ROSE-010 / Rose Pharma - LARVOL DELTA

MannKind and Rose Pharma Inc Enter Licensing and Collaboration Agreement to Develop an Inhaled Rapid-Acting, Short-Duration GLP-1 for Weight Management (GlobeNewswire) - "ROSE-010 is an investigational, rapid-acting glucagon-like peptide-1 (GLP-1) receptor agonist that will be formulated using MannKind’s proprietary Technosphere dry-powder inhalation technology. The companies intend to evaluate whether a rapid-acting, short-duration inhaled GLP-1 may offer a flexible approach to weight management...Under the agreement, Rose Pharma received an exclusive, worldwide license to use MannKind’s Technosphere technology to develop and commercialize ROSE-010 Technosphere. MannKind will support formulation development and advancement of the program through pharmaceutical development services to completion of Phase 1b in weight management...An abstract reporting findings from the research has been accepted for presentation at ObesityWeek 2026."

Licensing / partnership • Obesity

Glucagon-like Peptide-1 Receptor Agonists and Chronic Pain: Preclinical Antinociceptive Mechanisms, Indirect Metabolic-Functional Effects, and Clinical Considerations-A Narrative Review. (PubMed, J Clin Med) - "Liraglutide produced additional weight loss without superior knee-pain reduction. Diabetic peripheral neuropathy evidence was mainly structural or neurophysiologic; idiopathic intracranial hypertension and ROSE-010-treated irritable bowel syndrome showed disease-specific signals, whereas fibromyalgia- and opioid-related findings remained observational or hypothesis-generating...Current human signals are best interpreted as indirect metabolic-functional or disease-specific effects. Future trials should use validated pain-primary outcomes, control for weight loss, and monitor treatment-related harms."

Journal • Preclinical • Review • Cardiovascular • CNS Disorders • Diabetic Neuropathy • Fibromyalgia • Gastrointestinal Disorder • Genetic Disorders • Hypertension • Immunology • Inflammation • Musculoskeletal Pain • Osteoarthritis • Pain • Peripheral Neuropathic Pain • Rheumatology • IL10

The Pharmacokinetics of the GLP-1 Agonist ROSE-010 and Effect on Appetite, Food Consumption and Weight in Subjects with Overweight and Obesity (ECO 2026) - "Treatment with ROSE-010 at a single meal per day significantly reduces food intake which is reflected in measurable weight loss after 7 days. Peak concentrations are reached at 26 minutes post-dose which makes the product ideally suited for pre-prandial administration. The t½ of approximately 35 minutes results in both effective appetite control and reduced side effects associated with GLP-1 treatments."

Clinical • PK/PD data • Genetic Disorders • Obesity

The Effect of the GLP-1 Agonist ROSE-010 on Food Consumption in Subjects with Overweight and Obesity (OBESITY WEEK 2025) - "The results suggest that ROSE-010 taken prior to meals in subjects with overweight and obesity may aid long term weight maintenance and weight loss when coupled with recommended dietary and health advice. In particular, the reduced period of nausea compared to long acting GLP-1 agonists may aid adherence and persistence in treatment of subjects with low tolerance of continuous GLP-1 exposure and its side effects."

Clinical • Genetic Disorders • Obesity

Effect of GLP-1 Analogue ROSE-010 on Appetite in Overweight and Obese Subjects (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: Rose Pharma Inc | Not yet recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Improvement of irritable bowel syndrome with glucagon like peptide-1 receptor agonists: a systematic review and meta-analysis. (PubMed, Front Endocrinol (Lausanne)) - "GLP-1 and its analog ROSE-010 have been shown to inhibit the migrating motor complex and decrease gastrointestinal motility in IBS patients...Further investigation is needed to understand its impact on different IBS subtypes and long-term effects. https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42024613545."

Clinical • Journal • Retrospective data • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Pain

The Role of Glucagon-Like Peptide-1 Agonists on Gastric Emptying Measured by Scintigraphy Imaging (ACG 2024) - "Search words included ("GLP1 agonists" OR "GLP-1 analog" OR "liraglutide" OR "semaglutide" OR "exenatide" OR "lixisenatide" OR "albiglutide" OR "dulaglutide" OR "Tirzepatide") AND ("Gastric emptying" OR "residual gastric food" OR "residual gastric content*"). We identified 10 studies on scintigraphy imaging in patients on GLP-1 agonists.(Table-1) There were 239 patients 144 patients on GLP-1 and 141 patients on placebo. The medications used were Exenatide (5), liraglutide (2), semaglutide (1), ROSE-010 (1), GLP-1 (7–36)amide (1). The commonest indication for usage was obesity, Type 2 DM."

Diabetes • Genetic Disorders • Metabolic Disorders • Obesity

A Randomized Controlled Clinical Trial of the GLP-1 Agonist ROSE-010 in Appetite Reduction (OBESITY WEEK 2024) - "Background: Clinical studies on long acting GLP-1 agonists such as semaglutide and tirzepatide have shown significant benefits in promoting weight loss in people with obesity and overweight. The results suggest that ROSE-010 may have potential in appetite control at mealtimes in subjects with overweight and obesity as an aid to weight control in addition to nutrition advice and education. The reduced period of nausea compared to long acting GLP-1 agonists may aid adherence to long term treatment."

Clinical • Genetic Disorders • Obesity