NIDA CTN-0152: Evaluation of Tirzepatide As an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder: a Pragmatic, Multi-site, Double-blind, Randomized, Placebo-controlled Trial (TAB)

The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.

Start Date16 Sep 2025

Sponsor / Collaborator

University of Cincinnati (Ohio)

[+1]

NCT06759701

/ Not yet recruitingEarly Phase 1IIT

Pre-surgical Tirzepatide-assisted Weight Loss in Men with Diabetes and Prostate Cancer: a Pilot Feasibility Study

The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer

Start Date30 Jun 2025

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

ACTRN12624001278527

/ Not yet recruitingPhase 3

Effect of tirzepatide on asthma control in obese asthmatics aged 16 years and over: A phase III randomised double blinded placebo control trial

Start Date02 Jun 2025

Sponsor / Collaborator

The University of Queensland

100 Clinical Results associated with Tirzepatide

100 Translational Medicine associated with Tirzepatide

100 Patents (Medical) associated with Tirzepatide

667

Literatures (Medical) associated with Tirzepatide

01 Apr 2025·Endocrine Metabolic & Immune Disorders-Drug Targets

A New Drug for Obesity: Tirzepatide

Article

Author: Singh, Surjit ; Sidhu, Jaspreet K.

Obesity is now recognised as an emerging public health problem across the globe. Its incidence has been growing in the last two decades. Furthermore, as per the obesity treatment guidelines, a comprehensive approach that incorporates behavioural treatment, medications, lifestyle modifications, and/or bariatric surgery is the best way to manage weight. A novel dual agonist of Glucose-dependent insulinotropic peptide (GIP) and Glucagon-like peptide -1 (GLP- 1) receptors, Tirzepatide, was recently approved for the management of obesity. Tirzepatide manages blood sugar levels and enhances weight loss more than GLP-1 receptor agonists.

01 Mar 2025·METABOLISM-CLINICAL AND EXPERIMENTAL

Effect of glucagon-like peptide-1 receptor agonists and co-agonists on body composition: Systematic review and network meta-analysis

Review

Author: Fragakis, Nikolaos ; Mantzoros, Christos S ; Karakasis, Paschalis ; Patoulias, Dimitrios

BACKGROUND AND AIMS:

While glucagon-like peptide-1 receptor agonists (GLP-1RAs) effectively reduce body weight, their impact on lean mass remains uncertain. This meta-analysis evaluated the effects of GLP-1RAs and GLP-1/GIP receptor dual agonists (GLP-1/GIP-RAs) on body composition, focusing on total weight, fat mass, and lean mass in adults with diabetes and/or overweight/obesity.

METHODS:

A systematic search of Medline, Embase, and the Cochrane Library was conducted through November 12, 2024. Data were analyzed using random-effects pairwise and network meta-analyses to compare interventions with placebo or active comparators.

RESULTS:

Twenty-two randomized controlled trials (2258 participants) were included. GLP-1RAs significantly reduced total body weight (MD -3.55 kg, 95 %-CI [-4.81, -2.29]), fat mass (MD -2.95 kg, 95 %-CI [-4.11, -1.79]), and lean mass (MD -0.86 kg, 95 %-CI [-1.30, -0.42]), with lean mass loss comprising approximately 25 % of the total weight loss. However, the relative lean mass, defined as percentage change from baseline, was unaffected. Liraglutide, at 3.0 mg weekly or 1.8 mg daily, was the only GLP-1RA to achieve significant weight reduction without significantly reducing lean mass. Tirzepatide (15 mg weekly) and semaglutide (2.4 mg weekly) were the most effective for weight and fat mass reduction but were among the least effective in preserving lean mass.

CONCLUSIONS:

Potent GLP-1 RAs, such as tirzepatide and semaglutide, demonstrate greater overall weight loss but are associated with a significant reduction in lean mass.

