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Last update 15 Sep 2025

Lixisenatide

Last update 15 Sep 2025

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)

+ [11]

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 SyndromeGastroparesisParkinson Disease+ [1]

Originator Organization

Zealand Pharma A/S

Active Organization

Sanofi-Aventis U.S. LLC

Sanofi Winthrop Industrie SASanofi-Aventis Canada, Inc.

+ [2]

Inactive Organization

SanofiSanofi-Aventis Recherche & Développement SA

Sanofi (China) Investment Co. Ltd.

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

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.

NCT05804513

/ Unknown statusPhase 4IIT

The Effect of Lixisenatide on the Effect of Pituitary Hormones

The current study has two aims:
1. to test the hypothesis that a single dose of lixisenatide can be used as a growth hormone stimulation test;
2. to test if the growth hormone-stimulating effect is mediated by changes in blood glucose.
The secondary objective of the study is to monitor the effect of lixisenatide on other pituitary hormones and physiological parameters (blood glucose, blood pressure, heart rate, nausea).

Start Date17 Apr 2023

Sponsor / Collaborator

University of Tartu

[+1]

JPRN-UMIN000047518

/ RecruitingNot Applicable

Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients - Comparison of efficacy and safety of insulin glargine U-100/lixisenatide and insulin degludec/liraglutide in type 2 diabetes patients

Start Date03 Jun 2022

Sponsor / Collaborator-

100 Clinical Results associated with Lixisenatide

100 Translational Medicine associated with Lixisenatide

100 Patents (Medical) associated with Lixisenatide

579

Literatures (Medical) associated with Lixisenatide

01 Sep 2025·Journal of Diabetes

Impact of GLP‐1 Receptor Agonists on Suicide Behavior: A Meta‐Analysis Based on Randomized Controlled Trials

Article

Author: Zhang, Xiaoming ; Si, Yuexiu ; Dai, Tianfu ; Zhang, Qiufeng ; Xiang, Zhiyi ; Zhu, Sidong ; Wu, Qingping ; Chen, Jingqi

ABSTRACT:

Background:

This meta‐analysis aims to assess the association between exposure to glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and the incidence of suicidal behavior in patients with type 2 diabetes mellitus (T2DM)/obesity.

Methods:

A comprehensive search of electronic databases, including PubMed, Web of Science, the Cochrane Library, and ClinicalTrials.gov, was conducted from the inception of the databases. The risk ratio (RR) and 95% confidence intervals (95% CI) were calculated.

Results:

This meta‐analysis included data from 25 randomized controlled trials (RCTs). The results indicated no significant difference in the incidence of suicidal behavior between the GLP‐1 RA exposure group and the control group (RR = 0.84, 95% CI: 0.54–1.32, p = 0.46, I2 = 0%). Subgroup analysis showed no significant differences in the incidence of suicidal behavior among participants with T2DM (RR = 0.74), obesity (RR = 1.07), adolescents (RR = 0.91), and adults (RR = 0.84). Additionally, no significant differences were observed between the two groups in any type of suicidal behavior, including suicidal ideation (RR = 1.04), suicide attempts (RR = 0.68), depression‐related suicides (RR = 0.65), and completed suicides (RR = 1.06). There were also no significant differences between the groups for any type of GLP‐1 RA, including dulaglutide (RR = 0.46), exenatide (RR = 0.98), semaglutide (RR = 0.82), lixisenatide (RR = 1.25), and liraglutide (RR = 0.92). No significant differences were observed between the exposure group and control group according to different comparators, including placebo (RR = 0.91) and others (RR = 1.08). All subgroup analyses showed p‐values greater than 0.05 (two‐sided tests) and I2 values of 0%.

Conclusion:

Our findings suggest that there is no significant association between GLP‐1 RA exposure and suicidal behaviors in patients with T2DM or obesity.

