The Role of Sildenafil in Pulmonary Arterial Hypertension

∙ Werner, M.

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Molecularly distinct routes of mitochondrial Ca2+ uptake are activated depending on the activity of the sarco/endoplasmic reticulum Ca2+ ATPase (SERCA) Impact of Mitochondrial Ca2+-Sensitive Potassium (mBKCa) Channels in Sildenafil-Induced Cardioprotection in Rats Ca2+-activated K+ (KCa) channels are involved in the relaxations elicited by sildenafil in penile resistance arteries Checchetto, V. ∙ Leanza, L. ∙ De Stefani, D. .. Mitochondrial K+ channels and their implications for disease mechanisms Loss of the large conductance calcium-activated potassium channel causes an increase in mitochondrial reactive oxygen species in glioblastoma cells High-content analysis of neuronal morphology in human iPSC-derived neurons Local and long-range reciprocal regulation of cAMP and cGMP in axon/dendrite formation Regulate axon branching by the cyclic GMP pathway via inhibition of glycogen synthase kinase 3 in dorsal root ganglion sensory neurons Involvement of cyclic GMP and protein kinase G in the regulation of apoptosis and survival in neural cells Modulation of synaptic function by cGMP and cGMP-gated cation channels Schmidt, H. ∙ Heppenstall, P.A... cGMP-mediated signaling via cGKIalpha is required for the guidance and connectivity of sensory axons Metabolic rescue ameliorates mitochondrial encephalo-cardiomyopathy in murine and human iPSC models of Leigh syndrome Microglial response promotes neurodegeneration

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in the Ndufs4 KO mouse model of Leigh syndrome Activated microglia and neuroinflammation as a pathogenic mechanism in Leigh syndrome Human iPSC-Derived Blood-Brain Barrier Models: Valuable Tools for Preclinical Drug Discovery and Development?

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A scale to monitor progression and treatment of mitochondrial disease in children Schaefer, A.M.

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Increased longevity and refractoriness to Ca(2+)-dependent neurodegeneration in Surf1 knockout mice Tissue- and species-specific differences in cytochrome c oxidase assembly induced by SURF1 defects Complex I deficiency due to loss of Ndufs4 in the brain results in progressive encephalopathy resembling Leigh syndrome Ndufs4 knockout mouse models of Leigh syndrome: pathophysiology and intervention EPI-743 reverses the progression of the pediatric mitochondrial disease--genetically defined Leigh Syndrome Evaluating the efficacy of vatiquinone in preclinical models of Leigh syndrome and GPX4 deficiency de Haas, R. ∙ Das, D. ∙ Garanto, A... Cannabidiol ameliorates mitochondrial disease via PPARgamma activation in preclinical models Hypoxia as a therapy for mitochondrial disease HypoxyStat, a small-molecule form of hypoxia therapy that increases oxygen-hemoglobin affinity Modeling mitochondrial DNA diseases: from base editing to pluripotent stem-cell-derived organoids Defective metabolic programming impairs early neuronal morphogenesis in neural cultures and an organoid model of Leigh syndrome Galera-Monge, T. ∙ Zurita-Díaz, F.

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∙ Canals, I... Deep learning-driven neuromorphogenesis screenings identify repurposable drugs for mitochondrial disease High-content screening of mitochondrial polarization in neural cells derived from human pluripotent stem cells Sildenafil: from angina to erectile dysfunction to pulmonary hypertension and beyond Generation of two mother-child pairs of iPSCs from maternally inherited Leigh syndrome patients with m.8993 T > G and m.9176 T > G MT-ATP6 mutations Generation of four iPSC lines from four patients with Leigh syndrome carrying homoplasmic mutations m.8993T > G or m.8993T > C in the mitochondrial gene MT-ATP6 RNA-based generation of iPSCs from a boy carrying the mutation m.9185 T>C in the mitochondrial gene MT-ATP6 and from his healthy mother Haschke, A.M. ∙ Diecke, S. ∙ Schuelke, M. Characterization of two iPSC lines from patients with maternally inherited leigh (MILS) and neuropathy, ataxia, and retinitis pigmentosa (NARP) syndrome carrying the MT-ATP6 m.8993 T>G mutation at different degrees of heteroplasmy The Drug Repurposing Hub: a next-generation drug library and information resource A Simple Statistical Parameter for Use in Evaluation and Validation of High Throughput Screening Assays Clinical Efficacy and Safety of Different Doses of Sildenafil in the Treatment of Persistent Pulmonary Hypertension of the Newborn: A Network Meta-analysis Barst, R.J. ∙ Phoenix, C.

