Delving into the Latest Updates on Isavuconazonium Sulfate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

isavuconazole, Isavuconazonium, Isavuconazonium sulfate (JAN/USAN)

+ [16]

Target

fungal CYP51A1

Mechanism

fungal CYP51A1 inhibitors(Fungal CYP51A1 inhibitors)

Therapeutic Areas

Infectious DiseasesOther Diseases

Active Indication

CryptococcosisAspergillosisInvasive aspergillosis+ [2]

Inactive Indication

Acute Myeloid LeukemiaCandidemiaCOVID-19+ [5]

Originator Organization

Basilea Pharmaceutica AG

Active Organization

Basilea Pharmaceuticals Deutschland GmbHPfizer Pharmaceuticals Korea Ltd.Astellas Pharma US, Inc.

+ [7]

Inactive Organization

Astellas Pharma, Inc.

Basilea Pharmaceutica AGBasilea Pharmaceutica International Ltd.

Drug Highest PhaseApproved

First Approval Date

US (06 Mar 2015),

Invasive aspergillosisMucormycosis

RegulationOrphan Drug (EU), Orphan Drug (AU), Orphan Drug (US)

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Structure

Molecular FormulaC35H36F2N8O9S2

InChIKeyLWXUIUUOMSMZKJ-KLFWAVJMSA-M

CAS Registry946075-13-4

采用单中心、随机、开放、两制剂、两周期交叉、单剂量给药设计，分别在空腹和餐后给药条件下，评价江苏奥赛康药业有限公司提供的受试制剂（T）硫酸艾沙康唑胶囊（0.1 g）和Pfizer Australia Pty Ltd持证的参比制剂（R）硫酸艾沙康唑胶囊（100 mg；商品名：CRESEMBA®/康新博®）在健康人群中的吸收程度和吸收速度的差异，并评价江苏奥赛康药业有限公司生产的硫酸艾沙康唑胶囊的安全性。

[Translation]

A single-center, randomized, open-label, two-preparation, two-period crossover, single-dose administration design was used to evaluate the differences in absorption extent and absorption rate between the test preparation (T) isavuconazole sulfate capsules (0.1 g) provided by Jiangsu Aosaikang Pharmaceutical Co., Ltd. and the reference preparation (R) isavuconazole sulfate capsules (100 mg; trade name: CRESEMBA®/Kangxinbo®) certified by Pfizer Australia Pty Ltd in healthy people under fasting and postprandial administration conditions, and to evaluate the safety of isavuconazole sulfate capsules produced by Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Start Date12 Sep 2024

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

CTR20242761 / Active, not recruitingNot Applicable

评估受试制剂硫酸艾沙康唑胶囊（规格：按 C22H17F2N5OS 计100mg）与参比制剂硫酸艾沙康唑胶囊（康新博 ® ）（规格：按 C22H 17F2N5OS 计100mg）在健康成年参与者空腹和餐后状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验。

[Translation] This was a single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation, isavuconazole sulfate capsules (strength: 100 mg based on C22H17F2N5OS) and the reference formulation, isavuconazole sulfate capsules (Kangxinbo®) (strength: 100 mg based on C22H 17F2N5OS) in healthy adult participants under fasting and fed conditions.

主要试验目的：研究空腹和餐后状态下单次口服受试制剂硫酸艾沙康唑胶囊（规格：按C22H17F2N5OS 计100mg，江苏宣泰药业有限公司生产）与参比制剂硫酸艾沙康唑胶囊（康新博 ® ，规格：按C22H17F2N5OS计100mg；Swiss Co Services AG生产）在健康参与者体内的药代动力学特征，评价空腹和餐后状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂硫酸艾沙康唑胶囊（规格：按C22H17F2 N5OS 计100mg）和参比制剂硫酸艾沙康唑胶囊（康新博 ® ）（规格：按C22H17F2N5OS 计100mg）在健康参与者中的安全性。

[Translation]

Primary study objectives: To study the pharmacokinetic characteristics of a single oral dose of the test preparation isavuconazole sulfate capsule (specification: 100 mg based on C22H17F2N5OS, produced by Jiangsu Xuantai Pharmaceutical Co., Ltd.) and the reference preparation isavuconazole sulfate capsule (Kangxinbo ® , specification: 100 mg based on C22H17F2N5OS; produced by Swiss Co Services AG) in healthy participants under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations in fasting and fed conditions. Secondary study objectives: To study the safety of the test preparation isavuconazole sulfate capsule (specification: 100 mg based on C22H17F2 N5OS) and the reference preparation isavuconazole sulfate capsule (Kangxinbo ® ) (specification: 100 mg based on C22H17F2N5OS) in healthy participants.