01 Feb 2025·DIABETES OBESITY & METABOLISM

Correction to “Real‐world evaluation of the effects of tirzepatide in patients with type 2 diabetes mellitus”

1,043

News (Medical) associated with Tirzepatide

30 Jan 2025

·www.prnewswire.com

Metabolic Dysfunction-Associated Steatohepatitis Market to Register Stunning Growth at a CAGR of 17.9% in the US by 2034 | DelveInsight

The MASH treatment landscape is evolving rapidly, driven by a diverse array of therapeutic classes, each with unique mechanisms and potential impacts. The forecast period reveals significant shifts and emerging trends that will shape future market dynamics. LAS VEGAS, Jan. 30, 2025 /PRNewswire/ -- DelveInsight's Metabolic Dysfunction-Associated Steatohepatitis Market Insights report includes a comprehensive understanding of current treatment practices, MASH emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Metabolic Dysfunction-Associated Steatohepatitis Market Report According to DelveInsight's analysis, the market size for MASH was found to be USD 2.1 billion in the 7MM in 2023. In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM. Leading MASH companies such as Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, and others are developing novel MASH drugs that can be available in the MASH market in the coming years. The promising MASH therapies in the pipeline include Lanifibranor (IVA337), Semaglutide, Azemiglitazone (MSDC-0602K), Efruxifermin (EFX), BIO89-100 (Pegozafermin), Survodutide (BI 456906), GR-MD-02 (Belapectin), LPCN1144, VK2809, Tirzepatide, BOS-580, Ervogastat (PF-06865571) + Clesacostat (PF-05221304), HTD1801, Leronlimab (PRO 140), Efinopegdutide, HPG1860, Rencofilstat (CRV431), EYP001 (Vonafexor), Semaglutide/Cilofexor/Firsocostat, PXL065, Saroglitazar Magnesium, Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and others. In March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2–F3 fibrosis. Discover which therapies are expected to grab the major MASH market share @ Metabolic Dysfunction-Associated Steatohepatitis Market Report Metabolic Dysfunction-Associated Steatohepatitis Overview Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease that stems from metabolic dysfunction, often linked to obesity, diabetes, and other conditions of metabolic syndrome. MASH is characterized by the accumulation of fat in liver cells, accompanied by inflammation and liver cell injury, which can progress to fibrosis, cirrhosis, or even liver cancer. The primary drivers of MASH include insulin resistance, obesity, type 2 diabetes, and dyslipidemia. Genetic predisposition and a sedentary lifestyle also play significant roles. Environmental factors, such as a poor diet high in sugars and fats, exacerbate the condition. MASH is often asymptomatic in its early stages. When symptoms occur, they can include fatigue, vague abdominal discomfort, or pain in the upper right quadrant. In advanced stages, signs of liver dysfunction such as jaundice, swelling of the abdomen or legs, and confusion may arise. Diagnosis involves a combination of clinical history, physical examination, and diagnostic tests. Blood tests measuring liver enzymes (ALT, AST) often indicate liver inflammation. Imaging techniques like ultrasound, MRI, or FibroScan can identify liver fat and fibrosis. In some cases, a liver biopsy is required to confirm the diagnosis and assess disease severity. Metabolic Dysfunction-Associated Steatohepatitis Epidemiology Segmentation The MASH epidemiology section provides insights into the historical and current MASH patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The MASH market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Prevalent Cases of MASH Diagnosed Prevalent Cases of MASH Gender-specific Diagnosed Prevalent Cases of MASH Severity-specific Diagnosed Prevalent Cases of MASH Metabolic Dysfunction-Associated Steatohepatitis Treatment Market The approval of REZDIFFRA (resmetirom) in March 2024 represents a pivotal achievement in medical innovation, transforming the treatment landscape for MASH disease. This groundbreaking therapy addresses the root causes of MASH, offering renewed hope to patients grappling with this challenging condition. Clinical trials have shown impressive results, with REZDIFFRA effectively reducing symptoms like inflammation and fibrosis, enhancing liver function, and improving patients' quality of life. By providing healthcare professionals with a robust treatment option, this approval addresses a critical unmet need and has the potential to significantly alleviate the complications linked to advanced liver disease. The prevalence of MASLD is strongly linked to type 2 diabetes mellitus and obesity, particularly in individuals with a higher body mass index. However, MASLD occurrence is reduced in T2DM patients receiving treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor agonists, and insulin. Vitamin E, with its antioxidant properties, is regarded as a first-line pharmacological option for managing MASH, especially when dietary and lifestyle interventions are insufficient. Antifibrotic agents can help prevent the progression of liver fibrosis and MASLD into fibrotic MASH. The role of pioglitazone, an anti-diabetic