11 Aug 2025·CURRENT PHARMACEUTICAL DESIGN

An Insight into Pharmaceutical Design and Pharmacokinetic Characteristics of GLP-1 RAs

Article

Author: Alsubahi, Ramzyah A. ; Alamoudi, Mariam K. ; Khyat, Nada O. ; Alsibyani, Rawan W. ; Zayed, Mohamed F. ; Alshami, Rahaf Z.

Introdcution::

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are among the most effective treatments for type 2 diabetes mellitus (T2DM). GLP-1 RAs stimulate pancreatic receptors, improving glycemia by boosting insulin secretion while decreasing glucagon secretion. GLP-1 receptors are present in pancreatic tissue. They are also found in extra-pancreatic tissue and have been shown to reduce body weight while also protecting the heart and endothelial cells. The most prevalent types of GLP-1 RAs can be injected twice daily (exenatide), once daily (lixisenatide and liraglutide), or once weekly (albiglutide, dulaglutide, exenatide once, semaglutide, tirzepatide). GLP-1 receptor agonists also reduce gastric emptying, preventing substantial post-meal glycaemic increases. Many publications have been written regarding GLP-1 RAs, covering various features of this family. However, the purpose of this study is to investigate the pharmacological design models and pharmacokinetic characteristics of the most regularly used members of this class, as well as to highlight contemporary developments in GLP-1 RAs. It also describes the physicochemical features, techniques of manufacture, the effects of molecular structure, and structural modifications on pharmacological activity.

Methods::

The literature review was completed using a structured approach to identify and integrate relevant literature. It involved a broad search of reputable medical databases using inclusion and exclusion criteria.

Result::

They are classified as short-acting or long-acting based on the length of their action. Short-acting GLP-1 RAs and long-acting GLP-1 RAs have differing efficacy profiles. Furthermore, the methods of administration, mode of action, and side effects of these medications are relevant to their pharmacological design and pharmacokinetic properties.

Discussion::

The treatment of type 2 diabetes and obesity has evolved with the advent of GLP-1 RAs. These drugs have a multifaceted approach, emphasizing glycemic regulation, weight loss, and reduction of cardiovascular risk. Their unique mode of action, strong safety profile, and ability to be individualized according to each patient's needs make them a valuable therapeutic option in the management of metabolic disorders. Their pharmacological activities are also influenced by their different structural and pharmacokinetic properties.

Conclusion::

GLP-1 RAs have a complex strategy due to their pharmacological nature. The variations in their design have led to various members with varying pharmacodynamic and pharmacokinetic features.

01 Aug 2025·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Cardiovascular Effects and Tolerability of GLP-1 Receptor Agonists: A Systematic Review and Meta-Analysis of 99,592 patients

Article

Author: Federici, Massimo ; Angiolillo, Dominick J ; Bernardi, Marco ; Sciarretta, Sebastiano ; Simeone, Beatrice ; Benenati, Stefano ; Ortega-Paz, Luis ; Rocco, Erica ; Greco, Ernesto ; Spadafora, Luigi ; Mehran, Roxana ; Crea, Filippo ; Laudani, Claudio ; Sarto, Gianmarco ; Frati, Giacomo ; D'Amario, Domenico ; Galli, Mattia

BACKGROUND:

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have demonstrated significant cardiovascular (CV) benefits particularly in patients with diabetes mellitus (DM), but the safety and efficacy of different GLP-1 RAs across diverse populations remain insufficiently defined.

OBJECTIVES:

Previous meta-analyses of GLP-1 RAs have been limited by restricted populations, omission of recent trials, or incomplete safety synthesis; this study integrates the latest evidence across 21 RCTs and diverse populations using advanced meta-analytic methods.

METHODS:

Randomized controlled trials comparing GLP-1 RAs vs controls or placebo were included. Analyses were conducted in pre-specified subgroups based on the GLP-1 RA used. Pre-specified subgroups according to DM, kidney function, obesity or heart failure (HF) were also performed. Main outcomes comprised mortality (all-cause and CV), trial-defined major adverse cardiovascular events (MACE) and serious adverse events (SAEs). GRADE and trial sequential analyses were performed to evaluate certainty and conclusiveness of findings, respectively.