Start Date07 Sep 2024

Sponsor / Collaborator

Anhui Ruiqi Pharmaceutical Co., Ltd.

ChiCTR2400086245 / SuspendedNot ApplicableIIT

Study on theraputic drug monitoring and phamacokinetics of isavuconazole in children

Start Date01 Jul 2024

Sponsor / Collaborator-

100 Clinical Results associated with Isavuconazonium Sulfate

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100 Translational Medicine associated with Isavuconazonium Sulfate

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100 Patents (Medical) associated with Isavuconazonium Sulfate

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765

Literatures (Medical) associated with Isavuconazonium Sulfate

01 Feb 2025·PARASITOLOGY INTERNATIONAL

Pulmonary infection by Lophomonas spp. and Aspergillus spp. in a B-cell acute lymphocytic leukemia patient from Chile

Article

Author: Moenen-Locoz, Enzo ; Cabrera, Johanna ; Chahin, Carolina ; Hidalgo, Alejandro ; Briones, Javier ; Iturrieta-González, Isabel ; Fonseca-Salamanca, Flery ; Vega, Fernando ; Concha, Carla

The flagellated protozoan Lophomonas spp. is a commensal microorganism found in the intestinal tracts of cockroaches, termites, mites, and certain birds. It is the causative agent of a rare infection in humans called lophomoniasis, primarily affecting the lungs and mainly immunocompromised individuals. This parasitosis is transmitted to humans by air or through ingestion of the cystic forms of the parasite. We describe the case of a 50-year-old patient treated at a tertiary hospital in southern Chile with a history of B-cell acute lymphocytic leukemia. Radiological findings, along with increased levels of inflammatory parameters and galactomannan antigen in serum and Bronchoaveolar Lavage (BAL) raised the suspicion of a pulmonary infection. Microscopic study of BAL revealed oval to pyriform cells with mobile flagella at the anterior end, which were identified as Lophomonas spp. trophozoites, which based on EORTC/MSG criteria were associated with diagnosis of a probable pulmonary aspergillosis. Lophomoniasis was treated with metronidazole (500 mg IV every 8 h) for 14 days and pulmonary aspergillosis required a combination of fluconazole, voriconazole, anidulafungin, liposomal amphotericin B and isavuconazole. The patient responded favorably and was discharged after 95 days of hospitalization. This case highlights the importance of recognizing lophomoniasis as a parasitic infection in respiratory samples from immunocompromised patients who present pulmonary symptoms, especially those who do not respond satisfactorily to conventional antimicrobial treatments. Further research is needed to understand the various sources of Lophomonas spp. infection and develop infection prevention strategies particularly for high-risk patients.

01 Jan 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Multiparametric LC-MS/MS method for simultaneous determination of eleven antifungal drugs and metabolites in human plasma

Article

Author: Constans, Céline ; Cazaubon, Yoann ; Mathieu, Olivier ; Bendjilali-Sabiani, Jean-Joseph

