[Translation] Pharmacokinetics and safety studies of single/multiple doses of voriconazole for injection (0.2 g) in healthy Chinese adults and a single dose bioequivalence study in humans

以健康受试者为试验对象，天津力生制药股份有限公司研发的注射用伏立康唑（0.2g）为受试制剂，持证商为Pfizer Europe MA EEIG的注射用伏立康唑（商品名：威凡，规格：0.2g）为参比制剂；经单次给药试验和多次给药试验： 1）比较单次和多次给药后受试制剂和参比制剂药代动力学参数； 2）观察受试制剂和参比制剂在中国健康受试者中的安全性。经生物等效性试验： 1）评价两种制剂在中国健康受试者中的生物等效性； 2）观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Healthy subjects were used as test subjects, voriconazole for injection (0.2g) developed by Tianjin Lisheng Pharmaceutical Co., Ltd. was used as the test preparation, and voriconazole for injection (trade name: Weifan, specification: 0.2g) licensed by Pfizer Europe MA EEIG was used as the reference preparation; After single-dose and multiple-dose tests: 1) Compare the pharmacokinetic parameters of the test preparation and the reference preparation after single and multiple administrations; 2) Observe the safety of the test preparation and the reference preparation in Chinese healthy subjects. After bioequivalence test: 1) Evaluate the bioequivalence of the two preparations in Chinese healthy subjects; 2) Observe the safety of the test preparation and the reference preparation in Chinese healthy subjects.

Start Date19 Nov 2024

Sponsor / Collaborator

Tianjin Lisheng Pharmaceutical Co., Ltd.

[+1]

NCT06680544

/ Not yet recruitingPhase 2IIT

Comparing the Efficacy of Oral 200 Milligram Voriconazole Once a Day Vs. Twice a Day in the Treatment of Resisitant Dermatophyte Infections (Tinea Corporis and Tinea Cruris)

Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte infection.

Start Date15 Nov 2024

Sponsor / Collaborator

Sheikh Zayed Medical College

100 Clinical Results associated with Voriconazole

100 Translational Medicine associated with Voriconazole

100 Patents (Medical) associated with Voriconazole

8,601

Literatures (Medical) associated with Voriconazole

31 Dec 2025·Emerging Microbes & Infections

Emerging antifungal resistance in Trichophyton mentagrophytes : insights from susceptibility profiling and genetic mutation analysis

Article

Author: de Hoog, Sybren ; Shao, Jin ; Richardson, Malcolm ; Verweij, Paul ; Li, Ruoyu ; Wan, Zhe ; Song, Yinggai ; Bai, Lin ; Richardson, Riina ; Yu, Jin ; Shao, Yakun

ABSTRACTTrichophyton species, the leading cause of dermatophytosis globally, are increasingly resistant to antifungal treatments, concerns about effective management strategies. In light of the absence of established resistance criteria for terbinafine and azoles, coupled with a dearth of research on resistance mechanisms in Trichophyton, antifungal susceptibility and drug resistance gene diversity were analyzed across 64 T. mentagrophytes, 65 T. interdigitale, and 2 T. indotineae isolates collected in China between 1999 and 2024 and 101 published T. indotineae strains. Analyses of the minimum inhibitory concentrations (MICs) of terbinafine, itraconazole, voriconazole, posaconazole, and isavuconazole revealed a concerning increase in T. indotineae with terbinafine resistance, including two novel isolates from China. Compared with T. interdigitale, T. mentagrophytes presented higher terbinafine MICs but similar azole susceptibility. Notably, 27 T. interdigitale isolates were classified as non-wild-type for terbinafine. Genetic diversity was analyzed for the SQLE, CYP51A and CYP51B gene. Specifically, T. indotineae isolates presented SQLE protein changes linked to terbinafine resistance. SQLE diversity was linked to terbinafine sensitivity, whereas alterations in CYP51A were associated with itraconazole sensitivity, with notable statistical significance evident across various protein isoforms. The relationship between protein diversity and drug sensitivity is presented in detail. Together, these findings highlight a growing prevalence of antibiotic resistance among Trichophyton and identify potential target genes for new therapies, underscoring the need for ongoing monitoring and offering directions for novel therapeutics.

