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Last update 06 Sep 2025

Exenatide

Last update 06 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

Exenatide (JAN/USAN/INN), EXENATIDE SYNTHETIC, Exendin-4

+ [20]

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 2Diabetes Mellitus

Inactive Indication

Coronary Artery DiseaseDiabetes ComplicationsDiabetes Mellitus, Type 1+ [17]

Originator Organization

Eli Lilly & Co.

Amylin Pharmaceuticals, Inc.

Active Organization

Icure Pharmaceutical Inc.

Amylin Pharmaceuticals, Inc.AstraZeneca AB

+ [2]

Inactive Organization

Intarcia Therapeutics, Inc.

Eli Lilly & Co.

AstraZeneca PLC

+ [3]

License Organization

Shenyang Sunshine Pharmaceuticals Co., Ltd.

Invex Therapeutics Ltd.

Eli Lilly & Co.

+ [7]

Drug Highest PhaseApproved

First Approval Date

United States (28 Apr 2005),

Diabetes Mellitus, Type 2

RegulationOrphan Drug (European Union)

Structure/Sequence

Sequence Code 751

Source: *****

360

Clinical Trials associated with Exenatide

CTIS2024-519014-31-00

/ RecruitingPhase 1IIT

- CHDR2418

Start Date12 Mar 2025

Sponsor / Collaborator

Centre for Human Drug Research

NCT02586831

/ WithdrawnPhase 1/2IIT

A Pilot, Safety and Feasibility Trial of Anti-Thymocyte Globulin (ATG), Low Dose Interleukin-2 (IL-2), Adalimumab and Exenatide in the Treatment of New-Onset Type 1 Diabetes

To assess whether there is a difference in endogenous insulin secretion, measured as stimulated C-peptide secretion (area under the curve during a 4-hour mixed meal tolerance test), at the 1 year visit, for study subjects receiving combinational therapy versus those receiving placebo. The study will also examine the effect of the proposed treatments on immunological outcomes, specifically proportion of regulatory T cells at the 1 year visit.

Start Date01 Jan 2025

Sponsor / Collaborator

University of Miami

[+1]

NCT05663515

/ RecruitingNot Applicable

EXCEED - A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs

EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up.

Start Date30 Sep 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Exenatide

100 Translational Medicine associated with Exenatide

100 Patents (Medical) associated with Exenatide

4,242

Literatures (Medical) associated with Exenatide

01 Nov 2025·NEUROPHARMACOLOGY

Exendin-4 protects the dopaminergic neurons by attenuating inflammatory responses of microglial cells via activation of AMPK

Article

Author: Khanal, Shristi ; Choi, Dong-Young ; Bohara, Ganesh ; Rimal, Nikesh

Parkinson's disease (PD) is a neurodegenerative disease characterized by preferential loss of the dopaminergic neurons in the substantia nigra and consequent occurrence of typical symptoms including resting tremor, rigidity and bradykinesia. PD remains a significant challenge due to the lack of disease-modifying drugs despite extensive research efforts. Glucagon-like peptide-1 and its analogues have shown neuroprotective properties. However, its specific molecular mechanisms for the neuroprotection remains to elucidate. In this study, we explored the anti-inflammatory and neuroprotective effects of exendin-4 by employing BV2 microglial cells and the MPTP-induced mouse model for PD. Our study showed that exendin-4 significantly suppressed the production of pro-inflammatory cytokines, including TNF-α, IL-1β, and IL-6 in LPS-stimulated BV2 cells. Furthermore, exendin-4 increased AMPK phosphorylation and the activation of AMPK by exendin-4 played a crucial role in suppressing the production of proinflammatory cytokines, as addition of compound C, an inhibitor of AMPK diminished the effect. Additionally, exendin-4 demonstrated neuroprotective effects by attenuating SH-SY5Y cell death caused by conditioned media from BV2 cells exposed to LPS. Moreover, exendin-4 attenuated microglial and astroglial activation in the substantia nigra and striatum of MPTP-treated mice, which was accompanied by reduced proinflammatory cytokines. Exendin-4 also improved motor functions of MPTP-treated mice, as determined by beam test and rotarod test. In parallel with the anti-inflammatory effects, exendin-4 attenuated MPTP-mediated dopaminergic neurodegeneration as estimated by immunohistochemistry for tyrosine hydroxylase and HPLC analyses for the striatal dopamine and DOPAC. These results suggest that exendin-4 could be a promising therapeutic agent for PD, offering neuroprotection by modulating inflammatory pathways and preserving dopaminergic neurons.

