Ostarine (enobosarm) / Veru Inc - LARVOL DELTA

Enobosarm in Patients With Obesity on Semaglutide: Quality Weight Loss & Better Physical Function (OBESITY WEEK 2026) - No abstract available

Clinical • Genetic Disorders • Obesity

PLATEAU: Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (clinicaltrials.gov) - P2 | N=239 | Active, not recruiting | Sponsor: Veru Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Not Safer Than Steroids: Biopsy-Proven Designer Androgen Cholestasis Following Multi-Agent âSARMâ Supplement Use (ACG 2026) - "Case Description/ A 31-year-old man without prior liver disease presented with one month of progressive pruritus, jaundice, and acholic stools following use of a bodybuilding supplement âIron Solderâ containing four SARMs (LGD-4033, MK-2866, RAD-150, YK-11), a growth hormone secretagogue (MK-677/ibutamoren), and an aromatase inhibitor (arimistane)...The supplement was discontinued and the patient received cholestyramine and ursodiol symptomatically...Databases such as LiverTox provide freely accessible hepatotoxicity profiles for SARMs and may aid evaluation. Figure: Figure 1: H&E, low power - Liver biopsy core demonstrating preserved lobular architecture with bland cholestasis and minimal inflammation Figure: Figure 2: H&E, high power â canalicular bile plugging with intrahepatic cholestasis and focal hepatocyte dropout"

Biopsy • Cholestasis • Fibrosis • Hepatology • Immunology • Inflammation • Liver Failure • Pruritus

Improvement of Bone Healing by Combined Treatment with Selective Androgen and Estrogen Receptor Modulators in Female and Male Rats. (PubMed, Calcif Tissue Int) - "This study examined whether bone healing could be improved by combined treatment with the selective androgen and estrogen receptor modulators ostarine (Ost) and raloxifene (Ral), and compared its efficacy with monotherapy in female and male rat models. The combination with Ral reduced the androgenic effect of Ost on prostate. Combined treatment may represent a promising approach for osteoporotic bone repair in both sexes, though potential side effects of Ost require consideration."

Journal • Preclinical • Orthopedics • Osteoporosis

Phase 2b PLATEAU clinical trial of enobosarm and semaglutide combination for high quality weight loss is fully enrolled with 239 patients (The Manila Times) - "Phase 2b PLATEAU clinical trial interim analysis and results on track for calendar Q1 2027"

Enrollment closed • P2b data • Obesity

Completed Positive Phase 2b QUALITY Clinical Study (The Manila Times) - "After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of weight lost when the GLP-1 RA was discontinued."

P2b data • Trial completion • Obesity

Veru Announces Notice of Allowance for Key Methods of Use U.S. Patent for Enobosarm in Combination with Semaglutide for Quality Weight Loss (GlobeNewswire) - "The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued....When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension."

Patent • Obesity

Veru Announces Full Enrollment for Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss (Yahoo Finance) - "Phase 2b PLATEAU clinical trial exceeds targeted full enrollment of 200 patients...The interim analysis results from the study are expected in the first quarter of calendar year 2027 with final topline clinical data expected in the fourth quarter of calendar year 2027."

Enrollment closed • P2b data • Obesity

Limitations of Molecular Docking in Predicting the Selectivity of Selective Androgen Receptor Modulators (SARMs): A Comparative Study of YK11 and Ostarine Across Five Nuclear Receptors. (PubMed, Int J Mol Sci) - "The observed discordance between predicted receptor affinity and the established tissue-selective pharmacology of ostarine highlights the need for caution when using single-method docking workflows to infer selectivity among closely related steroid hormone receptors. The novelty of this study lies in demonstrating, using a defined AutoDock 4.2-based comparative protocol, that receptor-binding energetics alone do not recapitulate the functional tissue-selective behavior attributed to SARMs."

Clinical • Journal • ER

Androgen receptor expression and selective modulation in breast cancer subtypes (DGS 2026) - " The cells were with treated with the SARM Ostarine and compared with established therapies (tamoxifen, letrozole) and control substances (testosterone, cisplatin). All cell lines expressed AR to varying degrees, with the highest expression in the hormone receptor-positive cell lines MCF-7 and T-47D. Ostarine led to a significant reduction in cell viability as well as downregulation of AR and ERα mRNA in these cells (p < 0.0001). In AR-positive, ER-negative cell lines (BT-549, SKBR-3), ostarine also reduced viability, suggesting non-genomic AR effects."

Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • ER • HER-2

Veru partners with Novo Nordisk for obesity drug combination study (Streetinsider.com) - "The study will evaluate the combination of Veru's enobosarm, an oral selective androgen receptor modulator, with Novo Nordisk's Wegovy (semaglutide for injection) in older adults with obesity who are receiving Wegovy therapy for weight reduction...Under the agreement, Veru will conduct and sponsor the Phase 2b PLATEAU study while Novo Nordisk will supply Wegovy at no charge. Veru will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular study updates, protocol changes, and safety updates....Veru retains full global development and commercialization rights to enobosarm. The company has granted Novo Nordisk a right of first negotiation if Veru intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product for any indication."

Licensing / partnership • Trial status • Obesity

Phase 2b PLATEAU Clinical Study – Actively enrolling (GlobeNewswire) - "An interim analysis to assess change in lean body mass and fat mass as measured by DXA will be conducted at 36 weeks with data expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027."

P2b data • Trial status • Obesity

An Update on the Role of Androgens and Androgen Receptor in Triple-Negative Breast Cancer. (PubMed, Cells) - "Increasing interest in AR biology has led to the evaluation of several anti-androgen therapies in AR-positive TNBC, including agents such as enzalutamide, enobosarm, orteronel, bicalutamide, and seviteronel. Although clinical activity has generally been modest, these studies highlight the potential relevance of AR-targeted strategies in selected patient subgroups. This review summarizes current knowledge on androgen and AR signaling in TNBC, integrating molecular mechanisms, preclinical evidence, and clinical studies, and discusses emerging therapeutic strategies aimed at improving patient treatment outcomes."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR

PLATEAU: Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Veru Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

Effect of ostarine on glucose level, lipid profile, and osteoporosis in streptozotocin induced diabetic male rats. (PubMed, Can J Physiol Pharmacol) - "In conclusion, ostarine could have beneficial effects on diabetes such as improving glycemic state, dyslipidemia, and mainly diabetic osteoporotic bone. Ostarine should be further evaluated in diabetic osteoporosis or other types of osteoporosis."

Journal • Preclinical • Diabetes • Dyslipidemia • Metabolic Disorders • Osteoporosis • Rheumatology • RUNX2 • SPP1

PLATEAU: Proof-of-Concept Study Evaluating Total Body Weight, Physical Function & Safety of Enobosarm in Patients Treated With GLP-1 Receptor Agonist, for Weight Loss (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Veru Inc.

New P2 trial • Genetic Disorders • Obesity

Veru Enrolls First Patient in Phase 2b PLATEAU Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss (GlobeNewswire) - "The Phase 2b study to assess enobosarm’s ability to preserve lean mass, physical function, and bone as well as burn more fat to produce greater quality and quantity of weight loss in older patients with obesity receiving semaglutide. Interim analysis expected in the first quarter calendar year 2027. Final topline clinical data expected in the fourth quarter calendar year 2027."

P2b data • Trial status • Obesity

Comprehensive IM-MS approach for SARMs detection in urine: building CCS databases to support food safety monitoring. (PubMed, Food Addit Contam Part A Chem Anal Control Expo Ri) - "Comparisons with CCS prediction tools revealed deviations well above 2%, highlighting the importance of experimental measurements. Finally, a case study on urine samples from bovines treated with Ostarine demonstrated that IM can improve confidence in analyte identification by providing CCS as an additional confirmation parameter, while also cleaning the signal."

Journal

Veru Reports Fiscal 2026 First Quarter Financial Results and Clinical Program Progress (Veru Press Release) - "The Phase 2b PLATEAU clinical study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving semaglutide treatment to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 68 weeks...The Phase 2b PLATEAU clinical study is expected to begin in the first quarter of calendar 2026 and an interim analysis is planned for the first quarter of calendar 2027."

New P2b trial • P2b data • Obesity

Pharmacologic Treatments for the Preservation of Lean Body Mass During Weight Loss. (PubMed, J Clin Med) - "There are several mechanisms that govern the loss of lean body mass and, more specifically, the loss of muscle mass; as such, several classes of medications have been explored, targeting different pathways and receptors-including bimagrumab (activin receptor agonist), tesamorelin (growth hormone releasing hormone agonists), and enobosarm (selective androgen receptor modulator). Most of these drugs are in the early phases of research development, but some show great promise. This narrative review attempts to detail the physiology of muscle mass loss when accompanied by weight loss and identify pharmacological targets that can be utilized to minimize it with mechanisms, effects, side effects, and research developmental progress."

