tesofensine (NS-2330) / Saniona, Medix - LARVOL DELTA

Tesofensine, a novel antiobesity drug, silences GABAergic hypothalamic neurons. (PubMed, PLoS One) - "Unlike phentermine, a dopaminergic appetite suppressant, tesofensine causes few, if any, head-weaving stereotypy at therapeutic doses. Behavioral studies on rats with the tastant sucrose indicated that tesofensine's appetite suppressant effects are independent of taste aversion and do not directly affect the perception of sweetness or palatability of sucrose. In summary, our data provide new insights into the effects of tesofensine on weight loss and the underlying neuronal mechanisms, suggesting that tesofensine may be an effective treatment for obesity and that it may be a valuable adjunct to other appetite suppressants to prevent body weight rebound."

Journal • Genetic Disorders • Obesity

Traditional uses of Cannabis: An analysis of the CANNUSE database. (PubMed, J Ethnopharmacol) - "Several pharmaceutical companies are intensely working on developing new drugs with isolated chemical compounds or crude extracts, almost exclusively from Cannabis inflorescences. However, our review revealed that use of leaf or seed in traditional medicine is often more important than use of inflorescence for the treatment of certain ailments. A review of traditional medicine provides a body of knowledge and a an initial pathway to identify landraces and plant parts that could have an important role in future medicinal research. We are confident that traditional medicine still has a large potential for modern medicine. As more information on Cannabis diversity (genetics, biochemistry, and clinical studies) becomes available, ethnobotanical data are poised to be of much greater significance."

Journal • Review • CNS Disorders • Hematological Disorders • Immunology • Inflammation • Mental Retardation • Musculoskeletal Diseases • Pain • Psychiatry

[VIRTUAL] Weight Loss, Improved Body Composition and Fat Distribution by Tesomet in Acquired Hypothalamic Obesity (ENDO 2021) - P2 | "Objective This RCT investigated safety and efficacy of Tesomet (co-administration of 0.5mg tesofensine and 50mg metoprolol) in hypopituitary patients with acquired hypothalamic obesity. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021."

Cardiovascular • CNS Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Obesity • Psychiatry • Sleep Disorder • Xerostomia

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) (clinicaltrials.gov) - P2; N=21; Completed; Sponsor: Saniona; Active, not recruiting ➔ Completed

Clinical • Trial completion • Genetic Disorders • Obesity

[VIRTUAL] TESOMET CAUSES SIGNIFICANT WEIGHT LOSS RESULTING IN REDUCED LEVOTHYROXINE REQUIREMENTS IN HYPOPITUITARY PATIENTS WITH ACQUIRED HYPOTHALAMIC OBESITY (ENEA 2020) - "This trial investigated safety and efficacy of tesomet (0.5 mg tesofensine and 50 mg metoprolol) in hypopituitary patients with hypothalamic obesity. Twenty-one (16 females) hypopituitary patients with hypothalamic obesity were randomized to tesomet or placebo (2: 1 ) for 24 weeks (nCT03845075). Tesomet was generally well tolerated, did not affect heart rate or blood pressure, resulted in transient appetite-suppression, significant reductions in body weight and waist circumferences compared to placebo in this cohort of hypopituitary patients with hypothalamic obesity. Weight-loss necessitated reductions in levothyroxine dose in most subjects."

Clinical • Cardiovascular • CNS Disorders • Genetic Disorders • Hypothalamic Injury-associated Obesity • Metabolic Disorders • Mood Disorders • Obesity • Pain • Psychiatry • Sleep Disorder • Xerostomia

New insights into potential nutritional effects of dietary saponins in protecting against the development of obesity. (PubMed, Food Chem) - "Many dietary saponins, such as sibutramine, morgoside, sessiloside, soysaponin B, and diosgenin, have treatment potential against the development of obesity. Excellent scientific achievements have been developed for a better understanding the mechanism of saponins in preventing obesity."

Journal • Genetic Disorders • Obesity

New and emerging drug molecules against obesity (J Cardiovasc Pharmacol Ther) - PMID: 24064009; “Cetilistat, a lipase inhibitor is claimed to have superior safety profile to orlistat...have limited success in early clinical development include velneperit, tesofensine, and beloranib .Tesofensine is a triple monoamine re-uptake inhibitor, velneperit acts as a neuropeptide Y5 receptor antagonist and beloranib is a methionine amino peptidase 2 inhibitor.”

Review • Obesity

Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: Saniona; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Diabetes

Safety and Efficacy Study of Tesofensine/Metoprolol Treatment in Subjects With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2; N=60; Completed; Sponsor: Saniona; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) (clinicaltrials.gov) - P2; N=21; Active, not recruiting; Sponsor: Saniona; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Anorectic state of obesity medications in the United States. Are leaner times ahead? (PubMed, Expert Opin Pharmacother) - "The authors also give their expert opinion and provide their future perspectives on the treatment of obesity based on what is known.Expert opinion: Despite obesity being a chronic condition affecting 40% of the US population, there is a low demand for obesity medications in the US market. Although the potential obesity medications that are currently being investigated in phase II/III clinical trials are promising, it is unclear whether the future pharmacotherapies will be enough to meet the health care need."

Journal

TM002: Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS) (clinicaltrials.gov) - P2; N=18; Completed; Sponsor: Saniona; Recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ Jun 2019

Clinical • Trial completion • Trial completion date

A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate (clinicaltrials.gov) - P1; N=37; Completed; Sponsor: Saniona; Recruiting ➔ Completed; N=60 ➔ 37

Enrollment change • Trial completion

A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Saniona; Trial completion date: May 2019 ➔ Oct 2019

Trial completion date

Centrally Acting Agents for Obesity: Past, Present, and Future. (PubMed, Drugs) - "...This review of central nervous system (CNS) acting anti-obesity drugs evaluates current therapies such as phentermine/topiramate, which act through multiple neurotransmitter pathways to reduce appetite. In the synergistic mechanism of bupropion/naltrexone, naltrexone blocks the feed-back inhibitory circuit of bupropion to give greater weight loss. Lorcaserin, a selective agonist of a serotonin receptor that regulates food intake, and the glucagon-like-peptide-1 (GLP-1) receptor agonist liraglutide are reviewed. Future drugs include tesofensine, a potent triple reuptake inhibitor in Phase III trials for obesity, and semaglutide, an oral GLP-1 analog approved for diabetes and currently in trials for obesity. Another potential new pharmacotherapy, setmelanotide, is a melanocortin-4 receptor agonist, which is still in an early stage of development. As our understanding of the communication between the CNS, gut, adipose tissue, and other organs evolves, it is anticipated..."

Journal • Review

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) (clinicaltrials.gov) - P2; N=25; Recruiting; Sponsor: Saniona; Not yet recruiting ➔ Recruiting

Enrollment open

"Quite dependent on #tesofensine though, which I also had never heard of :)" (@portefeuillefun)

48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO) (clinicaltrials.gov) - P2; N=25; Not yet recruiting; Sponsor: Saniona

Clinical • New P2 trial