A multiparametric liquid chromatography-tandem mass spectrometry method has been developed for the simultaneous quantification of 11 antifungal drugs and their metabolites in human plasma. This method addresses the critical need for therapeutic drug monitoring in the treatment of invasive fungal infections, which are increasingly prevalent among immunocompromised patients and those in intensive care units. The method quantifies flucytosin, fluconazole, itraconazole, hydroxy-itraconazole, posaconazole, isavuconazole, voriconazole, voriconazole-N-oxide, anidulafungin, caspofungin, and micafungin. Key challenges in method development included optimising mass spectrometer settings, chromatographic conditions, and sample preparation techniques to ensure accurate, sensitive, and specific detection. Validation of this method was conducted in accordance with the guidelines set by the USA Food and drug administration and the European Medicines Agency covering linearity, precision, accuracy, selectivity, matrix effect, and stability. The method exhibited robust performance with intra- and inter-assay precision under 10 % and average accuracy for intra- and inter-assay comparison of -2.35 % and 0.80 %, respectively. Limits of detection (0.002 to 0.110 mg/L) and a quantification range between 0.005 and 200 mg/L make this method suitable for clinical TDM applications. The ability to simultaneously analyse eleven antifungals and their metabolites within a single 5-minute run enhances its utility in clinical settings, particularly for critically ill patients who may experience significant pharmacokinetic variations. The method requires only 100 µL of plasma, demonstrating good analytical performances rendering it a valuable tool for optimising antifungal therapy and improving patient outcomes in ICU management.

05 Dec 2024·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Safety, outcomes, and pharmacokinetics of isavuconazole as a treatment for invasive fungal diseases in pediatric patients: a non-comparative phase 2 trial

Article

Author: Deville, Jaime G. ; Engelhardt, Marc ; Croos-Dabrera, Rodney ; Hanisch, Benjamin ; Kovanda, Laura L. ; Manzanares, Angela ; Muller, William J. ; Arrieta, Antonio C. ; Bordon, Victoria ; Jones, Mark ; Groll, Andreas H. ; Lassaletta, Alvaro ; Desai, Amit ; Autmizguine, Julie ; Sinnar, Shamim ; Segers, Heidi ; Fisher, Brian T. ; Neely, Michael

ABSTRACT:

Invasive aspergillosis (IA) and mucormycosis (IM) cause significant morbidity and mortality in immunocompromised and/or hospitalized patients. Isavuconazonium sulfate, a prodrug of the antifungal triazole isavuconazole, has been approved for treatment of IA and IM in adults; and was recently approved in children. This study describes the outcomes, safety, and pharmacokinetics of isavuconazole for the treatment of proven, probable, or possible IA or IM in children. In this phase 2, open-label, non-comparative study, patients aged 1 to <18 years with at least possible invasive mold disease were enrolled across 10 centers in the US, Spain, and Belgium from 2019 to 2022. Patients received 10 mg/kg isavuconazonium sulfate daily (maximum 372 mg; equivalent to 5.4 mg/kg or 200 mg isavuconazole) for up to 84 (IA) or 180 days (IM). Outcomes included rates of all-cause case fatality, overall response, treatment-emergent adverse events (TEAEs), and pharmacokinetics. Of 31 patients enrolled, 61.3% were 1–<12 years old; 58.1% had underlying hematologic malignancies. The successful overall response rate at the end of treatment was 54.8%. Day 42 all-cause case fatality was 6.5%; 93.5% experienced TEAEs, and two patients discontinued treatment due to drug-related TEAEs. Dosing at 10 mg/kg (maximum dose: 372 mg) met the pre-defined exposure threshold of above the 25th percentile for the area under the concentration-time curve (≥60 mg·h/L). Simulated doses of 15 mg/kg improved drug exposures in patients aged 1–<3 years. Isavuconazole was well tolerated in children, with exposure consistent with adult studies. Successful response was documented in 54.8% of patients.

CLINICAL TRIALS:

This study is registered at ClinicalTrials.gov as NCT03816176 .