01 Dec 2025·Journal of Clinical Immunology

Disseminated Aspergillosis in X-linked Agammaglobulinemia: Beyond the norm

Article

Author: Goel, Sumit ; Thangaraj, Abarna ; Vignesh, Pandiarajan ; Jindal, Ankur Kumar ; Rawat, Amit ; Sil, Archan

X-linked agammaglobulinemia (XLA) due to a mutation in Bruton's tyrosine kinase (BTK), leads to the arrested development of B cells at the pro-B cell stage. This results in absent B cells and severe hypogammaglobulinemia. XLA patients usually present with recurrent sinopulmonary infection. Bacterial infections are the commonest [2], fungal infections like Pneumocystis jirovecii, Aspergillus and Candida species are rarely reported and they are associated with mortality in XLA [3]. We report a 3.5-year-old boy with disseminated aspergillosis, an uncommon presentation of XLA. Despite treatment with antifungals, including voriconazole and amphotericin B, the patient succumbed to the illness. Genetic analysis revealed a pathogenic variant in the BTK gene (R28H), confirming XLA diagnosis. This case highlights the potential for severe fungal infections in XLA patients and suggests broader immune system dysregulation beyond B-cell defects.

01 Dec 2025·Cancer Chemotherapy and Pharmacology

Pharmacokinetic analysis of crushed venetoclax tablets combined with azacitizine for recurrent pediatric acute myeloid leukemia (AML)

Article

Author: Makimoto, Atsushi ; Matsui, Motohiro ; Yasu, Takeo ; Yuza, Yuki

BACKGROUNDThe efficacy of a combination therapy consisting of venetoclax (VEN) and azacytidine (AZA) for newly diagnosed acute myeloid leukemia (AML) has been confirmed in elderly patients. However, the clinical data on VEN for pediatric AML are limited. A combination therapy consisting of crushed VEN tablets and AZA (VEN/AZA) was administered to two children with recurrent AML. The pharmacokinetics of VEN were then analysed.CASE PRESENTATION[Patient 1] A 1-year-old, male patient who experienced an AML relapse following an allogeneic hematopoietic stem cell transplantation received three courses of VEN/AZA. At the initial dosage of VEN (8 mg/kg), the minimum plasma concentration (C_min) was only 0.44 µg/ml, which was far less than the optimal C_min of 1.2 µg/ml. Subsequent dose-escalation to 10 mg/kg only achieved C_min 0.42 µg/ml. [Patient 2] A 3-year-old, female patient in whom infantile acute lymphoblastic leukemia was originally diagnosed experienced a recurrence in the form of AML after lineage-switching. Three courses of VEN/AZA were administered with the same therapeutic drug monitoring as in Case 1. The C_min of VEN was 0.15 µg/ml at 8 mg/kg. Afterwards, voriconazole 16 mg/kg/day was begun for a concomitant fungal infection together with VEN 2 mg/kg. This combination finally achieved C_min 1.14 µg/ml probably through CYP3A4 inhibition by voriconazole. In terms of safety, only grade 4 hematological adverse events were observed in both patients. In terms of efficacy, patient 1 and patient 2 achieved stable disease status for two months and six months, respectively.CONCLUSIONPediatric patients may scarcely achieve effective plasma concentration of VEN when crushed tablets are used at the same dosage as in adults.

132

News (Medical) associated with Voriconazole

26 Sep 2024

·www.businesswire.com

Vertex Highlights First Oral Presentation of Phase 3 Clinical Data of the Vanza Triple and New Data on Long-Term Impact of TRIKAFTA® at the North American Cystic Fibrosis Conference

