PUBLISHER: DelveInsight | PRODUCT CODE: 1159543
PUBLISHER: DelveInsight | PRODUCT CODE: 1159543
DelveInsight's , "Obesity - Pipeline Insight, 2022," report provides comprehensive insights about 100+ companies and 130+ pipeline drugs in Obesity pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Obesity Understanding
Obesity: Overview
Obesity is recognized as a chronic or noncommunicable disease, a complex, multifactorial phenotype, affecting, along with overweight, primarily associated with excess adiposity or body fatness which can manifest metabolically and not just concerning the size of the body. Unwanted body weight gain leading to obesity and overweight has become the main driver of the global rise in noncommunicable diseases; therefore, it is considered a noncommunicable disease. Because of the psychological and social stigma associated with being overweight and obese, those affected are also vulnerable to discrimination in their personal and work lives, low self-esteem, and depression. Childhood obesity results in the same comorbidities as obesity, with premature onset or greater likelihood in adulthood. The medical and psychological sequel of obesity contributes to a major threat to the socioeconomic healthcare burden, which is striking.
According to the World Health Organization (WHO), obesity is an abnormal or excessive accumulation of fat or adipose tissue in the body that presents a health risk. The body mass index (BMI) is used to define obesity, which is calculated as weight (kg)/height (m2). A person with a BMI greater than or equal to 30 is considered obese. It is the second most common cause of preventable death, which is associated with the risk of developing inflammatory components, directly and indirectly, related to cardiovascular disease, diabetes mellitus, respiratory problems, psychological issues, hypertension, obstructive sleep apnea, cancer, and hyperlipidemia. It imposes a significant public health epidemic that has progressively worsened over the past semi-centennial. An increase in obesity has been observed in children and adults of both genders and is prevalent in both developed and developing countries.
"Obesity - Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Obesity pipeline landscape is provided which includes the disease overview and Obesity treatment guidelines. The assessment part of the report embraces, in depth Obesity commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Obesity collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
This segment of the Obesity report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.
Obesity Emerging Drugs
Oral semaglutide (7 mg and 14 mg) is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in the US, EU, and Japan under the trade name, Rybelsus. The approval of Rybelsus is based on the results from 10 clinical trials, which included 9,543 adults with type 2 diabetes. Oral semaglutide received FDA approval in September 2019 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The product is available in 3, 7, and 14 mg tablets. Rybelsus demonstrated a safe and well-tolerated profile across the clinical trials, with the most common adverse event being mild-to-moderate nausea, which diminished over time.
GLP-1 receptor agonists lower glycemia via several mechanisms, including stimulating glucose-dependent insulin secretion from pancreatic B cells, suppressing glucagon secretion from pancreatic α cells, and delaying gastric emptying. The novelty of oral semaglutide is in the formulation that allows for oral administration and absorption of the drug. Oral semaglutide is coformulated with the absorption enhancer sodium N-(8-[2-hydroxylbenzoyl] amino) caprylate (SNAC). Currently, it is being evaluated in a Phase III clinical trial to treat obesity.
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist that integrates the actions of both incretins into a single novel molecule. GIP is a hormone that may complement the effects of GLP-1 receptor agonists. In preclinical models, GIP decreases food intake and increases energy expenditure, resulting in weight reductions. Combined with GLP-1 receptor agonism, it may have greater effects on markers of metabolic dysregulation such as body weight, glucose, and lipids. Tirzepatide is in Phase III development for adults with obesity or overweight with weight-related comorbidity and is currently under regulatory review as a treatment for adults with type 2 diabetes. It is also being studied as a potential treatment for non-alcoholic steatohepatitis (NASH) and heart failure with preserved ejection fraction (HFpEF). Studies of tirzepatide in obstructive sleep apnea (OSA) and morbidity/mortality in obesity are also planned.
Tesomet combines two active ingredients: tesofensine and metoprolol. Tesofensine is a novel, proprietary molecule developed in the labs of Saniona's founding scientists. It works in the brain to block the reabsorption of three monoamine neurotransmitters: serotonin, noradrenaline, and dopamine. Blocking reuptake increases the level of these neurotransmitters in the brain, which reduces food cravings, reduces appetite, and increases metabolic fat burn.
When administered alone, tesofensine has been shown in clinical studies to reduce weight while being generally well-tolerated. However, some doses increase heart rate and/or blood pressure. Tesomet combines tesofensine with metoprolol, a generic medicine used to treat hypertension, angina pectoris, and heart failure. The Tesomet combination has demonstrated a significantly improved cardiovascular safety profile compared to tesofensine alone. Saniona's Phase IIb trials of Tesomet in hypothalamic obesity and Prader-Willi syndrome have been voluntarily paused due to funding limitations; this pause is not related to the safety or efficacy of Tesomet.
Raziel Therapeutics is a clinical-stage pharmaceutical company developing RZL-012, an injectable treatment for aesthetics and fat disorders. A single treatment session in which RZL-012 is injected into subcutaneous fat, results in a significant and sustained reduction in fat volume. RZL-012 is a novel synthetic small molecule that kills fat cells when injected into subcutaneous fat. It is the first and only injectable drug that significantly and sustainably shrinks Lipomas' size in Dercum's disease, reducing abdominal fat volume (body contouring) and submental fullness (double chin).