73

News (Medical) associated with Isavuconazonium Sulfate

08 Oct 2024

·www.biospace.com

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases. “Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.” “As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.” Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (PDT) Location ORAL & LATE-BREAKING PRESENTATIONS 580 - Pharmacokinetics (PK) and Safety of Nirmatrelvir/Ritonavir (NMV/r) in Non-Hospitalized Symptomatic Pediatric Patients Ages 6 Years and Older with COVID-19 Who Are at Increased Risk of Progression to Severe Disease (EPIC-Peds) Jacqueline Gerhart, PhD Oct 19 2:45 – 2:57 PM US PT 403 A 88 - Efficacy of Nirmatrelvir/Ritonavir in High-Risk Trial Participants With Prior SARS-CoV-2 Infection or Vaccination: A Pooled Analysis John M. McLaughlin, PhD Oct 17 10:42 – 10:54 AM US PT 411 165 - Real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related severe acute respiratory infection (ARI) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC), November 2023-April 2024 Sara Tartof, PhD, MPH, (KPSC)* Oct 17 1:45 – 3:00 PM US PT 403A 571 – Safety and Immunogenicity of Coadministered Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine With and Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age Rahsan Erdem, MD Oct 19 1:45 – 2:03 PM US PT 408 A POSTER PRESENTATIONS COVID-19 P - 1194 - Comparison of COVID-19 Inpatient Burden in Hospitalized Children Age < 5years, by SARS-CoV-2 Variant Kathleen M. Andersen, PhD MSc Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1906 - Early COVID-19 and Severity of Subsequent Omicron Infection in Ontario, Canada Caroline Kassee, MPH (Sinai Health)* Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 1977 - Six-Month Trajectory of Symptoms of COVID-19 Fatigue by Age and BNT162b2 COVID-19 Vaccination Status: A Prospective Study Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2047 - Public Health Impact and Economic Value of an Additional Dose of Pfizer-BioNTech XBB.1.5-adapted COVID-19 Vaccine for Older Adults in the United States Alon Yehoshua, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2048 - COVID-19 XBB.1.5 vaccine uptake based on state vaccine registries compared to national survey data Angela Cook, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2054 - Effectiveness of a Single COVID-19 mRNA Vaccine Dose in Individuals Previously Infected with SARS-CoV-2: A Systematic Review Hannah R. Volkman, PhD, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2060 - Effectiveness of BNT162b2 COVID-19 Vaccination Against Long COVID Among Older Adults: A Nationwide Study Manuela Di Fusco, PhD Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2062 - COVID-19 XBB.1.5-adapted vaccine uptake in immunocompromised individuals using tokenized state vaccine registries Matthew A. Brouillette, MPH Oct 19 12:15 – 1:30 PM US PT Hall J & K P - 2017 - Patient Reported Outcomes of Nirmatrelvir/Ritonavir Treatment for High-risk, Nonhospitalized Adults with Symptomatic COVID-19 Ashley S. Cha-Silva, PharmD, MS Oct 19 12:15 – 1:30 PM US PT Hall J & K Lyme Disease P - 599 - 6-Valent, OspA-Based VLA15 Lyme Disease Vaccine Candidate Against Lyme Borreliosis in a Healthy Pediatric and Adult Study Population: A Phase 2 Study Update James H. Stark, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1287 - Incidence of Symptomatic Lyme Borreliosis in Nine European Countries, 2018−2022 Frederick Angulo, DVM PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1291 - Racial disparities in Lyme disease among beneficiaries of US Medicaid and Medicare L. Hannah Gould, PhD, MS, MBA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1293 - Healthcare Costs Associated with Lyme Disease in a U.S. Insured Population Holly Yu, MSPH Oct 18 12:15 – 1:30 PM US PT Hall J & K Meningococcal Disease P - 1299 - Epidemiology of Invasive Meningococcal Disease in the United States: Review of Recent Data and Identified Risk Factors Jessica Presa, MD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1304 - Public Health Impact of changes to Meningococcal vaccination platform in the United States Katharina Schley, Dr. rer pol. Oct 18 12:15 – 1:30 PM US PT Hall J & K Pneumococcal disease P - 8 - Assessment of 13-valent pneumococcal conjugate vaccine effectiveness among people living with HIV in the United States Amanda C. Miles, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 628 - Real-world impact of pneumococcal conjugate vaccines on vaccine serotypes and cross-reacting non-vaccine serotypes Kevin Apodaca, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 629 - The health and economic impact of the PCV15 and PCV20 priming series during the first year of life in the US Mark Rozenbaum, PhD, M.B.A Oct 17 12:15 – 1:30 PM US PT Hall J & K Respiratory Syncytial Virus (RSV) P - 673 - Respiratory Syncytial Virus (RSV) Hospitalizations During Off-Season Months Among Infants in US Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 674 - The Economic Burden of Infant RSV Among US Caregivers Amy W. Law, PharmD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 40 - Impact of case and control selection on influenza vaccine effectiveness (VE) among adults aged 40 years and older hospitalized with acute respiratory illness (ARI) during 2022-2023 using a test negative design (TND): secondary analysis of the North America Multi-Specimen Study Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1204 - Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1205 - Impact of the COVID-19 Pandemic on Hospitalizations Associated with Respiratory Syncytial Virus (RSV) Illness Among Children and Adolescents in Ontario, Canada Sazini Nzula, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 677 - Estimation of Respiratory Syncytial Virus-Attributable Hospitalizations Among Older Adults in Japan