BOSTON--( BUSINESS WIRE )-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the first accepted medical presentations of the Phase 3 data on the investigational once daily vanzacaftor/tezacaftor/deutivacaftor (“vanza triple”) — the potential next-in-class triple combination medicine — will take place at the North American Cystic Fibrosis Conference (NACFC). Vertex also announced presentations describing long-term outcomes in people with cystic fibrosis (CF) ages 2 to 11 years taking TRIKAFTA ® , demonstrating consistent and sustained improvements across multiple measures of disease. “ TRIKAFTA has transformed the treatment of CF in the 5 years since its approval, changing the outlook for patients with CF,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “ Toward our goal to bring all eligible patients to normal levels of CFTR function, we have made global regulatory submissions for our next-in-class vanza triple combination medicine for patients with CF aged 6 years and older. We are excited to bring this promising new medicine, which has the potential to deliver even greater improvements in sweat chloride, to patients with CF.” Data on the Investigational Once Daily Next-in-Class Triple Combination Therapy, vanzacaftor/tezacaftor/deutivacaftor Vertex will present data on the vanza triple in an oral presentation and two posters on Friday, September 27. This is the first time that the clinical data from the Phase 3 clinical trials of the vanza triple in patients 6 years and older with CF have been accepted for presentation at a medical meeting. These data formed the basis of global regulatory submissions. “ The additional, significant reductions in sweat chloride we see in the vanza triple clinical trials are noteworthy. I believe this improvement in CFTR function may lead to important benefits for people with CF,” said Claire L. Keating, M.D., Co-Director of the Gunnar Esiason Adult Cystic Fibrosis and Lung Program at Columbia University. “ If approved, as a clinician, I’m looking forward to being able to offer patients an option, with once daily dosing, that could advance the treatment for people living with CF.” Data from the Phase 3 clinical studies of the vanza triple will be presented in the following sessions: “ Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ Triple) in Adolescents and Adults with CF: Results from Two Randomized, Active-Controlled Phase 3 Trials,” will be an oral presentation during a session entitled: “Cutting Edge Research: What’s New” on Friday, September 27, from 10:15 a.m. to 12:15 p.m. EDT and be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT. “ Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ Triple) in Children 6 Through 11 Years of Age with Cystic Fibrosis,” will be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT. The vanza triple was granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) for the treatment of CF and has been submitted for regulatory approval in the U.S., Canada, U.K., EU, Switzerland, Australia and New Zealand. Vertex has been assigned a Prescription Drug User Fee Act (PDUFA) date by the FDA of January 2, 2025, for this submission. The vanza triple has not been approved by any global health authority. Long-Term Benefits of TRIKAFTA ® Vertex will present new data on TRIKAFTA ® from long-term (96 week and 192 week) studies in patients ages 2-11 years old that reinforce the sustained benefit seen in studies in older people with CF. Specifically, that early treatment with TRIKAFTA ® is associated with sustained improvements in lung function. These new data demonstrate that in these young children, TRIKAFTA ® could also lead to improved exocrine pancreatic function over time. The data presented at NACFC highlight the safety and tolerability of TRIKAFTA ® , which were generally consistent with the established safety profile. “ I have seen first-hand the positive long-term impact that improvement of CFTR function by TRIKAFTA can have on patients’ clinical outcomes. These improvements are particularly striking for me as a physician caring for young children, where improvements in things like lung function, pancreatic function and quality of life are so meaningful,” said Professor Marcus A. Mall, M.D., Professor and Chair of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine and Cystic Fibrosis Center at Charité - Universitätsmedizin Berlin. Vertex will have four poster presentations that include clinical trial and real-world evidence data, three specifically on TRIKAFTA ® and one showing sustained benefits from KALYDECO ® , which is approved for treatment in the youngest ages. “ Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in children 2 years and older with cystic fibrosis and at least one F508del allele: 96-week results from an open-label extension study,” will be a poster presentation on Friday, September 27, at 12:15-1:15 p.m. EDT. “ Long-term safety and efficacy of elexacaftor/tezacaftor/ivacaftor in children 6 years and older with cystic fibrosis and at least one F508del allele: Results from a 192-week extension