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Last update 12 Nov 2025

Lixisenatide

Last update 12 Nov 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)

+ [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 SyndromeGastroparesisParkinson Disease+ [1]

Originator Organization

Zealand Pharma A/S

Active Organization

Sanofi Winthrop Industrie SASanofi-Aventis Canada, Inc.Sanofi KK

+ [1]

Inactive Organization

Sanofi

Sanofi (China) Investment Co. Ltd.Sanofi-Aventis Recherche & Développement SA

+ [1]

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

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.

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]

100 Clinical Results associated with Lixisenatide

100 Translational Medicine associated with Lixisenatide

100 Patents (Medical) associated with Lixisenatide

522

Literatures (Medical) associated with Lixisenatide

01 Oct 2025·JOURNAL OF NEUROSURGERY

Impact of GLP-1 receptor agonists on stroke, subarachnoid hemorrhage, and intracerebral hemorrhage: a propensity-matched multi-institutional cohort study

Article

Author: Young, Christopher C. ; Srinivasan, Visish M. ; O’Leary, Sean ; Kan, Peter ; Price, Anthony M. ; Costa, Matias

OBJECTIVE:

The authors evaluated whether glucagon-like peptide-1 receptor agonists (GLP-1-RAs) improve outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH), spontaneous intracerebral hemorrhage (sICH), and acute ischemic stroke (AIS) and reduce the overall incidence of these events.

METHODS:

This retrospective study leveraged TriNetX data (2014–2024) to identify patients with aSAH, sICH, or AIS. Individuals receiving exenatide, lixisenatide, semaglutide, dulaglutide, liraglutide, or tirzepatide within 8 weeks of diagnosis were propensity matched to controls. Outcomes (e.g., mortality, rebleeding/recurrence, seizures, hydrocephalus) were assessed at 6 and 12 months; the incidence rates of stroke types were examined at 1 and 2 years.

RESULTS:

For aSAH patients, GLP-1-RA use at 6 months reduced rebleeding (OR 0.73, p = 0.003) and mortality (OR 0.41, p < 0.001) and at 1 year lowered cognitive deficits (OR 0.63, p = 0.034) and mortality (OR 0.39, p < 0.001). In sICH patients, GLP-1-RAs decreased hydrocephalus (OR 0.37, p = 0.005) and seizures (OR 0.56, p = 0.007) at 6 months, with persistent benefits at 1 year (hydrocephalus, OR 0.38, p = 0.007; seizures, OR 0.63, p = 0.018), alongside lower mortality (OR 0.45–0.40, both p < 0.001) and rebleeding (OR 0.70–0.69, both p < 0.001) rates. In AIS patients, mortality fell at 6 months (OR 0.27, p < 0.001) and 1 year (OR 0.44, p < 0.001), with reduced recurrence (OR 0.60, p < 0.001) and lower hydrocephalus (OR 0.32, p < 0.001) and seizure (OR 0.43, p < 0.001) rates at 6 months. At 1 year, GLP-1-RA users had lower incidence rates of SAH (OR 0.64, p = 0.001), ICH (OR 0.62, p < 0.001), and AIS (OR 0.82, p = 0.003), which were sustained at 2 years (ORs 0.77–0.87, all p < 0.05). Adverse events were similar.

CONCLUSIONS:

GLP-1-RAs were associated with improved survival and fewer complications across stroke subtypes, plus reduced hemorrhagic and ischemic stroke incidence. Prospective trials are warranted to confirm these observations.

12 Sep 2025·CNS DRUGS

Incretin Hormones GLP-1 and GIP Normalize Energy Utilization and Reduce Inflammation in the Brain in Alzheimer's Disease and Parkinson's Disease: From Repurposed GLP-1 Receptor Agonists to Novel Dual GLP-1/GIP Receptor Agonists as Potential Disease-Modifying Therapies.

