supplied to the U.S. Strategic National Stockpile. ACAM2000® is also licensed in Canada, Australia and Singapore and is currently stockpiled both in the U.S. and internationally. ACAM2000® is indicated in the U.S. for active immunization for the prevention of smallpox and mpox disease in individuals determined to be at high risk for smallpox and mpox infection. The labeling for ACAM2000® contains a contraindication for individuals with severe immunodeficiency. Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in persons with weakened immune systems. Individuals with severe immunodeficiency who are not expected to benefit from the vaccine should not receive ACAM2000®. The risk for experiencing severe vaccination complications must be weighed against the risk for experiencing a potentially severe or fatal smallpox or mpox infection. Additionally, there are warnings and precautions for myocarditis, pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major (including Stevens-Johnson Syndrome), eczema vaccinatum resulting in permanent sequelae or death, accidental eye infection (ocular vaccinia), which can cause ocular complications that may lead to blindness, and fetal death. These may occur following either primary vaccination or revaccination with live vaccinia virus vaccines, including ACAM2000®. These risks are increased in certain individuals and may result in severe disability, permanent neurological sequalae and/or death. Please see the Prescribing Information for ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) Vaccine for full Boxed Warning and additional safety information. The full U.S. Prescribing Information for ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) Vaccine can be found here. If it is not currently available via this link, it will be visible as soon as possible as the company works to finalize the document. Please check back for the full information shortly. About Emergent BioSolutionsAt Emergent, our mission is to protect and enhance life. For 25 years, we’ve been at work defending people from things we hope will never happen—so we are prepared just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we help protect public health, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Safe Harbor StatementThis communication includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the expected timing for delivery of the ACAM2000® vaccine and Emergent’s ability to increase inventories of ACAM2000® vaccine to meet requested levels within specified time frames, if needed, are forward-looking statements. We generally identify forward-looking statements by using words like “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “intend,” “may,” “plan,” “position,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statement will be accurate. Readers should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statement speaks only as of the date of this communication and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause our actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors and other disclosures included in our periodic reports filed with the Securities and Exchange Commission, when evaluating our forward-looking statements. Investor Contact:Richard S. LindahlExecutive Vice President, CFOlindahlr@ebsi.com Media Contact:Assal HellmerVice President, Communicationsmediarelations@ebsi.com