study,” will be a poster presentation on Friday, September 27, at 1:15-2:15 p.m. EDT. “ Effectiveness of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in people with cystic fibrosis and non-F508del CFTR variants: Interim results from a registry-based study,” will be a poster presentation on Friday, September 27, from 12:15-1:15 p.m. EDT. “ Long-term benefits of early ivacaftor (IVA) initiation in people with cystic fibrosis (CF),” will be a poster presentation on Friday, September 27, from 1:15-2:15 p.m. EDT. About Cystic Fibrosis Cystic fibrosis (CF) is a rare, life-shortening genetic disease affecting more than 92,000 people globally. CF is a progressive, multi-organ disease that affects the lungs, liver, pancreas, GI tract, sinuses, sweat glands and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF, and these mutations can be identified by a genetic test. While there are many different types of CFTR mutations that can cause the disease, the vast majority of people with CF have at least one F508del mutation. CFTR mutations lead to CF by causing CFTR protein to be defective or by leading to a shortage or absence of CFTR protein at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus, chronic lung infections and progressive lung damage that eventually leads to death for many patients. The median age of death is in the 30s, but with treatment, projected survival is improving. Learn more about the importance of sweat chloride (SwCl) in cystic fibrosis. Today Vertex CF medicines are treating over 68,000 people with CF across more than 60 countries on six continents. This represents 2/3 of the diagnosed people with CF eligible for CFTR modulator therapy. About vanzacaftor/tezacaftor/deutivacaftor (the “vanza triple”) In people with CF, mutations in the CFTR gene lead to decreased quantity and/or function of the CFTR protein channel at the cell surface. Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein at the cell surface by facilitating the processing and trafficking of the CFTR protein. Deutivacaftor is a potentiator designed to increase the channel open probability of the CFTR protein delivered to the cell surface to improve the flow of salt and water across the cell membrane. Investigational vanzacaftor/tezacaftor/deutivacaftor was granted Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration for the treatment of CF. The vanza triple will be subject to a meaningfully lower single-digit royalty obligation, compared to the rate payable on Vertex’s current CF portfolio. About TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) In people with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, and this can prevent the CFTR protein from reaching the cell surface and functioning properly. TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface. Elexacaftor and tezacaftor work together to increase the amount of mature protein at the cell surface. Ivacaftor, which is known as a CFTR potentiator, is designed to facilitate the ability of CFTR proteins to transport salt and water across the cell membrane. The combined actions of elexacaftor, tezacaftor and ivacaftor help hydrate and clear mucus from the airways. TRIKAFTA ® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation, or another mutation responsive to TRIKAFTA ® , in the CFTR gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA ® is safe and effective in children under 2 years of age. TRIKAFTA U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR INDICATIONS AND USAGE TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or another mutation that is responsive to treatment with TRIKAFTA. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 2 years of age. IMPORTANT SAFETY INFORMATION Before taking TRIKAFTA, patients should tell their doctor about all of their medical conditions, including if they: are allergic to TRIKAFTA or any ingredients in TRIKAFTA, have kidney problems, have or have had liver problems, are pregnant or plan to become pregnant because it is not known if TRIKAFTA will harm an unborn baby, or are breastfeeding or planning to breastfeed because it is not known if TRIKAFTA passes into breast milk. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. TRIKAFTA may affect the way other medicines work, and other medicines may affect how TRIKAFTA works. The dose of TRIKAFTA may need to be adjusted when taken with certain medicines. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take: antibiotics such as rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines including ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; antibiotics including telithromycin, clarithromycin, or erythromycin. Patients should avoid food or drink that contains grapefruit while taking TRIKAFTA. TRIKAFTA can cause serious side effects, including: Liver damage and worsening of liver function in patients with severe liver disease that can be serious and may require transplantation. Liver damage has also happened in patients without liver disease. High liver enzymes in the blood , which is a common side effect in patients treated with TRIKAFTA . These can be serious and may be a sign of liver injury. The patient’s doctor will do blood tests to check their liver before they start TRIKAFTA, every 3 months during the first year of taking TRIKAFTA, and every year while taking TRIKAFTA. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine. Serious allergic reactions have happened to patients who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives; tightness of the chest or throat or difficulty breathing; swelling of the face, lips and/or tongue; difficulty swallowing; and light-headedness or dizziness. Abnormality of the eye lens (cataract) has been noted in some children and adolescents treated with TRIKAFTA. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with TRIKAFTA to look for cataracts. The most common side effects of TRIKAFTA include headache, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, diarrhea, rash, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, flu (influenza), inflamed sinuses, and increase in blood bilirubin. Patients should tell their doctor if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of TRIKAFTA. For more information, patients should ask their doctor or pharmacist. Please click here to see the full U.S. Prescribing Information for TRIKAFTA. KALYDECO ® U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR INDICATIONS AND USAGE INDICATIONS AND USAGE KALYDECO (ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 1 month and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 1 month of age. IMPORTANT SAFETY INFORMATION Before taking KALYDECO, patients should tell their doctor about all their medical conditions, including if they : have liver or kidney problems; are allergic to KALYDECO or any ingredients; are pregnant or plan to become pregnant because it is not known if KALYDECO will harm an unborn baby; and are breastfeeding or planning to breastfeed because is not known if KALYDECO passes into breast milk. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. KALYDECO may affect the way other medicines work , and other medicines may affect how KALYDECO works. Patients should ask their doctor or pharmacist for a list of these medicines if they are not sure. Patients should especially tell their doctor if they take the antibiotics rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; St. John’s wort; antifungal medicines such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin. KALYDECO can cause dizziness in some patients who take it. If patients experience dizziness, they should not drive or operate machines until symptoms improve. Patients should avoid food or drink containing grapefruit while taking KALYDECO. KALYDECO can cause serious side effects including: High liver enzymes in the blood, which have happened in patients receiving KALYDECO . The patient’s doctor will do blood tests to check their liver before starting KALYDECO, every 3 months during the first year of taking KALYDECO, and every year while taking KALYDECO. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber-colored urine. Serious allergic reactions have happened to patients who are treated with KALYDECO. Patients should call their healthcare provider or go to the emergency room right away if they have symptoms of an allergic reaction. Symptoms of an allergic reaction may include rash or hives, tightness of the chest or throat or difficulty breathing, and light-headedness or dizziness. Abnormality of the eye lens (cataract), which has happened in some children and adolescents receiving KALYDECO. The patient’s doctor should perform eye examinations before and during treatment with KALYDECO to look for cataracts. The most common side effects include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness. Use of KALYDECO in patients aged 1 month to less than 6 months born from a pregnancy lasting (gestational age) less than 37 weeks has not been evaluated. These are not all the possible side effects of KALYDECO. Please click here to see the full Prescribing Information for KALYDECO. About Vertex Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn , Facebook , Instagram , YouTube and Twitter/X . Special Note Regarding Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, the statements by Carmen Bozic, M.D., Professor Marcus A. Mall, M.D., and Claire L. Keating, M.D., in this press release, and statements regarding our expectations for and the anticipated benefits of the vanza triple, our expectations that medical presentations of Phase 3 data on the vanza triple will take place at NACFC, our expectations for the long-term data for TRIKAFTA, plans to present long-term TRIKAFTA data and KALYDECO data, and our expectations for a lower royalty obligation for the vanza triple. While we believe the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy, and other reasons, and other risks listed under the heading “Risk Factors” in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company's website at www.vrtx.com . You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available. (VRTX-GEN)