RESULTS:

A total of 21 trials encompassing 99,592 patients were included. Eight different GLP-1 RAs were used (lixisenatide, liraglutide, exenatide, semaglutide, efpeglenatide, dulaglutide, albiglutide, and tirzepatide), each administered at therapeutic doses and compared vs placebo or controls. Mean follow-up duration was 2.4 years. We found conclusive, high certainty, evidence that GLP-1 RAs reduced all-cause death (IRR 0.88, 95% CI 0.84-0.92, NNT=121), CV death (IRR 0.87, 95% CI 0.81-0.92, NNT=170) and MACE (IRR 0.87, 95% CI 0.83-0.91, NNT=66), compared with controls. GLP-1 RAs reduced SAE (-9%), myocardial infarction (-15%), acute kidney failure (-9%), HF (-15%), and infections (-10%), but increased gastrointestinal (GI; +63%) and gallbladder (+26%) disorders. There were no differences in stroke, pancreatitis or neoplasm between groups. Results were mostly consistent across subgroups. Analysis by GLP-1 RA type revealed potential differences in efficacy and safety profiles.

CONCLUSIONS:

GLP-1 RAs reduce mortality and MACE in high-risk populations, highlighting benefits beyond glycemic control. These come at increased GI and gallbladder risks. Variation in efficacy and tolerability supports tailoring GLP-1 RA therapy to individual patient characteristics and treatment goals.

News (Medical) associated with Lixisenatide

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

29 Aug 2025

·www.einpresswire.com

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

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label 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

06 Jun 2025

·endpoints.news

EMA considers serious eye condition a ‘very rare’ side effect of semaglutide

The European Medicines Agency said Friday that the product information for Novo Nordisk’s Ozempic and Wegovy should be updated to list a serious eye condition as a “very rare” side effect. A flurry of studies have examined a possible association between eye-related conditions and the popular GLP-1 drugs. The EMA’s safety committee concluded this week that non-arteritic anterior ischemic optic neuropathy (NAION) “is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide).” NAION can cause the sudden loss of vision in one eye. The Pharmacovigilance Risk Assessment Committee, or PRAC, said it came to the conclusion after reviewing data “from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature.” “Results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing NAION compared with people not taking the medicine,” the committee said . PRAC’s recommendation to update semaglutide’s product information will now be reviewed by the EMA’s Committee for Medicinal Products for Human Use and the European Commission. A Novo Nordisk spokesperson told Endpoints News that it takes “all reports about adverse events from the use of our medicines very seriously,” and that it will work with the EMA to update the labels. The spokesperson added that semaglutide was studied in “robust clinical development programs with more than 52,000 semaglutide-exposed patients,” and post-marketing data have also been collected. “Based on the totality of evidence, Novo Nordisk concluded that the data did not suggest a reasonable possibility of a causal relationship between semaglutide and NAION and that the ‘benefit-risk profile of semaglutide remains favorable,’” the spokesperson said. An observational study published in JAMA Ophthalmology this week suggested GLP-1s such as semaglutide may be associated with a higher risk of a different eye condition called neovascular age-related macular degeneration (nAMD) in patients with diabetes. But the overall occurrence of nAMD was low, and the study’s authors emphasized that the data do not prove causation. The researchers conducted a retrospective study in Canada of 139,002 patients who were 66 years or older who had been diagnosed with diabetes. The study ran from 2020 to 2023. Of the patients who had been exposed to a GLP-1, 0.2% were newly diagnosed and treated for nAMD during that time period, as opposed to 0.1% in the non-GLP-1 group. A majority of patients in the trial received semaglutide, with a small group of patients receiving lixisenatide. The study had limitations — for example, the researchers were unable to account for other nAMD risk factors such as smoking or sun exposure. “I think that patients shouldn’t be scared of these complications,” Rajeev Muni, a vitreoretinal surgeon at St. Michael’s Hospital and other hospitals in Toronto and co-author on the study, said in an interview. “This is more about education and screening and kind of managing these issues when they arise,” he said. “But we in no way would suggest to anyone that they shouldn’t be on these drugs, even if they have a potentially higher risk of neovascular AMD, because their systemic health is, of course, very important as well.”