between 2015 and 2018: An Administrative Health Claims Database Analysis Asuka Yoshida, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 680 - Estimated Respiratory Syncytial Virus (RSV)-Related Hospitalizations and Deaths Among Adults in Norway between 2010–2019 Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 682 - The Risk of Cardiorespiratory Events for Up to 180 days Following Respiratory Syncytial Virus (RSV) Infection Hospitalization: A Self-Controlled Case Series Analysis Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P – 683 – Estimation of RSV-Attributable Cardiovascular and Respiratory Hospitalizations in Adults in Germany, Between 2015-2019 Caroline Beese Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 604 - Preliminary real-world Abrysvo vaccine effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related lower respiratory tract disease (LRTD) hospitalizations and emergency department (ED) visits—Kaiser Permanente of Southern California (KPSC) November 2023-April 2024 Negar Aliabadi, MD, MS Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 53 - Trends in Co-administration of Adult Vaccinations in the US Retail Pharmacy Setting Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 603 - Potential Public Health Impact of Respiratory Syncytial Virus (RSV) Vaccines for Prevention of RSV Among Older Adults in the United States Reiko Sato, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 600 - Efficacy Of a Bivalent RSVpreF Vaccine in Older Adults Across a Second RSV Season John Woodside, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 596 - Immunobridging Demonstrating Effectiveness of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Adults 18-59 Years of Age at High Risk of Severe RSV Disease in a Phase 3 Trial: The C3671023 MONeT Study Results Elliot N. DeHaan, MD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 681 - Estimated Incidence of Respiratory Syncytial Virus (RSV)-Related Hospitalizations for Acute Respiratory Infections (ARIs), including Community Acquired Pneumonia (CAP), in Adults in Germany Caihua Liang, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 605 - Bivalent RSV Prefusion F-Based Subunit Vaccine Generates High and Durable Neutralizing Titers Across an Entire RSV Season Among Older Adults Tarek Mikati, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 595 - Public Health Impact of RSVpreF Vaccination on Older Adult Disease Outcomes Daniel Eiras, MD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 21 - Comparison of Three RSV Vaccine Lower Respiratory Tract Disease Primary Endpoint Definitions for Adult Vaccine Sarah E. Williams, MD. MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 2357 - Respiratory Syncytial Virus (RSV) Disease Burden Among Adults in Primary Care Settings in High-Income Countries: A Systematic Review and Modelling Study You Li; multiple Pfizer co-authors Oct 19 12:15 – 1:30 PM US PT Hall J & K Aztreonam-Avibactam P - 105 - Aztreonam-Avibactam Compared with Adjunctive Colistin Combined with Meropenem for the Treatment of Serious Gram-Negative Bacterial Infections: Subgroup Analysis of the Phase 3 REVISIT Study Heidi Leister-Tebbe, BSN Oct 17 12:15-1:30 PM US PT Hall J & K P - 1080 Aztreonam-Avibactam Activity Against Gram-negative Bacteria Isolated From Patients with Pneumonia from Europe, Asia, and Latin America (2021–2023) Helio S. Sader, MD, PhD, FIDSA Oct 18 12:15 – 1:30 PM US PT Hall J & K P - 1256 - Pharmacokinetic/Pharmacodynamic (PK/PD) Target Attainment Analyses for Aztreonam-Avibactam Dosing Regimens Susan Raber*, PharmD, MPH Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1508 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program From 2018-2022 Mark Estabrook*, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P - 1509 - In Vitro Activity of Aztreonam-Avibactam Against Enterobacterales Isolated From Pediatric and Adult Patients Collected During the ATLAS Global Surveillance Program, 2018-2022 Mark Estabrook*, PhD Oct 18 12:15 – 1:30 PM US PT Hall J & K Isavuconazole P - 1168 - Activity of Isavuconazole and Comparator Agents Against Pediatric Fungal Isolates Collected from 2017–2023 in a Global Surveillance Program Marisa Winkler, MD, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K Ceftazidime-Avibactam P- 1506 - In Vitro Activity of Ceftazidime-Avibactam and Comparator Agents Against Pseudomonas aeruginosa Collected from Patients with Presumed Hospital- and Community-Acquired Respiratory Tract Infections as a Part of the ATLAS Global Surveillance Program 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K P- 1507 - In Vitro Activity of Ceftazidime-Avibactam Against Enterobacterales Isolates Producing Multiple β-lactamases Collected Globally as a Part of the ATLAS Global Surveillance Program from 2018-2022 Mark Estabrook, PhD Oct 17 12:15 – 1:30 PM US PT Hall J & K * =multiple Pfizer co-authors Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO ® (Respiratory Syncytial Virus Vaccine) or visit and . Please see full Prescribing Information for COMIRNATY ® (COVID-19 Vaccine, mRNA) or visit . Please see full Prescribing Information for CRESEMBA ® (Isavuconazonium Sulfate) or visit Please see full Prescribing Information for PAXLOVID TM (Nirmatrelvir and Ritonavir) or visit . Please see full Prescribing Information for PREVNAR 20 TM (Pneumococcal 20-valent Conjugate Vaccine) or visit . Please see full Prescribing Information for PREVNAR 13 ® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for ZAFICEFTA ® (Ceftazidime-Avibactam). About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at . In addition, to learn more, please visit us on and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer . DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and . Contacts Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