Phase 3Orphan DrugFast TrackDrug Approval

26 Sep 2024

·www.globenewswire.com

TFF Pharmaceuticals’ Technology Generates Superior Inhalational Dry Powder Formulations for Pulmonary Drug Delivery

Newly published data in the Journal of Drug Delivery Science and Technology demonstrate more uniform drug distribution in the lung compared with other technologiesFORT WORTH, Texas, Sept. 26, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the “Company” or “TFF Pharmaceuticals”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announces positive preclinical data published in the Journal of Drug Delivery Science and Technology further validating the Company’s TFF technology as superior approach to formulate dry powders for pulmonary drug delivery. The study demonstrates the superiority of TFF inhalational dry powders over jet-milling and spray-drying technologies in a rat model, with enhanced uniform drug distribution in the lungs, lower airway-to-lung distribution ratio, and rapid disaggregation of particles of the TFF powder and subsequent particle movement of the resulting TFF nanoaggregates. In the newly published study, voriconazole dry powder formulations for inhalation were prepared by three different methods: jet-milling, spray-drying, and Thin Film Freezing. The TFF processed voriconazole dry powder, consisting of brittle, easily shearable nanoaggregates, exhibited the most homogeneous distribution in lung tissue, with the lowest airway-to-lung voriconazole deposition ratio (1.27), followed by spray-dried (1.76) and jet-milled (2.73) powders. This enhanced distribution is attributed to the smaller particle size after disaggregation and rapid movement of particles on the liquid surface. The results suggest that TFF inhalational dry powders may enhance treatment efficiency and reduce toxicity for lung diseases, further supporting Thin Film Freezing as a promising technology to formulate dry powders for pulmonary drug delivery. “This is our first head-to-head comparison of TFF powder to powders made by other technologies, administered by inhalation to animals and characterized using mass spectrometry imaging to assess lung drug distribution. We are extremely pleased to confirm our hypothesis that Thin Film Freezing technology leads to the most homogeneous distribution of the drug in the lung,” said Dr. Robert O. Williams III, Co-inventor of TFF technology and Professor at The University of Texas at Austin College of Pharmacy. “These data, which examine formulations of voriconazole manufactured using different particle engineering technologies, suggest that the TFF dry powder technology for inhalation provides clear advantages over jet-milling and spray-drying methods,” said Dr. Harlan Weisman, TFF Pharmaceuticals Chief Executive Officer. “It is gratifying to have the continued support of the scientific community for our approach, and to have ongoing validation of our science. The more rapid and uniform distribution of TFF generated dry powders in the lung with their lower airway to lung deposition ratio differentiate our inhalational products from products generated by other technologies and provide the opportunity to increase efficacy and lower risk of toxicities.” ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGYTFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The TFF process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggest the aerodynamic properties of the powders created by TFF can deliver as much as 75% of the dose to the deep lung. TFF does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of TFF can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products. ABOUT TFF PHARMACEUTICALS TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile TFF technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, or for topical delivery to the eyes, nose and the skin. SAFE HARBOR This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expected benefits of its patented TFF technology platform over jet-milling and spray-drying methods,. Forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially, including (i) the risk that further testing may not be consistent with the data to date demonstrating the superiority of the TFF technology platform over jet-milling and spray-drying methods, (ii) the risk that the Company may not be able to obtain additional working capital with which to continue its current operations and clinical trials as and when needed, (iii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2024.. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company does not undertake and specifically disclaims any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. Investor Relations Contact:Core IRJason Nelsoninvestorinfo@tffpharma.com

09 Sep 2024

·www.prnewswire.com

RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines

First new American College of Gastroenterology (ACG) Clinical Guideline[1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of eradication without needing prior resistance testing Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for H. pylori infection, which affects approximately 35% of the U.S. adult population[3] Worldwide, around 66% of the population has H. pylori infection[4], which is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer[5] and a major risk factor for peptic ulcer disease[6] RALEIGH, N.C. and TEL-AVIV, Israel, Sept. 9, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the placement of low-dose rifabutin-triple therapy, Talicia, as an empirically-prescribed first-line option for the treatment of Helicobacter pylori (H. pylori) infection in the newly published American College of Gastroenterology (ACG) Clinical Guideline: Treatment of H. pylori Infection, previously updated in 2017. "The ACG Clinical Guideline is clear that clarithromycin-based triple therapy is no longer a reliable first-line option for the treatment of H. pylori infection, unless prior resistance testing has shown clarithromycin susceptibility. Resistance rates to both of the antibiotics contained in Talicia, amoxicillin and rifabutin, are minimal - <3.0% and <1.0%, respectively[7] - supporting Talicia as a rational empirically-prescribed first-line option," Dr. Colin W. Howden, MD, Professor Emeritus, Chief of the Division of Gastroenterology, University of Tennessee Health Science Center. "Talicia's all-in-one formulation and flexible dosing schedule – three times daily (TID), at least four hours apart with food, for 14 days – offers a simplified patient experience, supporting high rates of eradication without the requirement of prior resistance testing." It has been almost eight years since the ACG Clinical Guideline's last update, which was prior to the launch of Talicia. "The newly updated ACG Clinical Guideline confirms the use of Talicia as a first-line option," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "Healthcare providers can be confident in their choice of Talicia without the requirement of prior resistance testing, and we trust that this newly updated ACG Clinical Guideline will continue to change the status quo of H. pylori treatment to further improve patient outcomes." About H. pylori H. pylori is a bacterial infection that affects approximately 35%[8] of the U.S. population, with an estimated two million patients treated annually3. Worldwide, around 66% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[9] and a major risk factor for peptic ulcer disease[10] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[11]. More than 27,000 Americans are diagnosed with gastric cancer annually[12]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[13]. About Talicia® Talicia® is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the WHO in recent years. Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[14] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[15]. Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at . About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[16], and Aemcolo®, for the treatment of travelers' diarrhea in adults[17]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first -in -class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Category: Commercial [1] Chey, William D. MD, FACG1; Howden, Colin W. MD, FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH, FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6; Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology 119(9):p 1730-1753, September 2024. | DOI: 10.14309/ajg.0000000000002968 [2] IQVIA XPO Data on file [3] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. [4] [5] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. [6] NIH – Helicobacter pylori and Cancer, September 2013. [7] Ho JJC, Navarro M, Sawyer K, Elfanagely Y, Moss SF. Helicobacter pylori Antibiotic Resistance in the United States Between 2011 and 2021: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2022 Aug 1;117(8):1221-1230. doi: 10.14309/ajg.0000000000001828. Epub 2022 May 5. PMID: 35509128. [8] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. [9] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. [10] NIH – Helicobacter pylori and Cancer, September 2013. [11] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. [12] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). [13] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. [14] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. [15] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001). [16] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . [17] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: . Logo - SOURCE RedHill Biopharma Ltd.

