Priligy (dapoxetine) / AbbVie - LARVOL DELTA

Comparative evaluation of safety and efficacy of dapoxetine, silodosin, and citalopram in the management of premature ejaculation: a randomized clinical trial. (PubMed, BMC Urol) - P4 | "In this direct head-to-head comparison of active treatments for lifelong PE, daily citalopram (20 mg) demonstrated superior efficacy in prolonging IELT and improving psychosocial outcomes compared to daily or on-demand dapoxetine and silodosin. The findings suggest that citalopram is a highly effective first-line option, while the dose-dependent efficacy of dapoxetine and the distinct side-effect profile of silodosin provide alternative considerations for personalized treatment strategies."

Clinical • Journal • Sexual Disorders

Combined chiral-achiral supercritical fluid chromatography method for the impurity analysis of dapoxetine reveals insights in entropy-driven retention and acid-modulated selectivity. (PubMed, J Chromatogr A) - "The neutral complexes impact retention depending on the amine substitution pattern and may suppress polar and enhance hydrophobic interactions. These results underscore the potential application of combined additive systems to enhance SFC applications in the field of ionizable analytes."

Journal

Enantiodivergent Rh-Catalyzed Reductive Hydroformylation of Alkenyl Boronic Esters. (PubMed, Angew Chem Int Ed Engl) - "The chiral γ-boryl alcohol or diol products are versatile building blocks applicable to the synthesis of a series of APIs including (S)-tolterodine, (S)-dapoxetine, and (R)-atomaxetine. DFT calculation has revealed the origin of enantiodivergence of Rh-catalyzed reductive AHF of alkenyl boronic esters with Ph-BPE as the chiral ligand. The transformation is promised to provide great synthetic potential in both academia and industry."

Journal

Frequency-Dependent Effects of Repetitive Transcranial Magnetic Stimulation on Sexual Behavior Parameters in Premature Ejaculation Rodent Models. (PubMed, Andrology) - "rTMS exhibited frequency-dependent therapeutic efficacy in rapid ejaculation rat models, with high-frequency protocols demonstrating superior benefits compared with low-frequency interventions. These effects are mediated through activation of the BDNF-TrkB pathway and enhanced serotonergic signaling, suggesting high-frequency rTMS as a promising non-pharmacological therapy for PE."

Journal • Preclinical • Sexual Disorders

Study on the efficacy and safety of rTMS combined with dapoxetine hydrochloride in the treatment of premature ejaculation (ChiCTR) - P=N/A | N=90 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Anhui Medical University

New trial • Sexual Disorders

Amine-Borane-Promoted Rhodium-Catalyzed Asymmetric Transfer Hydrogenation of β-Chloro Ketones. (PubMed, Org Lett) - "A broad range of substrates was reduced in up to 99% yield and >99% ee, with gram-scale reactions completed within 1 h. The resulting 3-chloroalkanols serve as versatile intermediates for the synthesis of pharmaceuticals such as (S)-Nisoxetine, (S)-Fluoxetine, (S)-Tomoxetine, (S)-Duloxetine, (S)-Dapoxetine, and Ezetimibe analogues. DFT calculations reveal that C-H···π interactions and hydrogen bonding control stereoselectivity, and the effect of different amine-boranes on enantioselectivity was rationalized, providing guidance for broader application in asymmetric transfer hydrogenation."

Journal

The Inaugural Pre-Treatment Nomogram to Assess the Eight-Week Efficacy of Dapoxetine: A Prospective Multi-Center Study. (PubMed, Andrology) - "We constructed and validated the inaugural 8-week DapE-Nomo. In outpatient settings, it will enable andrologists to more accurately evaluate the efficacy and promptly adjust treatment plans for patients with scores below 153.4. Moreover, It will help patients who've taken dapoxetine for 4 weeks with poor results decide whether to stop."

Journal • Sexual Disorders

Efficacy and safety of on-demand dapoxetine combined with phosphodiesterase-5 inhibitor compared to monotherapy dapoxetine as a treatment of premature ejaculation without erectile dysfunction: a systematic review and meta-analysis. (PubMed, Arch Ital Urol Androl) - "This study demonstrates that the combination of dapoxetine and PDE-5i significantly improves post-treatment scores of IELT and sexual satisfaction compared to dapoxetine monotherapy. Despite an increased risk of certain side effects, the overall tolerability of the combination therapy remains favorable."

Clinical • Journal • Monotherapy • Retrospective data • Review • CNS Disorders • Constipation • Erectile Dysfunction • Fatigue • Gastroenterology • Gastrointestinal Disorder • Pain • Sexual Disorders • Sleep Disorder • Urology

Population Pharmacokinetics of Dapoxetine in Healthy Chinese Male Subjects. (PubMed, J Clin Pharmacol) - "The CYP3A4*1G allele influenced Q/F, while body mass index (BMI) was a significant covariate on Vc/F. Our analysis identified CYP2D6*10 and CYP2D6*41 polymorphisms as the significant factors contributing to inter-individual variability and influencing drug exposure."

Journal • PK/PD data • Sexual Disorders • CYP3A4 • CYP3A5

Dapoxetine combined with non-pharmacological approaches for lifelong premature ejaculation. A systematic review and meta-analysis. (PubMed, J Sex Med) - "This systematic review and meta-analysis indicate that while dapoxetine is recognized for its beneficial effects, its clinical efficacy is significantly enhanced when combined with non-pharmacological interventions. Combination therapy increases IELT, reduces PEDT scores, and improves PEP scores. These findings suggest that combination therapy is more effective than dapoxetine monotherapy in improving functional outcomes and self-perception in patients with LPE, supported by moderate certainty of evidence."

Journal • Retrospective data • Sexual Disorders

Causal association between erectile dysfunction and the risk of myocardial infarction: A two-sample bidirectional Mendelian randomization study (PubMed, Zhonghua Nan Ke Xue) - "There is a causal relationship between ED and MI, with smoking as a potential mediating factor, and the gene PTPN11 being a co-target gene."

Journal • Cardiovascular • Erectile Dysfunction • Myocardial Infarction • PTPN11

Clinical research of Zhuangdan Yanshi Decoction combined with dapoxetine hydrochloride in the treatment of premature ejaculation with cholestasis and phlegm disturbance syndrome (PubMed, Zhonghua Nan Ke Xue) - "The combination therapy with Zhuangdan Yanshi Decoction and dapoxetine hydrochloride for premature ejaculation associated with cholestasis and phlegm disturbance syndrome is definite, and it can reduce the side effects of drugs, which is better than oral dapoxetine hydrochloride alone."

Clinical • Journal • Cholestasis • Hepatology • Sexual Disorders

Comparative Evaluation of Safety and Efficacy of Dapoxetine, Silodosin, and Citalopram in the Management of Premature Ejaculation (clinicaltrials.gov) - P4 | N=450 | Completed | Sponsor: Beni-Suef University

New P4 trial • Sexual Disorders

On-demand Silodosin 4mg vs Dapoxetine 60mg in Treatment of Primary Premature Ejaculation (clinicaltrials.gov) - P2/3 | N=95 | Completed | Sponsor: Benha University

New P2/3 trial • Sexual Disorders

Dapoxetine hydrochloride versus paroxetine for the treatment of primary premature ejaculation (PubMed, Zhonghua Nan Ke Xue) - "In term of overall effectiveness, paroxetine was superior to dapoxetine in the treatment of primary premature ejaculation. And the patients obviously preferred the former to the latter, which might be partly attributed to the higher price of dapoxetine."

Clinical • Journal • Sexual Disorders

Comparison of the Efficacy and Safety of Dapoxetine, Kegel Exercises, and Acupuncture in the Treatment of Premature Ejaculation: A Randomized, Double-Blind, Placebo-Controlled Trial (clinicaltrials.gov) - P=N/A | N=250 | Not yet recruiting | Sponsor: Medipol University

New trial • Sexual Disorders

Uncovering novel therapeutic targets for premature ejaculation from gut microbiota: A prospective high-throughput sequencing study. (PubMed, Andrology) - "This study identified gut microbiota associated with the efficacy of dapoxetine for the first time. Targeted modulation of specific gut microbiota may provide a novel strategy for PE treatment."