Clinical Result

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
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
Acute Coronary Syndrome	Phase 3	Bulgaria	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)	eddyfmulpx(ffaayvapuy) = epltmhwacr ncpfhurjsv (ndyqtfkrjg )	Negative	13 Feb 2025
				Placebo/non-GLP-1 RA regimens	eddyfmulpx(ffaayvapuy) = jzenrhvxkl ncpfhurjsv (ndyqtfkrjg )
NCT03439943 (LIXIPARK, Pubmed \| N Engl J Med)	Phase 2	Parkinson Disease	156	Lixisenatide	mhylxhnprp(rbrwpbqtke) = Nausea occurred in 46% of participants receiving lixisenatide hnikqdkmkl (dhpwqcckbt ) View more	Positive	04 Apr 2024
				Placebo
NCT03439943 (LIXIPARK, Literature) Manual	Phase 2	Parkinson Disease	156	Lixisenatide	okmlaksyyx(ydpswfaegl) = mymoayzlng bmznwezbsx (elurrkapap ) View more	Positive	03 Apr 2024
				Placebo	okmlaksyyx(ydpswfaegl) = lyokaujudd bmznwezbsx (elurrkapap ) View more
NCT03798054 \| NCT03798080 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	iGlarLixi	bqistdpthq(fqifhbuanr): 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	xfxmwgfbhg(eyznzyckfa) = uzdnizumeg rwwkwzscjz (krjjewumin ) View more	Superior	28 Jun 2022
				insulin glargine	xfxmwgfbhg(eyznzyckfa) = ttatlmfufh rwwkwzscjz (krjjewumin ) View more
STAR.Ro (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 2	901	Lixisenatide+Insulin glargine	ucttfwkbwk(bcuiymhfew) = nxltrvbfbp qstkplxhea (gadxazcdsk, -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	nxxnsxqnzx(duslpksghg) = pszcjfcgvn bepszyigcs (kysajaeavd ) View more	Positive	19 Apr 2022
				Insulin glargine 100 U/mL	nxxnsxqnzx(duslpksghg) = eyrfixwcyg bepszyigcs (kysajaeavd )
NCT02231658 (EASD2020)	Phase 1	Diabetes Mellitus, Type 2	57	Lixisenatide	eqlyiwemlc(ynuztzdogf) = fvfqdhjwkn jpxuzohbwg (ndqbmaleys ) View more	Positive	24 Sep 2020
				Liraglutide	eqlyiwemlc(ynuztzdogf) = stdxbqljbv jpxuzohbwg (ndqbmaleys )
NCT02231658 (Pubmed \| Diabetes Care)	Phase 1	Diabetes Mellitus, Type 2	57	Lixisenatide	cirgtlwhln(bsufrigqap) = ithmikturo uyvseocllx (lbucwgqrwi, -40.6, - 0.8) View more	-	09 Jul 2020
				Liraglutide	glpbaxwwpv(vdvxwmxwdl) = nddqpqqaov nbtdofzist (iiounauwhd, 3 - 46)
NCT02640118 (Pubmed \| Diabetologia)	Not Applicable	Diabetes Mellitus	12	Lixisenatide	ziljeqkcec(skrxqtoxil) = sgwcjclfny nrerwjljpl (rczubgsggf ) View more	-	01 Jul 2020
				Placebo	ziljeqkcec(skrxqtoxil) = vurqbnitgb nrerwjljpl (rczubgsggf ) View more

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