Clinical ResultPhase 3Phase 2Drug Approval

100 Deals associated with Voriconazole

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KEGG	Wiki	ATC	Drug Bank
D00578	Voriconazole	J02AC03	DB00582

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Candidemia	NO	Pfizer Europe MA EEIG	19 Mar 2002
Candidemia	EU	Pfizer Europe MA EEIG	19 Mar 2002
Candidemia	LI	Pfizer Europe MA EEIG	19 Mar 2002
Candidemia	IS	Pfizer Europe MA EEIG	19 Mar 2002
Candidiasis	NO	Pfizer Europe MA EEIG	19 Mar 2002
Candidiasis	EU	Pfizer Europe MA EEIG	19 Mar 2002
Candidiasis	IS	Pfizer Europe MA EEIG	19 Mar 2002
Candidiasis	LI	Pfizer Europe MA EEIG	19 Mar 2002
Invasive aspergillosis	LI	Pfizer Europe MA EEIG	19 Mar 2002
Invasive aspergillosis	EU	Pfizer Europe MA EEIG	19 Mar 2002
Invasive aspergillosis	IS	Pfizer Europe MA EEIG	19 Mar 2002
Invasive aspergillosis	NO	Pfizer Europe MA EEIG	19 Mar 2002
Invasive Fungal Infections	LI	Pfizer Europe MA EEIG	19 Mar 2002
Invasive Fungal Infections	EU	Pfizer Europe MA EEIG	19 Mar 2002
Invasive Fungal Infections	NO	Pfizer Europe MA EEIG	19 Mar 2002
Invasive Fungal Infections	IS	Pfizer Europe MA EEIG	19 Mar 2002
Mycoses	LI	Pfizer Europe MA EEIG	19 Mar 2002
Mycoses	EU	Pfizer Europe MA EEIG	19 Mar 2002
Mycoses	NO	Pfizer Europe MA EEIG	19 Mar 2002
Mycoses	IS	Pfizer Europe MA EEIG	19 Mar 2002

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Candidemia	Preclinical	-	Pfizer Inc.	01 Sep 1998
Invasive Fungal Infections	Discovery	CA	Pfizer Inc.	01 Mar 2006
Invasive Fungal Infections	Discovery	CH	Pfizer Inc.	01 Mar 2006
Invasive Fungal Infections	Discovery	RU	Pfizer Inc.	01 Mar 2006
Invasive Fungal Infections	Discovery	EG	Pfizer Inc.	01 Mar 2006
Invasive Fungal Infections	Discovery	TR	Pfizer Inc.	01 Mar 2006
Invasive Fungal Infections	Discovery	JO	Pfizer Inc.	01 Mar 2006
Pulmonary Aspergillosis	Discovery	FR	Pfizer Inc.	01 Jul 2005
Fever	Discovery	DE	Pfizer Inc.	01 Jan 2005
Candidemia	Discovery	-	Pfizer Inc.	01 Sep 1998

