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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

PubMedBehavioural brain research2026-07-17

LPS‑induced impairment of neuroregeneration is alleviated by fluoxetine in Dugesia japonica.

Yuan Zuoqing Z, Huang Jinying J, Chen Qi Q, Sun Jingyi J et al.

Freshwater planarians (Dugesia japonica) are excellent models for neural regeneration due to their neoblast-dependent regenerative capacity. This study explored the regulatory effects of fluoxetine (FLX) on lipopolysaccharide (LPS)-triggered neuroinflammation as well as cyclosporin A (CsA)-mediated mitophagy inhibition during the regeneration of Dugesia japonica. Planarians were exposed to LPS, FLX, and CsA alone or in combination for 10 days, with assessments of regeneration, locomotion, antioxidant function, DNA damage, neoblast proliferation, apoptosis, and PINK1/Parkin pathway activity. Results showed LPS (10 μg/mL) and CsA (0.5 μg/mL) significantly impaired eyespot regeneration and locomotion, disrupted antioxidant enzyme (SOD, CAT, GST, GR) activity/expression, induced DNA damage, suppressed neoblast proliferation, disturbed neurotransmitter-related gene expression, and reduced the level of LC3B, a key protein in the PINK1/Parkin pathway. FLX (2 μg/mL) alleviated these adverse effects by restoring antioxidant balance, mitigating DNA damage, promoting proliferation, potentially associated with the activation of PINK1/Parkin-related mitophagy, and normalizing neurotransmitter synthesis-related genes. Notably, CsA reversed FLX's neuroprotective effects, implying FLX-mediated protection against LPS toxicity may be linked to the PINK1/Parkin-associated mitophagy pathway. This study validates FLX's neuroprotective potential, reinforces D. japonica as a model for mitophagy-related neuroregeneration, and provides preliminary insights for FLX's application in neurological disorders with impaired mitophagy and neuroregeneration.

PMID 42463029
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PubMedThe British journal of psychiatry : the journal of mental science2026-07-17

Understanding antidepressant change patterns in the UK Biobank.

Li Danyang D, Lo Chris Wai Hang CWH, Lewis Cathryn M CM, Vassos Evangelos E et al.

Antidepressants are the most frequently prescribed medications in psychiatry. Medical records of thousands of individuals provide a valuable opportunity to explore prescribing patterns and identify factors that influence treatment outcomes. To investigate antidepressant change patterns in depression and non-depression indications and assess clinical and genetic factors associated with outcomes of antidepressant treatment. Using primary care records from the UK Biobank, we examined outcomes including number of antidepressant changes and discontinuation due to either side-effects or inadequate response. Genetic analyses including heritability estimation, genetic correlation and polygenic score association were performed. A total of 82 633 individuals were prescribed at least 1 antidepressant. Of these, 28 332 individuals with at least 1 primary care depression diagnosis were classified as the depression group, and 24 543 individuals without evidence of depression were classified as the non-depression group. Citalopram and fluoxetine were the most prescribed antidepressants for depression, whereas amitriptyline dominated prescriptions for non-depression indications. Individuals with depression were more likely to stay on antidepressants longer than those without depression and to follow preferred antidepressants that changed over time. Antidepressant changes and discontinuation were associated with a range of psychiatric and somatic conditions, including recurrent depression (early discontinuation: odds ratio = 1.96; late discontinuation: odds ratio = 2.63) and anxiety (early discontinuation: odds ratio = 1.37; late discontinuation: odds ratio = 1.99) in the depression group, and pain-related conditions in the non-depression group. Genetic analyses identified two novel variants associated with early discontinuation of selective serotonin reuptake inhibitors. Notable genetic overlap was shown between these outcomes and multiple psychiatric and physical traits, including the number of antidepressant changes with anxiety and depression (rg = 0.81-0.83), and polygenic scores for depression and attention-deficit hyperactivity disorder showed significant predictive value with respect to treatment outcomes. These findings characterise antidepressant change patterns in primary care records and highlight the potential value of integrating clinical and genetic data to better understand factors associated with treatment outcomes.

PMID 42464625
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PubMedJournal of affective disorders2026-07-16

Treatment-related associations of nucleus accumbens connectivity within mesocorticolimbic circuits in depression.

Li Hong H, Wang Junjie J, Li Junxia J, Pan Jie J et al.

Pharmacological treatment remains a mainstay in managing depression, yet the neural correlates associated with treatment response remain incompletely understood. This study used multimodal neuroimaging to examine nucleus accumbens (NAc)-centered structural and functional alterations associated with fluoxetine and Shugan Jieyu Capsule (SG), a traditional Chinese medicine, in patients with mild-to-moderate depression (MMD). Sixty patients were randomized to an 8-week course of fluoxetine or SG. Depression severity was assessed using the 24-item Hamilton Depression Rating Scale (HAMD-24), and structural and functional MRI scans were acquired at baseline and endpoint. Both treatments were associated with significant symptom improvement. Neuroimaging analyses revealed structural and functional alterations involving the NAc. Changes in NAc-amygdala connectivity showed an exploratory association with symptom improvement in the SG group, whereas changes in NAc-rostral anterior cingulate cortex connectivity were associated with symptom improvement in the fluoxetine group and remained significant after correction for multiple comparisons. In addition, remitters exhibited stronger baseline connectivity between the NAc and ventral tegmental area and between the NAc and middle frontal gyrus compared with non-remitters. These findings suggest that NAc-centered connectivity may be relevant to treatment-related neural changes in depression and may inform future research on imaging-based candidate markers of treatment response and personalized treatment approaches. TRIAL REGISTRATION: The study is registered in https://www.chictr.org.cn/ with a registration number ChiCTR1900024988 (date: 08.06.2019).

