Vyleesi (bremelanotide) / Kwang Dong, Fosun Pharma, Palatin Technologies - LARVOL DELTA

FDA-approved drugs as potential covalent inhibitors of key SARS-CoV-2 proteins: an in silico approach. (PubMed, Turk J Biol) - "Several promising drug repurposing candidates were identified: bremelanotide, lanreotide, histrelin, and leuprolide as potential RdRp inhibitors; azlocillin, cefiderocol, and sultamicillin for Mpro inhibition; tenapanor, isavuconazonium, and ivosidenib targeting TMPRSS2; and cefiderocol, cefoperazone, and ceftolozane as potential ACE2 inhibitors. This study provides valuable insights into repurposing existing drugs as potential COVID-19 therapeutics by targeting crucial viral proteins. However, further experimental validation and preclinical studies are necessary to confirm the efficacy and safety of these compounds before consideration for clinical application."

FDA event • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk (clinicaltrials.gov) - P4 | N=10 | Recruiting | Sponsor: Cosette Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

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

A biodegradable suction patch for sustainable transbuccal peptide delivery. (PubMed, J Control Release) - "Recent studies on a bioinspired suction patch demonstrated positive effects in vivo with three peptides - desmopressin, semaglutide, and teriparatide - yet materials used for patch fabrication were non-degradable. Additionally, the patch achieved a relative bioavailability of 26 % for bremelanotide (1.03 kDa) compared to subcutaneous administration. This work underscores the potential of replacing silicone devices with biodegradable alternatives, providing a more sustainable approach for peptide delivery via the buccal suction patch."

Journal

Obesity Program Highlights (PRNewswire) - P2 | N=108 | NCT06565611 | Sponsor: Palatin Technologies, Inc | "Phase 2 Study Co-administration of Bremelanotide (MC4R agonist) + Tirzepatide (GLP-1/GIP dual agonist): Met primary endpoint in the 8-week treatment study with high statistical significance (p<0.0001). Patients receiving co-administration showed a 4.4% weight reduction, vs. 1.6% for placebo. 19% of patients achieved ≥7% weight loss (p<0.1). Low-dose bremelanotide prevented weight regain typically seen following tirzepatide discontinuation. No added tolerability or safety issues observed with the combination. IND filings planned for Q1 2026; initial clinical data expected in 1H 2026. Planned Phase 1 SAD/MAD studies will include patients with hypothalamic obesity."

IND • New P1 trial • P2 data • Obesity

Palatin Reports Positive Appetite Suppression Results From Phase 2 Obesity Study of MC4R Agonist Bremelanotide and Tirzepatide (PRNewswire) - P2 | N=108 | NCT06565611 | Sponsor: Palatin Technologies, Inc | "Palatin Technologies, Inc...announced positive appetite suppression results from its BMT-801 Phase 2 obesity study. The study included a co-administered melanocortin 4 receptor (MC4R) agonist bremelanotide plus glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) tirzepatide arm, bremelanotide alone, and tirzepatide alone arms...Overall appetite suppression: Bremelanotide + tirzepatide: 71% increase; Tirzepatide only: 73% increase; Bremelanotide only: 71% increase...'How full do you feel (fullness)?': Bremelanotide + tirzepatide: 65% increase; Tirzepatide only: 62% increase; Bremelanotide only: 79% increase...'How satisfied do you feel (satiety)?': Bremelanotide + tirzepatide: 56% increase; Tirzepatide only: 56% increase; Bremelanotide only: 68% increase."