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


1480 (ASH2024)	Not Applicable	Acute Myeloid Leukemia	295	Isavuconazole	fbaaizqgcf(khihjalicc) = jpfdvsuoei tjxlvjpvzr (zwnkswzwtz ) View more	Positive	07 Dec 2024
				Voriconazole	fbaaizqgcf(khihjalicc) = vvjjbfpxey tjxlvjpvzr (zwnkswzwtz ) View more
NCT03672292 (SCYNERGIA, CTgov)	Phase 2	Invasive Pulmonary Aspergillosis	22	Voriconazole+SCY-078 (SCY-078 Plus Voriconazole)	xgmokbshya(uspxkcgfqy) = sakrnflmbb cjbqwjibkv (hzvpxzoeoo, bjlkmqmtoe - omcbpuqmuu) View more	-	09 Aug 2024
				Oral Placebo Tablets+Voriconazole (Voriconazole Mono-therapy)	xgmokbshya(uspxkcgfqy) = mwlhwtyolw cjbqwjibkv (hzvpxzoeoo, eyhlyiclrn - kkexgswuzg) View more
ENDO2024	Not Applicable	Addison Disease	-	Voriconazole	(jfmnxbxomd) = udvbwsjzth kypmyqxeah (awyptfpcno ) View more	-	01 Jun 2024
				Isavuconazole	(esiyvmgtzu) = fdrqgksqsm ubsvivsijh (vtlhhjskcl ) View more
ENDO2024	Not Applicable	Addison Disease	-	Voriconazole	(fyegqlusdn) = czpjldxqrb cxwqinatry (mdjafqwxii ) View more	-	01 Jun 2024
				Hydrocortisone	(fyegqlusdn) = kyvdpyfcvw cxwqinatry (mdjafqwxii ) View more
EHA2024	Not Applicable	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	20	Azacitidine + Venetoclax + Voriconazole	fqokekihnl(osjpurhaur) = ccpfhymlfs jtrpjectln (otftzwktsa ) View more	Negative	14 May 2024
Tandem Meetings ASTCT and CIBMTR2024 Manual	Not Applicable	Hematopoietic stem cell transplantation CMV seropositive	249	Voriconazole	famebpavzm(juroqwmphi) = hdlbmcbnln zoeuggjywj (ytdfzrmdju )	Positive	01 Feb 2024
				Voriconazole+Letermovir	famebpavzm(juroqwmphi) = izbxudhznh zoeuggjywj (ytdfzrmdju )
NCT04551963 (CTgov)	Phase 1	B-Cell Lymphoma	26	Fluconazole+Diltiazem+Zanubrutinib (Arm A: Zanubrutinib With or Without Moderate CYP3A)	lokdojcrxm(deinpgjxox) = zgddgkmmzt qtwaxyqgus (ymzzlzopfc, lsuegdvhzu - nuaykmchsj) View more	-	27 Nov 2023
				Voriconazole+Clarithromycin+Zanubrutinib (Arm B: Zanubrutinib With or Without Strong CYP3A)	puzujjkbsn(errtxdhghx) = ovirlucmbf yyhxorvqun (cuceknengf, lafvkrmnfe - tdvntofimg) View more
ARVO2023	Not Applicable	Fungal keratitis	108	5% Natamycin and 1% Voriconazole	(mlajbjnouj) = vipbnqivqn yqyckrrynv (iresoaczns ) View more	Negative	23 Apr 2023
				5% Natamycin and placebo (Voriconazole vehicle)	(mlajbjnouj) = rlqqjaqowv yqyckrrynv (iresoaczns ) View more
NCT05330000 (Pubmed)	Phase 1	-	48	Test formulation of Voriconazole	(kiyrwamveu) = skboqesgxj cbeqxprmkt (oenqscnufw ) View more	-	03 Mar 2023
				Reference formulation of Voriconazole (Vfend®)	(kiyrwamveu) = wzjxsmeqmd cbeqxprmkt (oenqscnufw ) View more
TCTR20210316001 (WCN23-0919, ISN WCN2023)	Phase 3	Peritoneal dialysis-associated peritonitis	85	Voriconazole	ngequjcjiq(ocvczbdgxj) = vwwiwbaeyz wcllsxmazd (vgwddvsspz ) View more	Positive	01 Mar 2023
				Amphotericin B + Flucytosine	ngequjcjiq(ocvczbdgxj) = ukdenvvfkq wcllsxmazd (vgwddvsspz ) View more

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