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fluoxetine (EDG005)

✓ Approved

Edgemont Pharmaceuticals, LLC · SLC6A4 · Small Molecule

What is fluoxetine?

fluoxetine is a small molecule developed by Edgemont Pharmaceuticals, LLC. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesEDG005
CompanyEdgemont Pharmaceuticals, LLC
Drug ClassSmall Molecule
Molecular TargetSLC6A4
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Edgemont Pharmaceuticals, LLC

Mechanism of Action

Molecular Targets

fluoxetine acts on 1 molecular target:

SLC6A4solute carrier family 6 member 4 (5HTT, 5-HTT)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

fluoxetine is developed for 4 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Psychiatric disordersBulimia nervosa✓ Approved
Psychiatric disordersObsessive-compulsive disorder✓ Approved
Psychiatric disordersPanic disorder✓ Approved
Psychiatric disordersMajor depression✓ Approved

Related Research Articles

PubMedRevista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)2026-09-18

Brazilian Psychiatric Association Guidelines for the Treatment of Eating Disorders.

Appolinario Jose C JC, Nunes Maria Angélica A MAA, Mourilhe Carla C, Claudino Angelica A et al.

Eating disorders (ED), such as anorexia nervosa (AN), bulimia nervosa (BN), and binge eating disorder (BED), are serious psychiatric conditions that significantly impact psychological and medical health. This paper aims to summarize the recommendations of the Brazilian Association of Psychiatry - [Associação Brasileira de Psiquiatria (ABP)] for the treatment of EDs, based on the latest available evidence. Systematic reviews focused on the multidisciplinary treatment of ED were conducted. Findings were evaluated based on evidence strength, and recommendations using the evidence-based methodology of the Oxford Centre for Evidence-Based Medicine, finalized by an expert panel consensus. A summary of the recommendations and their corresponding levels of evidence was produced. Overall, the management of AN should use the least restrictive setting, combining monitored nutritional rehabilitation with psychotherapy. Pharmacotherapy plays a limited role in selected cases. BN is typically managed in an outpatient setting, focusing on structured nutritional care and CBT-based treatment, with pharmacotherapy adjunctive, preferably fluoxetine. BED is treated in an outpatient setting with structured care and CBT, with lisdexamfetamine as the preferred pharmacotherapy when needed. These guidelines represent a significant advancement in managing eating disorders in Brazil, providing a structured framework for clinical care while also supporting the development of future public mental health policies.

PMID 42758807
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PubMedFrontiers in child and adolescent psychiatry2026-09-18

Acceptability and feasibility of the Ushirikiano treatment model for Kenyan adolescents: a pilot randomized controlled trial.

Ali Nabila Amin NA, Mwavua Shillah Mwaniga SM, Yator Obadia O, Kathono Joseph J et al.

Adolescents in low- and middle-income countries experience high rates of common mental disorders (CMDs) but have limited access to adolescent-friendly, evidence-based care. While Interpersonal Psychotherapy for Adolescents (IPT-A) is effective, brief group IPT-A delivered through task-shifted, stepped-care has not been rigorously evaluated in Kenyan primary care. We conducted a pilot randomized controlled trial to examine the acceptability, feasibility, and preliminary effectiveness of the Ushirikiano treatment model, a task-shifted, stepped-care approach combining a brief (four-session) group IPT-A (IPT-G-A) delivered by community health promoters, with fluoxetine for severe cases where indicated. Adolescents aged 12-18 years with DSM-5 TR depression, anxiety, and/or somatic symptom disorder (N = 32) were randomized to the Ushirikiano Model or enhanced treatment as usual (eTAU). Quantitative and qualitative data were collected at baseline, post-treatment, and at follow-up at months 1 and 2. The COM-B framework informed the assessment of behavior change. All adolescents in the intervention arm were retained compared with 69% in eTAU. Intervention fidelity ranged from moderate to high and showed improvement with supervision. Participants found the intervention acceptable, relevant, and supportive, and reported applying IPT-G-A skills to handle interpersonal and school-related stressors. Community health promoters reported increased confidence with blended training and ongoing supervision. Preliminary outcomes trends suggested potential reductions in depressive symptoms and modest functional improvement in the Ushirikiano arm, with most participants achieving symptomatic remission at the month 2 follow-up. As a pilot study, these findings provide preliminary evidence of potential benefit and support further evaluation of the intervention in a fully powered trial. The Ushirikiano treatment model appears acceptable and feasible for addressing adolescent depression in Kenyan primary care. While preliminary findings suggest the potential for improvements in depressive symptoms and functioning, the study was not designed to establish effectiveness and did not assess for anxiety and somatic symptom disorder. These findings support further evaluation in fully powered trials to determine clinical effectiveness for CMDs, cost-effectiveness, and optimal implementation strategies. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=33227, Pan African Clinical Trial Registry, PACTR202503728947243.