VaccinePhase 3Phase 2Clinical Result

08 Oct 2024

·www.pfizer.com

Pfizer to Showcase Scientific Advancements in Respiratory and Other Infectious Diseases at IDWeek 2024

Presentations highlight momentum of Pfizer’s portfolio of infectious disease prevention and treatment options NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) will present data across its infectious disease portfolio at the upcoming IDWeek 2024 congress, held in Los Angeles from October 16-19, 2024. Data in 49 abstracts from company- and collaborator-led studies, will highlight the advances Pfizer is making in helping prevent and treat infectious diseases. “Pfizer is at the forefront of vaccine and therapeutic development in respiratory and infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Head, Vaccine Research and Development, Pfizer. “IDWeek 2024 provides a crucial platform to showcase our innovative advancements and engage with the scientific community, as we work to effectively tackle the ongoing challenge posed by infectious diseases.” "As we approach another respiratory virus season, the importance of preventive vaccines and treatments to help keep us healthy is more apparent than ever,” said Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals, Pfizer. “We’re excited to present new, meaningful data that we hope will help further inform healthcare providers.” Pfizer will present research from its robust infectious disease portfolio, covering RSV, COVID-19, pneumococcal disease, Lyme disease, meningococcal disease, and serious bacterial and fungal infections. Details for Pfizer-sponsored, investigator-sponsored and collaborative research oral and poster presentations are below: * =multiple Pfizer co-authors Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO ® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com/ and https://abrysvomaternal.pfizerpro.com/. Please see full Prescribing Information for COMIRNATY ® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com. Please see full Prescribing Information for CRESEMBA ® (Isavuconazonium Sulfate) or visit www.cresemba.com. Please see full Prescribing Information for PAXLOVID TM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com. Please see full Prescribing Information for PREVNAR 20 TM (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com/. Please see full Prescribing Information for PREVNAR 13 ® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for ZAFICEFTA ® (Ceftazidime-Avibactam). About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of October 8, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848

VaccineClinical Study

24 Sep 2024

·www.globenewswire.com

Basilea initiates clinical phase 3 study with antifungal fosmanogepix in candidemia and invasive candidiasis