medication, in improving MASH histology in T2DM patients is well-documented, but concerns remain regarding potential side effects like weight gain, fluid retention, cancer risk, and bone fractures. Additional therapeutic targets for MASLD and MASH include G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRα), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery, or weight loss surgery, is the most effective intervention for treating obesity and diabetes, as it reduces food absorption while influencing gut hormone secretion and metabolic function. To know more about MASH treatment guidelines, visit @ Metabolic Dysfunction-Associated Steatohepatitis Management Metabolic Dysfunction-Associated Steatohepatitis Pipeline Therapies and Key Companies Lanifibranor (IVA337): Inventiva Pharma Semaglutide: Novo Nordisk A/S Azemiglitazone (MSDC-0602K): Cirius Therapeutics Efruxifermin (EFX): Akero Therapeutics BIO89-100 (Pegozafermin): 89bio Survodutide (BI 456906): Boehringer Ingelheim/Zealand Pharma GR-MD-02 (Belapectin): Galectin Therapeutics LPCN1144: Lipocine VK2809: Viking Therapeutics Tirzepatide: Eli Lilly and Company BOS-580: Boston Pharmaceuticals Ervogastat (PF-06865571) + Clesacostat (PF-05221304): Pfizer HTD1801: HighTide Biopharma Leronlimab (PRO 140): CytoDyn Efinopegdutide: Merck & Co./Hanmi Pharmaceutical HPG1860: Hepagene (Shanghai) Rencofilstat (CRV431): Hepion Pharmaceuticals EYP001 (Vonafexor): Enyo Pharmaceuticals Semaglutide/ Cilofexor/ Firsocostat: Gilead Sciences PXL065: Poxel SA Saroglitazar Magnesium: Zydus Therapeutics Denifanstat (TVB-2640): Sagimet Biosciences ION224: Ionis Pharmaceuticals Miricorilant (CORT118335): Corcept Therapeutics Discover more about MASH drugs in development @ Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics The MASH market dynamics are expected to change in the coming years. Growing research activities and multiple clinical trials for MASH, driven by the rapid surge in its prevalence due to rising obesity and type 2 diabetes rates, highlight an active drug development pipeline and an expanding market size. The large pool of patients and lucrative growth opportunities present attractive prospects for key players, further supported by ongoing preclinical studies aimed at advancing imaging techniques for MASH diagnosis, potentially eliminating the need for invasive biopsy-based histopathological confirmation. Furthermore, potential therapies are being investigated for the treatment of MASH, and it is safe to predict that the treatment space will significantly impact the MASH market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the MASH market in the 7MM. However, several factors may impede the growth of the MASH market. Lack of awareness and negligence in the early stages of MASH by physicians often lead to disease progression, culminating in irreversible damage where liver transplantation becomes the only viable option. Diagnosing advanced MASH typically requires procedures like liver biopsy, which are costly, invasive, and risky. Regulatory challenges also pose hurdles, as the FDA mandates achieving one MASH endpoint for approval, while the EMA's draft guidance requires efficacy in both endpoints, potentially delaying first-mover approvals in major European markets. Additionally, access to expensive MASH treatments may be limited in certain regions, further hindering patient adoption. Moreover, MASH treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, MASH market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact MASH market growth. Scope of the Metabolic Dysfunction-Associated Steatohepatitis Market Report Therapeutic Assessment: Metabolic Dysfunction-Associated Steatohepatitis current marketed and emerging therapies Metabolic Dysfunction-Associated Steatohepatitis Market Dynamics: Key Market Forecast Assumptions of Emerging Metabolic Dysfunction-Associated Steatohepatitis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Metabolic Dysfunction-Associated Steatohepatitis Market Access and Reimbursement Download the report to understand which factors are driving MASH market trends @ Metabolic Dysfunction-Associated Steatohepatitis Market Trends Table of Contents Related Reports Non-Alcoholic Steatohepatitis Epidemiology Forecast Non-Alcoholic Steatohepatitis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted NASH epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc. , among others. Non-Alcoholic Fatty Liver Disease Pipeline Non-Alcoholic Fatty Liver Disease Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key NAFLD companies, including BeiGene, Inventiva Pharma, Cirius Therapeutics, Madrigal Pharma, Novo Nordisk, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Dr. Falk Pharma GmbH, Sagimet Biosciences, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, Novartis Pharmaceuticals, Afimmune, Poxel SA, AngioLab, Pfizer, Oramed Pharmaceuticals, Can Fite Biopharma, MediciNova, Metacrine, Inc., Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Mitsubishi Tanabe Pharma, Chemomab Therapeutics, NuSirt Biopharma, HK inno.N, Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Enanta Pharmaceuticals, Cascade Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3