P2 data • Patient reported outcomes • Obesity

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

Palatin to Present Positive Phase 2b Data for Melanocortin Agonist in Diabetic Kidney Disease at the National Kidney Foundation Spring Meeting (PRNewswire) - P2b | N=16 | BREAKOUT (NCT05709444) | Sponsor: Palatin Technologies, Inc | "Palatin Technologies...today announced that data from the Phase 2b BREAKOUT study will be presented today at the National Kidney Foundation Spring Meeting in Boston, MA. The poster presentation titled Efficacy of Bremelanotide (BMT) to Stabilize Podocyte Function and Reduce Proteinuria in Adults with Diabetic Type II Nephropathy...71% of patients achieved a >30% reduction in the urine protein to creatinine ratio (UP/Cr), a key indicator of kidney damage. 71% of patients demonstrated improved or stabilized estimated glomerular filtration rate (eGFR), signaling preserved kidney function. 37.5% of patients had increased urinary vascular endothelial growth factor (VEGF) levels, suggesting better blood vessel support in the kidneys. 36% of patients had reduced urinary synaptopodin loss, indicating healthier kidney cells and structure."

P2b data • Diabetic Nephropathy • Renal Disease

Palatin Announces MC4R Agonist Bremelanotide Co-Administered with GLP-1/GIP Tirzepatide Meets Primary Endpoint in Phase 2 Obesity Study (PRNewswire) - P2 | N=108 | NCT06565611 | Sponsor: Palatin Technologies, Inc | "Low dose bremelanotide arm stopped weight regain seen post tirzepatide treatment...40% of patients in the co-administered group achieved a 5% reduction in their body weight, compared to 27% for the tirzepatide alone group (p<0.05); 27% of patients in the co-administered group achieved a 6% reduction in their body weight, compared to 13% for the tirzepatide alone group (p<0.05); 19% of patients in the co-administered group achieved a 7% reduction in their body weight, compared to 0% for the tirzepatide alone group (p<0.1); Increase in the percent of subjects on co-administration achieving 5%, 6% and 7% weight loss over tirzepatide alone, indicates that co-administration had a synergistic effect....Further data analysis is ongoing, including exploratory endpoints such as body composition and body mass index (BMI). The complete study results will be presented at an upcoming medical conference."

P2 data • Obesity

Efficacy of Bremelanotide (BMT) to Stabilize Podocyte Function and Reduce Proteinuria in Adults with Type II Diabetic Nephropathy: Results from a Phase IIb, Open-Label Study. (NKF-SCM 2025) - "Post-hoc analysis demonstrated that BMT therapy increased urinary VEGF levels in 37.5% of patients and reduced urinary synaptopodin levels by ≥30% in 50% of evaluable patients, consistent with previous reports that activation of melanocortin receptors can block synaptopodin degradation and stabilize podocyte function and viability. Further studies will need to be conducted using various combinations of MCR receptor agonists and antagonists to fully optimize this promising treatment pathway."

Clinical • P2b data • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk (clinicaltrials.gov) - P4 | N=10 | Not yet recruiting | Sponsor: Cosette Pharmaceuticals, Inc.

New P4 trial

Cosette Pharmaceuticals Announces Acquisition of Mayne Pharma, Transforming Company into a Leader in Women’s Health and Dermatology (Businesswire) - "Cosette Pharmaceuticals...announced today that it has entered into a definitive agreement to acquire all the outstanding shares of Mayne Pharma Group Limited (ASX: Ticker MYX) (Mayne Pharma) at AUD$7.40/share for a total consideration of approximately USD $430 Million. The Boards of Directors of both companies have approved the transaction and Mayne Pharma’s Board of Directors has unanimously recommended that its shareholders vote in favor of the transaction. The transaction is expected to close in the second quarter of 2025....Upon close, Cosette will market 12 patent-protected products focused on women’s health and dermatology, including leading brands such as VYLEESI, INTRAROSA, NEXTSTELLIS, ANNOVERA, BIJUVA, IMVEXXY and RHOFADE, and several programs in clinical development."

M&A • Dermatology • Women's Health

Palatin Completes Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide (PRNewswire) - "Palatin Technologies, Inc...today announced the completion of its Phase 2 BMT-801 clinical study of the co-administration of MC4R bremelanotide + GLP-1/GIP tirzepatide for the treatment of obesity. The last patient enrolled has completed their last visit. Final data collection and quality control will conclude shortly. Topline data results from the Phase 2 BMT-801...are expected later this quarter."