Allschwil, Switzerland, September 24, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has initiated the Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis (FAST-IC) phase 3 study. This registrational study evaluates the efficacy and safety of Basilea’s broad-spectrum antifungal fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, that is Candida yeast bloodstream or deep-seated tissue infections.1 Fosmanogepix is a first-in-class antifungal treatment candidate with a novel mechanism of action. It is available in intravenous and oral formulations and has been evaluated for efficacy and safety in a phase 1 / phase 2 program, including three open-label phase 2 studies for the treatment of Candidemia, including Candida auris, and invasive mold infections.2, 3, 4, 5 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We are very pleased to have activated the first study center in the phase 3 program for fosmanogepix and look forward to enrolling patients into FAST-IC. Invasive Candida infections are life-threatening complications for many hospitalized patients and associated with high mortality, and fosmanogepix offers a potential new treatment option in this high medical need area. In addition, we are working towards starting the second phase 3 study investigating fosmanogepix in the treatment of adult patients with invasive mold infections around year-end.” FAST-IC is a global, multi-center, randomized, active-controlled, double-blind phase 3 study and investigates intravenous (i.v.) fosmanogepix versus a standard-of-care regimen of i.v. caspofungin in adult patients with candidemia and/or invasive candidiasis. The study is expected to enroll approximately 450 patients, who will be randomized in a 2:1 ratio to either fosmanogepix or caspofungin. There is an optional oral switch to fosmanogepix in the fosmanogepix group and to fluconazole in the caspofungin group. The Swiss-based global company PSI CRO AG will manage the phase 3 program. Basilea acquired fosmanogepix from Amplyx Pharmaceuticals, Inc., an affiliate of Pfizer Inc., in November 2023. Under the terms of the asset purchase agreement, Basilea assumed all rights and obligations from previous agreements, and will make a USD 6.0 million milestone payment under these obligations, upon the enrolment of the first patient, which is fully reflected in Basilea’s most recent financial guidance for the full year 2024. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration of Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.2 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris, and invasive mold infections.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the US Food and Drug Administration for seven separate indications, and is designated as a Qualified Infectious Disease Product (QIDP). About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.6, 7 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.8 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate as high as 40%, even when patients receive antifungal therapy.9 About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhDHead of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone+41 61 606 1102 E-mailmedia_relations@basilea.cominvestor_relations@basilea.com This press release can be downloaded from www.basilea.com. References ClinicalTrials.gov identifier: NCT05421858K. J. Shaw, A. S. Ibrahim. Fosmanogepix:A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239M. R. Hodges, E. Ople, P. Wedel et al. Safety and Pharmacokinetics of Intravenous and Oral Fosmanogepix, a First-in-Class Antifungal Agent, in Healthy Volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22J. A. Vazquez, P. G. Pappas, K. Boffard et al. Clinical Efficacy and Safety of a Novel Antifungal, Fosmanogepix, in Patients with Candidemia Caused by Candida auris: Results from a Phase 2 Trial. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22P. G. Pappas, J. A. Vazquez, I. Oren et al. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480J. Cadena, G. R. Thompson 3rd, T. F..Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: September 23, 2024)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF).pdf

Phase 2Phase 3Orphan DrugFast TrackClinical Result

100 Deals associated with Isavuconazonium Sulfate

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KEGG	Wiki	ATC	Drug Bank
D10643	Isavuconazonium Sulfate	G01AG J02AC	DB06636