01 Nov 2025·NEUROPHARMACOLOGY

Effects of glucagon-like peptide 1 receptor signaling in the dorsolateral septum on ethanol operant self-administration and relapse behaviors

Article

Author: Xiao, Yuqing ; Yap, Jo Ann ; Ong, Zhi Yi

Alcohol Use Disorder (AUD) is a chronic relapsing disorder affecting more than 400 million people globally. Glucagon-like peptide-1 (GLP-1) has recently shown promise as a treatment for AUD but the underlying neural mechanisms are unclear. Given that dorsolateral septum (dLS) highly expresses GLP-1 receptors and is implicated in reward processing, this study investigated whether GLP-1 reduces ethanol intake and relapse behaviors via dLS. Long Evans rats were given intermittent access to 20 % ethanol solution before receiving training for ethanol operant self-administration. To examine relapse, operant self-administration was extinguished and two relapse tests were conducted: reacquisition of ethanol self-administration and prime + context-induced reinstatement of ethanol seeking. On self-administration test days, rats received intra-dLS injections of GLP-1 receptor agonist Exendin 4 (Ex4; 5 ng, 25 ng) or vehicle. During relapse tests, rats received intra-dLS infusion of either vehicle or 25 ng Ex4. Food intake and body weight were also measured. Results showed that intra-dLS Ex4 (25 ng) reduced ethanol self-administration in male high responders, but not in male low responders or females. Thus, only male rats were included in subsequent relapse tests. Intra-dLS Ex4 also reduced reacquisition of ethanol self-administration but had no impact on prime + context-induced reinstatement. No sustained changes in 24-h food intake or body weight were observed following intra-dLS Ex4 infusions. Finally, retrograde tracing results showed that dLS receive input from NTS GLP-1-expressing neurons. Together, these findings support the dLS as a key region in mediating the effects of GLP-1 receptor signaling on ethanol self-administration and reacquisition but suggest different contributing mechanisms in reinstatement of ethanol seeking.

01 Sep 2025·MEDICINA CLINICA

Review

Author: Alonso, Silvia Patricia ; Valdes, Sergio ; Doulatram-Gamgaram, Viyey Kishore

Obesity and type 2 diabetes mellitus (DM2) are interrelated global problems affecting 988 and 537 million people, respectively, figures that are continuously increasing. Obesity is a key factor in DM2, as it intensifies insulin resistance and β-cell dysfunction, accelerating disease progression. Weight loss improves glycemic control, reduces the occurrence of comorbidities and, in some cases, induces diabetes remission. In this regard, GLP-1 receptor agonists have revolutionized the treatment of DM2. Since the introduction of exenatide in 2005, more effective drugs have been developed that improve glycemic control, reduce weight, and decrease the occurrence of cardiovascular events. This article discusses the mechanisms of action and efficacy of these agents, highlighting recent advances such as polyagonists and oral formulations.

128

News (Medical) associated with Exenatide

04 Sep 2025

·www.globenewswire.com

Vivani Medical Provides Update on Clinical Development Plans for NPM-139 Semaglutide Implant for Chronic Weight Management