Drug ApprovalVaccine

100 Deals associated with Brincidofovir

External Link

KEGG	Wiki	ATC	Drug Bank
D10547	Brincidofovir	J05A	DB12151

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Smallpox	US	Emergent Biodefense Operations Lansing LLC	04 Jun 2021
Smallpox	US	Emergent BioDefense Operations Lansing, Inc.	04 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pyelonephritis	Phase 2	US	Chimerix, Inc.	01 Sep 2015
Adenoviridae Infections	Phase 2	US	Chimerix, Inc.	01 Mar 2014
Adenoviridae Infections	Phase 2	US	Chimerix, Inc.	01 Mar 2014
Cytomegalovirus Infections	Phase 2	CA	Chimerix, Inc.	01 Aug 2013
Cytomegalovirus Infections	Phase 2	US	Chimerix, Inc.	01 Aug 2013
Cytomegalovirus Infections	Phase 2	CA	Chimerix, Inc.	01 Aug 2013
Cytomegalovirus Infections	Phase 2	BE	Chimerix, Inc.	01 Aug 2013
Cytomegalovirus Infections	Phase 2	BE	Chimerix, Inc.	01 Aug 2013
Cytomegalovirus Infections	Phase 2	US	Chimerix, Inc.	01 Aug 2013
DNA Virus Infections	Phase 2	US	Chimerix, Inc.	01 Dec 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2024	Not Applicable	Peripheral T-Cell Lymphoma	-	Brincidofovir	deqlenhawy(cestdfjjoo) = zdncvmiynf mgzufxalsj (wgnqkuzbos ) View more	Positive	14 May 2024
				Vehicle	deqlenhawy(cestdfjjoo) = qivivnwmix mgzufxalsj (wgnqkuzbos ) View more
NCT04706923 (ATHENA, Tandem Meetings ASTCT and CIBMTR2024) Manual	Phase 2	Adenoviridae Infections	27	Brincidofovir IV 0.2 mg/kg	bamltpdocm(pbzauvnsuk) = vwclsbsios qsofemangb (cfqklitwjj ) View more	Positive	01 Feb 2024
				Brincidofovir IV 0.3 mg/kg	bamltpdocm(pbzauvnsuk) = tidlvbaydk qsofemangb (cfqklitwjj ) View more
NCT01143181 (CTgov)	Phase 3	DNA Virus Infections	210	BCV (BCV (≤4 mg/kg/Week))	svwnbwtvyz(ihqmjolyrv) = qhmbabbnhz aemvevjgfl (xogbreazyq, cjoiadilbt - bhosrvjoev) View more	-	12 Aug 2021
				BCV (BCV (>4 mg/kg/Week))	svwnbwtvyz(ihqmjolyrv) = olsqdbnmod aemvevjgfl (xogbreazyq, huaitwdzma - shdqwsilft) View more
NCT01241344 (CTgov)	Phase 2	Adenoviridae Infections	52	Placebo	xzblwqmrgr(godjpcfyrq) = xbikpnnbov xgardinuhx (vtmlpxmjmy, jlzumlnqlz - yzsygbfogt) View more	-	16 Jul 2021
NCT02439970 (SUSTAIN, CTgov)	Phase 3	Cytomegalovirus Infections	5	Brincidofovir (Treatment 1)	evzncafrbk(xzdozfsnyw) = utscqphgkv azzcykvwhg (radynprvio, urhvnbjujf - vaaggabuof) View more	-	16 Jul 2021
				Valganciclovir (Treatment 2)	evzncafrbk(xzdozfsnyw) = bardmnrrzt azzcykvwhg (radynprvio, innbtxijqz - xbuhmfvkvy) View more
NCT02439957 (CTgov)	Phase 3	Cytomegalovirus Infections \| Pyelonephritis	6	Brincidofovir (Treatment 1)	usqlnsmkzh(fxaczpqygn) = uecxrapesh zdtupuxofi (ylhxpjwhsv, dlcmrgtkdr - rvqncygnqk) View more	-	16 Jul 2021
				Valganciclovir (Treatment 2)	usqlnsmkzh(fxaczpqygn) = zsoxaravdx zdtupuxofi (ylhxpjwhsv, fnchbvflmp - cysbwfmuvz) View more
NCT03339401 (AdAPT, CTgov)	Phase 2	Adenoviridae Infections	29	Brincidofovir (Brincidofovir)	ihapmjcuuu(xswbhmkunf) = cbnpngkhfb rtrphemucs (htcjqhkqag, dapqojrrwl - mvmphwbaln) View more	-	25 Jan 2021
				Standard of Care (Standard of Care)	ihapmjcuuu(xswbhmkunf) = fvrsbtfxyd rtrphemucs (htcjqhkqag, eenstddxat - iryrtmnlni) View more
NCT01769170 (CTgov)	Phase 3	Cytomegalovirus Infections	452	Brincidofovir (Brincidofovir)	ardtdqdswi(oubhkjetwx) = vebfzrbyzr ckqnwplfzf (gmgkmsrptg, jwkkwfougf - iheyouwezs) View more	-	05 Jan 2021
				Placebo (Placebo)	ardtdqdswi(oubhkjetwx) = nlqmyziuis ckqnwplfzf (gmgkmsrptg, hutxybjdqw - bkzggpymwz) View more
ASN2020	Not Applicable	Adenoviridae Infections	-	Cidofovir	(lghpojsywi) = svibpwxref zofntxmfod (njekpchzmb )	Positive	19 Oct 2020
				Brincidofovir	(lghpojsywi) = usehnnhqlt zofntxmfod (njekpchzmb )
P369 (EBMT2020)	Not Applicable	Adenoviridae Infections	28	Brincidofovir	(tvnqushjdb) = We registered 47 ADV infection episodes with positive viremia (median peak: 1.077.546 copies/mL, range: 15.100-75.000.000) rsvqzaqrjm (bdwvvcexsf ) View more	Positive	29 Aug 2020

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis