Addyi (flibanserin) / Sprout Pharma - LARVOL DELTA

Integrated Sustainability Evaluation of Electrochemical Quantification of Flibanserin and Caffeine in Various Matrices. (PubMed, Anal Biochem) - "Sustainability was comprehensively evaluated using the Carbon Footprint Reduction Index, Multi-Color Assessment Tool, Analytical Green Star Area, and Click Analytical Chemistry Index. Overall, the proposed method provides a rapid, sensitive, and sustainable alternative for the simultaneous determination of FLB and CAF."

Journal

RAD 2003: Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (clinicaltrials.gov) - P2 | N=44 | Completed | Sponsor: Andrew McDonald | Active, not recruiting ➔ Completed

Trial completion • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Flibanserin safety in real-world use: a decade of US Food and Drug Administration Adverse Event Reporting System pharmacovigilance evidence. (PubMed, Sex Health) - "Flibanserin's real-world safety profile is largely consistent with preapproval data, dominated by early-onset, reversible central nervous system reactions linked to its serotonergic mechanism. However, persistent hypotension and off-label or product-use-related reports underscore the need for continued pharmacovigilance, clinician education, and strict adherence to Risk Evaluation and Mitigation Strategy requirements to maintain an optimal benefit-risk balance."

Adverse events • Journal • Real-world evidence • Retrospective data • CNS Disorders • Fatigue • Hypotension • Insomnia • Mental Retardation • Psychiatry • Sexual Disorders • Sleep Disorder

EVALUATING THE EFFECTIVENESS OF GPT-5 IN ADDRESSING PATIENT QUERIES ABOUT SEXUAL DYSFUNCTION IN BREAST CANCER PATIENTS (MASCC-ISOO 2026) - "Highest-rated responses on both correctness and completeness scales addressed FSD prevalence in BC patients, flibanserin safety in survivors, specialist referral indications, and frequency of sexual health discussions with clinicians during survivorship...However, performance varied by topic complexity, with limitations emerging for multifaceted topics. While GPT-5 is promising as a patient educational resource, clinician oversight remains critical for safe use."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Sexual Disorders • Solid Tumor

Clinical trial evidence on emerging pharmacological therapies for hypoactive sexual desire disorder in women: a systematic review and analysis of completed studies registered on ClinicalTrials.gov. (PubMed, Front Med (Lausanne)) - "Investigational therapies predominantly targeted central nervous system pathways, with flibanserin and bremelanotide representing the most extensively studied agents. Variability in trial design, outcome measures, and reporting practices limits cross-trial comparison and clinical interpretation. Further research with standardized methodologies and comprehensive reporting is needed to strengthen the evidence base."

Clinical • Journal • Review • Sexual Disorders • Women's Health

Quantification of "Mercy Sex" in Heterosexual Women. (PubMed, J Sex Marital Ther) - "However, HSDD clinical trials evaluating testosterone therapy, flibanserin, and bremelanotide spanning nearly a decade show women with HSDD, encompassing low to no sexual desire, are still engaging in sexual activity. These results have important implications for further HSDD clinical research, as mercy sex frequency may skew therapeutic efficacy while having significant implications in calculating trial sample size, and assessing a clinically meaningful response to therapy, when SSEs are used as a primary endpoint. Although this paper explores only a biopsychosocial explanation for the phenomenon of mercy sex in clinical trials of HSDD therapies, it provides a valuable understanding that will benefit patients, clinicians, and researchers."

Journal • Review • Sexual Disorders

Dually Acting Ligands Targeting Serotonin Receptors: Implications in CNS Disorders. (PubMed, J Med Chem) - "Clinically relevant examples include flibanserin (5-HT1A receptor agonist/5-HT2A receptor antagonist), pimavanserin (5-HT2A/5-HT2C receptors inverse agonist), and eltoprazine (5-HT1A/5-HT1B receptors partial agonist), alongside experimental 5-HT2A/5-HT6, 5-HT3/5-HT6 or TAAR1/5-HT2C receptors ligands. Integrating structure-activity insights and clinical findings, we discuss challenges of rational dual modulation. Advances in biased signaling, targeting distinctive conformational states, and optopharmacology utilizing photochromic ligands may further enable the design of innovative dually acting agents with improved efficacy and safety profiles."

Journal • Review • Alzheimer's Disease • CNS Disorders • Mood Disorders • Movement Disorders • Parkinson's Disease • Psychiatry • Schizophrenia

Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system. (PubMed, Medicine (Baltimore)) - "The top 3 medications with the highest reporting frequency were mefloquine, viloxazine, and flibanserin. Subgroup analyses revealed distinct drug signal profiles across age groups and genders, with pediatric cases dominated by nervous system and anti-infective agents, adults and the elderly showing additional endocrine or hormonal signals, and sex specific signals such as finasteride in males and flibanserin in females. This pharmacovigilance study identifies insomnia risk signals across multiple drug classes, underscoring the need for clinical vigilance regarding drug-related sleep disturbances. Further prospective research is required to confirm these associations."

Adverse events • Journal • CNS Disorders • Insomnia • Pediatrics • Sleep Disorder

A computationally informed framework for lipid-based formulation developability: Integrating predictive models with case studies. (PubMed, J Pharm Sci) - "A database of >200 FDA-approved oral drugs (2010-2023) was screened through the computational framework, and four case studies (dapagliflozin, mavacamten, ospemifene, flibanserin) illustrate the framework's ability to classify risk and guide formulation decisions. This integrated approach enables rapid, data-driven formulation decisions, reducing reliance on trial-and-error methods and supporting early-stage development of PWSDs. By coupling computational predictions with targeted experimental validation, the framework offers a practical roadmap for accelerating LBF adoption and improving R&D efficiency."

Journal

Determination of Flibanserin in Female Sexual Desire Enhancer Products by LC-MS/MS and Its Confirmation by LCMS-IT-TOF. (PubMed, ACS Omega) - "Commercial samples collected from various sources were analyzed using both LC-MS/MS and LC-MS-IT-TOF techniques, revealing the absence or very low levels of flibanserin in the investigated products, raising concerns regarding product authenticity and potential risks to women's health. In addition, the proposed analytical approach was evaluated using greenness, blueness, and whiteness metrics, demonstrating its suitability as a sustainable and applicable method for routine control analyses."

Journal • CNS Disorders • Depression • Psychiatry • Sexual Disorders • Women's Health

HSDD: Hypoactive Sexual Desire Disorder in Males (clinicaltrials.gov) - P2 | N=8 | Terminated | Sponsor: Mohit Khera | N=60 ➔ 8 | Trial completion date: Dec 2026 ➔ Jan 2026 | Recruiting ➔ Terminated; The study's inclusion and exclusion criteria are tight and could not enroll any patients

Enrollment change • Trial completion date • Trial termination • Sexual Disorders

Strategies for Treating Sexual Health Concerns After Breast and Gynecologic Cancer. (PubMed, J Minim Invasive Gynecol) - "Sexual dysfunction following breast and gynecologic cancer requires individualized, multimodal management. A combination of non-hormonal and hormonal therapies, behavioral interventions, and emerging pharmacologic treatments offers promising avenues for improving sexual health and overall quality of life in survivors. Future research should focus on the effects of specific cancer therapies on sexual health, investigate the role of biological markers and dysfunction, and refine more personalized approaches to care."

Journal • Breast Cancer • Gynecologic Cancers • Oncology • Sexual Disorders • Solid Tumor • Women's Health

Development of Spraying Based Liquid Phase Microextraction Method for the Preconcentration of Flibanserin From Urine Samples via GC-MS Analyses. (PubMed, Biomed Chromatogr) - "Recovery experiments were performed in artificial urine samples within the specified linear working range of 33.15-505.66 μg kg-1. The SFDF-LPME-GC-MS method was efficiently applied to artificial urine samples by computing the matrix-matching calibration strategy, with percentage recovery values ranging from 90.0% to 105.9%."

Journal • Sexual Disorders

A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2025 ➔ Oct 2026 | Trial primary completion date: Oct 2025 ➔ Oct 2026

Trial completion date • Trial primary completion date • Breast Cancer • Oncology • Sexual Disorders • Solid Tumor • PGR

Practical considerations and emerging approaches for the management of vasomotor and sexual symptoms in breast cancer patients on endocrine therapies. (PubMed, Expert Rev Clin Pharmacol) - "Pharmacologic therapy for VMS has been centered on selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors, gabapentin, and clonidine...This review summarizes the current pharmacologic therapy for VMS, focusing on the practical considerations for use of the novel VMS (fezolinetant, elinzanetant) and libido agents (flibanserin, bremelanotide)...These novel agents are eagerly awaited therapeutic options; however, clinical trials excluded breast cancer patients. This review provides clinicians with relevant considerations to assess when recommending these therapies for patients with breast cancer, while awaiting ongoing research to give additional insights for best tailoring therapy for this patient population."

Journal • Review • Breast Cancer • Oncology • Solid Tumor

FDA Grants Priority Review for Addyi (flibanserin) Paving the Way for Expanded Access to Treat Low Sexual Desire in Postmenopausal Women (PRNewswire) - "Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its supplemental application to expand the indication of Addyi (flibanserin 100mg), the first and only FDA-approved pill for low sexual desire in women, to also include women who have gone through menopause...Following the FDA's recent public meeting on removing outdated estrogen labeling, Addyi's Priority Review reflects the same urgency and momentum signaling the Agency's commitment to ensuring that women at every life stage receive evidence-based care grounded accurately with the current science and focused on improving their quality of life."