30 Jan 2025

·www.pharmaceutical-technology.com

RFK Jr. thrusts domestic manufacturing agenda on Day 2 of confirmation hearings

Robert F. Kennedy Jr. nominee for Secretary of Health and Human Services testifies during his Senate Committee on Health, Education, Labor and Pensions confirmation hearing. Image credit: Getty Images / Kevin Dietsch Robert F. Kennedy Jr. (RFK Jr) has claimed that “China will be able to ransom medical health” in America due to its hold on drug manufacturing during his high-profile confirmation hearing. During the Senate Health, Education, Labor, and Pensions (HELP) Committee meeting held on Thursday (30 January), the nominee for the United States Secretary of Health and Human Services (HHS) under the Trump administration said that it was vital for the US to take back control of drug manufacturing. Kennedy said: “This is a huge priority for President Trump. It is perhaps our greatest national security vulnerability and over the past few years so much of our critical medicine production and supply chains have been moved to China. This is a crisis in our country. If there is a pandemic, if there is a war or any conflict, China will now be able to ransom American health and that is not a good situation. We need to bring that production home and President Trump is committed to doing just that.” This comes soon after the BIOSECURE Act, widely seen as a law that targets China-based pharma manufacturers like Wuxi Biologics, WuXi AppTec and more, was excluded from the National Defense Authorization Act (NDAA) for fiscal year 2025 that was put forth for Senate approval in early December . The BIOSECURE act was expected to be a part of the NDAA after it was passed by the House of Representatives in September 2024. The act seeks to prohibit federal agencies from contracting with or providing funding to any company working with a “biotechnology company of concern”. Medicare & Medicaid, vaccines and obesity drugs also discussed Senators grilled Kennedy on several topics as part of the nomination hearings, including his stance on vaccines , which was also raised yesterday (29 January). Kennedy stated he is not “anti-vaccine” in yesterday’s session, and added today that he would continue to evaluate safety and efficacy of all vaccines. Addressing Kennedy in today’s hearing, Republican Senator Bill Cassidy said: “Your past of undermining confidence in vaccines with unfounded or misleading arguments concerns me. I have constituents who partly credit you for their decision to not vaccinate their child…..You have cast doubt on some of these vaccines, but the data has been there for a long time.” Another concern raised in today’s committee was Kennedy’s “lack of knowledge” about Medicare and Medicaid, both of which would come under the aegis of the Department of the Health and Human Services, which Kennedy has been nominated to lead. Kennedy incorrectly stated Medicare Part A is “mainly for primary care or physicians,” while it covers seniors’ inpatient hospital care. On Medicare Part B, Kennedy said “it’s for physicians and doctors,” but Democratic Senator Maggie Hassan clarified it is for outpatient care and home health. On Medicare Part C, Kennedy said it’s for “the full menu of all the services A, B, C and D” but Hassan corrected him that it is for Medicare Advantage, which includes Medicare Part A and Part B. Kennedy also shared his views on glucagon-like peptide 1 agonists (GLP-1RAs) at the hearing. He said: “The GLP class of drugs are miracle drugs, but I do not think they should be the first front line intervention for six-year-old kids. That is the standard of practice now” Novo Nordisk ’s Wegovy (semaglutide) has been approved by the US Food and Drug Administration (FDA) for the treatment of obesity in children 12 years of age or older. It has not been approved anywhere globally for children under the age of 12. Eli Lilly’s Zepbound is not approved in children of any age. Frequently asked questions Who is RFK Jr.? Robert Francis Kennedy Jr., also known by his initials RFK Jr., is an American politician and is the nominee for United States Secretary of Health and Human Services in President Donald Trump's second cabinet.