NPM-139 has potential to provide Wegovy®-level efficacy with once or twice-yearly administration First-in-human Phase 1 study is expected to initiate in the first half of 2026, pending regulatory clearance Preparations for dose-ranging Phase 2 study of NPM-139 to occur in parallel with Phase 1 study ALAMEDA, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing novel, ultra long-acting drug implants, today announced plans to initiate a Phase 1 clinical study in the NPM-139 semaglutide implant program in the first half of 2026, pending regulatory clearance. The Company is also preparing to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback. The NPM-139 clinical program will evaluate the Company’s investigational semaglutide implant for chronic weight management in patients who are either obese or overweight with a related comorbidity. “Recent promising results from LIBERATE-1™, the first-in-human study of NPM-115, an exenatide implant utilizing NanoPortal™ technology, combined with positive preclinical weight loss data with NPM-139, compel us to move forward aggressively with clinical development of NPM-139. The Phase 1 study, designed to evaluate the safety, tolerability and pharmacokinetic profile of the semaglutide implant and to enable a Phase 2 efficacy study, is expected to initiate in the first half of 2026, pending regulatory clearance,” said Vivani President and Chief Executive Officer Adam Mendelsohn, Ph.D. “The overall GLP-1 market in weight management continues to grow at an impressive rate, primarily because of considerable unmet medical needs and the fact that current GLP-1 options have a much better safety and efficacy profile compared to medications previously approved to treat obesity. We believe that NPM-139 could provide clear and compelling differentiation due to its potential to provide Wegovy®-level efficacy with convenient once or twice-yearly administration. Having recently obtained approval for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and with an expected near-term Phase 3 readout in the treatment of Alzheimer’s disease, semaglutide-based products continue to demonstrate tremendous potential to treat chronic diseases, and we believe the therapeutic potential of semaglutide could be significantly enhanced with an option that enables once or twice-yearly administration.” Dr. Mendelsohn continued, “If clinically validated and approved, we expect our products to stand out in a crowded and competitive field as the only available implant which could potentially enable providers to address new and currently underserved market segments. In addition, we continue to believe that NPM-139 could demonstrate improved tolerability relative to currently available oral or injectable GLP-1 medications, both because of the avoidance of drug fluctuations at each administration of oral or injectable options which provide each dose as a bolus, and by eliminating missed doses that further exacerbate the dosing fluctuations which are largely responsible for the gastrointestinal side effects of GLP-1 treatments.” Clinical Program for Semaglutide Implants for Chronic Weight Management The first clinical study of NPM-139 is planned as a small Phase 1 randomized, controlled investigation of the safety, tolerability and pharmacokinetic profile of the semaglutide NanoPortal implant in GLP-1 naïve obese or overweight subjects. The planned control arm is low-dose Wegovy injected weekly. The semaglutide implant to be used in this study is expected to produce comparable semaglutide exposure levels to low dose Wegovy injections. This study is expected to be initiated in the first half of 2026, pending regulatory clearance. The design of the second clinical study will be finalized pending results from the Phase 1 study but is anticipated to be a Phase 2, randomized, placebo-controlled, dose-ranging investigation over 4 to 6 months to evaluate the effects of the semaglutide NanoPortal implant on weight management in obese or overweight subjects. This study will provide safety, efficacy, and dose selection information for Phase 3 and will initiate shortly after Phase 1 completes, if warranted by the Phase 1 results and pending regulatory clearance. About Vivani Medical, Inc. Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for chronic weight management and other metabolic diseases including type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 Phase 1 study and reporting of study results, Vivani’s emerging development plans for NPM-139, NPM-115 or Vivani’s plans with respect its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani’s products, including NPM-139 and NPM-115; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities, including Vivani’s ability to commence clinical development of NPM-139; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical studies and the results therefrom; or Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law. Company Contact:Donald DwyerChief Business Officerinfo@vivani.com(415) 506-8462 Investor Relations Contact:Jami TaylorInvestor Relations Advisorinvestors@vivani.com(415) 506-8462 Media Contact:Sean LeousSenior Vice PresidentICR HealthcareSean.Leous@ICRHealthcare.com(646) 866-4012