P2 data • Trial completion • Obesity

Palatin Provides Update on Anticipated 2025 Corporate Milestones - "Expected 2025 Milestones: Obesity Programs...Topline results from our Phase 2 BMT-801 'signal detection' clinical study with MC4R agonist bremelanotide plus a glucagon like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist tirzepatide, expected in the first quarter of calendar year 2025...General obesity, weight loss management, and orphan/rare neuroendocrine and genetic diseases, including hypothalamic obesity: Potential for monotherapy or combination (with a GLP-1 agonist) therapy; Investigational new drug (IND) enabling activities expected to commence 1Q calendar year 2025; Filing of INDs anticipated 2H of calendar year 2025; Commencement of Phase 1 clinical studies targeted for 4Q calendar year 2025."

IND • New P1 trial • P2 data • Obesity

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

Female Syrian hamster analyses of bremelanotide, a US FDA approved drug for the treatment of female hypoactive sexual desire disorder. (PubMed, Neuropharmacology) - "Finally, sexual experience resulted in a conditioned place preference (CPP) in female Syrian hamsters, though bremelanotide treatment failed to enhance sexual reward in this test. The results of this study are discussed in conjunction with similar studies in rats, with the conclusion that bremelanotide does not act on the VTA-NAc reward circuit and does not enhance the rewarding effects of sexual interactions."

FDA event • Journal • Sexual Disorders • MC4R

BMT-801: A Phase 2 Study Evaluating the Co-Administration of Bremelanotide with Tirzepatide for the Treatment of Obesity (clinicaltrials.gov) - P2 | N=108 | Active, not recruiting | Sponsor: Palatin Technologies, Inc | Recruiting ➔ Active, not recruiting | N=60 ➔ 108

Enrollment change • Enrollment closed • Genetic Disorders • Obesity

Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy (PRNewswire) - P2b | N=16 | BREAKOUT (NCT05709444) | Sponsor: Palatin Technologies, Inc | "The BREAKOUT Study (BMT-701) enrolled 16 patients with confirmed Type 2 diabetic nephropathy and >1000 mg/gm UP/Cr ratio, with 8 patients completing the six-month treatment regimen, at multiple sites in the United States....Clinically meaningful endpoints included; 71% of patients achieved a >30% reduction in the urine protein to creatinine ratio (UP/Cr), 71% of patients achieved improved or stabilized estimated glomerular filtration rate (eGFR), increased urinary vascular endothelial growth factor (VEGF) levels in 37.5% of patients and reduced urinary synaptopodin losses in 36% of patients."

P2b data • Diabetic Nephropathy

KD-BMT-301: A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) (clinicaltrials.gov) - P3 | N=193 | Completed | Sponsor: Kwang Dong Pharmaceutical co., ltd. | Recruiting ➔ Completed

Trial completion • Sexual Disorders

BREAKOUT: A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: Palatin Technologies, Inc | Recruiting ➔ Completed | Phase classification: P2b ➔ P2 | N=45 ➔ 16

Enrollment change • Phase classification • Trial completion • Diabetic Nephropathy • Nephrology • Renal Disease

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

Melanocortin Receptor Agonist Bremelanotide Induces Cell Death and Growth Inhibition in Glioblastoma Cells via Suppression of Survivin Expression. (PubMed, Anticancer Res) - "The present results identified melanocortin receptors 3 and 4 as novel and viable therapeutic targets for glioblastoma. Activation of these receptors by bremelanotide may inhibit the expression of survivin, thereby sensitizing glioblastoma cells to cell death."

Journal • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • BIRC5

BMT-801: A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Palatin Technologies, Inc

New P2 trial • Genetic Disorders • Obesity