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Last update 27 Feb 2026

Lixisenatide

Last update 27 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

des-38-proline-exendine-4 (Heloderma suspectum)-(1-39)-peptidylpenta-L-lysyl-L-lysinamide, DesPro38Exendin-4(1-39)-Lys6-NH2, Lixisenatide (JAN/USAN/INN)

+ [13]

Target

GLP-1R

Action

agonists

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 2

Inactive Indication

Acute Coronary SyndromeDiabetes Mellitus, Type 1Gastroparesis+ [4]

Originator Organization

Zealand Pharma A/S

Active Organization

Sanofi-Aventis Canada, Inc.Sanofi KK

Sanofi-Aventis U.S. LLC

Inactive Organization

Sanofi

Sanofi Winthrop Industrie SASanofi-Aventis Recherche & Développement SA

+ [3]

License Organization

Sanofi

Royalty Pharma Plc

Zealand Pharma A/S

Drug Highest PhaseApproved

First Approval Date

European Union (31 Jan 2013),

Diabetes Mellitus, Type 2

Regulation-

Structure/Sequence

Sequence Code 25682

Source: *****

Clinical Trials associated with Lixisenatide

NCT07173712

/ Not yet recruitingPhase 4IIT

Regimen Transition After Short-Term Intensive Insulin Therapy in Type 2 Diabetes Mellitus Patients With Inadequate Glycemic Control on Oral Hypoglycemic Agents: A Multicenter, Open-Label, Randomized Controlled Study

Failure of oral antidiabetic drugs (OADs) is a frequent challenge in patients with type 2 diabetes mellitus (T2DM), and inadequate long-term glycemic control substantially increases the risk of diabetic complications. Short-term intensive insulin therapy (SIIT) is an established approach to mitigate glucotoxicity; however, the optimal strategy to sustain long-term glycemic benefits after SIIT in T2DM patients with OAD failure remains unclear. To address this gap, we designed a randomized controlled trial to evaluate subsequent treatment options, aiming to identify a simple and effective regimen for patients with poor glycemic control who undergo SIIT.
A total of 324 eligible patients will be enrolled. After screening, previous antidiabetic regimens will be discontinued, and patients will be randomly assigned to the SIIT- iGlarLixi group (A), the SIIT-IDegAsp group (B), or the SIIT-iGlar group (C). All patients will be hospitalized for short-term insulin pump therapy, followed by 24 weeks of treatment: group A with insulin glargine/lixisenatide, group B with insulin degludec/aspart, and group C with insulin glargine U300 plus metformin. During the extension follow-up period, patients in all groups may either continue their assigned regimen or return to their original pre-study therapy. A total of 10 clinic visits are scheduled for each patient throughout the study.
Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at 24 weeks.Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at 24 weeks; differences in weight gain, hypoglycemic events among treatment groups, and differences in proportion of patients continuing the assigned regimen, glycemic control and body weight at the extension follow-up period.

Start Date15 Mar 2026

Sponsor / Collaborator

Sun Yat-Sen University

NCT07117240

/ Enrolling by invitationPhase 4IIT

Efficacy of Treatment Strategies for Steroid-induced Diabetes - a Comparison of GLP-1 Receptor Agonist Plus Basal Insulin With Intensive Insulin Therapy

Glucocorticoids are commonly used in the treatment of autoimmune, inflammatory, and neoplastic diseases. Despite their therapeutic efficacy, they are associated with significant metabolic side effects. In the proposed research, the aim is to assess the metabolic efficacy and safety of fixed-ratio combination therapy (basal insulin + GLP-1 receptor agonist) compared to standard insulin therapy in patients with SID. In a selected group of patients, a randomised clinical trial would be conducted to assess the potential benefits of GLP-1 receptor agonists in the management of SID.