Drug ApprovalExecutive Change

29 Jan 2025

·jaguarhealth.gcs-web.com

Jaguar Health Supports Evaluation of FDA-Approved Crofelemer to Address GI Side Effects of GLP-1 and Other Weight Loss Therapies: Files Patent Application with USPTO

Gastrointestinal disorders are the most frequently reported adverse effects during clinical trials of GLP-1 agonists; GI adverse events usually develop in 40-70% of treated patients, and have been reported in up to 85% Crofelemer, approved by the FDA under the brand name Mytesi® for HIV-related diarrhea, has demonstrated a significant benefit in improving gastrointestinal symptoms, including diarrhea, abdominal pain and discomfort, incontinence, bloating and constipation, when studied in populations with HIV-related diarrhea, cancer therapy-related diarrhea, and IBS Crofelemer could have a significant supportive impact on GLP-1 therapies, one of the fastest growing classes of drugs, estimated to be a $56 billion global market in 2025 and projected to grow at a CAGR of 21% to $322 billion 20341 SAN FRANCISCO, CA / ACCESS Newswire / January 29, 2025 / Jaguar Health, Inc . (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced Napo's filing of a broad defining provisional patent application with the U.S. Patent and Trademark Office (USPTO) for crofelemer, Jaguar's novel plant-based FDA-approved gastrointestinal normalizing prescription drug, to mitigate the gastrointestinal side effects associated with glucagon-like peptide-1 (GLP-1) receptor agonists and antagonists, together with other incretin-based therapies including glucose-dependent insulinotropic polypeptide (GIP) agonists and antagonists, and glucagon-agonist drugs. GLP-1 and GIP drugs are analogs for incretin hormones that are released by the gut and bind to receptors in the brain and gastrointestinal tract, suppressing appetite, which consequently leads to body weight loss. "Gastrointestinal disorders were the most frequently reported adverse effects during clinical trials and real-world experience of GLP-1 receptor agonists, 2 such as semaglutide, tirzepatide, and liraglutide. GI adverse events usually develop in 40-70% of patients treated with GLP-1 receptor agonists, although they have sometimes been reported in up to 85%, 3 which can lead to dose limitations or dose discontinuations. There are also numerous investigative agents, including incretins and combinations with GLP-1 drugs, both as receptor agonists and antagonists, all of which are associated with significant GI side effects, often in a dose-dependent manner. Our IP strategy includes claims for both commercialized obesity drugs and incretin-based therapies in development. Crofelemer, approved by the U.S. Food and Drug Administration under the brand name Mytesi for HIV-related diarrhea, has demonstrated a significant benefit in improving gastrointestinal symptoms, including diarrhea, abdominal pain and discomfort, incontinence, bloating and constipation, when studied in populations with HIV-related diarrhea, cancer therapy-related diarrhea, and IBS," said Lisa Conte , Jaguar's founder, president, and CEO. "Crofelemer has a safety profile supporting its chronic utilization, and we are excited about crofelemer's possible potential to normalize specific GI side effects associated with obesity therapies, address patient comfort, and help patient's stay on their therapy." About CrofelemerCrofelemer is a novel, oral plant-based prescription medicine purified from the red bark sap, also referred to as "dragon's blood," of the Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities. About the Jaguar Health Family of Companies Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi ® for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription medicines derived from plants for mental health indications. For more information about: Jaguar Health , visit https://jaguar.health Napo Pharmaceuticals , visit www.napopharma.com Napo Therapeutics, visit napotherapeutics.com Magdalena Biosciences, visit magdalenabiosciences.com Visit the Make Cancer Less Shitty patient advocacy program on Bluesky, X, Facebook & Instagram Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements." These include statements regarding Jaguar's expectation that crofelemer could have a significant supportive impact on GLP-1 therapies, and Jaguar's expectation that crofelemer may have the potential to normalize specific GI side effects associated with obesity therapies, address patient comfort, and help patient's stay on their therapy. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 1 GLP-1 Analogues Market Outlook: Rapid Growth at 21.3% CAGR to Surpass USD 322.85 Billion by 2034 | PMR 2 Sun F, Chai S, Yu K, Quan X, Yang Z, Wu S, Zhang Y, Ji L, Wang J, Shi L. Gastrointestinal adverse events of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes: a systematic review and network meta-analysis. Diabetes Technol Ther. 2015;17(1):35-42. doi: 10.1089/dia.2014.0188 3 J Clin Med. 2022 Dec 24;12(1):145. Clinical Recommendations to Manage Gastrointestinal Adverse Events in Patients Treated with GLP-1 Receptor Agonists: A Multidisciplinary Expert Consensus CONTACT:hello@jaguar.healthJaguar-JAGX SOURCE: Jaguar Health, Inc.