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cryptococcosis	JP	Asahi Kasei Pharma Corp.	23 Dec 2022
Aspergillosis	CA	Avir Pharma, Inc.Startup	19 Dec 2018
Invasive aspergillosis	US	Astellas Pharma US, Inc.	06 Mar 2015
Mucormycosis	US	Astellas Pharma US, Inc.	06 Mar 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Invasive Fungal Infections	NDA/BLA	JP	Asahi Kasei Corp.	30 Jan 2022
COVID-19	Phase 3	US	Astellas Pharma Global Development, Inc.	16 Mar 2021
Pulmonary Aspergillosis	Phase 3	US	Astellas Pharma Global Development, Inc.	16 Mar 2021
Deep mycosis	Phase 3	JP	Asahi Kasei Pharma Corp.	16 Apr 2018
Candidemia	Phase 3	US	Basilea Pharmaceutica AG	08 Mar 2007
Candidemia	Phase 3	US	Astellas Pharma, Inc.	08 Mar 2007
Candidemia	Phase 3	CN	Basilea Pharmaceutica AG	08 Mar 2007
Candidemia	Phase 3	CN	Astellas Pharma, Inc.	08 Mar 2007
Candidemia	Phase 3	AR	Basilea Pharmaceutica AG	08 Mar 2007
Candidemia	Phase 3	AR	Astellas Pharma, Inc.	08 Mar 2007

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Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


1480 (ASH2024)	Not Applicable	Acute Myeloid Leukemia	295	Isavuconazole	yroptolwwt(abxkgjfisl) = ayqpcufaqh pkzkllxclp (zivbpqmehd ) View more	Positive	07 Dec 2024
				Voriconazole	yroptolwwt(abxkgjfisl) = uzaaitlhxe pkzkllxclp (zivbpqmehd ) View more
NCT04550936 (Pubmed \| Infect Dis Ther)	Not Applicable	-	218	Isavuconazole monotherapy	hswosxdcpn(wbnrwnlntd) = 45 patients (21%) experienced at least one adverse event (AE) wxymkejcma (orusjtvtnw ) View more	Positive	24 Oct 2024
				Salvage therapy
NCT03816176 (CTgov)	Phase 2	Invasive aspergillosis \| Mucormycosis	31	Isavuconazonium sulfate	yhrwcoqrtg(puqespfwux) = pqsaxvwmtq luredwryij (uzhndksoeq, cvhglelyya - rjprdiefkp) View more	-	21 Sep 2023
EBMT2023	Not Applicable	Hematopoietic stem cell transplantation	50	Isavuconazole	ptepwayiuv(jscicpvgxj) = No adverse events related to ISA were reported wwpgyitwmp (gjtssunhdy )	-	23 Apr 2023
ASN2022	Not Applicable	Hyponatremia	-	Isavuconazonium sulfate	aokzxmymay(ekozhexyfy) = Isavuconazonium sulfate was discontinued for severe hyponatremia and patient was initiated on intravenous voriconazole. SNa progressively improved to 134 mmol/L, 10 days after discontinuation of isavuconazonium sulfate. vpjdakdgew (zuoyzlvioa )	-	05 Nov 2022
				Voriconazole
NCT03471988 (Pubmed)	Phase 3	Mycoses	103	Isavuconazole	(gjlnzvuxaq) = Adverse drug reactions were reported in 32 (61.5%) patients receiving isavuconazole and 23 (85.2%) patients receiving voriconazole idwwozsluc (wzpmsoxrck ) View more	Positive	25 Oct 2022
				Voriconazole
EBMT2022	Not Applicable	Hematopoietic stem cell transplantation	166	Isavuconazole for treatment of IFI	cdwvzqrhxn(omfczxaxna) = vylsytyykl tspjeyqthe (ngpustmztw ) View more	-	19 Mar 2022
				Isavuconazole for off-label prophylaxis	cdwvzqrhxn(omfczxaxna) = dtpfkdblaz tspjeyqthe (ngpustmztw ) View more
NCT03019939 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Neutropenia \| Invasive Fungal Infections ... View more	65	Isavuconazole	dyvitdpqop(ozqudfrktv) = ixjreydodn uhamnjprcf (pddvzmpfyb, tcdieypcql - nhtvcmlgpi) View more	-	24 Sep 2021
NCT03019939 (Pubmed \| Clin Infect Dis) Manual	Phase 2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	75	Isavuconazole	pnoqkabbsh(mpxambjmcn) = tljkmisvtw kvrkjvbvrr (qemopkolye )	Positive	18 May 2021
				venetoclax+Isavuconazole	pnoqkabbsh(mpxambjmcn) = nmxynfhkrc kvrkjvbvrr (qemopkolye )