In in vitro studies, RZL-012 reduced the ability of fat cells to accumulate or store fat. RZL-012 is administered by several injections delivered in a single injection session. Once injected, RZL-012 triggers immediate fat cell death, followed by a transient inflammatory process that lasts about a month, during which necrotic fat tissue is replaced by fibrotic tissue. This results in a significant long-term, sustained shrinkage of fat tissue. Raziel therapeutics evaluates RZL-012 in Phase II clinical trial in treating obesity.
CT-868 is a dual GLP-1 and GIP receptor modulator with a unique pharmacological profile optimized for improved tolerability at the GLP-1 receptor. The combined action of GLP-1 and GIP results in greater body weight loss and glucose control. CT-868 is dosed once daily to maximize efficacy and tolerability. CT-868 dual agonist candidate was discovered using the chemotype evolution technology as a peptide-small molecule hybrid compound, able to mimic the native GLP-1 hormone.
In the Phase I trial, CT-868 demonstrated compelling pharmacodynamic activity across several clinical measures in overweight and obese healthy individuals a safe and generally well-tolerated profile. Carmot Therapeutics is now expanding the observations in overweight and obese patients with type 2 diabetes to demonstrate CT-868's effects on glycemic control, weight loss, and tolerability. Currently, the product is in the Phase II stage of development to treat obesity
Empros Pharma has developed a revolutionary drug - EMP16. The main mechanism of action for EMP16 is to delay normal food digestion and absorption processes toward the end of the small intestine. EMP16 is based on a proprietary advanced drug delivery technology designed to have features that optimize its effect throughout the gastrointestinal system. EMP16 is an oral product with a local effect on the gastrointestinal system. It is a fixed dose combination of two locally active, safe, and established active drugs (orlistat and acarbose). The advanced multiple-unit, the modified-release formulation is designed to maximize the drug's effect and improve tolerability. Empros Phase IIa trial has demonstrated a best-in-class safety profile and potentially improved effect compared to XENICAL. EMP16-01 can potentially be a safe and effective treatment of obese and overweight children and adults with and without reduced glucose control. Due to its excellent safety profile, overweight children and adults with decreased glucose tolerance, "pre-diabetic" and/or "pre-obese" could be a big additional treatment group as there are currently no relevant (and safe) products available. Empros Pharma conducted a Phase II study to evaluate the effect of a novel, oral, modified-release formulation of the lipase inhibitor orlistat and the glucosidase/amylase inhibitor acarbose (EMP16) on relative body weight after 26 weeks compared with placebo.
DD01 is a proprietary, imbalanced dual agonist of GLP-1 and glucagon receptors with a half-life of 11 days in non-human primates. DD01 is being developed as a potential disease-modifying agent for obesity and liver fatty disease. Treatment with DD01 caused weight loss, reduced liver fat, and improved glucose tolerance in preclinical obesity, diabetes, and fatty liver models. In preclinical models of diabetes and nonalcoholic fatty liver disease (NAFLD), DD01 could reduce weight and blood sugar and improve insulin sensitivity and lipid and fat metabolism, which could ameliorate NASH. DD01 demonstrated greater efficacy in preclinical models than semaglutide, an approved GLP-1R receptor agonist; from a mechanical perspective, the effect of DD01 persisted after cessation of treatment. It is currently being evaluated in Phase I clinical trial to investigate the safety, tolerability, PK, and PD of DD01 administered by subcutaneous (SC) injection in overweight/obese subjects with type 2 diabetes mellitus and nonalcoholic fatty liver disease (NAFLD).
ZP8396 is an investigational, potent long-acting amylin analogue designed to improve solubility, minimize fibrillation and allow for co-formulation with other peptides, including GLP-1 analogues. In preclinical studies ZP8936 has shown potent anti-obesity effects. The Phase I, First-In-Human, randomized, single ascending dose trial, will assess safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP8396 administered to healthy subjects.
ERX-1000, a first-in-class leptin sensitizer, is developing to treat obesity and related diseases. Using a systems-biology approach, ERX scientific co-founder Dr. Umut Ozcan identified ERX-1000, a first-in-class leptin sensitizer. While ERX-1000 is highly effective at reducing appetite and decreasing weight in diet-induced obese mouse models (an experimental model of human obesity), it does not have any effect on leptin-deficient obese mice, obese mice lacking leptin signaling (genetically deficient in leptin or its receptor), or non-obese mice, demonstrating that ERX-1000 is a true leptin sensitizer.
Further product details are provided in the report……..
Obesity: Therapeutic Assessment
This segment of the report provides insights about the different Obesity drugs segregated based on following parameters that define the scope of the report, such as:
There are approx. 100+ key companies which are developing the therapies for Obesity. The companies which have their Obesity drug candidates in the most advanced stage, i.e. Phase III include, Novo Nordisk.
DelveInsight's report covers around 130+ products under different phases of clinical development like
Obesity pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
Products have been categorized under various Molecule types such as
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Obesity: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Obesity therapeutic drugs key players involved in developing key drugs.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Obesity drugs.
Key Questions
Current Treatment Scenario and Emerging Therapies:
Key Players
Key Products
Introduction
Executive Summary
Obesity: Overview
Pipeline Therapeutics
Therapeutic Assessment
Late Stage Products (Phase III)
Oral Semaglutide: Novo Nordisk
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
RZL-012: Raziel Therapeutics
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
DD01: D&D Pharmatech
Product Description
Drug profiles in the detailed report…..
Inactive Products
Obesity Key Companies
Obesity Key Products
Obesity- Unmet Needs
Obesity- Market Drivers and Barriers
Obesity- Future Perspectives and Conclusion
Obesity Analyst Views
Obesity Key Companies
Appendix