Start Date10 Jul 2025

Sponsor / Collaborator

Warszawski Uniwersytet Medyczny

CTRI/2024/10/075222

/ Not yet recruitingPhase 4

A Multicentre Phase IV single arm clinical trial to evaluate the safety and efficacy of a fixed ratio combination of Insulin Glargine and Lixisenatide in adult patients with Type 2 diabetes who are sub optimally controlled on oral anti-hyperglycemic drugs and/or basal Insulin/GLP-1 RA - iGlarLixi Phase 4 study in India

Start Date28 Oct 2024

Sponsor / Collaborator

Sanofi Healthcare India Pvt Ltd.

100 Clinical Results associated with Lixisenatide

100 Translational Medicine associated with Lixisenatide

100 Patents (Medical) associated with Lixisenatide

506

Literatures (Medical) associated with Lixisenatide

01 Apr 2026·CURRENT OPINION IN NEUROBIOLOGY

The challenges of experimental pharmacology in identifying novel treatments for Parkinson's disease

Review

Author: Huot, Philippe ; Teil, Margaux

An important part of the field of experimental pharmacology encompasses the study of the effects of molecules in animals. In the case of Parkinson's disease (PD), animal models have played an invaluable role in refining our understanding of the disease, in characterizing the effect of new compounds on the illness, and in bringing new treatments to the clinic. Indeed, it is now hardly conceivable that a drug would be tested in humans if several parameters pertaining to safety, toxicology, efficacy, etc. had not previously been evaluated in animal models. Quite unfortunately, efficacy in experimental models of PD does not necessarily guarantee positive clinical outcomes. In this article, which primarily focusses on the past five years, we review drugs that entered clinical trials for the treatment of levodopa-induced dyskinesia, parkinsonism, disease modification, and had previously been assessed in animal models of PD. The drugs discussed are buspirone, JM-010, befiradol, mesdopetam, foliglurax, dipraglurant, tavapadon, prasinezumab, cinpanemab, nilotinib, minzasolmin, exenatide, NLY01, liraglutide, lixisenatide, and semaglutide. For each molecule, we examine how previous preclinical studies succeeded or failed in predicting efficacy in clinical trials and discuss possible ways to optimize animal-model design and selection to maximize the probability of translational success.

01 Feb 2026·DIABETES OBESITY & METABOLISM

One‐year usage patterns of SGLT ‐2 inhibitors and GLP ‐1 receptor agonists in individuals with type 2 diabetes in a real‐world population

Article

Author: Donnelly, Louise A. ; McCrimmon, Rory J. ; Singh, Katyayeni ; Pearson, Ewan R.

Abstract:

Aims:

Real‐world studies of sodium‐glucose co‐transporter‐2 inhibitors (SGLT2i) and glucagon‐like peptide‐1 receptor agonists (GLP‐1RA) typically assess adherence and discontinuation as separate outcomes. We applied a novel approach that integrates these measures to categorize patterns of drug usage. We describe patterns across individual subclasses, and in overall class‐level models, we examined clinical characteristics associated with each category with particular interest in poor adherence and intolerance.

Materials and Methods:

We conducted an observational cohort study using electronic health records from the Scottish Care Information Diabetes Collaboration database, including individuals with type 2 diabetes who initiated a SGLT2i or GLP‐1RA. Each initiation was followed for 1 year and classified into five mutually exclusive groups: adherent, poor adherence and three discontinuation categories including a proxy for intolerance.

Results:

Among SGLT2is, poor adherence was more common in younger individuals, with greater socioeconomic deprivation, and higher HbA 1c , while intolerance was more frequent in older, leaner females and in those with prior genital thrush. For GLP‐1RAs, newer agents were associated with more favourable usage patterns. Poor adherence was more frequent with liraglutide, lixisenatide, and exenatide compared to semaglutide, and intolerance was more common with lixisenatide. In addition, poor adherence was associated with younger age and prior GLP‐1RA use, while intolerance was linked to lower BMI, female sex, and more advanced CKD.

Conclusions:

Distinct clinical and biochemical characteristics are associated with poor adherence versus discontinuation. Understanding these patterns is crucial for developing targeted strategies to improve sustained use, ultimately enhancing treatment outcomes for people with type 2 diabetes.