Drug Approval

100 Deals associated with Tirzepatide

External Link

KEGG	Wiki	ATC	Drug Bank
D11360	Tirzepatide	-	DB15171

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Sleep Apnea, Obstructive	US	Eli Lilly & Co.	20 Dec 2024
Obesity	US	Eli Lilly & Co.	08 Nov 2023
Overweight	US	Eli Lilly & Co.	08 Nov 2023
Weight Gain	AU	Eli Lilly Australia Pty Ltd.	23 Dec 2022
Diabetes Mellitus, Type 2	US	Eli Lilly & Co.	13 May 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heart failure with normal ejection fraction	NDA/BLA	CN	Eli Lilly & Co.	22 Nov 2024
Obesity Hypoventilation Syndrome	NDA/BLA	CN	Eli Lilly & Co.	15 Sep 2024
Plaque psoriasis	Phase 3	US	Eli Lilly & Co.	30 Sep 2024
Plaque psoriasis	Phase 3	PR	Eli Lilly & Co.	30 Sep 2024
Arthritis, Psoriatic	Phase 3	US	Eli Lilly & Co.	24 Sep 2024
Arthritis, Psoriatic	Phase 3	PR	Eli Lilly & Co.	24 Sep 2024
Cardiovascular Diseases	Phase 3	US	Eli Lilly & Co.	29 May 2020
Cardiovascular Diseases	Phase 3	US	Lilly Asia Shanghai Representative Office	29 May 2020
Cardiovascular Diseases	Phase 3	AR	Lilly Asia Shanghai Representative Office	29 May 2020
Cardiovascular Diseases	Phase 3	AR	Eli Lilly & Co.	29 May 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04847557 (SUMMIT, Pubmed \| N Engl J Med)	Phase 3	Heart failure with normal ejection fraction	731	Tirzepatide	opowflghpm(kccdjemvqp) = mainly gastrointestinal, leading to discontinuation of the trial drug occurred in 23 patients (6.3%) in the tirzepatide group and in 5 patients (1.4%) in the placebo group nvgpbopkvl (fbbmvvvidf )	Positive	30 Jan 2025
				Placebo
NCT04166773 (SYNERGY-NASH, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	190	Tirzepatide (5 mg Tirzepatide)	lugzdfgjct(ptjtfunebb) = zbgpnvteme ucsvakliuj (vyarrrijrm, ymitzlzamj - ditduznhjb) View more	-	24 Jan 2025
				Tirzepatide (10 mg Tirzepatide)	lugzdfgjct(ptjtfunebb) = cfxirwnuzt ucsvakliuj (vyarrrijrm, jbuozvatnd - jgxucffahj) View more
