2025
A Vaccine to Block Plasmodium falciparum Transmission.
Healy S, Sagara I, Assadou M, Katile A, Kone M, Imeru A, Kwan J, Swihart B, Fintzi J, Potter G, Zeguimé A, Dolo A, Diarra B, Narum D, Rausch K, MacDonald N, Zhu D, Mohan R, Thera I, Morrison R, Zaidi I, Doritchamou J, Sylla D, Hume J, Coulibaly M, Morelle D, Lievens M, Doumbo O, Duffy P. A Vaccine to Block Plasmodium falciparum Transmission. NEJM Evidence 2025, 4: evidoa2400188. PMID: 40552966, DOI: 10.1056/evidoa2400188.Peer-Reviewed Original ResearchConceptsStandard membrane feeding assayPfs230D1-EPASafety trialsAntibody responseEnd pointsSkin feeding assaysTransmission-reducing activityWeeks of follow-upMembrane feeding assaysAs-treated populationPrimary efficacy analysisSecondary end pointsPrimary end pointInfected mosquitoesEnzyme-linked immunosorbent assayMalian adultsMalaria vaccineComparator-controlledDouble-blindProportion of infected mosquitoesDosing regimensEfficacy analysisThird doseYears postvaccinationBlock disease transmissionSulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection.
Puttagunta S, Aronin S, Gupta J, Das A, Gupta K, Dunne M. Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection. NEJM Evidence 2025, 4: evidoa2400414. PMID: 40552968, DOI: 10.1056/evidoa2400414.Peer-Reviewed Original ResearchConceptsUrinary tract infectionUncomplicated urinary tract infectionsIntent-to-treat populationSusceptible to amoxicillin/clavulanateTract infectionsUrine cultureAdverse eventsTreatment of uncomplicated urinary tract infectionsCombined population of patientsPatients treated with amoxicillin/clavulanateTreatment-emergent adverse eventsBaseline urine culturePositive urine cultureMild adverse eventsPopulation of patientsTreatment of adult womenClasses of antibioticsMicrobiological eradicationBaseline pathogensClinical cureDouble-blindMedian ageTrial medicationAmoxicillin/clavulanateAntimicrobial resistanceOnce-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial
Jastreboff A, Ryan D, Bays H, Ebeling P, Mackowski M, Philipose N, Ross L, Liu Y, Burns C, Abbasi S, Pannacciulli N. Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial. New England Journal Of Medicine 2025 PMID: 40549887, DOI: 10.1056/nejmoa2504214.Peer-Reviewed Original ResearchBaseline to weekDose escalationTreatment of obesityTreatment policy estimandType 2 diabetesObese cohortBody weightDose-ranging trialPhase 2 trialGastrointestinal adverse eventsGlycated hemoglobin levelsPeptide-antibody conjugatesGlucagon-like peptide-1 receptor agonismIntention-to-treat approachOnce-monthlyDouble-blindPlacebo groupPlacebo-controlledReceptor antagonismReceptor agonismHemoglobin levelsAdverse eventsPlaceboSafety signalsObesityTirzepatide for reduction of morbidity and mortality in adults with obesity: rationale and design of the SURMOUNT‐MMO trial
Lam C, Rodriguez A, Aminian A, Ferrannini E, Heerspink H, Jastreboff A, Laffin L, Pandey A, Ray K, Ridker P, Sanyal A, Yki‐Jarvinen H, Mason D, Strzelecki M, Bartee A, Cui C, Hurt K, Linetzky B, Bunck M, Nissen S. Tirzepatide for reduction of morbidity and mortality in adults with obesity: rationale and design of the SURMOUNT‐MMO trial. Obesity 2025 PMID: 40545827, DOI: 10.1002/oby.24332.Peer-Reviewed Original ResearchSecondary cardiovascular disease preventionCardiovascular disease preventionCardiovascular diseaseGlucagon-like peptide-1 receptor agonistsGlucose-dependent insulinotropic polypeptide receptorPeptide-1 receptor agonistsMultiple cardiovascular risk factorsCardiovascular risk factorsHeart failure eventsNonfatal myocardial infarctionType 2 diabetesReduction of morbidityDisease preventionDouble-blindPrimary endpointReceptor agonistsClinical benefitImprove morbidityObesityCoronary revascularizationRisk factorsOutcome trialsTirzepatideMultiple outcomesSubstantial weight reductionInternational phase II randomized placebo-controlled study investigating the combination of YIV-906 plus sorafenib (SORA) in HBV (+) patients (Pts) with advanced hepatocellular carcinoma.