05 Dec 2025·MEDICINE

Assessing the shadows: A meta-analysis of GLP-1 agonists and suicidal ideation

Article

Author: Alsalmi, Bodour Saleh ; Alansari, Amal Omar ; Alamer, Bader ; Alharbi, Ahlam Saleem ; AlAjlan, Fadiyah Abdullah ; Alharbi, Abeer Abdullah ; Alzahrani, Basmah Saleh ; Alshehri, Khaled Mohammad ; Alatawi, Amirah M. ; Alhabib, Ali Tareq ; Almosfer, Waleed Abdulaziz

Background::

Glucagon-like peptide-1 receptor agonists (GLP-1 agonist) have revolutionized the treatment of obesity. However, regulatory agencies have reported an association with suicidality. To the best of our knowledge, this is the first meta-analysis to assess the association between GLP-1 agonist use, suicidal ideation, and suicide completion. We aimed to assess the same in patients with diabetes and obesity.

Methods::

We searched 6 databases for relevant articles, from the first published article to October 2024. The keywords used were GLP-1 agonists, suicidal ideation, suicide, suicidal behavior, semaglutide, liraglutide, tripeptide, exenatide, and lixisenatide. We identified 354 studies and 126 stands after the removal of duplicates, of which 23 were eligible, and only 12 studies were included in the final meta-analysis.

Results::

No significant statistical difference was found in suicidal ideations in patients on GLP-1 agonists compared to their counterparts on other obesity and diabetes drugs (odds ratio [OR], 1.0; 95% confidence interval [CI]: 1.0–1.0). No significant difference was observed between patients on GLP-1 agonists and their counterparts regarding complete suicide (OR, 1.77; 95% CI: 0.80–3.91). In a subgroup analysis, suicide was higher among patients on liraglutide compared to their counterparts on semaglutide (OR, 1.48; 95% CI: 1.17–1.89). No significant statistical difference was observed when comparing monjaro and semaglutide (OR, 0.98; 95% CI: 0.94–1.03).

Conclusion::

No significant statistical difference was found between GLP-1 agonists and other obesity and diabetes drugs regarding suicide/suicidal ideation. In a subgroup analysis, suicide was higher in patients on liraglutide compared to semaglutide, with no significant difference between semaglutide and monjaro. Randomized controlled trials that assess the association between GLP-1 agonists and suicidality are highly recommended.