PMID 42456817
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PubMedProgress in neuro-psychopharmacology & biological psychiatry2026-07-16

Working memory deficits and altered prefrontal-hippocampal activation in p35 knockout mice with ADHD-like phenotypes: influence of sex and acute monoaminergic treatments.

Dadam Florencia F, Basmadjian Osvaldo Martín OM, Berardo Gimena G, Haehnel Franco Adrián FA et al.

Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental condition characterized by persistent deficits in working memory (WM) and executive control. Dysregulation of the Cyclin-dependent kinase 5 (Cdk5)/p35 signaling pathway has been implicated in ADHD pathophysiology due to its impact on neuronal connectivity and dopamine regulation. Using p35 knockout (p35KO) mice-an animal model exhibiting ADHD-like phenotypes-we investigated WM performance, task-related c-Fos immunoreactivity (c-Fos-IR) expression under basal conditions as a function of sex and genotype, as well as WM responses to acute treatment with methylphenidate (MPH) or fluoxetine (FLX), administered alone or in combination. Under basal conditions, p35KO mice exhibited significantly reduced spontaneous alternation in the Y-maze test compared with wild type (WT), whereas recognition memory remained intact. Analysis of c-Fos-IR expression, used as a marker of task-related neuronal activity, revealed region- and genotype-dependent differences, with effects of sex. p35KO animals showed reduced c-Fos-IR expression in prefrontal cortical regions and increased expression in hippocampal regions. In the prefrontal cortex, males generally displayed higher c-Fos-IR expression than females, whereas hippocampal increases were evident in p35KO mice of both sexes, with a female-specific increase in the dentate gyrus. Acute MPH or FLX treatment significantly increased spontaneous alternation in p35KO mice in a genotype-dependent manner, whereas this effect was not observed following combined treatment (MPH + FLX). In WT mice, treatment with MPH, FLX, or MPH + FLX reduced spontaneous alternation; this reduction appeared more pronounced in females, although no significant interaction involving sex was detected. Exploratory activity was increased in p35KO mice independently of treatment. These findings support a role for Cdk5/p35 signaling in the prefrontal-hippocampal activation patterns associated with WM performance and suggest that cognitive and pharmacological responses to monoaminergic treatments are shaped by neurobiological background, with potential sex-related differences, underscoring the importance of considering these factors in preclinical ADHD research.

PMID 42457071
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PubMedJournal of veterinary pharmacology and therapeutics2026-07-15

Concurrent Use of Tasipimidine Oral Solution and Fluoxetine in Dogs.

Lindstedt Jenni J, Levijoki Jouko M JM, Tuunainen Johanna J, Häggström Jens J et al.

This exploratory randomized crossover study investigated pharmacokinetic interactions, functional alertness, and cardiovascular safety of tasipimidine oral solution administered alone and in combination with fluoxetine in healthy Beagle dogs (n = 8; 4 dogs per dose level), with a 7-day washout between phases. Dogs received single oral doses of tasipimidine (20 or 30 μg/kg) alone and following single or repeated fluoxetine administration (~1 mg/kg/day for 12 days). Functional alertness was assessed using a semi-quantitative, observer-based scale evaluating responsiveness and ability to walk. Cardiovascular effects were monitored by telemetry, including heart rate, blood pressure, and ECG. Co-administration with fluoxetine increased tasipimidine exposure, with Cmax and AUC0-24h rising approximately 1.3-1.4-fold after single fluoxetine dosing and up to 1.4-fold at the 30 μg/kg tasipimidine dose after repeated fluoxetine administration; these changes were variable and not consistently statistically significant. Reduced alertness and transient mild ataxia were more frequent at 30 μg/kg, whereas the 20 μg/kg dose showed minimal sedative effects. Tasipimidine reduced heart rate by 30-52 bpm and mean arterial pressure by 13-21 mmHg. No clinically relevant ECG abnormalities were detected. The increased tasipimidine exposure is likely related to metabolic inhibition by fluoxetine. Overall, concurrent use was well tolerated, supporting a reduced tasipimidine dose (20 μg/kg) when combined with fluoxetine.

PMID 42454745
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PubMedInternational journal of molecular sciences2026-07-15

Skin on Drugs: Psychotropic Compounds in Cutaneous Biology.

Fernández-Guarino Montserrat M, Yagüe-Septién Nicolás N, Marín-Ochoa Laura L, Hernández Bule María Luisa ML et al.

Recent evidence reveals that several psychotropic compounds exert significant biological effects on the skin through neurochemical and immunomodulatory pathways. Cannabinoids such as tetrahydrocannabinol (THC) show potent anti-inflammatory, antipruritic, and anti-aging properties when applied topically, and may hold therapeutic potential. Antidepressants, particularly fluoxetine (Prozac), have been shown to regulate the expression of pro-inflammatory cytokines in keratinocytes, suggesting benefits applied in allergic pathologies. Additionally, fluoxetine promotes wound healing and cell regeneration, indicating broader dermatological applications. Psychedelics, acting as serotonin receptor agonists (5-HTR), may influence cellular aging and immune modulation via the serotonergic system. Studies report that 5-HT receptor agonists can prevent UV-induced photocarcinogenesis, while psilocybin has been observed to reduce aging markers in human fibroblasts. Furthermore, recent data suggests that psilocin may alleviate acute itch involving the kynurenine pathway. These findings highlight the emerging relevance of psychoactive compounds in cutaneous biology, bridging neuropharmacology and dermatology toward novel therapeutic strategies.

PMID 42450081
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