Abou-Alfa G, Yen Y, Harding J, Whang-Peng J, Shi Y, Yuen M, Li X, Gu S, Liu C, Jeng L, Yen C, Pan C, Chen S, Hsieh J, Saif M, Liu S, Li F, Lam W, Chu E, Cheng Y. International phase II randomized placebo-controlled study investigating the combination of YIV-906 plus sorafenib (SORA) in HBV (+) patients (Pts) with advanced hepatocellular carcinoma. Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.e16244.Peer-Reviewed Original ResearchProgression-free survivalPer-protocol setPlacebo armYIV-906Child-Pugh A liver functionMulti-targeted tyrosine kinase inhibitorRandomized phase 2 studyTumor rejection in vivoRandomized placebo-controlled studyRisk of disease progressionTumor microenvironment inflammationAdvanced hepatocellular carcinomaECOG performance statusPlacebo-controlled studyPhase 2 studyTyrosine kinase inhibitorsRejection in vivoCohort of patientsPotential clinical benefitCTCAE versionTolerated sorafenibSorafenib monotherapyDouble-blindPlacebo-controlledITT groupQuANTUM-Wild: A phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3 -ITD–negative acute myeloid leukemia (AML).
Montesinos P, Cheong J, Daver N, Fathi A, Levis M, Luger S, Miyamoto T, Oliva E, Perl A, Recher C, Schlenk R, Wang J, Zeidan A, Liu L, Duong Y, Imadalou K, Alexis K, Nahar A, Burns K, Erba H. QuANTUM-Wild: A phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3 -ITD–negative acute myeloid leukemia (AML). Journal Of Clinical Oncology 2025, 43 DOI: 10.1200/jco.2025.43.16_suppl.tps6580.Peer-Reviewed Original ResearchAcute myeloid leukemiaRelapse-free survivalEvent-free survivalArm AOverall survivalComplete remissionDouble-blindArm CCases of acute myeloid leukemiaAcute myeloid leukemia blastsAcute myeloid leukemia casesFLT3-ITD-negativeHigh-dose cytarabineFLT3 gene mutationsType II FLT3 inhibitorsPlacebo-controlled trialProlonged overall survivalAllele frequency <5%Leukemic cell survivalArm BStandard chemotherapyEligible ptsInduction/consolidation chemotherapyPrimary endpointSecondary endpointsModulation of dopaminergic transmission and brain activity by frontotemporal tDCS: A multimodal PET-MR imaging study
Fonteneau C, Merida I, Redoute J, Haesebaert F, Lancelot S, Costes N, Mondino M, Brunelin J. Modulation of dopaminergic transmission and brain activity by frontotemporal tDCS: A multimodal PET-MR imaging study. Brain Stimulation 2025, 18: 1065-1073. PMID: 40340023, DOI: 10.1016/j.brs.2025.05.006.Peer-Reviewed Original ResearchTranscranial direct current stimulationPositron emission tomographyArterial spin labelingMagnetic resonance imagingWhite matter microstructural integrityModulation of dopaminergic transmissionParallel-group studyNo significant effects of tDCSOptimization of therapeutic strategiesNon-displaceable binding potentialEffects of transcranial direct current stimulationCerebral blood flowNeurophysiological mechanismsDiffusion weighted imagingMicrostructural integrityPET-MR imagingActive transcranial direct current stimulationDopaminergic transmissionDouble-blindSimultaneous positron emission tomographyDopamine releaseDopamine transmissionClinical benefitDirect current stimulationDopamine systemSafety, pharmacokinetics, and efficacy of HY-072808 ointment, a novel PDE4 inhibitor, in adolescent and adult patients with mild-to-moderate AD