News (Medical) associated with Lixisenatide

11 Dec 2025

·pharma.economictimes.indiatimes.com

Regeneron drug wipes out residual multiple myeloma cells in small trial

London: A recently approved antibody drug from Regeneron Pharmaceuticals eradicates residual traces of multiple myeloma after initial treatments, potentially allowing patients to avoid grueling bone marrow transplants, preliminary data from a small mid-stage trial suggest. Patients in the trial had received initial treatments that eliminated nearly all of their cancer cells. Usually, individuals with residual cancer cells , accounting for roughly half of patients treated with modern first-line drugs, would go on to receive high-dose toxic chemotherapy to destroy the remaining cancer cells and a bone marrow transplant to regrow healthy replacements. Study leader Dr. C. Ola Landgren of University of Miami Miller School of Medicine called the regimen "a brutal treatment." Instead, patients in the study received Regeneron's Lynozyfic, which was approved by the U.S. Food and Drug Administration in July for treatment of recurrent multiple myeloma. While most therapeutic antibodies attach to a single target, Lynozyfic attaches to two, CD3, a protein on T cells that destroys cancerous cells, and BCMA, a protein on multiple myeloma cells. None of the 18 trial participants who have so far completed up to six cycles of treatment with Lynozyfic have had detectable residual disease afterward on highly sensitive tests, the researchers reported at the American Society of Hematology annual meeting in Orlando. Ultimately they plan to enroll a total of 50 patients. Those who test negative for residual multiple myeloma cells can expect to live years longer without their cancer returning than those positive for it, Landgren said in a statement. "Based on my experience, I would predict that after having such a good response after such a short time, the disease most likely could stay away for many years," he said. "Could it never come back in some patients? I would say it's possible." GLP-1 DRUGS DO NOT APPEAR TO CUT CANCER RISKS Widely used weight-loss medications from the class known as GLP-1s likely have little or no effect on risk for obesity-related cancers, a large study suggests, although longer follow-up is needed to be certain. Researchers analyzed data from 48 trials involving 94,245 participants with type 2 diabetes or overweight or obesity who were randomly assigned to receive GLP-1 drugs or a placebo. Results showed the drugs probably have little or no effect on risk for cancers of the thyroid, pancreas, colon and rectum, stomach, esophagus, liver, gallbladder, breast, ovaries, endometrium, kidneys, or the blood cancer multiple myeloma or the brain cancer meningioma, researchers reported in Annals of Internal Medicine. Twenty of the trials tested semaglutide, the main ingredient in Novo Nordisk's Ozempic, Wegovy, and Rybelsus. Ten tested Novo's liraglutide, sold as Victoza and Saxenda. Eli Lilly's tirzepatide, sold as Mounjaro and Zepbound, was tested in eight trials. The remaining 11 trials tested Sanofi's Adlyxin (sold as Lyxumia outside the U.S.), Lilly's Trulicity, or AstraZeneca's Byetta. Most of the studies were not designed to assess cancer risks or benefits, and for some outcomes the findings were of low certainty, the researchers acknowledged. Longer-term studies with cancer-specific end points are needed to clarify potential risks or protective effects of the medicines, the researchers said. PRE-TEEN SMARTPHONE OWNERSHIP LINKED WITH HEALTH RISKS Smartphone ownership in early adolescence is linked with higher risks for depression, obesity, and insufficient sleep, according to a large U.S. study. More than 10,500 youngsters from 21 states were surveyed annually between 2018 and 2021 and also screened for depression, obesity, and whether or not they were getting a full nine hours of sleep per night. By age 12, roughly two-thirds of the children owned a smartphone, researchers reported in Pediatrics. These young smartphone owners had a 31% higher risk of depression, a 40% higher risk of obesity, and a 62% higher risk of insufficient sleep compared to their peers who did not own smartphones, the researchers found. By age 13, those who hadn't owned a smartphone at age 12 but who had acquired one in the past year were 57% more likely to report symptoms of clinical depression and 50% more likely to be getting insufficient sleep, compared to children who still didn't own smartphones. The younger the age at which children acquired a smartphone, the greater their risk of obesity and insufficient sleep at age 13, the researchers also found. "Our findings suggest that we should view smartphones as a significant factor in teen health, approaching the decision to give a child a phone with care and considering potential impacts on their life and health," study leader Dr. Ran Barzilay of the Hospital of the University of Pennsylvania said in a statement. The study cannot prove the smartphones caused these problems, and the authors say the devices will not be associated with detrimental outcomes in every adolescent. "Rather, we advocate for thoughtful consideration of the health implications, balancing both positive and negative consequences," Barzilay said. "For many teens, smartphones can play a constructive role by strengthening social connections, supporting learning, and providing access to information and resources that promote personal growth," he added. (To receive the full newsletter in your inbox for free sign up here) (Reporting by Nancy Lapid; Editing by Bill Berkrot)