Side Effect	Severity	Notes
Headache	Common	Usually mild
Flushing	Common	Transient
Dizziness	Common	Particularly when standing up quickly
Vision disturbances	Less common	Temporary, includes blue tint or blurred vision
Priapism	Rare	Needs urgent medical attention

∙ Elson, J.L...

Country/Region	Approval Status	Regulatory Body
United States	Approved for ED, PAH	FDA
European Union	Approved, generic available	EMA
India	Approved, widely available	CDSCO
Canada	Approved	Health Canada

Mitochondrial disease in adults: a scale to monitor progression and treatment Natural History of Leigh Syndrome: A Study of Disease Burden and Progression Natural History of Patients With Mitochondrial ATPase Deficiency Due to Pathogenic Variants of MT-ATP6

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∙ Beghetti, M. ∙ Pulido, T. ..., STARTS-2 Investigators STARTS-2: long-term survival with oral sildenafil monotherapy in treatment-naive pediatric pulmonary arterial hypertension A randomized, double-blind, placebo-controlled, dose-ranging study of oral sildenafil citrate in treatment-naive children with pulmonary arterial hypertension An open-label study to evaluate sildenafil for the treatment of lymphatic malformations Expanding the molecular and phenotypic spectrum of truncating MT-ATP6 mutations Subcomplexes of human ATP synthase mark mitochondrial biosynthesis disorders Kenvin, S. ∙ Torregrosa-Muñumer, R. ∙ Reidelbach, M.

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.. Threshold of heteroplasmic truncating MT-ATP6 mutation in reprogramming, Notch hyperactivation and motor neuron metabolism MICOS assembly controls mitochondrial inner membrane remodeling and crista junction redistribution to mediate cristae formation Li, C. ∙ Enomoto, M. ∙ Rossi, A.M. .. and MT-ATP8 Safety of sildenafil citrate: review sildenafil 45 mg chewable tablets of 67 double-blind placebo-controlled trials and

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When possible, data are presented as scatter plots with individual data points showing all individual measurements. Unless otherwise indicated, we expressed the data as mean and standard deviation (mean ± SD). Experiments were repeated in independent biological experiments. Information on statistical details and number of replicates can be found in the respective figure legends. A guide to diagnosis and treatment of Leigh syndrome McCormick, E.M.

Patient resources

∙ Keller, K. ∙ Taylor, J.P., NICHD ClinGen U24 Mitochondrial Disease Gene Curation Expert Panel .. Expert Panel Curation of 113 Primary Mitochondrial Disease Genes for the Leigh Syndrome Spectrum Mitochondrial DNA-Associated Leigh Syndrome and NARP Mutations of SURF-1 in Leigh disease associated with cytochrome c oxidase deficiency A nonsense mutation in the NDUFS4 gene encoding the 18 kDa (AQDQ) subunit of complex I abolishes assembly and activity of the complex in a patient with Leigh-like syndrome Drug Development for the Therapy of Mitochondrial Diseases Disease models of Leigh syndrome: From yeast to organoids Mitochondrial Genome Engineering: The Revolution May Not Be CRISPR-Ized SURF1 knockout cloned pigs: Early onset of a severe lethal phenotype Dell’agnello, C. ∙ Leo, S. ∙ Agostino, A... the postmarketing safety database The Role of Sildenafil in Treating Brain Injuries in Adults and Neonates Endophenotype-based in silico

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∙ Ooi, L. ∙ Sluyter, R. The P2X4 Receptor: Cellular and Molecular Characteristics of a Promising Neuroinflammatory Target The SLC37 family of sugar-phosphate/phosphate exchangers Generation of Human Brain Organoids for Mitochondrial Disease Modeling Generation of human striatal organoids and cortico-striatal assembloids from human pluripotent stem cells WDR45, one gene associated with multiple neurodevelopmental disorders Klim, J.R. ∙ Williams, L.A. ∙ Limone, F.