Yao F, He M, Wang J, Li Y, Zhang Q, Yang J, Wu J, Zhang Q, Zhou R, Zhang M, Meng L, Wu L, Chu Z, Hu W. Safety, pharmacokinetics, and efficacy of HY-072808 ointment, a novel PDE4 inhibitor, in adolescent and adult patients with mild-to-moderate AD. Expert Opinion On Investigational Drugs 2025, 34: 435-447. PMID: 40411316, DOI: 10.1080/13543784.2025.2510671.Peer-Reviewed Original ResearchConceptsMild to moderate ADAnti-atopic dermatitisAdult patientsHealthy subjectsPDE4 inhibitorsPhase I clinical trialWell-tolerated treatmentOpen-label trialDouble-blindPlacebo-controlledSafety profileAdverse eventsEASI scoreClinical developmentPharmacokinetic analysisAtopic dermatitisHealthy individualsPatientsPharmacokineticsDrug concentrationsEczema severityQuality of lifeEfficacyTrialsOintmentA Modern Design for a Phase 2/3 Randomized, Double-blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BHV-7000 in Idiopathic Generalized Epilepsy with Generalized Tonic-Clonic Seizures (P8-9.016)
Lerner J, Stock D, Bozik M, Suarez V, Jensen C, Donahue L, DeGrosky M, Kozauer N, Coric V, Qureshi I, Kerr W, French J. A Modern Design for a Phase 2/3 Randomized, Double-blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BHV-7000 in Idiopathic Generalized Epilepsy with Generalized Tonic-Clonic Seizures (P8-9.016). Neurology 2025, 104 DOI: 10.1212/wnl.0000000000211240.Peer-Reviewed Original ResearchNirmatrelvir–ritonavir versus placebo–ritonavir in individuals with long COVID in the USA (PAX LC): a double-blind, randomised, placebo-controlled, phase 2, decentralised trial
Sawano M, Bhattacharjee B, Caraballo C, Khera R, Li S, Herrin J, Christian D, Coppi A, Warner F, Holub J, Henriquez Y, Johnson M, Goddard T, Rocco E, Hummel A, Mouslmani M, Hooper W, Putrino D, Carr K, Charnas L, De Jesus M, Nepert D, Abreu P, Ziegler F, Spertus J, Iwasaki A, Krumholz H. Nirmatrelvir–ritonavir versus placebo–ritonavir in individuals with long COVID in the USA (PAX LC): a double-blind, randomised, placebo-controlled, phase 2, decentralised trial. The Lancet Infectious Diseases 2025 PMID: 40188838, DOI: 10.1016/s1473-3099(25)00073-8.Peer-Reviewed Original ResearchPhysical health summary scoreBaseline to dayAdverse eventsNirmatrelvir-ritonavirSARS-CoV-2 infectionDouble-blindStudy drug-related treatment-emergent adverse eventsDrug-related treatment-emergent adverse eventsTreatment-emergent adverse eventsIntention-to-treat populationWeek 6Baseline to week 6Documented SARS-CoV-2 infectionActive liver diseaseEffective pharmacological interventionsLong COVIDAcute medical illnessSafety populationPatient-Reported Outcomes Measurement Information SystemEarly treatment terminationRenal impairmentTreat long-COVIDPlacebo-controlledEfficacy endpointRandomised controlled trialsUnderstanding eyebrow and eyelash involvement in patients with alopecia areata and responsiveness to treatment with baricitinib
Mostaghimi A, Craiglow B, King B, Shapiro J, Ko J, Tosti A, Ohyama M, Brogan Y, Yu G, Sontag A, Somani N. Understanding eyebrow and eyelash involvement in patients with alopecia areata and responsiveness to treatment with baricitinib. British Journal Of Dermatology 2025, ljaf088. PMID: 40179237, DOI: 10.1093/bjd/ljaf088.Peer-Reviewed Original ResearchBaricitinib 4 mgBaricitinib 2 mgHair-bearing sitesAlopecia areataResponse rateBenefit of baricitinibTreated with baricitinibRandomised to placeboPlacebo-controlled trialResponse to treatmentScalp hair lossSALT scoreDouble-blindClinical presentationBaricitinib treatmentTreatment successHair regrowthBaricitinibBaseline severityPatientsClinician reportsHair lossPlaceboPooled dataScalpQuinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial
Pellicer A, Taylor H, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta K, Pinton P, Heiser P, Bagger Y. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. European Journal Of Obstetrics & Gynecology And Reproductive Biology 2025, 310: 113946. PMID: 40188683, DOI: 10.1016/j.ejogrb.2025.113946.Peer-Reviewed Original ResearchConceptsDeep infiltrating endometriosisVaginal ringNo significant differenceLesion sizeBleeding patternsMenstrual cycleSignificant differenceImaging biomarkersSerum prolactin levelsPhase 2 trialMenstrual bleeding patternsEndpoint of reductionPatient-reported outcomesHigh-resolution MRIInfiltrating endometriosisPlacebo groupDouble-blindPlacebo-controlledAdvanced diseaseEndometriotic lesionsPrimary endpointPain reductionSecondary endpointsProlactin levelsAdverse eventsThe therapeutic effects of psychedelics for opioid use disorder: A systematic review of clinical studies
Weleff J, Pulido-Saavedra A, Aghaei A, Ing K, Arakelian M, Fontenele R, Nero N, Barnett B, Anand A, Bassir Nia A, Angarita G. The therapeutic effects of psychedelics for opioid use disorder: A systematic review of clinical studies. Psychiatry Research 2025, 348: 116446. PMID: 40147088, DOI: 10.1016/j.psychres.2025.116446.Peer-Reviewed Original ResearchOpioid use disorderStudies of psychedelicsSystematic review of clinical studiesUse disorderReview of clinical studiesTherapeutic effects of psychedelicsEffects of psychedelicsOpioid receptor systemApplications of psychedelicsClinical studiesMu-opioid receptorsNaturalistic studySerotonergic psychedelicsOpioid withdrawalPlacebo-controlled trialPsychedelicsSubstance useUnited States Food and Drug AdministrationStates Food and Drug AdministrationMu-opioidFood and Drug AdministrationSystematic reviewReceptor systemClinical study designDouble-blindA randomized, placebo-controlled, double-blind, pilot study of cannabis-related driving impairment assessed by driving simulator and self-report
Meda S, Stevens M, Boer E, Pittman B, Gueorguieva R, Huestis M, Pearlson G. A randomized, placebo-controlled, double-blind, pilot study of cannabis-related driving impairment assessed by driving simulator and self-report. Journal Of Psychopharmacology 2025, 39: 364-372. PMID: 40077985, DOI: 10.1177/02698811251324379.Peer-Reviewed Original ResearchConceptsCannabis-induced impairmentBlood THC levelsDouble-blindCannabis useVaporized cannabisTHC levelsActual impairmentAcute doseWithin-subjectSelf-reportSimulated driving testDrug effectsDriving impairmentPlacebo-controlledImpairment indicatorsImpairmentCannabisAssessment daysEffect of doseParticipants' willingnessPost-doseTHCBehavioral metricsCar-followingParticipantsOlezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial
Bergmark B, Marston N, Prohaska T, Alexander V, Zimerman A, Moura F, Kang Y, Murphy S, Zhang S, Lu M, Karwatowska-Prokopczuk E, Tsimikas S, Giugliano R, Sabatine M. Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial. American Heart Journal 2025, 286: 116-124. PMID: 40081744, PMCID: PMC12065083, DOI: 10.1016/j.ahj.2025.02.022.Peer-Reviewed Original ResearchMeSH KeywordsAgedApolipoprotein C-IIICardiovascular DiseasesClinical Trials, Phase III as TopicComputed Tomography AngiographyCoronary AngiographyDouble-Blind MethodFemaleHeart Disease Risk FactorsHumansHypertriglyceridemiaMaleMiddle AgedOligonucleotidesOligonucleotides, AntisenseRandomized Controlled Trials as TopicTriglyceridesConceptsCoronary computed tomography angiographyCardiovascular riskTriglyceride levelsModerate hypertriglyceridemiaBaseline coronary computed tomography angiographyPlacebo-controlled phase 3 trialClearance of triglyceride-rich lipoproteinsApoC-IIIBaseline triglyceride levelsBaseline to 6 monthsLipid-lowering therapyAntisense oligonucleotidesNoncalcified coronary plaquesPhase 3 trialComputed tomography angiographyLowering triglyceride levelsIncreased cardiovascular riskElevated cardiovascular riskReduce cardiovascular riskAtherosclerotic cardiovascular diseaseTriglyceride-rich lipoproteinsPotential therapeutic strategyPooled placeboApolipoprotein C-IIIDouble-blindThe Safety Profile of Pridopidine, a Novel Sigma-1 Receptor Agonist for the Treatment of Huntington’s Disease
Goldberg Y, Navon-Perry L, Cruz-Herranz A, Chen K, Hecker-Barth G, Spiegel K, Cohen Y, Niethammer M, Tan A, Schuring H, Geva M, Hayden M. The Safety Profile of Pridopidine, a Novel Sigma-1 Receptor Agonist for the Treatment of Huntington’s Disease. CNS Drugs 2025, 39: 485-498. PMID: 40055280, PMCID: PMC11982116, DOI: 10.1007/s40263-025-01171-x.Peer-Reviewed Original ResearchSafety profileAdverse eventsAntidopaminergic medicationsOpen-label extension studySigma-1Sigma-1 receptor agonistCytosine-adenine-guaninePlacebo-controlled studySpectrum of disease severityAnalysis of pooled dataTotal Functional CapacityFirst-in-classRecommended human doseSigma-1 receptorTreatment of Huntington's diseaseUnmet medical needLong-term useDouble-blindReceptor agonistsPridopidineHuman doseSafety signalsEffective treatmentPlaceboExtension studyPembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial
Petrylak D, Ratta R, Matsubara N, Korbenfeld E, Gafanov R, Mourey L, Todenhöfer T, Gurney H, Kramer G, Bergman A, Zalewski P, De Santis M, Armstrong A, Gerritsen W, Pachynski R, Byun S, Retz M, Levesque E, McDermott R, Bracarda S, Manneh R, Levartovsky M, Li X, Schloss C, Poehlein C, Fizazi K. Pembrolizumab Plus Docetaxel Versus Docetaxel for Previously Treated Metastatic Castration-Resistant Prostate Cancer: The Randomized, Double-Blind, Phase III KEYNOTE-921 Trial. Journal Of Clinical Oncology 2025, 43: 1638-1649. PMID: 40043230, PMCID: PMC12058370, DOI: 10.1200/jco-24-01283.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerTreat metastatic castration-resistant prostate cancerRadiographic progression-free survivalAndrogen receptor pathway inhibitorsCastration-resistant prostate cancerTreatment-related adverse eventsStandard of careAdverse eventsOverall survivalDouble-blindProstate cancerMedian radiographic progression-free survivalDual primary end pointsImmune-mediated adverse eventsEnd pointsBlinded independent central reviewData cutoff dateSafety of pembrolizumabAndrogen deprivation therapyProgression-free survivalIndependent central reviewSecondary end pointsPrimary end pointConcomitant prednisoneMedian OSA Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus
Peng X, Klingensmith G, Hsia D, Xie Y, Czerniak R, Tamborlane W, Shah A. A Randomized Phase 3 Study Evaluating the Efficacy and Safety of Alogliptin in Pediatric Participants with Type 2 Diabetes Mellitus. Diabetes Therapy 2025, 16: 865-883. PMID: 40032809, PMCID: PMC12006607, DOI: 10.1007/s13300-025-01700-3.Peer-Reviewed Original ResearchType 2 diabetes mellitusAlogliptin treatmentEfficacy endpointPediatric patientsAntihyperglycemic therapyOral dipeptidyl peptidase-4 inhibitorHbA1c levelsRandomized phase 3 studyDipeptidyl peptidase-4 inhibitorsSafety of alogliptinPlacebo-controlled trialPhase 3 studyBaseline to weekPeptidase-4 inhibitorsBody mass indexImprove glycemic controlDouble-blindPlacebo groupSecondary endpointsBackground metforminSchedule APharmacological therapyMass indexGlycosylated hemoglobinInsulin therapyImmunogenicity and reactogenicity of fractional vs. full booster doses of COVID-19 vaccines: a non-inferiority, randomised, double-blind, phase IV clinical trial in Brazil
Puga M, de Oliveira R, da Silva P, Charu V, Hedlin H, Lu D, Zhang A, Shaw B, Rosser J, Seidman J, Carter A, Qamar F, Luby S, Garrett D, Croda J. Immunogenicity and reactogenicity of fractional vs. full booster doses of COVID-19 vaccines: a non-inferiority, randomised, double-blind, phase IV clinical trial in Brazil. The Lancet Regional Health - Americas 2025, 44: 101031. PMID: 40083966, PMCID: PMC11904515, DOI: 10.1016/j.lana.2025.101031.Peer-Reviewed Original ResearchDose of BNT162b2Fractionated dosesNon-inferiorityNon-inferiority thresholdSeroresponse ratesDouble-blindBooster vaccinationAdverse eventsSystemic adverse eventsPhase IV clinical trialBaseline antibody levelsIV clinical trialDose of COVID-19 vaccineDose of vaccineNon-inferiority studyReduced side effectsAdministering booster vaccinationResource-limited settingsBinding IgG antibodiesImmunocompetent adultsStudy vaccineDose boosterTreatment armsParallel-groupBooster doseIn‐Hospital or Out‐of‐Hospital Initiation of Sacubitril/Valsartan Versus Valsartan in Patients With Mildly Reduced or Preserved Ejection Fraction After A Worsening Heart Failure Event: The PARAGLIDE‐HF Trial
Nouhravesh N, Cyr D, Hernandez A, Morrow D, Velazquez E, Ward J, Sarwat S, Sharma K, Williamson K, Starling R, Lepage S, Zieroth S, Solomon S, Mentz R. In‐Hospital or Out‐of‐Hospital Initiation of Sacubitril/Valsartan Versus Valsartan in Patients With Mildly Reduced or Preserved Ejection Fraction After A Worsening Heart Failure Event: The PARAGLIDE‐HF Trial. Journal Of The American Heart Association 2025, 14: e037899. PMID: 39968788, PMCID: PMC12132675, DOI: 10.1161/jaha.124.037899.Peer-Reviewed Original ResearchOut-of-hospitalWorsening renal functionSafety end pointNT-proBNP changesEjection fractionIn-hospitalNT-proBNPHeart failureRenal functionSymptomatic hypotensionTime-averaged proportional changeEnd pointsWorsening heart failure eventEffects of Sac/ValSacubitril/valsartan (sac/valWorsening HF eventsHeart failure eventsStatistically significant differenceWorsening HFDouble-blindHF hospitalizationSac/ValCardiovascular deathWeek 4HF events
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