Drug ApprovalClinical ResultASH

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

100 Deals associated with Lixisenatide

External Link

KEGG	Wiki	ATC	Drug Bank
D09729	Lixisenatide	A10BJ03	DB09265

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	European Union	Sanofi Winthrop Industrie SA	31 Jan 2013
Diabetes Mellitus, Type 2	Iceland	Sanofi Winthrop Industrie SA	31 Jan 2013
Diabetes Mellitus, Type 2	Liechtenstein	Sanofi Winthrop Industrie SA	31 Jan 2013
Diabetes Mellitus, Type 2	Norway	Sanofi Winthrop Industrie SA	31 Jan 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nutrition Disorders	Phase 3	Italy	Sanofi-Aventis Recherche & Développement SA	08 Feb 2013
Acute Coronary Syndrome	Phase 3	United States	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	China	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Japan	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Argentina	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Australia	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Austria	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Belarus	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Belgium	Sanofi	01 Jun 2010
Acute Coronary Syndrome	Phase 3	Brazil	Sanofi	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GU2025	Phase 3	Prostatic Cancer	-	GLP-1 receptor agonists (GLP-1RAs)	jyejyaffix(dsrgzugmte) = ctcqtxyogn ovlyaatgvv (znpuugcvaz )	Negative	13 Feb 2025
				Placebo/non-GLP-1 RA regimens	jyejyaffix(dsrgzugmte) = saeencdggi ovlyaatgvv (znpuugcvaz )
NCT03439943 (LIXIPARK, Pubmed \| N Engl J Med)	Phase 2	Parkinson Disease	156	Lixisenatide	toisclqrkm(ooomplopue) = Nausea occurred in 46% of participants receiving lixisenatide dvcjedtygm (dbopnaiztf ) View more	Positive	04 Apr 2024
				Placebo
NCT03439943 (LIXIPARK, Literature) Manual	Phase 2	Parkinson Disease	156	Lixisenatide	pojdszlojb(ajobagdagd) = akwfspxmji avimvrisrq (yozocnpoot ) View more	Positive	03 Apr 2024
				Placebo	pojdszlojb(ajobagdagd) = tiszwggwna avimvrisrq (yozocnpoot ) View more
NCT03798054 \| NCT03798080 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	iGlarLixi	uukznnoxmd(uudqvplrnh): P-Value = 11.45	-	30 Mar 2023
				Glargine 100 U/mL
NCT03798080 (LixiLan-L-CN, Pubmed \| Diabetes Obes Metab) Manual	Phase 3	Diabetes Mellitus, Type 2	426	iGlarLixi	lnfccueiyb(yrmamvadex) = cuwcwzgqtf mxjjrbilgf (dllrkvdyco ) View more	Superior	28 Jun 2022
				insulin glargine	lnfccueiyb(yrmamvadex) = pmkemoswou mxjjrbilgf (dllrkvdyco ) View more
STAR.Ro (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 2	901	Lixisenatide+Insulin glargine	pacmuyxziy(tjhrjtqrfy) = rdsdulypzd vyrecuvdeg (zwkoopsolx, -1.4 to -1.2) View more	Positive	27 May 2022
NCT03798054 (LixiLan-O-AP, Pubmed \| Diabetes Obes Metab)	Phase 3	Diabetes Mellitus, Type 2	878	iGlarLixi	hmcghzdejf(bwuxwdgfgn) = pnxqgpzpyh axjztggtug (gwuakpkabp ) View more	Positive	19 Apr 2022
				Insulin glargine 100 U/mL	hmcghzdejf(bwuxwdgfgn) = gnqpebtids axjztggtug (gwuakpkabp )
NCT02231658 (EASD2020)	Phase 1	Diabetes Mellitus, Type 2	57	Lixisenatide	qftguofanl(brkolyxcmw) = bstwvxzxjq zwviaiahcp (argyzvuutg ) View more	Positive	24 Sep 2020
				Liraglutide	qftguofanl(brkolyxcmw) = kifzipulrw zwviaiahcp (argyzvuutg )
NCT02231658 (Pubmed \| Diabetes Care)	Phase 1	Diabetes Mellitus, Type 2	57	Lixisenatide	fanoxwtwsi(qydtkstmvy) = okwizsdliu okcnzpgxkh (svpoxnlorj, -40.6, - 0.8) View more	-	09 Jul 2020
				Liraglutide	ctgrwvwxuo(yvvqidydas) = zopzkprauf qxtvvdpycx (xsqwgeqfvl, 3 - 46)
NCT02640118 (Pubmed \| Diabetologia)	Not Applicable	Diabetes Mellitus	12	Lixisenatide	szsxtoyxra(neqpenxkzd) = diwlruzsvx xmgxujshbt (jjtvpvjmbv ) View more	-	01 Jul 2020
				Placebo	szsxtoyxra(neqpenxkzd) = gzhjonmpmp xmgxujshbt (jjtvpvjmbv ) View more

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