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.. ALS-implicated protein TDP-43 sustains levels of STMN2, a mediator of motor neuron growth and repair RGS6 interacts with SCG10 and promotes neuronal differentiation. Role of the G gamma subunit-like (GGL) domain of RGS6 An integrated transcriptomic cell atlas of human neural organoids Petersilie, L. ∙ Heiduschka, S. ∙ Nelson, J.S.E... network medicine discovery combined with insurance record data mining identifies sildenafil as a candidate drug for Alzheimer’s disease Phosphodiesterase

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Inhibitors for Alzheimer’s Disease: A Systematic Review of Clinical Trials and Epidemiology with a Mechanistic Rationale Regulation of hippocampal

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Hoxa5: A Key Player in Development and Disease Sustained Hox5 gene activity is required for respiratory motor neuron development Dbx1 triggers crucial molecular programs required for midline crossing by midbrain commissural axons Eichholtz-Wirth, H. ∙ Fritz, E. ∙ Wolz, L. Overexpression of the ‘silencer of death domain’, SODD/BAG-4, modulates both TNFR1- and CD95-dependent cell death pathways Lisowski, P. ∙ Lickfett, S.

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∙ Rybak-Wolf, A... Mutant huntingtin impairs neurodevelopment in human brain organoids through CHCHD2-mediated neurometabolic failure cGMP-dependent protein kinases and cGMP phosphodiesterases in nitric oxide and cGMP action Andrieu, G. ∙ Tran, A.H. ∙ Strissel, K.J... BRD4 Regulates Breast Cancer Dissemination through Jagged1/Notch1 Signaling Bromodomain protein 4 mediates the roles of TGFβ1-induced Stat3 signaling in mouse liver fibrogenesis Neuregulin 1: an intriguing therapeutic target for neurodevelopmental disorders Sophocleous, R.A. cGMP sildenafil from canada levels as a candidate to treat cognitive deficits in Huntington’s disease Sildenafil protects against

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Cortical brain organoid slices (cBOS) for the study of human neural cells in minimal networks Interplay Between Intracellular Ca(2+) Oscillations and Ca(2+)-stimulated Mitochondrial Metabolism Impaired mitochondrial function due to familial Alzheimer’s disease-causing presenilins mutants via Ca(2+) disruptions The gain-of-function enhancement of IP3-receptor channel gating by familial Alzheimer’s disease-linked presenilin mutants increases the open probability of mitochondrial permeability transition pore Intracellular Injection of Brain Extracts from Alzheimer’s Disease Patients Triggers Unregulated Ca2+ Release from Intracellular Stores That Hinders Cellular Bioenergetics D’Angelo, D. ∙ Sánchez-Vázquez, V.H. Dependence of mitochondrial calcium signalling and dynamics on the disaggregase, CLPB Waldeck-Weiermair, M. ∙ Deak, A.T. ∙ Groschner, L.N... 3-nitropropionic acid neurotoxicity through the modulation of calpain, CREB, and BDNF Resurrection of sildenafil: potential for Huntington’s Disease, too?

Parameter	Description	Typical Value
Bioavailability	Percent absorbed into bloodstream	~40%
Tmax (time to peak)	Time to reach maximum plasma concentration	30-120 minutes
Half-life	Duration of drug activity	4-5 hours
Metabolism	Main route	Liver (CYP3A4 enzyme)
Excretion	How the drug leaves the body	Mainly feces, some urine