Journal • Sexual Disorders

Management and treatment variations in premature ejaculation: a nationwide survey by the Andrology Working Group of the Society of Urological Surgery in Turkey. (PubMed, Int Urol Nephrol) - "This study revealed substantial variability in PE management, its multifaceted etiology and guideline limitations. The findings underscore the need for standardized, evidence-based protocols to enhance clinical outcomes and optimize patient satisfaction."

Journal • Anesthesia • Psychiatry • Sexual Disorders

A prospective clinical study of progressive penile root behavior training and Dapoxetine hydrochloride in the treatment of premature ejaculation (ChiCTR) - P1 | N=468 | Not yet recruiting | Sponsor: Affiliated Panyu Central Hospital of Guangzhou Medical University; Affiliated Panyu Central Hospital of Guangzhou Medical University

New P1 trial • Sexual Disorders

CD9, a novel potential biomarker of sarcopenia. (PubMed, Sci Rep) - "Besides, dapoxetine, levomilnacipran, and milnacipran were predicted to target CD9 through molecular docking. Our study reported for the first time that CD9 is a novel potential biomarker of sarcopenia, and targeting CD9 may be a new idea for the development of therapeutic drugs for sarcopenia."

Biomarker • Journal • Musculoskeletal Diseases • Orthopedics • Sarcopenia • CD9

A prospective and comparative evaluation of a male masturbation device for premature ejaculation-functional outcomes, safety, and satisfaction assessment: a pilot study. (PubMed, J Sex Med) - "This pilot study suggests that the cognitive-behavioral therapy program supported by the male masturbation device may offer potential benefits for managing PE, but further research with larger samples is needed to confirm these preliminary findings."

Journal • Erectile Dysfunction • Sexual Disorders

Efficacy and safety of pharmacological treatments in patients with premature ejaculation: an umbrella review of meta-analyses of randomized controlled trials. (PubMed, J Sex Med) - "Topical anesthetics, tramadol, and SSRIs significantly increase IELT. However, substantial heterogeneity among meta-analyses may limit the robustness of these findings. Future RCTs should include extended follow-up periods to better assess the long-term efficacy and safety of these treatments."

Journal • Anesthesia • Sexual Disorders

Unraveling the Anticancer Potential of SSRIs in Prostate Cancer by Combining Computational Systems Biology and In Vitro Analyses. (PubMed, ACS Omega) - "The combination of SSRIs with cisplatin, 5-fluorouracil, and raloxifene resulted in either synergistic or additive effects...Dapoxetine, paroxetine, and sertraline resulted in cell cycle arrest at the G0/G1 phase...At the same time, sertraline decreases the expression of Bcl-2 and VEGF and increases the expression of CASP8 and DR5. Results revealed that SSRIs can potentially act as antiproliferative agents against prostate cancer cells, and their activity is mediated through different signaling pathways."

IO biomarker • Journal • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ANXA5 • BCL2 • CASP8

Evaluating the Safety and Clinical Impact of Selective Dorsal Neurotomy in Lifelong Premature Ejaculation: A Multi-Center Prospective Study (AUA 2025) - "Medical treatments included a Serotonin Reuptake Inhibitor (dapoxetine) and a topical anesthetic (lidocaien)... SDN appears to be an effective and safe treatment option for lifelong PE patients who do not respond to medication or prefer to avoid oral treatments. The procedure significantly increased IELT, improved IIEF scores, and decreased PEDT scores without serious postoperative complications, suggesting that SDN may be a viable alternative for treating PE."

Clinical • Anesthesia • Erectile Dysfunction • Infectious Disease • Sexual Disorders • Urology

British Society for Sexual Medicine (BSSM) Position statement on Premature Ejaculation. (PubMed, World J Mens Health) - "The British Society for Sexual Medicine (BSSM) takes issue with the advice to use off label treatments, such as daily selective serotonin reuptake inhibitors treatment, favoring on-demand dapoxetine...As a result, general practitioners in the UK have relied on local guidance, and international guidelines which are heterogeneous, indicating diagnostic and therapeutic approaches that are often inconsistent. The aim of this position statement is to improve the management of PE in the UK."

Journal • Review • Endocrine Disorders • Erectile Dysfunction • Sexual Disorders