Journal • Review • Genetic Disorders • Obesity

Endocrine Therapies and the Bone Metastatic Microenvironment: Dissecting Immune Modulation and Spatial Heterogeneity in Hormone Receptor-Positive Breast Cancer (LCC 2026) - "Here, we investigated how endocrine therapies, including Tamoxifen, Fulvestrant and Enobosarm, affect BM homeostasis using metastatic syngeneic mouse models. Together, these findings illuminate how endocrine therapies remodel the BM niche and highlight the spatial complexity of metastatic BCa. This integrative approach provides a foundation for developing therapeutic strategies that combine endocrine modulation with immune targeting to prevent or treat bone metastases in HR+ BCa."

Heterogeneity • Metastases • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8

Planned Phase 2b PLATEAU clinical study (Veru Press Release) - "Company plans to initiate Phase 2 PLATEAU clinical study in calendar Q1 2026...The planned Phase 2b PLATEAU clinical trial will measure incremental weight loss in this enriched patient population that has more weight to lose (BMI ≥ 35) and more at risk for physical decline and functional limitations (age ≥ 65) to better inform the design of the Phase 3 development program. For the planned Phase 2b PLATEAU clinical trial, we will evaluate the effect of enobosarm 3 mg on total body weight, physical function, and safety in approximately 200 patients who have obesity (BMI ≥ 35) and are older (age ≥ 65) and are initiating GLP-1 RA treatment for weight reduction."

New P2b trial • Obesity

Manhole Sampling at Gyms and Sports Centers in Denmark: A Pilot Study Using Wastewater Analysis as a Tool for Monitoring the Use of Performance-Enhancing Drugs. (PubMed, Drug Test Anal) - "The study showed the presence of anabolic agents such as oxandrolone, stanozolol, and ostarine in wastewater sampled from the gyms. Wastewater analysis may be used as an easy and cost-effective tool to complement both preventive and control measures, such as information campaigns, surveys, or personal testing. However, not all locations are suitable for manhole sampling, and it is necessary to consider the legal, ethical, and practical aspects before using wastewater analysis to monitor communities or specific populations."

Journal

Muscle Loss in Obesity Therapy as a Therapeutic Target: Trial Design and Endpoints for Regulatory Discussions. (PubMed, J Cachexia Sarcopenia Muscle) - "Discussions highlighted the impact of glucagon-like peptide-1 (GLP-1) receptor agonists or GLP-1/glucose-dependent insulinotropic polypeptide (i.e., GLP-1/GIP) agonists on body composition and muscle health; the challenges of distinguishing 'true' skeletal muscle from fat-free tissue; the impact of treatment discontinuation and weight regain; advances in imaging and quantitative assessment of lean body mass; as well as insights from emerging muscle-preserving therapies (e.g., bimagrumab, pemvidutide and enobosarm)...These also involve significant regulatory considerations for future drug development and approval pathways, for instance related to the very large number of individuals that may be considered for these therapeutic approaches as well as from the potential long (or life-long) duration of therapy considered with these drugs. Together, these discussions highlight the growing importance of integrating body composition and functional assessments in future..."

Journal • Cachexia • Genetic Disorders • Obesity • Sarcopenia

Sarcopenia in Aging: Pathogenesis, Diagnosis, and Emerging Therapeutic Frontiers. (PubMed, Mol Imaging Biol) - "Resistance-based exercise and targeted nutritional support remain first-line, but late-phase trials of myostatin-neutralising antibodies (e.g., LY2495655, bimagrumab) and oral selective androgen-receptor modulators (SARMs; e.g., enobosarm, GSK2881078) now show dose-dependent gains in appendicular lean mass and preliminary functional benefits, signalling that combination regimens integrating lifestyle and drug therapy are imminent. Addressing these challenges requires an interdisciplinary strategy that encompasses molecular, clinical, and public health perspectives to mitigate the personal and societal impacts of sarcopenia. Future efforts must focus on harmonizing diagnostic criteria, refining therapeutic regimens, and leveraging emerging technologies to develop targeted interventions that preserve muscle function and enhance quality of life in the aging population."

Journal • Review • Inflammation • Metabolic Disorders • Muscular Atrophy • Sarcopenia