FDA filing • Priority review • Women's Health

2024 SOGC, 2024 NCCN, 2022 ESO, AND 2018 ASCO: A COMPARISON OF BREAST CANCER/SURVIVORSHIP GUIDELINES FOR THE MANAGEMENT OF SEXUAL HEALTH CONCERNS (MASCC-ISOO 2025) - "Although all guidelines, except ESO–ESMO, include recommendations for androgens, bupropion, flibanserin, bremelanotide, and buspirone for low sex drive, there is limited data to support the use of these interventions. Conclusions There is consensus between guidelines on sexual health recommendations, with some variation. Additional research is needed on pharmacological interventions and type of counselling to strengthen the evidence supporting these recommendations."

HEOR • Breast Cancer • Infectious Disease • Obstetrics • Oncology • Pain • Sexual Disorders • Solid Tumor

Title: Female Sexual Desire, Arousal, and Orgasmic Dysfunctions: A Systematic Review and Meta-analysis of Treatment Options. (PubMed, J Minim Invasive Gynecol) - "In this systematic review of treatments of females with sexual DAO dysfunctions without pain, we found that CBT improves DAO; flibanserin improves desire; and bremelanotide improves both desire and arousal; and all three treatments reduce distress. Our findings align with previous literature and expand upon it to include multiple treatment modalities. This broader perspective offers a starting point for clinicians, including gynecologists, who frequently serve as the first point of care for female sexual dysfunction. Conclusions regarding most other treatments could not be drawn due to limited numbers of studies of FSD excluding pain, heterogeneous terminology for DAO disorders, and varying outcome measures across studies."

Journal • Retrospective data • Pain • Sexual Disorders

2024 SOGC, 2024 NCCN, 2022 ESO-ESMO, and 2018 ASCO: a comparison of female cancer survivorship guidelines for the management of sexual health concerns. (PubMed, Support Care Cancer) - "There is consensus among guidelines on certain sexual health recommendations, with some variation. Additional research is needed on pharmacological interventions and types of counselling to strengthen their evidence."

Clinical • HEOR • Journal • Review • Infectious Disease • Obstetrics • Oncology • Pain • Sexual Disorders

Sex-induced alterations in rumen microbial communities and metabolite profiles: implications for lamb body weight. (PubMed, BMC Microbiol) - "This study shows that sex-induced alterations in rumen microbial communities and metabolite profiles, adapting to the growth and development of lambs. The findings may help develop targeted strategies to optimize sheep rumen microbiota and improve productivity."

Journal

A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Phase classification: P ➔ P2

Phase classification • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Sexual Disorders • Solid Tumor • PGR

Oxytocin for male orgasmic disorder: fact or fiction? (AUA 2025) - "This starts with vibratory stimulation, followed by oxytocin, bupropion, and cabergoline, and finally bremelanotide and flibanserin. Intranasal oxytocin failed to significantly improve orgasmic disorder in the majority of men in our cohort. Male orgasmic disorder remains a difficult to treat condition. A significant proportion of patients with orgasmic disorder are co-morbid with erectile dysfunction and a psychiatric diagnosis, most commonly major depressive disorder."

CNS Disorders • Depression • Endocrine Disorders • Erectile Dysfunction • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry • Sexual Disorders

HSDD: Hypoactive Sexual Desire Disorder in Males (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Mohit Khera | Trial primary completion date: Oct 2024 ➔ Oct 2025

Trial primary completion date • Sexual Disorders

Novel Pharmacologic Treatments of Female Sexual Dysfunction. (PubMed, Clin Obstet Gynecol) - "We provide clinically relevant applications for Food and Drug Administration (FDA)-approved medications (flibanserin and bremelanotide) and investigational therapies (Lorexys and testosterone combinations). Detailed study outcomes, safety profiles, and clinical strategies guide clinicians in appropriate diagnosis, patient selection, expectation setting, side effect management, and patient education, improving treatment outcomes and patient satisfaction."

Journal • Review • Sexual Disorders

Gap in Sexual Dysfunction Management Between Male and Female Patients Seen in Primary Care: An Observational Study. (PubMed, J Gen Intern Med) - "Primary care patients with FSD are less likely to receive management if they are diagnosed by a PCP than by an OB/GYN. The opposite was true of ED patients, exposing a gap in the quality of care female patients receive."

Journal • Observational data • Erectile Dysfunction • Pain • Sexual Disorders • Urology • Women's Health