PMID 42756521
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PubMedFrontiers in microbiology2026-09-18

Sishen wan modulates gut microbial and short-chain fatty-acid imbalances and ameliorates behavioral and inflammatory abnormalities in mice with chronic sleep deprivation.

Jiao Yu Y, Zhao Yichun Y, Zhang Zhongqiang Z, Sun Hui H et al.

Chronic sleep deprivation (CSD) disrupts mood-related behavior, gut microbial ecology, and inflammatory homeostasis. Sishen Wan (SSW), a medicinal plant formula used clinically for chronic diarrhea, has shown microbiota- and inflammation-modulating effects in colitis models, but its protective effects under sleep-deprivation conditions remain unclear. The chemical profile of SSW was characterized by ultra-performance liquid chromatography-quadrupole time-of-flight mass spectrometry. Male C57BL/6 J mice underwent CSD using a modified multiple-platform method and received three doses of SSW or fluoxetine. Behavioral performance, histopathology, gut microbiota composition, and short-chain fatty acid (SCFA) concentrations in feces, serum, and hippocampal tissue were assessed. Fecal material from Control, Model, and high-dose SSW (SSW-H) donors was transplanted into antibiotic-pretreated recipients. Serum untargeted metabolomics, hippocampal transcriptomics, RT-qPCR, and resting-state functional magnetic resonance imaging were used to characterize metabolic, transcriptional, and brain-function changes. CSD reduced sucrose preference and open-field activity, prolonged immobility in the tail-suspension and forced-swim tests, aggravated colonic and hippocampal injury, and increased pro-inflammatory cytokines. SSW-H produced the most consistent improvements. CSD also reduced gut microbial richness and diversity, altered community composition, and lowered fecal acetate, propionate, and butyrate and serum acetate. SSW-H shifted the community toward the Control profile, increased Akkermansia, reduced several Model-enriched taxa, and increased major fecal SCFAs and serum acetate. Recipients of Model-donor feces developed reduced sucrose preference and activity, prolonged immobility, and colonic and hippocampal abnormalities. In contrast, recipients of SSW-H-donor feces showed milder behavioral and histological changes and a microbial profile distinct from that of FMT-Model recipients. SSW-H was also associated with partial normalization of lipid-, amino-acid-, and one-carbon-metabolism-related serum features, modulation of hippocampal immune pathways involving chemokines, cytokines, and NF-κB signaling, and attenuation of several CSD-associated regional brain abnormalities. SSW alleviated CSD-associated behavioral abnormalities, tissue injury, and inflammation, with the high dose showing the most consistent effects. These improvements were accompanied by changes in gut microbial composition and SCFA profiles.

PMID 42756370
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PubMedScience (New York, N.Y.)2026-09-17

Transcriptome-based classification in mice with ASD-risk mutations.

Roh Junyeop Daniel JD, Jun Yukyung Y, Jeon Heesu H, Kim Junyoung J et al.

Autism spectrum disorder (ASD) is a neurodevelopmental condition with a strong genetic component. Large-scale human genetic studies have identified >1200 ASD-risk genes. We report a sex-balanced atlas of 1008 prefrontal RNA sequencing (RNA-seq) profiles from 17 mouse lines carrying ASD-risk mutations. Our analysis identified two opposing transcriptomic states. The two groups differed in sex bias, regional specificity, developmental stability, cell type remodeling, and responses to fluoxetine and lithium. Single-nucleus RNA-seq revealed broader cell type remodeling in group 1 than in group 2, and cell type-specific modules showed reciprocal associations that mirrored bulk transcriptomic signatures. The framework classifies independent mouse lines and identifies subgroups with conserved synaptic directionality, supporting molecular stratification.

PMID 42752124
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PubMedCurrent opinion in pharmacology2026-09-17

Pharmacological insights into fluvoxamine maleate: σ1 receptor agonism, multimodal mechanisms, and therapeutic repositioning.

Sharma Chirag C, Sharma Sheenam S, Chaudhary Rishabh R, Kumar Satish S et al.

Fluvoxamine maleate (FM) is a selective serotonin reuptake inhibitor (SSRI) that has attracted increased attention owing to its strong agonistic activity at the sigma 1 receptor (σ1R). This review consolidates the current understanding of its processes highlighting σ1R-mediated chaperone activity in the endoplasmic reticulum (ER), which alleviates protein misfolding, ER stress, and neuroinflammation in mental and neurological illnesses. Fluvoxamine demonstrates one of the highest affinities for σ1R among SSRIs, exceeding those of sertraline and fluoxetine, via dissociating σ1R from BiP chaperones to improve protein refolding and cellular resilience. Preclinical experiments illustrate its inhibition of unfolded protein response indicators, reinstatement of glutamatergic transmission, and stimulation of parvalbumin interneurons, resulting in antipsychotic-like effects in schizophrenia and neuroprotection against ketamine-induced impairments. In addition to serotonin reuptake inhibition, fluvoxamine influences inflammation, apoptosis, and extracellular matrix dynamics. Supplementary activities include advantages against tardive dyskinesia and cognitive improvement in depression by mitigating stress induced neuronal atrophy. Repurposing initiatives underscore fluvoxamine's potential beyond obsessive compulsive disorder (OCD) and depression. σ1R agonism is fundamental to its effectiveness in disorders caused by ER stress, such as schizophrenia and tardive dyskinesia, and in neuropsychiatric sequelae associated with protracted COVID. Clinical translation encounters obstacles in dose optimization and σ1R selectivity; yet, current studies highlight its multimodal efficacy in neurodegeneration, fibrosis, and psychopharmacology.

PMID 42753377
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PubMedChemosphere2026-09-16

Design of a sodium polyacrylate/carboxymethyl-chitosan-based imprinted cryogel for fluoxetine adsorption in continuous mode.

Nkana Gilbert Romeo Nkana GRN, Eesaee Mostafa M, Chabot Bruno B, Nguyen Tri Phuong P

Fluoxetine (FLX) contamination in aquatic environments poses significant ecological risks, highlighting the need for efficient and selective removal technologies. In this study, a bio-based macroporous molecularly imprinted cryogel (MIC/NaPA-CMCs) was developed for continuous-flow FLX adsorption. The cryogel was synthesized from sodium polyacrylate and carboxymethyl chitosan by cryopolymerization at -18 °C for 24 h using genipin and N,N'-methylenebis(acrylamide) as crosslinkers, with FLX as the template molecule. Template removal using an acidified solvent (5 % methanol/0.1 M HCl, 1:1 v/v) generated selective recognition cavities, while a non-imprinted cryogel (NIC/NaPA-CMCs) was prepared for comparison. The materials were characterized by Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), confocal laser scanning microscopy (CLSM), Brunauer-Emmett-Teller (BET) analysis, and point-of-zero-charge (pHPZC) determination. MIC/NaPA-CMCs exhibited a pHPZC of 4.9 and a specific surface area of 36.8 m2/g. Fixed-bed adsorption experiments (pH 8.5, bed height 0.4 cm, 20 ± 2 °C) showed that increasing the FLX inlet concentration (10-40 mg/L) accelerated bed saturation and shifted breakthrough to shorter times, whereas increasing the flow rate (1.5-2.5 mL/min) reduced residence time, decreasing the adsorption capacity from 22.05 to 6.61 mg/g. The Thomas and Yoon-Nelson models accurately described the breakthrough curves (R2 > 0.990), indicating that adsorption performance was governed by mass-transfer limitations under dynamic conditions. Competitive adsorption with citalopram confirmed the selective recognition of FLX by MIC/NaPA-CMCs, yielding higher FLX uptake and a relative selectivity coefficient (K' > 1) than the non-imprinted cryogel. These results demonstrate the potential of the developed imprinted cryogel for selective FLX removal under continuous-flow conditions.

PMID 42748788
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