Pubmed Manual	Not Applicable	Overweight \| Obesity	15,491	Tirzepatide 15 mg once weekly	jwlpallvyo(nxochasijs) = hufqcdqsgh qbnrujvyrq (anhshsabub )	Positive	07 Jan 2025
				Semaglutide 2.4 mg once weekly	jwlpallvyo(nxochasijs) = phejdbyobo qbnrujvyrq (anhshsabub )
NCT04093752 (SURPASSAP-Combo, NEWS) Manual	Phase 3	Diabetes Mellitus, Type 2	-	替尔泊肽 15mg每周一次	zuorsqkiqn(njptaobrjp) = xrssytcelr jqqqhxcvch (ufvjueiznx ) View more	Positive	31 Dec 2024
NCT05822830 (SURMOUNT-5, Company_Website) Manual	Phase 3	Obesity	751	Zepbound (tirzepatide)	mauhtfbeis(xojnyhzpwm) = jrkwouxctd bgmsfexfny (wzijqcldqd ) View more	Superior	04 Dec 2024
				Wegovy (semaglutide)	mauhtfbeis(xojnyhzpwm) = qtpoqymqmo bgmsfexfny (wzijqcldqd ) View more
NCT04847557 (SUMMIT, Pubmed) Manual	Phase 3	Heart failure with normal ejection fraction \| Obesity	731	Tirzepatide	kcfzfhnzrk(sjtcwohyyz) = djdseainvw iivcyepsfy (nguwwmwyru ) View more	Positive	16 Nov 2024
				Placebo	kcfzfhnzrk(sjtcwohyyz) = swwdinucmt iivcyepsfy (nguwwmwyru ) View more
NCT04184622 (SURMOUNT-1, Literature) Manual	Phase 3	Diabetes Mellitus \| Obesity	2,539	Tirzepatide	hsaunszeyy(jiwjnorvqq) = ipgplygauj sqqiprzwcw (unfybvclti ) View more	Positive	13 Nov 2024
				Tirzepatide 5 mg	hsaunszeyy(jiwjnorvqq) = kzkloayntf sqqiprzwcw (unfybvclti ) View more
NCT04184622 (Pubmed \| N Engl J Med)	Phase 3	Diabetes Mellitus \| Obesity	-	Tirzepatide 5 mg	lwacjymxla(ftrzherqsv) = most common adverse events were gastrointestinal, most of which were mild to moderate in severity and occurred primarily during the dose-escalation period in the first 20 weeks of the trial fzuqpoqcnm (trhpnotgky )	-	13 Nov 2024
				Tirzepatide 10 mg
NCT03730662 \| NCT03954834 \| NCT04039503 \| NCT03987919 \| NCT03882970 (SURPASS-1 to -5, Pubmed \| Diabetes Ther)	Phase 3	Diabetes Mellitus, Type 2	-	Tirzepatide 5 mg	pqrnprlgmu(zbkcggxlxv) = The most common treatment-emergent adverse events were gastrointestinal in nature iyromwcluj (swkjksrbgx )	Positive	12 Nov 2024
				Tirzepatide 10 mg

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