Phase 1Phase 2IND

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

100 Deals associated with Exenatide

External Link

KEGG	Wiki	ATC	Drug Bank
D04121	Exenatide	A10BJ01	DB01276

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	United States	AstraZeneca AB	28 Apr 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pseudotumor Cerebri	Phase 3	United States	Invex Therapeutics Ltd.	18 Nov 2022
Pseudotumor Cerebri	Phase 3	Australia	Invex Therapeutics Ltd.	18 Nov 2022
Pseudotumor Cerebri	Phase 3	Germany	Invex Therapeutics Ltd.	18 Nov 2022
Pseudotumor Cerebri	Phase 3	Israel	Invex Therapeutics Ltd.	18 Nov 2022
Pseudotumor Cerebri	Phase 3	New Zealand	Invex Therapeutics Ltd.	18 Nov 2022
Pseudotumor Cerebri	Phase 3	United Kingdom	Invex Therapeutics Ltd.	18 Nov 2022
Diabetes Mellitus, Type 1	Phase 3	Netherlands	AstraZeneca PLC	21 Feb 2017
Obesity	Phase 3	United States	AstraZeneca PLC	22 Mar 2016
Polycystic Ovary Syndrome	Phase 3	United States	AstraZeneca PLC	22 Mar 2016
Heart Failure	Phase 3	France	AstraZeneca PLC	01 May 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00845507 (Exenatide for the Treatment of Weight Gain Associated with Olanzapine in Obese Adults, Pubmed \| J Affect Disord)	Phase 4	Obesity	-	Exenatide	lcfdcvyrid(nshrnvtdcf) = The most common side effects in the exenatide group were gastrointestinal symptoms cwsnuwypuf (rtharnodnf ) View more	Positive	01 Aug 2025
				Placebo
NCT04909333 (Pubmed \| Eur J Endocrinol)	Phase 2	Congenital Hyperinsulinism	14	Exenatide	ankppgxxxk(yqklaydzbz) = ltjppgaknd jcfeehhpnx (tunmbwvtdv, 2.26 - 3.02) View more	Positive	31 Jul 2025
				Placebo	ankppgxxxk(yqklaydzbz) = vvtcnorcfl jcfeehhpnx (tunmbwvtdv, 2.92 - 3.77)
NCT02673931 (Pubmed \| Circ Cardiovasc Interv)	Not Applicable	Cardiovascular Diseases	1,389	Exenatide infusion	vgzuhuntcm(pusosgbezk) = hflwcqyezh imjmssavhp (yafcooljbv, 2.5 - 8.3)	Negative	01 May 2025
				Placebo infusion	vgzuhuntcm(pusosgbezk) = wlunteqmfd imjmssavhp (yafcooljbv, 2.5 - 8.3)
NCT01107717 (EDICT, Pubmed \| BMJ Open Diabetes Res Care)	Phase 4	Diabetes Mellitus Add-on	55	Metformin/Exenatide/Pioglitazone	xfpucraeia(rcppkpxovq) = hojfbyjkou nswjdcoizr (rbvzjaspex )	Positive	01 Mar 2025
				Metformin/Glipizide/Insulin Glargine	xfpucraeia(rcppkpxovq) = xopquevran nswjdcoizr (rbvzjaspex )
ASCO_GU2025	Phase 3	Prostatic Cancer	-	GLP-1 receptor agonists (GLP-1RAs)	pmmpgvrlfr(twknimajjr) = ubpubokdfe rotmjsrife (wymdskvzpc )	Negative	13 Feb 2025
				Placebo/non-GLP-1 RA regimens	pmmpgvrlfr(twknimajjr) = akuupmfrva rotmjsrife (wymdskvzpc )
NCT04232969 (Pubmed) Manual	Phase 3	Parkinson Disease	194	exenatide	fgzhetznlc(gpssacgrul) = kyidfamefa rnqlnoidkp (bfsnyammoz, 11.2) View more	Negative	04 Feb 2025
				placebo	fgzhetznlc(gpssacgrul) = jfsnzsumpn rnqlnoidkp (bfsnyammoz, 11.4) View more
NCT01107717 (EDICT \| EDICT study, CTgov)	Phase 4	Diabetes Mellitus, Type 2	318	exenatide+pioglitazone+metformin (Triple Therapy)	qyejfppovo(beabukxems) = okjkrcyyoi rqxubxifnn (miezaohdim, 0.1) View more	-	05 Sep 2024
				glargine+metformin+glyburide (Conventional Therapy)	qyejfppovo(beabukxems) = hxikmqwvqm rqxubxifnn (miezaohdim, 0.1) View more
NCT03029351 (1981, CTgov)	Phase 4	Kidney Diseases \| Diabetes Mellitus, Type 2 \| Albuminuria	15	Exenatide Extended Release for Inj Susp 2 MG (Exenatide Extended Release)	uhaupnqhyk(evpgbbvhcv) = pcijrfvfnr pnotkdvgtw (arhirkoyof, 122) View more	-	16 Apr 2024
				Placebo (Placebo)	uhaupnqhyk(evpgbbvhcv) = hemtgsbbne pnotkdvgtw (arhirkoyof, 132) View more
NCT02962492 (CTgov)	Not Applicable	Diabetes Mellitus, Type 1	70	Placebo (Placebo Arm:)	pohvviydrl(pjxazwmhxc) = zbvjfjkbnb mtotjirzme (fcljeklmim, 0.17) View more	-	29 Feb 2024
				Dapagliflozin (Dapagliflozin Arm:)	pohvviydrl(pjxazwmhxc) = kupzmsmede mtotjirzme (fcljeklmim, 0.22) View more
NCT01524705 (FLAT-SUGAR, CTgov)	Phase 4	Diabetes Mellitus, Type 2	102	Insulin Glargine+Metformin+Exenatide	lafggymfeu(bvcwfrfntw) = gcpjkwlkxy mbhwkzuzjz (abuzeyroaf, 7.89) View more	-	29 Dec 2023

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