Article

Author: Hölscher, Christian

Alzheimer's disease (AD) and Parkinson's disease (PD) are chronic neurodegenerative disorders with few effective drug treatments available. An underrated element of these diseases is that glucose uptake and energy utilization is much reduced in neurons. In the brains of patients, signaling of insulin, insulin-like growth factor 1, and other growth factors is downregulated early on. This leads to reduced glucose utilization and impaired mitochondrial function. In an attempt to compensate for the loss, other pathways are upregulated, e.g., the increased use of ketones produced from fatty acids by astrocytes that are shuttled to neurons. In addition, amino acids are increasingly used to generate energy. Despite this, neurons generate less and less energy over time, leading to impaired synaptic activity, reduced cell repair, mitogenesis, autophagy, the accumulation of misfolded proteins, and finally, to cell death. At the same time, the chronic inflammation response in the brain that is part of these diseases continues to damage neurons. Glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are peptide hormones and growth factors that have shown neuroprotective effects in animal studies and in clinical trials. GLP-1 and GIP receptor agonists were able to reduce inflammation while normalizing growth factor signaling and energy utilization in the brain. Insulin signaling was improved and energy utilization, glucose uptake, mitogenesis, and mitochondrial functionality was brought back to physiological levels. In addition, the chronic inflammation response and the levels of proinflammatory cytokines in the brain were much reduced. Clinical trials testing GLP-1 receptor agonists in patients with AD or PD have been conducted and have shown first successes, serving as proof of concept that activating GLP-1 receptor is a sensible strategy to treat AD/PD. A phase II study testing liraglutide in patients with AD showed first improvements, and two phase II trials testing exendin-4 (exenatide, Bydureon^®) or lixisenatide showed improvements in patients with PD. A recent phase III trial testing exendin-4 did not show an improvement, which may be linked to the lack of insulin desensitization in the study participants. Semaglutide (Rybelsus^®; Wegovy^®; Ozempic^®) is currently in two phase III trials for AD. Current drugs that are on the market have a long half-life in the blood and do not readily cross the blood-brain barrier (BBB). Newer dual GLP-1/GIP receptor agonists have been developed that can more easily cross the BBB and that show improved protection in animal models of AD and PD. Therefore, GLP-1 and GIP receptor agonists that can cross the BBB show promise as treatments for chronic neurodegenerative disorders.

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.

News (Medical) associated with Lixisenatide

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

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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

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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

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)	fonozqnihp(ckmhsgdkir) = lsccbkwauq zxdifiunuv (hngrsswgoa )	Negative	13 Feb 2025
				Placebo/non-GLP-1 RA regimens	fonozqnihp(ckmhsgdkir) = laqdjhjxly zxdifiunuv (hngrsswgoa )
NCT03439943 (LIXIPARK, Pubmed \| N Engl J Med)	Phase 2	Parkinson Disease	156	Lixisenatide	zjsemvhtpv(vnzqqtjccm) = Nausea occurred in 46% of participants receiving lixisenatide agcbvaqewt (bfjalmbaut ) View more	Positive	04 Apr 2024
				Placebo
NCT03439943 (LIXIPARK, Literature) Manual	Phase 2	Parkinson Disease	156	Lixisenatide	ijqxoabrpb(diryndflhd) = axzsjxmlyj qvkaihvzxt (iflipotxgf ) View more	Positive	03 Apr 2024
				Placebo	ijqxoabrpb(diryndflhd) = ssrcqwpjpx qvkaihvzxt (iflipotxgf ) View more
NCT03798054 \| NCT03798080 (Pubmed)	Phase 3	Diabetes Mellitus, Type 2	-	iGlarLixi	htsywymnck(nmbpubjzqm): 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	wfctaahlnx(pnvqcehhus) = fhdrrpzeqf xzjkkcbywu (woyzgnlhlv ) View more	Superior	28 Jun 2022
				insulin glargine	wfctaahlnx(pnvqcehhus) = uifvbkrydj xzjkkcbywu (woyzgnlhlv ) View more
STAR.Ro (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 2	901	Lixisenatide+Insulin glargine	xnoelkjaor(bztyiaieoy) = ugwbtvgprx exxjwtcdyj (jwmhtlmdtp, -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	pejvtkvltu(ddqbjwacxk) = xwtdjrpxpj zbprlqeukv (qepcbvggdw ) View more	Positive	19 Apr 2022
				Insulin glargine 100 U/mL	pejvtkvltu(ddqbjwacxk) = ykuhnzxcsr zbprlqeukv (qepcbvggdw )
NCT02231658 (EASD2020)	Phase 1	Diabetes Mellitus, Type 2	57	Lixisenatide	mqkyosfvoz(aifygrzepf) = rwubzthqcw lhhwxywtqg (yiktyqaceu ) View more	Positive	24 Sep 2020
				Liraglutide	mqkyosfvoz(aifygrzepf) = qvndwswnpp lhhwxywtqg (yiktyqaceu )
NCT02231658 (Pubmed \| Diabetes Care)	Phase 1	Diabetes Mellitus, Type 2	57	Lixisenatide	drvyaxcrhq(zwylbtjbbw) = kivmgsuunx kmzpqwtnqy (uebjfyduvd, -40.6, - 0.8) View more	-	09 Jul 2020
				Liraglutide	zuulwguydh(vracllkgon) = qupxvxclfi cskydnjyjw (xvrvfwkwgk, 3 - 46)
NCT02640118 (Pubmed \| Diabetologia)	Not Applicable	Diabetes Mellitus	12	Lixisenatide	vcnhiejqew(fkrlmlidlj) = lohqeibpdr sixqdpjmuv (ytxsglajoc ) View more	-	01 Jul 2020
				Placebo	vcnhiejqew(fkrlmlidlj) = eeshztmdnn sixqdpjmuv (ytxsglajoc ) View more

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